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510(k) Data Aggregation
(105 days)
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
STRATAFIX Symmetric PDS Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX Symmetric PDS Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX Symmetric PDS Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX Symmetric PDS Plus Devices consists of an absorbable monofilament thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.
This document describes a 510(k) premarket notification for the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device. The information provided is sufficient to answer some, but not all, of your specific questions.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. The performance data section describes what was tested, but not the quantitative results or the specific criteria for "adequacy" or "integrity."
| Test Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary, not quantitative) |
|---|---|---|
| Tissue Holding Strength | Not specified (implied to be comparable to predicate) | "verify the integrity and adequacy... in a simulated wound closure and support substantial equivalence" |
| Initiation Strength | Not specified (implied to be comparable to predicate) | "verify the integrity and adequacy... during application at the proximal end of a simulated wound closure compared to the predicate device." |
| Cyclic Compression | Not specified (implied to be comparable to predicate) | "verify the integrity and adequacy... when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device." |
| Usability Study | Not specified (usability confirmed, IFU refined) | "confirmed the usability of the device and to refine the Instructions for Use." |
| Preclinical Survival Study | Not specified (implied to be comparable to predicate) | "demonstrated substantial equivalence in wound approximation and healing to the predicate device." |
2. Sample sizes used for the test set and the data provenance
- Sample sizes for the test set: Not provided. The document states "performance testing-bench models" and "performance testing-animal models" but does not specify the number of samples, animals, or human users involved in these tests.
- Data provenance:
- Country of origin of the data: Not specified.
- Retrospective or prospective: Not specified. The nature of the "Preclinical Survival Study" suggests it was prospective, but this is not explicitly stated for all tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical suture, not an AI/CAD diagnostic device that typically relies on expert interpretation for ground truth. The "ground truth" for its performance would be derived from physical measurements (strength, cyclic loading) and biological observations (wound healing in animal models), not expert consensus on images or diagnoses. No experts are mentioned for establishing ground truth in this context.
4. Adjudication method for the test set
Not applicable. As above, this is not an AI/CAD diagnostic device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting data, which is not relevant to the described performance testing of a physical medical device.
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 a physical surgical device, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical device. "Standalone performance" in the context of an algorithm is not relevant here.
7. The type of ground truth used
For the performance tests mentioned, the "ground truth" implicitly would be:
- Physical measurements: For Tissue Holding Strength, Initiation Strength, and Cyclic Compression. This would involve calibrated instruments measuring force, displacement, etc.
- Biological observations: For the Preclinical Survival Study, ground truth would be based on direct observation and potentially histological analysis of wound approximation and healing in the animal models.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.
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