(27 days)
The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as componens, into surgeries where constructs, including those with allograft tissues, are used for repair.
The Arthrex Bio-Suture is a dyed or non-dyed braided polyester suture construct coated with type 1 bovine collagen. The suture construct is made of UHMWPE and polyester braided over a UHMWPE core. The suture tape construct is a flat suture construct composed of UHMWPE and polyester yarns braided over a FiberWire suture core and UHMWPE yarns. Arthrex Bio-Suture strands that are dyed black are made of nylon. The suture ends are stiffened with cyanoacrylate. The Arthrex Bio-Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter.
This looks like a 510(k) submission for a medical device (suture) and not an AI/ML product. The document describes a special 510(k) "to extend the shelf-life of the Arthrex BioSuture." Therefore, many of the requested fields for AI/ML performance evaluation (such as sample size for training/test sets, expert ground truth, MRMC studies, etc.) are not applicable here.
However, I can extract information relevant to the device's acceptance criteria and the study that indicates it meets those criteria for its extended shelf-life.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (as of extended shelf-life) |
|---|---|
| Ultimate Load (Tensile Strength) | Demonstrated to meet performance criteria |
| Anchor Pullout Strength | Demonstrated to meet performance criteria |
| USP Standards for Suture (except diameter) | Met for the BioSuture constructs |
Study Details:
- Device Name: Arthrex BioSuture
- Purpose of Submission: Extend the shelf-life of the Arthrex BioSuture.
- Methodology to demonstrate extended shelf-life: Real-time stability testing.
- Parameters evaluated in stability testing: Ultimate Load and Anchor Pullout strength.
- Result: The real-time stability testing data demonstrates that the extended shelf life does not affect the performance of the device for Ultimate Load and Anchor Pullout. This indicates the device continues to meet its pre-defined performance requirements (acceptance criteria) even with the extended shelf-life.
- General Performance Statement: The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter, implying these standards are the baseline acceptance criteria for the device's physical properties.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for the shelf-life study. The document refers to "real-time stability testing data" for Ultimate Load and Anchor Pullout, which would involve a sample of sutures tested over time.
- Data Provenance: Not specified, but generally, such stability testing would be conducted by the manufacturer (Arthrex, Inc.) in a controlled laboratory environment. Retrospective/Prospective is not applicable in the context of stability testing; it's an ongoing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML diagnostic or prognostic device that requires expert ground truth for classification. The "ground truth" for suture performance is based on established engineering and material science standards (e.g., tensile strength, pullout force) measured objectively, not by expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML diagnostic or prognostic device that requires adjudication of expert opinions.
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/ML device, nor does it involve human readers/interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance of the Arthrex BioSuture (including the extended shelf-life) is based on objective physical and mechanical measurements derived from established engineering and material science testing protocols, compared against recognized industry standards (specifically USP standards for sutures). It's not a "ground truth" in the sense of clinical diagnoses or pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device and does not involve a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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.