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The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic, and/or therapeutic procedures, such as ventriculostomies, biopsies and removal of cysts, tumors, and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, Sheath with integrated illumination LEDs and camera, with an Obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The Sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the Sheath for user reference. The proximal end of the Sheath also incorporates a Tab, which serves as the location for fixation arm to hold the device.

At the proximal end of the Sheath is the Imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• The LEDs provide illumination to the surgical field by directing light down the Sheath, along the working channel.
• The camera captures videos of the surgical field.
• The focus knob allows the user to adjust the focus of the camera to obtain the desired image quality.

To facilitate insertion of the Sheath into the surgical site, an Obturator is provided with the device. During device insertion, the Obturator is fully inserted into the Sheath, and the entire AURORA Surgiscope is advanced to the desired surgical location. The distal end of the Obturator is conical in shape to minimize tissue damage during device insertion. In addition, the proximal handle of the Obturator is designed to accommodate various stereotactic instruments for neuronavigation, which can further aid in device placement. The Obturator is removed after insertion.

The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:

• To power the LEDs and camera of the AURORA Surgiscope.
• To relay the video feed captured by the AURORA Surgiscope camera to a connected Medical Grade Surgical Monitor for real-time image visualization.
• To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), and to vary the light output of the LEDs.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, and brightness. The connection ports to the AURORA Surgiscope, Medical Grade Surgical Display Monitor, and Power are located on the side of the ICB, along with the ON/OFF switch.

The provided FDA 510(k) clearance letter for the AURORA Surgiscope System (K250752) does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K201840) based on technological characteristics and functional requirements. It explicitly states that "No clinical test/studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device (K201840)."

Therefore, for many of the requested points, the answer will be that the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document mentions "functional requirements" and "performance tests" but does not detail specific acceptance criteria or quantitative performance results. It only states that the device meets these requirements after sterilization, environmental, and transit conditioning, and equivalent to a 1-year shelf-life.

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 for test set: Not specified. The document states "non-clinical testing was performed" but does not detail the number of units tested.
• Data provenance: Not specified. The nature of the testing (functional performance, sterilization effects) suggests it would be laboratory testing rather than patient data.

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)

• Not applicable / Not specified. Since no clinical studies were performed, there was no need for expert review of clinical data to establish ground truth. The "ground truth" here would be the successful function of the device in engineering tests.

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

• Not applicable / Not specified. No clinical data was being adjudicated.

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. The document explicitly states: "No clinical test/studies were required or performed". This device is a surgical endoscope, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.

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

• Not applicable. This is a physical medical device (endoscope), not a standalone algorithm.

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

• For the non-clinical performance tests mentioned, the "ground truth" would be the engineering specifications and functional integrity of the device. This is typically verified through direct measurement, visual inspection, and functional tests (e.g., image quality assessment, illumination intensity, camera function, mechanical integrity) against predefined specifications. It is not based on clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This notice does not describe an AI/machine learning device that requires a training set.

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

• Not applicable. No training set was involved for this 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 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 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 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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INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.

INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.

The provided text is a 510(k) Pre-market Notification document for a medical device called INTEGRA® Wound Matrix (Macro-Channels). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device study might.

Since this document is not for an AI/ML device, the typical metrics and study designs (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size of a test set, etc.) are not applicable here. The device is a collagen wound dressing, meaning its evaluation relies on material properties, biocompatibility, and animal models, rather than diagnostic accuracy or human interpretation of outputs.

However, I can extract the information relevant to its acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria in the sense of predefined thresholds for clinical outcomes (e.g., wound closure rate) for the subject device. Instead, it focuses on demonstrating that the technological characteristics of the subject device are substantially equivalent to the predicate device, and that its performance meets general scientific and safety standards.

Here's a breakdown of the key characteristics and findings:

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

• Test Set Sample Size: Not specified for any of the individual tests. For the in vivo study, a "porcine wound healing model" was used, but the number of animals or wounds is not mentioned.
• Data Provenance: The biocompatibility data was leveraged from the predicate device (K022127). The in vivo study was conducted, likely by the manufacturer, but country of origin is not specified. The studies are retrospective in the sense that existing data from the predicate device was largely used, and any new tests (like the in vivo porcine study) would be considered prospective for the subject device.

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

• Not Applicable. This is not a diagnostic device that requires expert interpretation for ground truth. The evaluation is based on material science, chemical analysis, and animal model outcomes.

4. Adjudication method for the test set:

• Not Applicable. No human adjudication of results in the context of interpretation of diagnostic outputs. Results are from laboratory tests and an animal 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, nor does it involve human readers or comparative effectiveness in that sense.

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

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• Laboratory Measurements & Animal Study Outcomes:
  • Compositional analysis: Used to confirm material identity.
  • Physical property measurements: (e.g., pore size, thickness, resistance to collagenase, endotoxin levels).
  • Biocompatibility test results: Against ISO 10993 standards.
  • Histopathological & clinical observations from porcine wound healing model: To assess safety and effectiveness in wound healing.

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. As there is no training set.

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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.

The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament.

The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.

This document describes the acceptance criteria and study results for the Integra LifeSciences Corporation's Codman Surgical Pattie & Strip (K193346).

1. Table of Acceptance Criteria and Reported Device Performance:

2. X-ray weld strength
3. X-ray flash
   (Demonstrates that proposed patties meet the same performance specification as the predicate device) | All samples passed the acceptance criteria. |
   | Visual Inspection (Strips) | 1. X-ray weld strength
4. X-ray flash
   (Demonstrates that proposed strips meet the same specifications as the predicate strips and that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the acceptance criteria. |
   | Radiopacity (Patties and Strips) | Qualitative acceptance criteria (as per FDA recognized standard ASTM F640-12).
   (Supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the qualitative acceptance criteria. |
   | Sterilization Validation | Achieve a 10⁻⁶ sterility assurance level (SAL) using the overkill process per FDA recognized standard, ISO 11135:2014, with a reference product load that included "worst case" product, and meet EO/ECH residual and bioburden acceptance criteria.
   (Same as predicate device, supporting substantial equivalence) | Test results met the EO/ECH residual and bioburden acceptance criteria and achieved a sterility assurance level of 10⁻⁶. |
   | Shelf-Life (2-years) | • X-ray shall not protrude
   • Meets ASTM F640
   • X-ray shall exhibit adequate adherence
   • X-ray shall not overlap string.
   (Within the current shelf life claim for the predicate device, does not raise new questions of safety and effectiveness as per FDA recognized standard ASTM F640) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Cytotoxicity | Less than or equal to grade 2 reactivity on the 0 to 4 reactivity scale (per ISO 10993-5).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Intracutaneous Study | Difference between test article extract overall mean score and control group score is 1.0 or less (per ISO 10993-10).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - USP Rabbit Pyrogen Study | No single animal shows a rise of 0.5 °C above its baseline temperature (per ISO 10993-11).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Acute Systemic Toxicity | No single animal treated with the individual test extract exhibits a significantly greater reaction than the control animals; no more than two animal deaths; no abnormal behavior such as convulsions or prostration occurs in two or more animals; no final body weight loss greater than 10% occurred in three or more animals (per ISO 10993-11).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Guinea Pig Maximization Sensitization Test | A grade of 0 on a patch test reaction scale of 0-3 (per ISO 10993-10).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - ASTM Hemolysis Study | Hemolytic index for the test article extract to be 0.1% and non-hemolytic (as per ASTM F756 and ISO 10993-4).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |

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

The document does not explicitly state the exact sample size for each test. However, it indicates "All samples" passed the acceptance criteria for most tests, suggesting an appropriate number of samples were tested to demonstrate substantial equivalence. The data provenance is derived from bench testing conducted by Integra LifeSciences Corporation, as stated under "Bench Testing" and "Performance Data." This is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

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 a physical medical instrument (surgical pattie and strip), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance evaluation relies on objective physical, chemical, and biological tests.

4. Adjudication method for the test set:

Not applicable. As described in point 3, this is not an AI/imaging device subject to expert adjudication of results.

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 a physical medical instrument and does not involve AI assistance or human readers.

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

Not applicable. This device is a physical medical instrument.

7. The type of ground truth used:

The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (e.g., ASTM, ISO standards) and meeting predefined objective specifications for physical, chemical, and biological properties. This includes measurements of weld strength, X-ray visibility, sterility assurance levels, and biocompatibility endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument and does not involve AI models or training sets.

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

Not applicable. As described in point 8, this device does not involve AI models or training sets.

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The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:

• Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
• Primary arthritis (e.g. degenerative disease)
• Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
  Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
  Provided sufficient bone stock is present.
  Note - In the United States, this device is intended for cemented use only.
  Note - Outside the United States, this device is intended for cemented or cementless use.

The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar dome and an insert. The tibial tray and talar dome are secured to patient anatomy. The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Each of the three components is available in a variety of sizes and design configurations intended for both primary and revision surgery applications. The Cadence System also consists of various instrumentation to allow for appropriate implantation of the Cadence Prosthesis.
The scope of the Cadence System is being extended to include additional options for the talar domes. The new talar dome option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design. New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design.

The provided document is a 510(k) premarket notification for a medical device called the "Cadence Total Ankle System". This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate.

Crucially, this document describes a comparative study for substantial equivalence, not a study proving an AI/software device meets specific performance acceptance criteria for a novel functionality. Therefore, the information requested in the prompt, such as acceptance criteria for reported device performance (e.g., accuracy, sensitivity, specificity for an algorithm), sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this type of medical device submission.

The document states:

• "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device." (Page 5)
• The substantial equivalence conclusion is based on:
  • The modified and predicate device having exactly the same intended use.
  • Both devices operating using the same fundamental scientific technology.
  • Both devices sharing the same functional and technological characteristics via the same operational principles.
  • No new issues or concerns related to safety or effectiveness raised by the modified device.

Instead of clinical performance data, the submission relies on nonclinical performance data to show that the modified device (Cadence Total Ankle System) is substantially equivalent to the unmodified device (Integra Total Ankle Replacement System, K151459).

Here's an analysis of the provided information, addressing the prompt's points where applicable, and clarifying why others are not relevant given the document's nature:

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

Explanation: The "acceptance criteria" here are not performance metrics like accuracy or sensitivity for an algorithm, but rather engineering and biomechanical equivalence to the predicate device. The document states these tests were performed and imply they met the necessary thresholds to demonstrate substantial equivalence. Specific quantitative results are not provided in this summary.

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

• Not Applicable. This document describes non-clinical (mechanical/materials) testing for a physical implant, not a study involving patient data or test sets in the context of an algorithm. The "data" refers to engineering test results, not clinical patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not relevant.

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)

• Not Applicable. No human experts (like radiologists) were involved in establishing "ground truth" for the non-clinical tests described. The "ground truth" for these tests would be established by engineering standards and measurement techniques.

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

• Not Applicable. As no expert review or human interpretation of a "test set" (like medical images) was performed, no adjudication method was needed.

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/software device, so MRMC studies and human reader improvement with AI assistance are irrelevant.

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

• Not Applicable. This is not an algorithm, so standalone performance is not relevant.

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

• The "ground truth" for this device's testing is based on engineering and biomechanical standards and measurements. For example, force applied, displacement, material properties, and wear rates would be measured against established benchmarks and the performance of the predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set."

Summary of the Study Proving the Device Meets Substantial Equivalence Criteria:

The "study" in this context is a series of nonclinical verification tests and analyses designed to demonstrate that the modified Cadence Total Ankle System is as safe and effective as its predicate device (Integra Total Ankle Replacement System, K151459). These tests focus on the physical and mechanical properties of the implant.

• Nonclinical Performance Data: The device was subjected to testing and/or analyses related to:

  1. Constraint
  2. Bone Stability
  3. Range of Motion
  4. Fatigue Strength
  5. Contact Area and Pressure Distribution
  6. Wear

• Conclusion: The submission concludes that "substantial equivalence of the modified device and predicate device is based on" the factors listed above, and that "After evaluation of the risks and performance data, the modified device does not raise any new issues or concerns related to safety or effectiveness." This implies that the device met the implicit acceptance criteria for these nonclinical tests by performing comparably to the predicate or within acceptable engineering limits.

In essence, this document is a regulatory submission for a physical medical device, not an AI/software device, and thus the prompt's questions related to AI/software performance validation are not answered because they are not relevant to this type of submission.

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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 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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