(85 days)
XBraid TT Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgieries.
XBraid TT Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable, sterile suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/violet coloration patterns. XBraid TT Suture Tape complies with USP standards for #2 suture with the exception of size classifications and needle attachment. Three configurations are being proposed that differ only in coloration pattern and dimensions. Each configuration will be cut to length and provided to the end user in a singleuse sterile barrier system (SBS).
The provided document is a 510(k) summary for a medical device called "XBraid TT Suture Tape". A 510(k) submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
However, I can extract information related to the acceptance criteria and the study that was performed for this specific device.
Acceptance Criteria and Device Performance for XBraid TT Suture Tape
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (USP Standard for #2 Nonabsorbable Surgical Suture) | Reported Device Performance (XBraid TT Suture Tape) |
|---|---|
| Minimum requirements for knot pull tensile strength. | Meets or exceeds the minimum requirements. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document.
- Data Provenance: Not applicable as this was non-clinical benchtop testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: "Ground truth" in the context of expert consensus is typically for diagnostic imaging or similar AI/ML applications. This device underwent benchtop testing against a standard.
4. Adjudication method for the test set:
- Not Applicable: No adjudication for expert consensus was performed. Performance was measured against USP standards.
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: This is not applicable to a non-clinical benchtop study for a surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device, not an algorithm. Benchtop testing is inherently "standalone" in that it doesn't involve human-in-the-loop performance for its core function.
7. The type of ground truth used:
- USP Standards: The "ground truth" for performance was the minimum requirements set by the United States Pharmacopeia (USP) for #2 nonabsorbable surgical sutures, specifically for knot pull tensile strength.
8. The sample size for the training set:
- Not Applicable: This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable: No training set was used.
Summary of the Study:
- Study Type: Non-clinical benchtop testing.
- Objective: To verify that the XBraid TT Suture Tape devices meet or exceed the minimum requirements of USP standards for knot pull tensile strength of size #2 nonabsorbable surgical sutures.
- Key Finding: The proposed devices demonstrated performance that meets or exceeds the specified USP standards.
- Conclusion: Based on this performance data and comparison to the predicate device regarding intended use, materials, performance attributes, and technological characteristics (with only a colorant difference which was shown to be biologically safe and functionally acceptable), the device was deemed substantially equivalent to the predicate. Clinical testing was not required for this submission.
§ 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.