(13 days)
The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.
SuperStitch GW Models 06-15-04-GW; 08-15-04-GW
The provided text is a 510(k) summary for the Sutura, Inc.'s SuperStitch GW. This document primarily focuses on establishing substantial equivalence to a predicate device and obtaining regulatory clearance for market access. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as would typically be found in performance evaluation reports.
Therefore, many of the requested details, such as a table of acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth establishment, are not available in the provided text.
The document indicates the following:
1. A table of acceptance criteria and the reported device performance
- Not available. The document is a 510(k) summary, which focuses on establishing substantial equivalence for regulatory clearance rather than presenting detailed performance study results against predefined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No information about a specific test set or data provenance is provided.
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 available. No information about ground truth establishment or experts is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No information about adjudication methods is provided.
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 available. This device is a surgical suture delivery device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (a suture delivery tool), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. The document does not describe performance studies that would require a defined ground truth.
8. The sample size for the training set
- Not available. The SuperStitch GW is a physical medical device, not an AI or machine learning algorithm that requires a training set in that context.
9. How the ground truth for the training set was established
- Not applicable. As a physical medical device, the concept of a "training set" with established ground truth is not relevant in the context of AI/ML models.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.