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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary malignant and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.

The information provided describes a 510(k) premarket notification for the CUSA® Clarity Ultrasonic Surgical Aspirator System, primarily focusing on a modification to its Indications for Use to include more specific gynecological surgery indications. The submission claims substantial equivalence to a predicate device (K182809) and did not involve any design or technological changes to the device itself. Therefore, the "acceptance criteria" and "device performance" in the traditional sense of a new or modified device's functional characteristics are not directly presented as a series of quantitative benchmarks met by a specific study on the device's technical performance. Instead, the "acceptance criteria" here refer to demonstrating that the expanded indications for use for gynecological surgery are safe and effective, supported by existing literature and showing no new safety or effectiveness concerns compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The "test set" in this context refers to the body of clinical evidence reviewed to support the expanded indications.

• Sample Size: 1,465 patients. This total is comprised of:
  • 272 patients for dysplasia or condyloma.
  • 630 patients for debulking procedures (cancers).
  • 18 patients for endometriosis.
  • The remaining patients likely fall into categories not specifically broken down or represent overlaps in articles.
• Data Provenance: The data was derived from an "analysis of peer-reviewed articles." This indicates a retrospective review of published clinical literature. The country of origin of the data is not specified but would likely span various international institutions given the nature of peer-reviewed publications over an extended period.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the typical sense. This was a literature review, not a study where experts established ground truth for a novel dataset. The "ground truth" is implicitly established by the reported outcomes in the published clinical studies themselves, which are conducted by various medical professionals (surgeons, pathologists, etc.) in their respective fields. The submission does not specify an independent panel of experts reviewing the collected literature to establish a "ground truth" for the purpose of this 510(k).

4. Adjudication method for the test set

Not applicable. There was no explicit adjudication method for a test set as this was a review of existing peer-reviewed literature. The outcomes reported in the individual studies within the literature served as the evidence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an ultrasonic surgical aspirator system, not an AI or imaging diagnostic device that involves human "readers" interpreting output. This submission focuses on the safety and effectiveness of the existing device for expanded (gynecological) indications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The CUSA Clarity is a surgical instrument used by a surgeon, not a standalone algorithm.

7. The type of ground truth used

The "ground truth"-like evidence used was outcomes data and reported effectiveness/safety from published clinical studies. This includes:

• Achievement of desired treatment outcomes (e.g., successful removal of tissue).
• Reported presence or absence of postoperative complications.
• Preservation of vessels and nerves.
• Comparison of procedure durations.

8. The sample size for the training set

Not applicable. This was a 510(k) submission for an existing device with expanded indications, not an AI/algorithm development where a training set would be used. The "evidence" supporting the expanded indications comes from published literature.

9. How the ground truth for the training set was established

Not applicable. As above, there was no training set for an algorithm.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The provided text describes the CUSA Clarity Ultrasonic Surgical Aspirator System, specifically focusing on a modified CEM nosecone accessory for the 23 kHz components. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes various non-clinical tests undertaken to ensure the safety and efficacy of the device and its substantial equivalence to the predicate.

The reported device performance is broadly stated as:

• "Testing was determined successful and supports the conclusion that all product specifications and design inputs have been met."
• "The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity 23 kHz Expanded CEM Nosecone is substantially equivalent to the predicate device."

Therefore, a table of quantitative acceptance criteria and specific reported device performance cannot be generated from the provided text. The information indicates that all tests were passed and specifications met, implying the device performed within acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing but does not specify a "test set" in terms of subject or patient data. The tests are focused on device characteristics rather than clinical outcomes with a patient population.

• Sample size for test set: Not applicable in the context of device performance testing described. The tests are on the device itself (e.g., handpiece life, functionality, mechanical properties).
• Data provenance: Not applicable in the context of patient data. The provenance is from internal testing conducted by Integra LifeSciences Corporation. There is no mention of country of origin for data related to clinical or patient studies, as none were performed. The tests are prospective as they were conducted as part of the submission process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of experts: Not applicable. The "ground truth" for the non-clinical tests is established by engineering specifications, recognized standards (FDA guidance documents, ISO standards for biocompatibility, EMC, and electrical safety), and comparison to the predicate device's established performance.
• Qualifications of experts: Not specified as a separate set of experts for ground truth. However, the development and testing would have been overseen by Integra LifeSciences Corporation's engineering and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The testing described is objective device performance (e.g., sterilization, biocompatibility, electrical safety, mechanical, thermal effects). Success or failure is determined by meeting predefined engineering specifications and regulatory standards, not by an adjudication process between human experts on a specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device."
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or study involving human readers with or without AI assistance was conducted. The device is a surgical aspirator system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone study: Not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on:

• Established engineering specifications and design inputs: Ensuring the device functions as intended.
• Compliance with FDA guidance documents and recognized standards: Such as those for sterilization, biocompatibility, EMC, electrical safety, thermal effects, and capacitive coupling.
• Substantial equivalence to the legally marketed predicate device (CUSA® Clarity Ultrasonic Surgical Aspirator System K190180): This implies that the predicate's established safety and effectiveness profile serves as a benchmark for the new component.

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is assessed through traditional engineering and regulatory compliance testing.

9. How the Ground Truth for the Training Set Was Established

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device.

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The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kit
Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
  Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. · Wound Care
  The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:
· Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery

neXus SonaStar Handpieces with SonaStar Probe Kits
Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:
· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
  · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
  · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
• · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The system may also be combined with electrosurgery using optional RF surgery interface components.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console.

The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation system provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, disposable electrocautery cable, and waste collection canisters.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) K231117 clearance letter for the "neXus Ultrasonic Surgical Aspirator System." This type of document is a summary of the FDA's decision and the manufacturer's provided information. It does not present a detailed study report that would typically include all the specific parameters requested (like sample size for test/training sets, experts, adjudication methods, MRMC studies, effect sizes, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K221235). The "performance data" section primarily refers to verification and validation activities rather than a comparative clinical trial or large-scale evaluation of a new AI algorithm.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Information Not Provided in this Document," as this submission is for a modified traditional medical device, not an AI/ML-driven diagnostic or treatment planning system that would typically undergo the stringent evaluation methods you've outlined.

Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the modified neXus Ultrasonic Surgical Aspirator System is substantially equivalent to its predicate device (K221235). The "acceptance criteria" here are implicitly tied to maintaining the safety and effectiveness profile of the predicate device, particularly regarding the added "Pulsed Wave, NEW" feature for the vibration system and "DTC (DYNAMIC TISSUE RESPONSE)" capability.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) summary, the acceptance criteria are not presented in a quantitative table with specific targets as one might see for an AI/diagnostic device. Instead, they are framed as demonstrating continued functionality, safety, and equivalence to the predicate. The "reported device performance" is largely qualitative, indicating that the new features function as intended and that the overall system still meets the established performance of the predicate.

Key Difference/New Feature: Vibration System: "Pulsed Wave, NEW" (p. 10).
New GUI Setting: "DTC (DYNAMIC TISSUE RESPONSE): Off" (default) and adjustable range 1-6 (p. 16). |
| Biocompatibility | No new patient-contacting materials; existing biocompatibility data remains valid. | "Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid." (p. 17) |
| Electrical Safety & EMC | Continued compliance with relevant safety and EMC standards; minor software update does not impact electrical safety or EMC. | "No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid." (p. 18) |
| Software V&V | Software performs as intended, new features function correctly, regression testing confirms no adverse impact elsewhere. Software classification remains "major level of concern." | "Software verification and validation testing was conducted and a summary of testing provided."

Specific verification tests conducted: "DTC DSP pulse mode verification," "DTC GUI verification," "Fault detection and response test using the SonaStar Elite handpiece," "neXus test and calibration (Regression testing)," "System performance verification (Regression testing)," "SonaStar Elite GUI verification (Regression testing)." (p. 18) |
| Bench Testing | New features function as intended and device maintains performance characteristics (e.g., tissue removal) of the predicate. | "Tissue removal test using the SonaStar Elite handpiece," "DTC mode vibration test using the SonaStar Elite handpiece." (p. 18) |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in terms of number of "cases" or "samples" as might be seen for a diagnostic AI. For a surgical aspirator, "test set" typically refers to the physical devices and materials (e.g., tissue phantoms, actual tissue samples for bench testing) used for verification and validation. The document does not specify the quantity of these for bench testing.
• Data Provenance: Not applicable in the conventional sense of patient data. The "data" here comes from internal engineering and quality testing (software V&V, electrical safety, biological compatibility assessments, and bench performance testing). These are typically conducted in a controlled lab environment by the manufacturer. No country of origin for a patient dataset. The tests are prospective as they are conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts/Qualifications: Not applicable for this type of device submission. Ground truth for a surgical tool's performance is established through engineering specifications, physical measurements, and performance against defined test methods (e.g., how effectively it removes tissue from a phantom, its vibration amplitude). Clinical "experts" (like radiologists) are not used to establish this type of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. This concept applies to human consensus on complex subjective data (e.g., image interpretation). For an ultrasonic surgical aspirator, performance testing involves objective measurements (e.g., output power, vibration frequency, tissue removal efficiency, software function).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This is not an AI-driven diagnostic or image-interpretation device, so MRMC studies are not relevant. This device is a surgical tool.
• Effect Size of Human Improvement with AI: Not applicable for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable as this is not an AI algorithm but a physical medical device. The "software" component is for controlling the device's functions (e.g., vibration, irrigation, aspiration). The software's performance is verified through testing its functionalities and its impact on the device's physical outputs, but not as a "standalone" interpretation tool.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For this device, ground truth is established through:
  • Engineering specifications and design requirements: The device's components and software features are designed to meet specific physical and functional performance parameters.
  • Validated test methods: Performance is measured against established procedures using instruments and materials (e.g., tissue phantoms) to quantify characteristics like vibration, flow rates, and tissue ablation effectiveness.
  • Comparison to predicate device: The predicate device itself acts as a "ground truth" for acceptable performance for the intended use.
  • Compliance with recognized standards: Adherence to standards like IEC62304 for software and electrical safety standards.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a "training set" of data for model development. The software is deterministic control software, subject to traditional software development and verification processes.

9. How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery – including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. All CUSA systems are surgical aspirators that use ultrasonics and cavitation with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.

The CUSA Clarity 23kHz Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. It appears to be a 510(k) summary for a medical device (CUSA® Clarity Ultrasonic Surgical Aspirator System) focusing on establishing substantial equivalence to a predicate device.

The information provided describes:

• Device Name: CUSA® Clarity Ultrasonic Surgical Aspirator System
• Indication for Use: Surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue are desirable. This includes various surgical specialties like neurosurgery, gastrointestinal, urological, general, and laparoscopic surgery.
• Predicate Device: CUSA® Clarity Ultrasonic Surgical Aspirator System K200774
• Device Description: The subject device is a CUSA® Clarity 23kHz Single-Sided Bone Tip Pack. The primary modification compared to the predicate bone tip is a limited abrasive fragmentation surface at the distal end.
• Non-clinical testing performed: Sterilization, shipping, stability, biocompatibility, EMC, electrical safety, and bench testing to verify requirements like tissue fragmentation rate, tip life, torque functionality, and functionality within environmental variations.
• Conclusion: The non-clinical testing indicates substantial equivalence to the predicate device.
• Clinical Studies: No clinical studies were performed or required, as performance tests were deemed sufficient to support substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or type of ground truth, as these details are not present in the provided document.

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The Misonix Inc. neXus Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel and SonicOne OR probe kit accessory configurations, the SonaStar®long and short handpieces in combination with SonaStar probe kit accessory configurations, the BoneScalpel AccessTM handpiece with BoneScalpel AccessTM probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kits

Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology

External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.

• · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectornes.

· Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits

Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:

· Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

· Plastic and Reconstructive Surgery

neXus SonaStar Handpieces with SonaStar Probe Kits

· Indicated for use in the fragmentation, emulsification of both soft and hard (i.e. bone) tissue in the following surgical specialties:
· Neurosurgery

· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

· Plastic and Reconstructive Surgery

· General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures

• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery

· Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectorny, laparoscopic colon resection or laparoscopic partial gastrectomy

· Thoracoscopic Surgery

The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits

Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology

External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.

• · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite Probe Kits

Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
  • Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

• · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy

• · Plastic and Reconstructive Surgery

• · General Surgery including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures

• · Orthopedic Surgery

• · Gynecological Surgery except as contraindicated for uterine fibroids.

• · Thoracic Surgery

· Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectorny, laparoscopic colon resection or laparoscopic partial
· Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF surgery interface components.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console.

The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation unit provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/software performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

The document primarily focuses on:

• Device Description and Intended Use: Detailing the neXus Ultrasonic Surgical Aspirator System and its various configurations for fragmentation, emulsification, and aspiration of soft and hard tissue in different surgical specialties.
• Technological Comparison: Comparing the subject device's features (Compatible Handpieces, Principle of Operation, Reusable/Disposable Accessories, Cleaning & Sterilization, Electrosurgery, Console features, etc.) to a predicate device (CUSA Clarity Ultrasonic Aspirator System, K200774).
• Performance Data: Presenting evidence for biocompatibility, sterility/shelf life, electrical safety, electromagnetic compatibility (EMC), and software verification/validation.
  • Biocompatibility: Mentions testing against ISO 10993 standards (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity).
  • Sterility and Shelf Life: Describes testing for single-use and reusable components and accelerated/real-time aging studies for shelf life.
  • Electrical Safety and EMC: Confirms testing to IEC 60601 standards.
  • Software Verification and Validation: States that V&V testing was conducted as per FDA guidance for "major" level of concern software.
  • Bench Testing: Lists tests performed, including Acoustic Intensity, Applied Part Temperature, Probe Vibration, Soft Tissue Performance, and Probe Life Testing.
• Absence of Animal or Clinical Data: Explicitly states that animal and clinical studies were "Not applicable" as they were "not necessary to establish the substantial equivalence of this device."

In summary, this document is a regulatory submission for substantial equivalence based on technological and performance similarities to an existing device, not a performance study for a new AI/software feature with defined acceptance criteria and clinical outcome measures.

Ask a specific question about this device

The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of beingn or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in lapatic resection, lobectomy or trisegmentectony, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. There are three (3) systems currently marketed in the United States: CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). All CUSA systems are surgical aspirators that use ultrasonics and cavitation, in combination with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.

The CUSA Clarity 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.

The provided text K221763 is a 510(k) summary for the CUSA® Clarity Ultrasonic Surgical Aspirator System, specifically for new 23kHz Laparoscopic Tip Packs. The submission claims substantial equivalence to predicate devices, and therefore, does not present a typical study with acceptance criteria and device performance analysis as one would expect for a de novo device or a device requiring clinical trials.

The document states: "No clinical studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices." This means the FDA cleared the device based on non-clinical (bench) testing, demonstrating that it performs as intended and is as safe and effective as existing legally marketed predicate devices.

Therefore, the requested information, which typically pertains to studies proving a device meets acceptance criteria, is not fully applicable in the context of this 510(k) summary claiming substantial equivalence. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn.

1. A table of acceptance criteria and the reported device performance

The document lists types of bench testing performed but does not explicitly provide a table of quantitative acceptance criteria and corresponding device performance results for each criterion. It broadly states that "Bench testing to verify requirements" was conducted.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each non-clinical test. Given these are bench tests for substantial equivalence, the "data provenance" would be laboratory testing conducted by the manufacturer, Integra LifeSciences Corporation, in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. For bench testing used in a 510(k) to demonstrate substantial equivalence, ground truth as established by human experts (e.g., radiologists) is not typically required. Performance is measured against engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable, as it pertains to human interpretation/adjudication of results, which was not part of this non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. No clinical or comparative effectiveness studies involving human readers or AI assistance were performed or required for this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a surgical aspirator, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" refers to established engineering specifications, recognized industry standards (e.g., ISO for biocompatibility, IEC for electrical safety), and FDA guidance documents. Tissue fragmentation rate, tip life, and mechanical performance would be measured against internal design requirements and predicate device performance.

8. The sample size for the training set

This section is not applicable. This is not an AI/ML device, and therefore no "training set" of data was used.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in combination with SonaStar® probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kits

Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology

External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or maligmant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.

• · Thoracic Surgery
  Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

· Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits

Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery

Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits

Indicated for use in the fragmentation, emulsification of both soft and hard (i.e. bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kit

Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology

External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.

· Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console.

The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation unit provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.

The acceptance criteria and supporting study details for the Misonix Inc. neXus Ultrasonic Surgical Aspirator System (K212060) are described below based on the provided text.

Based on the provided document, the device described is an ultrasonic surgical aspirator system, and the filing is a 510(k) premarket notification for substantial equivalence. This type of filing generally focuses on comparing a new device to an existing predicate device rather than presenting novel clinical efficacy studies with specific acceptance criteria directly comparable to new AI/diagnostic technologies. Therefore, the information provided does not directly align with a typical acceptance criteria table and study design for AI-based diagnostic devices.

However, I can extract the relevant performance data and study types conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The performance data presented are primarily to show that the technological characteristics and performance are substantially equivalent.

Study Details:

The provided document describes studies conducted to support a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device (K190160). This is not equivalent to a performance study for an AI diagnostic device.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • The document primarily discusses bench testing, biocompatibility testing, electrical safety, EMC, and software V&V. These are engineering and laboratory tests, not clinical studies in the context of diagnostic device performance.
  • No "test set" of patient data (images, clinical records) is mentioned.
  • The provenance of materials for bench/biocompatibility testing (e.g., simulated bone, biological samples) is not specified.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. This device is not an AI diagnostic algorithm requiring expert "ground truth" for a test set of patient data. The studies involve laboratory measurements and engineering assessments.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. No expert adjudication of a test set is described.

• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No MRMC study was conducted. This device is an ultrasonic surgical aspirator, a therapeutic surgical tool, not a diagnostic AI system assisting human readers.

• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

  • Not applicable. This is a hardware surgical device, not an algorithm. Performance tests evaluate the device's physical outputs and safety parameters.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • For biocompatibility: Ground truth is defined by the biological response of cells/tissue to the device materials, evaluated against established ISO standards.
  • For electrical safety/EMC: Ground truth is defined by compliance with published international safety standards (e.g., IEC 60601 series).
  • For software V&V: Ground truth is defined by the software specifications and requirements.
  • For bench testing: Ground truth is defined by engineering specifications, physical measurements, and comparison to the predicate device's known performance characteristics.

• 8. The sample size for the training set:

  • Not applicable. This is not an AI/machine learning device that uses a "training set."

• 9. How the ground truth for the training set was established:

  • Not applicable, as there is no training set mentioned for this device.

Ask a specific question about this device

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological surgery
• · Plastic and Reconstructive surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Wound Care
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue breakage and aspiration.
• Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
• . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
  The Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.

This looks like a 510(k) summary for an Ultrasonic Surgical Aspirator System (Model: XD880B) seeking to demonstrate substantial equivalence to a predicate device (K202299).

Here's an analysis based on your request, focusing on acceptance criteria and supporting studies. It's important to note that for a Class II device like this, the focus is often on demonstrating equivalence to an existing device rather than establishing novel clinical efficacy against specific, quantitative acceptance criteria in the same way a new drug or high-risk device might. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs at least as well as the predicate device, especially for any design changes.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the entire device. Instead, it describes changes from the predicate and then cites testing to show these changes do not negatively impact safety or effectiveness.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to the modifications:

Note: The document states, "the test results confirm that the performance specifications meets the modification inputs." This is the general statement of "acceptance," indicating compliance with internal specifications derived from the predicate's performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and "bench testing." It does not specify sample sizes for these tests, nor does it provide details on data provenance like country of origin or whether a "retrospective" or "prospective" design applies to bench testing (these terms are more relevant for human data). These are laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is typically not relevant or included for non-clinical, bench testing of an ultrasonic surgical aspirator system. The "ground truth" for such tests would be measurable physical parameters (e.g., thermal output, acoustic frequency, cutting depth/speed) against established engineering specifications or comparisons to the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading, clinical outcomes). Since the testing described is non-clinical bench testing, this concept and information are not applicable or provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not mentioned as this device is not an AI-powered diagnostic imaging tool requiring human interpretation. It is a surgical tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of an algorithm or AI without human involvement. The Ultrasonic Surgical Aspirator System is a physical surgical device, not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The device's performance is inherently linked to its physical operation properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned:

• Soft Tissue Protection in Bone Cutting Mode: The ground truth would likely be based on objective measurements of tissue damage or protection, adhering to predetermined safety thresholds.
• Acoustic Performance Testing for modified tips: The ground truth would be quantitative measurements of acoustic parameters (e.g., frequency spectrum, amplitude) compared to design specifications or predicate measurements.
• Cutting Efficiency and Thermal testing Report for Modified Tips: The ground truth would be objective measurements of cutting speed/volume and temperature generated during operation, compared against predicate performance or safety limits.

The "ground truth" is thus based on objective physical measurements and engineering specifications, rather than subjective human interpretation, pathology, or clinical outcomes data for these non-clinical tests.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical surgical tool and not an AI or machine learning system, there is no "training set."

9. How the ground truth for the training set was established

As there is no training set for an AI/ML model, this question is not applicable.

Ask a specific question about this device

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological surgery
• · Plastic and Reconstructive surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Wound Care
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
• . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
• . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
  The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

This document describes the FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System (XD880B), focusing on its substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria.

Therefore, the specific information requested, such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance, is not present or applicable in the provided document.

The document details the device's technical specifications and non-clinical performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the context of this document. This document focuses on demonstrating substantial equivalence based on technical characteristics and non-clinical testing, not on achieving specific clinical performance metrics against predefined acceptance criteria from a clinical trial.
• The "performance" described is in terms of passing various non-clinical standard tests (e.g., electrical safety, EMC, software verification, sterilization validation, shelf-life, lifetime validation, acoustic performance, efficiency and temperature characteristics).

2. Sample sizes used for the test set and the data provenance:

• Not applicable. This submission relies on non-clinical testing and comparison to predicate devices, not on a clinical test set in the way a diagnostic AI would.
• The document implies that various units of the device and its components were tested to meet the specified non-clinical standards, but explicit "sample sizes" for a clinical test set are not mentioned as no clinical performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical ground truth establishment involving human experts is described. The "truth" for this submission is based on engineering standards and technical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. A MRMC study was not conducted as this is an ultrasonic surgical aspirator system, not a diagnostic AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is a surgical tool, not a standalone diagnostic algorithm. Its function inherently involves human operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Technical Specifications and Standard Compliance: The "ground truth" for this submission is adherence to engineering specifications and compliance with international and national standards for medical devices (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 62304 for software, ISO 17665-1 and ISO 11135 for sterilization). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/ML model that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Summary of Device Acceptance (from the document's perspective):

The acceptance mechanism for this device's FDA clearance is "Substantial Equivalence" to legally marketed predicate devices. This is achieved by demonstrating that the new device:

• Has the same intended use.
• Has the same or similar indications for use.
• Has the same or similar technological characteristics.
• Does not raise new or different questions of safety or effectiveness.

Studies/Data that Proved Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The document states that the following non-clinical tests were conducted and passed to support substantial equivalence:

• Electrical safety testing per IEC 60601-1
• EMC testing per IEC 60601-1-2
• Software verification and validation per IEC 62304 / FDA Guidance
• Moist heat sterilization validation per ISO 17665-1
• EO sterilization validation per ISO 11135 (demonstrates SAL of 10^-6)
• Shelf-life Testing
• Lifetime validation test for handpieces
• Acoustic Performance Test per IEC 61847
• Efficiency and Temperature Characteristics Test

These tests confirm that the device's design inputs and performance specifications are met, allowing the FDA to determine that it is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance by way of substantial equivalence.

Ask a specific question about this device

The CUSA Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:

Device: CUSA Clarity Ultrasonic Surgical Aspirator System
510(k) Number: K200774

This submission appears to be an update to an existing device (CUSA Clarity K182809), specifically an expansion of its neurosurgical indications for use, rather than a new device entirely. Therefore, the "acceptance criteria" and "study" described are primarily focused on supporting this updated indication for neurosurgery.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device, based on the provided text, is a substantial equivalence determination. This means the device is being compared to a predicate device (CUSA Clarity Ultrasonic Surgical Aspirator; K182809) rather than requiring specific performance targets independent of a predicate. The "acceptance criteria" revolve around demonstrating the new indications for use are safe and effective, and that the device's technological characteristics remain the same.

2. Sample size used for the test set and the data provenance

• Test Set (Clinical Data): 72 peer-reviewed articles discussing neurosurgical cases.
• Number of Cases: Approximately 1,706 cases reported across these 72 articles.
• Data Provenance: Retrospective, derived from published peer-reviewed clinical literature. The country of origin is not specified but would be global as it's from peer-reviewed literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable in the traditional sense for this submission. The "ground truth" for this substantial equivalence determination is established by the existing body of peer-reviewed clinical literature. The "experts" are the authors and peer reviewers of the 72 articles themselves, who conducted the studies and produced the reported outcomes. Their qualifications would vary widely but generally include neurosurgeons, neurologists, and other medical professionals involved in the care and study of neurosurgical patients. The submission does not describe an independent panel of experts reviewing cases specifically for this 510(k) alongside the device.

4. Adjudication method for the test set

None in the context of an independent adjudication process for this 510(k) submission. The clinical data comes from already published and peer-reviewed articles, implying that any internal adjudication or consensus methods used by the authors of those individual studies would have occurred prior to publication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function or clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical tool, not a standalone diagnostic algorithm.

7. The type of ground truth used

The ground truth is established by clinical outcomes data reported in peer-reviewed medical literature. This includes observations on the safety and effectiveness of the CUSA device in various neurosurgical procedures, tumor debulking, tissue selectivity, and patient outcomes over approximately 40 years of use.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical literature serves as the justification for the expanded indications.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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