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The Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.

The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes.

The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.

This document is a 510(k) premarket notification for a medical device called "Infinity-Lock 3" and "Infinity-Lock 5" surgical sutures. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a diagnostic device. It concerns a mechanical surgical suture. Therefore, many of the requested criteria (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

The "performance data" section in the document refers to mechanical testing of the sutures, not performance in a diagnostic or AI context.

Here's a breakdown of the relevant information provided in the document:

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

The document states: "Mechanical testing was performed on the modified device and original poly-tape in both knotted and unknotted conditions to determine the ultimate tensile strengths using an internal method, QT010, and following USP 39 NF33:2016 for non-absorbable surgical sutures, where applicable. The modified devices were found to be equivalent or superior in all cases."

While specific numerical acceptance criteria and performance values are not explicitly tabulated in this summary, the statement indicates that the new device met or exceeded the performance of the predicate device based on tensile strength tests. The standard followed, USP 39 NF33:2016, would contain the specific criteria.

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

• Sample Size: Not explicitly stated for the mechanical testing.
• Data Provenance: The testing was "internal" (Xiros Ltd.) as per method QT010.
• Retrospective or Prospective: This type of mechanical testing is typically a prospective validation of manufactured samples.

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

• Not applicable for this type of mechanical device. "Ground truth" for mechanical properties is established through standardized physical measurements and tests, not expert interpretation of diagnostic data.
• There was "Validation... undertaken by clinicians using cadaveric materials to demonstrate the suitability of the modified device for the intended use." This is about usability and fit-for-purpose, not diagnostic ground truth. The number and qualifications of these clinicians are not specified in this summary.

4. Adjudication method for the test set:

• Not applicable for this type of mechanical device. Mechanical tests have objective, measurable outcomes.

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/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used:

• For mechanical properties: Objective physical measurements (ultimate tensile strength) against standards (USP 39 NF33:2016).
• For usability: Clinician assessment on cadaveric materials.

8. The sample size for the training set:

• Not applicable. This is a manufactured medical device, not an AI model requiring a "training set."

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

• Not applicable. See point 8.

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