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The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as:

· Carpal tunnel release in the wrist

· Cubital tunnel release in the elbow

The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available.

The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece.

During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.

The provided text does not contain information about acceptance criteria for the VECTR - Video Endoscopic Carpal Tunnel Release System, nor does it detail a study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies.

Here's an overview of the information that is available in the provided text, categorized as much as possible according to your request, but highlighting the absence of the specific details you're looking for:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available in the provided text. The document describes a series of non-clinical tests conducted (sterility, package stability, shelf life, biocompatibility, EMC, electrical/mechanical/thermal safety, and bench testing) to support substantial equivalence. However, it does not specify quantitative acceptance criteria for each of these tests, nor does it present the results in a comparative table format against such criteria. It generally states that the device "performs the intended functions as designed" and "is substantially equivalent."

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

• Test Set Sample Size: Not specified for any of the non-clinical tests. The document mentions "nonclinical testing provided," "testing completed," or "testing referenced," but does not give numerical sample sizes for these tests.
• Data Provenance: The data described are from non-clinical tests performed by Rafael Medical Devices, LLC, and referenced standards. This indicates the testing was conducted in a controlled environment, likely by the manufacturer or contracted labs, rather than being derived from patient data (retrospective or prospective). The geographical origin of the testing is not specified beyond the company's location (Newark, NJ, USA).

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

• Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes. The provided text details non-clinical laboratory testing.

4. Adjudication method for the test set

• Not applicable. Adjudication is typically associated with clinical studies or expert review of data where discrepancies might arise. The non-clinical tests described would follow standardized protocols without an adjudication process in this context.

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 VECTR system is a physical surgical device (handpiece with integrated camera and knife) and proprietary tablet, not an AI or software-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Not applicable. As noted above, the device is not an algorithm, but a surgical instrument with integrated video capabilities. The "standalone" performance here refers to the device itself performing its intended functions (e.g., blade deployment, video output, safety features), which was assessed through bench testing as described.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" would be established by the specifications and validated methodologies of the referenced standards (e.g., ISO, ASTM, ANSI, AAMI, USP). For example:
  • Sterility: Absence of viable microorganisms, confirmed by biological indicators and bioburden testing according to AAMI/ISO 11135, ISO 11138, ISO 11737.
  • Package Stability: Maintenance of seal integrity and protection against shipping hazards, evaluated against ASTM standards (D5276-19, D642-20, D999-08, D4728-17, D6344-04).
  • Biocompatibility: Absence of toxicological effects (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) as defined by ISO 10993 series and USP .
  • EMC: Compliance with immunity and emission levels as per IEC 60601-1-2.
  • Electrical, Mechanical, Thermal Safety: Adherence to safety requirements outlined in ANSI/AAMI ES60601-1, ISO 14971, and IEC 60601-2-18.
  • Bench Testing (functionality): Device specifications for parameters like blade deployment, insertion force, blade height, sharpness, deflection, and video output, verified through direct measurement.

8. The sample size for the training set

• Not applicable. This device is a surgical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question is not relevant.

In summary, the provided document focuses on non-clinical testing to demonstrate substantial equivalence of a physical medical device. It does not contain the specific details regarding acceptance criteria, clinical study design, or AI performance metrics as requested.

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