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The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.
The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.

The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers).

This document is a 510(k) summary report for the Stryker Mini-Mender Meniscal Repair System, which is a medical device and not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria and study design for software performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the device's regulatory pathway and the criteria for its marketing clearance:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant standards and guidance documents. The device performance is assessed in terms of its ability to meet these equivalence criteria and comply with safety and efficacy guidelines for surgical sutures and instruments.

Details Regarding Study/Evaluation (For a non-AI/software device)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   For a physical medical device like this, there isn't a "test set" in the sense of a dataset for an algorithm. Rather, the device undergoes specific engineering, material, and biological testing to ensure it meets the required standards. The document doesn't specify sample sizes for these tests (e.g., how many sutures were tested for tensile strength, how many devices for sterility, etc.), but it implicitly states these tests were conducted to demonstrate compliance with standards like USP, ISO-10993, EN 552, and ASTM 4169. Data provenance is not specified but would typically be from in-house or contracted laboratory testing in the country of manufacture or testing.

2. 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 (N/A). The "ground truth" for this device is established by adherence to recognized medical device standards and regulations, rather than expert interpretation of a clinical dataset. Compliance is assessed by regulatory bodies (FDA) and manufacturers through established testing protocols.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   N/A. Adjudication methods are relevant for clinical trials or diagnostic performance studies involving human interpretation. For this physical device, compliance is based on meeting pre-defined physical, chemical, and biological specifications.

4. 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:
   N/A. This is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This device is a physical surgical tool, not an algorithm. Its performance is inherent in its design, materials, and manufacturing, and it is used by a human surgeon.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device's clearance is established through compliance with recognized standards and regulations. Specifically:

   • Predicate device's safety and efficacy: The Linvatec SharpShooter Meniscal Repair System serves as a basis for determining substantial equivalence, implying its established safe and effective use.
   • USP Section XXV - Nonabsorbable Surgical Sutures: A pharmacopeial standard detailing requirements for surgical sutures.
   • ISO-10993 (Biocompatibility): International standard for biological evaluation of medical devices.
   • EN 552 (Sterilization): European standard related to sterilization of medical devices.
   • ASTM 4169 (Sterility packaging): Standard for sterility assurance and packaging.
   • Class II Special Controls Guidance Document: Surgical Sutures: FDA guidance document outlining specific controls for this device type.
   • Clinical acceptance of meniscal repair with suture: The submission explicitly states suture repair is the "Gold Standard" and "has been well published in professional journals."

7. The sample size for the training set:
   N/A. This is a physical device, not an AI model. There is no "training set" in this context.

8. How the ground truth for the training set was established:
   N/A. As there is no training set, this question is not applicable.

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