(77 days)
POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.
Here's an analysis of the provided text regarding the acceptance criteria and study for the POLYGLYCOLIC ACID surgical suture:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (USP Standards) | Reported Device Performance |
|---|---|---|
| Suture Diameter | Meet U.S.P. Requirements | Meets U.S.P. Requirements |
| Suture Length | Meet U.S.P. Requirements | Meets U.S.P. Requirements |
| Knot Pull Tensile Strength | Meet U.S.P. Requirements | Meets U.S.P. Requirements |
| Needle Attachment Strength | Meet U.S.P. Requirements | Meets U.S.P. Requirements |
| Original Tensile Strength (at 2 wks) | Retains approximately 65% (implied USP standard for absorbable sutures) | Retains approximately 65% |
| Original Tensile Strength (at 3 wks) | Retains approximately 40% (implied USP standard for absorbable sutures) | Retains approximately 40% |
| Suture Absorption | Absorption essentially complete between 60 and 90 days (implied USP standard for absorbable sutures) | Absorption essentially complete between 60 and 90 days |
| Sterility | Ethylene Oxide Gas sterilization (implied by predicate, conformity to USP) | Ethylene Oxide Gas |
| Material Composition | Composed of glycolide polymer (implied by product name and predicate comparison) | Composed of glycolide polymer |
| Biocompatibility | (Implicitly covered by USP standards and substantial equivalence to predicate) | (Not explicitly stated, but implied by USP and substantial equivalence) |
| Packaging | Dry packaged in Aluminum Foil and Polyester tear open packaging. | Dry packaged in Aluminum Foil and Polyester tear open packaging. |
| Labeling | In conformance with CDRH instructions and FDA Guidance documents | In conformance with CDRH instructions and FDA Guidance documents |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards." This implies a sample size adequate for the tests required by USP, but the specific number of units tested is not provided.
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Non-Clinical Testing," which is typically laboratory-based and not tied to specific patient populations or geographical locations. It is a retrospective study in the sense that the tests were performed and then reported, but it's not a retrospective analysis of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The ground truth for the non-clinical testing is based on the United States Pharmacopeia (U.S.P.) standards. These are established, widely accepted objective performance metrics for medical devices, particularly sutures. No human experts are described as establishing "ground truth" for these physical and chemical tests.
4. Adjudication Method for the Test Set
- Not applicable. The evaluation relies on objective measurements against pre-defined U.S.P. standards. There is no human adjudication process described for interpreting the results of these standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing the impact of AI assistance on their performance. The device in question is a surgical suture, which is a physical product, and its evaluation relies on non-clinical performance characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a surgical suture, not an algorithm or AI system. The concept of "standalone performance" for an algorithm does not apply here. The evaluation is of the physical product's performance against established standards.
7. The Type of Ground Truth Used
- U.S.P. Standards: The ground truth for the device's performance is objective compliance with the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. These standards define the acceptable range for physical properties like diameter, tensile strength, length, and absorption characteristics.
8. The Sample Size for the Training Set
- Not applicable. The device is a surgical suture, not an AI or machine learning model. Therefore, there is no "training set" of data in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is not relevant here.
§ 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.