(68 days)
The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.
The provided document is a 510(k) summary for a medical device, specifically an absorbable surgical suture. It describes the device, its intended use, and its equivalence to a predicate device. It does not present a study that establishes acceptance criteria for new functionality or a new AI/software-driven device. Instead, it refers to "in-vitro studies" to demonstrate substantial equivalence to a predicate device for an existing product with a modified packaging.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will fill in the applicable information and note when a section is not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. It states that "In-vitro studies were performed...to demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." This implies that the performance after pre-wetting should be comparable to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture's functional performance remains substantially equivalent to the predicate device after pre-wetting with sterile saline (0.9% NaCl) via the injection port for up to 12 hours at room temperature prior to use. | In-vitro studies "demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." (No specific metrics or data provided in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified in the provided 510(k) summary.
- Data provenance: Not specified, but the studies were "in-vitro."
3. 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. This device is a surgical suture, and the studies were "in-vitro" to assess physical properties and performance, not diagnostic interpretations requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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/software-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The equivalence was based on "functional performance" in "in-vitro studies," likely involving mechanical testing or other objective physical measurements, rather than clinical ground truth as understood in diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI/software-driven device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.