(105 days)
The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.
Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2.
PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.
This is a 510(k) premarket notification for a medical device called "DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles". The provided text describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device (K984374 Surgisorb - Samyang Corp.).
However, the provided document does not contain a study with acceptance criteria and reported device performance in the way typically found for AI/imaging devices. This document is a regulatory submission for a physical medical device (sutures), not a software or AI device that relies on performance metrics like sensitivity, specificity, or accuracy derived from a test set of data.
Therefore, most of the questions you've asked, which are geared towards AI/software device studies, cannot be answered from this document.
For completeness, I can address the parts that are relevant to this type of traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For this type of device, acceptance criteria are typically related to meeting established standards (e.g., USP and European Pharmacopoeia for sterile, synthetic, absorbable sutures) and demonstrating substantial equivalence to a legally marketed predicate device.
- Reported Device Performance: The document states, "PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures." This is the reported performance in relation to the established standards. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the primary "performance" metric in a 510(k) – demonstrating equivalence.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compliance with Standards | Fulfill all requirements of USP and European Pharmacopoeia for sterile, synthetic, absorbable sutures. | Fulfills all requirements of USP and European Pharmacopoeia. |
| Substantial Equivalence to Predicate | Substantially equivalent to K984374 Surgisorb - Samyang Corp. for stated indications of use. | Determined to be substantially equivalent. |
The following questions cannot be answered from the provided document as they pertain to AI/software device studies, not traditional medical device submissions like sutures:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
In summary, the provided document is a 510(k) summary and FDA clearance letter for a physical medical device (sutures). It demonstrates compliance with recognized standards and substantial equivalence to a predicate device, which are the primary "performance" aspects for such a submission. It does not involve a study with a test set, ground truth established by experts, or AI performance metrics as described in your questions.
§ 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.