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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 Ultrasonic System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Ultrasonic Surgical System is an ultrasonic dissection and coagulation system composed of four components: Ultrasonic Generator (HD-CSD01), Hand Piece (HD-CSH01), a disposable Ultrasonic Shears includes 4 shaft lengths (HD-CS-DJ45, HD-CS-DJ36, HD-CS-DJ22, HD-CS-DJ14) and foot switch (HRF-M52).

A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery.

This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The provided text is a 510(k) Summary for a medical device called "Ultrasonic Surgical System." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain details about specific acceptance criteria for performance tests or the detailed study results that would typically prove a device meets those criteria in a format directly applicable to the table requested.

The document mentions "Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria." but does not list those criteria or the specific performance data against them.

It also includes results from animal testing (burst pressure, acute, and chronic animal studies) but these are comparative to a predicate device rather than against predefined, quantitative acceptance criteria for the subject device itself.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document. The document states that "Data generated from the test met the predetermined acceptance criteria" but does not list the specific criteria or the exact performance data against them for each test.

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

• The document specifies a "porcine model" for animal testing.
• It does not specify the sample size for the burst pressure, acute, or chronic animal studies (e.g., number of animals or number of vessels tested per animal/group).
• The data is prospective, generated from the animal study using the subject device and a predicate device.
• The country of origin of the data is not specified, but the applicant (Hunan Handlike Minimally Invasive Surgery Co., Ltd.) is from China.

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

• This information is not provided in the document. The animal studies would typically involve veterinarians and potentially pathologists, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done, as this is a surgical device, not an imaging/diagnostic AI device that would typically involve human readers interpreting cases. The comparative effectiveness assessment was against a predicate device in animal models.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable, as this is a physical surgical device, not a standalone algorithm. The device itself is evaluated.

7. The Type of Ground Truth Used

• For the animal studies, the "ground truth" would be established through direct observation during the procedures, histological examination of tissue samples, and measurements (e.g., burst pressure). These are effectively pathology and direct physiological measurements/observations.

8. The Sample Size for the Training Set

• Not applicable, as this is a physical surgical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable, as this is a physical surgical device.

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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 K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.

Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.

The provided text describes a 510(k) submission for the K500 Ultrasonic Surgical System, asserting its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.

The study described is a non-clinical performance comparison test to ensure that the proposed device, an ultrasonic surgical system, meets its design specifications and is substantially equivalent to a predicate device. This is a traditional medical device submission, not specifically an AI/ML device submission that would involve human-in-the-loop performance or standalone algorithm performance testing.

Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment cannot be fulfilled from the provided document.

Here's a breakdown of the available information based on the provided text, acknowledging that it's for a traditional medical device and not an AI/ML device performance study:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for device performance in the way one would for an AI/ML model (e.g., sensitivity, specificity thresholds). Instead, it describes performance comparison tests to demonstrate substantial equivalence to a predicate device.

Table 1: Non-Clinical Performance Testing and Outcomes

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

• Sample Size: Not specified for any of the non-clinical tests (e.g., number of vessels, number of animals).
• Data Provenance: Not specified. "Animal study" mentioned without country or specific details. The manufacturer is Miconvey Technologies Co., Ltd. from Chongqing, China.

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 is not applicable as the study described is a non-clinical performance and biocompatibility study for a surgical device, not a diagnostic or AI/ML study requiring expert ground truth for interpretation.

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

Not applicable for this type of non-clinical device performance study.

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 is not an AI/ML device or a diagnostic device where human readers would be involved in interpreting data assisted by AI.

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

Not applicable. This is not an AI/ML device. The "device" is an ultrasonic surgical system, a physical tool.

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

For the non-clinical performance tests:

• Performance Metrics: Measured directly (e.g., burst pressure, thermal spread, physical dimensions) against established engineering specifications and comparison to the predicate device's known performance.
• Biocompatibility: Assessed against ISO standards (e.g., presence/absence of irritation, cytotoxicity).
• Animal Studies: Observed physiological effects and outcomes (e.g., vessel sealing success, survival).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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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.

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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.

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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® 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.

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The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.

This is an electrosurgical generator, not an AI/ML powered device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable. This is not an AI/ML powered device that uses a "test set" in the context of data analysis. The testing involved hardware and software validation against established medical device standards.

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

Not applicable. Ground truth, in the context of data for AI/ML, is not relevant for this device. Compliance was assessed against engineering and performance standards by qualified testing personnel and regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" for adjudication as it's understood in AI/ML studies. Compliance was determined by meeting predefined standards and test protocols.

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

No. This type of study is typically conducted for diagnostic AI tools involving human interpretation of data. This device is an electrosurgical generator, and such a study is not relevant to its function.

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

Not applicable. This is a hardware device with embedded software. It does not operate as a standalone algorithm in the sense of AI/ML. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used:

Ground truth for this device is established by:

• Engineering and Performance Standards: International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) set the objective criteria for electrical safety, electromagnetic compatibility, and specific electrosurgical device performance.
• FDA Guidance: FDA guidance documents for electrosurgical devices provide criteria for aspects like thermal effects.
• Software Validation Principles: Ground truth for software validation involves adherence to established software engineering principles and documentation requirements outlined in FDA guidance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. As there is no training set of data, no ground truth needs to be established for it.

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