(50 days)
The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Lukens® · PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.
Here's an analysis of the provided text regarding device acceptance criteria and studies:
The document describes the Lukens® - PGA (Polyglycolic Acid) Synthetic Absorbable Surgical Suture, Coated, Braided U.S.P. and its equivalence to a predicate device, Dexon II. The studies presented are for regulatory clearance (510(k) submission), not for AI/ML device performance. Therefore, many of the requested AI/ML specific details (like AI effect size, training data, ground truth establishment for AI, etc.) are not applicable or present in this document.
However, I can extract the relevant acceptance criteria and study information provided.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (USP Requirements) | Reported Device Performance (Lukens® - PGA) |
|---|---|
| Suture diameter | Meets or exceeds USP requirements; equivalent to Dexon II polyglycol acid surgical sutures. |
| Suture length | Meets or exceeds USP requirements; equivalent to Dexon II polyglycol acid surgical sutures. |
| Knot-pull tensile strength | Meets or exceeds USP requirements; equivalent to Dexon II polyglycol acid surgical sutures. |
| Needle attachment strength | Meets or exceeds USP requirements; equivalent to Dexon II polyglycol acid surgical sutures. |
| Biocompatibility (toxicity) | No evidence of toxicity. |
| Tensile strength retention (2 weeks) | Approximately 50% of original tensile strength retained. |
| Tensile strength retention (3 weeks) | Approximately 20% of original tensile strength retained. |
| Absorption completion | Essentially complete between 60 and 90 days. |
Study Details (Based on Provided Text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The text mentions "Testing...demonstrates," but no specific number of samples or batches is provided for the physical tests.
- Data Provenance: Not specified, but generally for medical device testing like this, it would be internal lab testing by the manufacturer or a certified contract lab. The implantation studies were in "animals," implying pre-clinical, non-human data.
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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. This is not a study involving human experts establishing ground truth for perception/diagnostic tasks, but rather laboratory and animal testing of a physical medical device. The "ground truth" for the physical and biocompatibility properties are standards set by USP and observed biological responses.
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Adjudication method for the test set:
- Not Applicable. See point 2.
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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:
- No. This is a conventional medical device (suture) and the studies describe its physical properties and biocompatibility, not an AI/ML system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical properties (diameter, length, tensile strength, needle attachment): USP XXIII standards are the ground truth/reference.
- For biocompatibility: Observed biological response (absence of toxicity) from standard in-vitro or in-vivo tests.
- For absorption and tensile strength retention: Observed in-vivo biological response in animals.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.