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The Akro-Vu Videoscopic Carpal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a capal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated solely for releasing the flexor retinaculum (transverse carpal lig ament).

The AKRO-VU Videoscopic Carpal Tunnel Release System (VCTRS) is designed as a stand-alone platform to address less invasive surgical approaches for Carpal Tunnel Release procedures performed by trained physicians. The AKRO-VU VCTRS is comprised of a reusable Video-Monitor with Li lon Battery and Charger, an autoclavable Sterile Enclosure with Base Stand to house the Video-Monitor within the sterile field, an autoclavable Handle with cable assembly and Locking Ring, and two styles of single use disposable Video-Blades each containing a camera, light source and deployable blade. The AKRO-VU VCTRS is designed to be a battery powered system.

The Akro-Vu Videoscopic Carpal Tunnel Release System (VCTRS) is a medical device designed for less invasive surgical approaches to Carpal Tunnel Release procedures. The submission K092723 focuses on establishing its substantial equivalence to a predicate device, the Microaire CTRS / 3M Inside Job (K912871). The acceptance criteria for this device are primarily based on performance testing demonstrating its safety and effectiveness, and comparability to the predicate device in terms of indications for use, design, materials, and operating principles.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify exact "sample sizes" in terms of number of patients or specific image datasets, as this is a submission for a surgical instrument, not a diagnostic AI system or a drug. The "test set" for this device consists of various physical tests performed on the device components.

• For physical tests like blade actuation, temperature, cut force, and strength, the sample size would refer to the number of device units or components tested. While not explicitly stated, the phrasing "all test samples" suggests multiple units were used for each test. For example, "After cyclic testing, all test samples actuated smoothly..." indicates more than one sample was subjected to the cyclic test.
• Data Provenance: The tests performed are laboratory-based, in-vitro (e.g., microbial barrier, temperature, strength tests on materials), and ex-vivo (cadaveric evaluations for cut force on tissue). Therefore, the "country of origin of the data" is primarily the testing facility of Skeletal Dynamics, LLC or their contracted labs. The data is prospective in the sense that these tests were specifically performed for this device submission to evaluate its characteristics.

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

This type of submission for a surgical instrument does not involve establishing ground truth through expert review of medical images or patient outcomes in the same way an AI diagnostic tool would. The "ground truth" for these performance tests is based on established engineering standards, material science properties, and biological functionality (e.g., what constitutes an "effective microbial barrier," what "necessary cut force on cadaver tissue" means in a surgical context, acceptable temperature rise, etc.). These standards are typically defined by:

• Engineers and Technicians: Qualified personnel with expertise in mechanical testing, material science, and medical device design.
• Surgeons/Clinical Experts: While not explicitly mentioned as "establishing ground truth" for specific test results, the design and performance criteria would have been informed by surgical requirements, likely with input from surgeons who perform carpal tunnel release procedures. The "cadaveric evaluations" were performed to assess cut force on tissue, implying a clinical relevance check, likely interpreted by individuals with anatomical and surgical knowledge.

The document does not specify the number or detailed qualifications (e.g., "radiologist with 10 years of experience") of such experts, as it's not relevant to this type of device submission.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device and its testing. Adjudication methods like "2+1" or "3+1" are typically used for disagreements in human expert interpretations of medical data (e.g., reading scans for an AI diagnostic study). For performance tests of a surgical instrument, the results are typically quantitative measurements that either meet or do not meet a predefined specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are characteristic of diagnostic imaging AI systems where multiple human readers interpret medical cases with and without AI assistance to measure the AI's impact on diagnostic performance. This submission is for a surgical instrument, not a diagnostic tool, and therefore, such a study design is not applicable.

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

Yes, the various performance tests are essentially "standalone" evaluations of the device's physical and functional characteristics. The "device performance" reported in the table above refers to the intrinsic performance of the Akro-Vu VCTRS itself, without a human operator's performance being assessed or factored into the results of these specific tests. For example, the battery capacity test measures how long the system powers on, not how long a surgeon can operate with it.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed can be categorized as:

• Engineering Specifications/Standards: For tests like blade actuation, temperature rise, strength, and cut force on test media, the ground truth is defined by pre-established engineering specifications and industry standards for medical devices of this type.
• Comparative Analysis: For blade sharpness, the ground truth is established by direct comparison with the legally marketed predicate device, Microaire CTRS / 3M Inside Job (K912871).
• Biological/Anatomical Functionality: For cadaveric evaluations of cut force on tissue, the ground truth relates to the device's ability to effectively perform its intended surgical function (releasing the flexor retinaculum) on human tissue.
• Functional Effectiveness: For microbial barrier and visualization tests, the ground truth is whether the system performs its designed safety and functional roles effectively (e.g., "effective microbial barrier," "focused, illuminated and discernible image").

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a physical surgical instrument.

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

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

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