(108 days)
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The STRATAFIX™ Spiral PDS™ Plus Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTN Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDS™ Plus Device can be compared to USP knot strength of nor-broad sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
The provided document is a 510(k) premarket notification for a medical device (STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device). While it details the device description, indications for use, and a general statement about performance data, it does not contain detailed acceptance criteria or the specific results of a study in a manner that allows for a direct population of the requested table.
Here's an analysis based on the available information, highlighting what the document provides and what it omits:
1. A table of acceptance criteria and the reported device performance
The document states: "Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter." And "STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device met all testing criteria to demonstrate substantial equivalence to the predicates devices."
This indicates that the acceptance criteria are based on the USP Monograph for absorbable surgical sutures (with a noted exception for diameter) and likely additional criteria to show equivalence to predicate devices. However, the exact numerical or qualitative acceptance criteria and the corresponding reported performance values are not detailed in this summary. It's a high-level statement of compliance.
Therefore, a table cannot be fully populated with specific criteria and performance values from this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document.
- Data provenance: "Non-clinical laboratory performance testing" and "bench and animal testing" are mentioned. The document is a submission to the US FDA, so the testing was likely conducted in compliance with US regulatory standards, but the physical location/country of origin of the labs is not stated. Whether it was retrospective or prospective is also not mentioned, but given it's "performance testing," it would inherently be prospective for the purpose of demonstrating device performance.
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)
This type of information is not applicable to this document. The device is a surgical suture, and the performance testing mentioned (USP monograph, bench, and animal testing) does not involve human expert interpretation of data points that would require "ground truth" establishment by medical experts in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons in 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-assisted diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a surgical suture, "ground truth" would relate to its physical and biological performance. The document implies the "ground truth" or standard for performance is based on:
- USP Monograph for absorbable surgical sutures: This outlines standardized physical and chemical properties.
- Bench testing: In vitro evaluation of mechanical properties.
- Animal testing: In vivo assessment of tissue reaction, absorption, and performance in a biological system.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable for the reasons in point 8.
In summary, the provided document is a regulatory submission for a physical medical device (suture) and therefore lacks the detailed information on statistical studies, expert ground truth, and AI-specific performance metrics that would be relevant for an AI/diagnostic device. The "study" mentioned is general performance testing against established standards (USP Monograph) and comparison to predicate devices for substantial equivalence.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.