(131 days)
The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
The ExpressBraid Graft Manipulation device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The suture may be all white or blue/white MaxBraid suture. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polyethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (-2)] cooper
This document describes the ExpressBraid Graft Manipulation device, a non-absorbable surgical suture. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in a clinical context with AI.
However, based on the provided text, we can extract details related to the performance testing conducted to support substantial equivalence. It's important to note that this is not a study assessing AI performance or human reader improvement.
Here's an analysis of the provided text in relation to your request, with the understanding that the "device" in this context is the ExpressBraid Graft Manipulation suture:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with corresponding performance data in the typical sense for an AI device. Instead, it states that the device was tested against USP (United States Pharmacopeia) standards for non-absorbable surgical sutures and also compared to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly from USP) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Meets USP requirements | Meets USP requirements |
| Diameter | Meets USP requirements | Meets USP requirements |
| Needle Attachment | Meets USP requirements | Meets USP requirements |
| Equivalence to Predicate | Performs equivalently to Arthrex #2 Suture | Testing concluded equivalent performance |
| Biocompatibility | Meets ISO 10993-1 standard requirements | Meets ISO 10993-1 requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the performance testing (tensile strength, diameter, needle attachment, or comparative testing).
The data provenance is from laboratory testing performed by the manufacturer, Biomet Manufacturing Corp., as part of their 510(k) submission. No information on country of origin of the data or whether it's retrospective or prospective is given, as it's mechanical and biocompatibility testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and testing described. The "ground truth" for mechanical and biocompatibility testing is established by adherence to recognized standards (USP, ISO 10993-1) and direct measurement, not by expert consensus on clinical findings.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or image interpretations, not for direct mechanical or chemical property testing.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant to AI-assisted diagnostic tools, not to a surgical suture. The document describes comparative performance between two sutures (the subject device and a predicate) in terms of mechanical properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical surgical suture, not a software algorithm.
7. The type of ground truth used
The "ground truth" used for this device's performance assessment relies on:
- Established standards: United States Pharmacopeia (USP) requirements for surgical sutures and ISO 10993-1 for biocompatibility.
- Direct measurement and comparison: Mechanical and chemical properties were measured and compared to the predicate device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI model, there is no ground truth established for one.
In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a surgical suture based on its mechanical properties and biocompatibility as compared to predicate devices and recognized standards. It does not contain information related to AI performance, clinical trials with human readers, or expert-based ground truth establishment as would be relevant for an AI/ML medical device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.