(361 days)
TRULENE™ Non-absorbable Polypropylene Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.
The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.
The provided document is a 510(k) summary for a surgical suture and does not contain information about a device that uses an algorithm or AI. Therefore, it does not include the specific details requested regarding acceptance criteria, study methodologies, ground truth establishment, or human-in-the-loop performance typical of AI/algorithm-based medical devices.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a physical medical product. The "acceptance criteria" can be inferred from the performance requirements outlined in the United States Pharmacopeia (USP) for surgical sutures, and the "study" is a series of tests performed to ensure the device meets these USP specifications.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (USP 26 Specifications) | Reported Device Performance (TRULENE™) |
|---|---|
| Diameter () | Meets or exceeds USP specifications |
| Tensile Strength () | Meets or exceeds USP specifications |
| Needle Attachment () | Meets or exceeds USP specifications |
| Extractable Color (Official Monograph) | Meets or exceeds USP specifications |
| Length Requirement (95% of stated label) | Meets or exceeds USP specifications |
| Biocompatibility | Biologically compatible |
| Sterility | Sterilized by EO method |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility." This implies a set of samples was tested for each characteristic, but the exact number is not provided.
- Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Sutures India Pvt. Ltd. The country of origin of the data would be India, where the testing was conducted. The nature of the testing is most likely prospective, as it's part of the pre-market submission for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device. The "ground truth" for suture performance is established by the United States Pharmacopeia (USP) specifications and standardized testing methods, not by expert consensus in the typical sense of AI/algorithm evaluation. Regulatory bodies like the FDA then review data demonstrating adherence to these established standards.
4. Adjudication method for the test set:
- Not applicable. The "adjudication" in this context is the comparison of test results against predefined USP standards. There isn't a process of expert adjudication of individual test outcomes mentioned beyond the general oversight and review by the manufacturer and, subsequently, the FDA.
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 suture, not an AI/algorithm-based diagnostic or assistive device, so MRMC studies do not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used:
- Standardized Specifications/Performance Requirements: The "ground truth" is defined by the performance requirements outlined in the United States Pharmacopeia (USP) current edition (USP 26) for nonabsorbable surgical sutures. This includes specifications for diameter, tensile strength (knot pull), needle attachment, extractable color, and length. Biocompatibility and sterility are also key "ground truths" that must be met.
8. The sample size for the training set:
- Not applicable. This is a physical product, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.