(177 days)
TENOLIG is indicated for recent ruptures of the Achilles tendon.
Tenolig® consists of:
- a thread in polyester (poly(ethylene terephthalate)) with a diameter of 0.85mm and -360mm length, crimped at its proximal end, onto which is mounted a 7mm-wide harpoon, and crimped at its distal end by a triangular-tipped needle, 150mm long, slightly curved at delivery and which can be adjusted during surgery according to a curve suitable for the type of rupture treated;
- two perforated lead pellets for tightening;
- an UHMW polyethylene disc, with a convex surface offering support that does not excessively compress the skin and a flat surface.
A complete kit required for normal percutaneous tenosynthesis includes two Tenolig®.
The provided document does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it is a 510(k) summary for the TENOLIG® surgical suture, primarily focusing on demonstrating substantial equivalence to predicate devices for market clearance.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
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Table of acceptance criteria and reported device performance:
- Not available. The document states "All results demonstrate that the Tenolig® is safe and effective" but does not define specific acceptance criteria or provide quantitative performance metrics to compare against them.
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Sample size used for the test set and the data provenance:
This information is not provided in detail.- The document mentions "Tensile tests were performed to characterize in tension the strength of the crimping of the braid with the needle and of the braid with the spear." However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "performance data" described are mechanical tensile tests and biocompatibility tests, not clinical studies requiring expert ground truth for interpretation of patient data.
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Adjudication method for the test set:
- Not applicable. See point 3.
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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 document describes a surgical suture, not an AI-powered diagnostic device or a study involving human readers and AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (surgical suture), not an algorithm.
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The type of ground truth used:
- For the mechanical performance tests, the "ground truth" would be the measured physical properties of the suture system (e.g., tensile strength, crimping strength) and compliance with relevant standards.
- For biocompatibility, the "ground truth" refers to the results of biological assays determining the material's safety for body contact, evaluated against the requirements of ISO-10993.
- There is no mention of pathology, outcomes data, or expert consensus in the context of establishing ground truth for performance.
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The sample size for the training set:
- Not applicable. This document describes a physical medical device and its performance testing, not a machine learning model so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.