(123 days)
CAPROLON® is Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures
CAPROLON® is a synthetic absorbable surgical suture. Primary material is Poly(L-lactide-co-ε-caprolactone), P(LA/CL) Material presentation is Monofilament Undyed and dyed (D&C violet No.2) variants Coated with a mixture of calcium stearate and the copolymer of L-lactide and ε-caprolactone Suture material is a sterile, flexible, thread offered in a variety of lengths (35cm to 90cm), reels, range of diameters (USP 7-0 to 2), with or without needles attached.
The provided text describes the 510(k) submission for CAPROLON®, an absorbable poly(glycolide/l-lactide) surgical suture. The review determined that the device is substantially equivalent to a legally marketed predicate device. The document does not describe a study involving an AI or an algorithm. Instead, it outlines the performance testing for a medical device (surgical suture) against established USP (United States Pharmacopeia) standards. Therefore, an answer to your request regarding AI/algorithm-specific acceptance criteria and studies cannot be fully provided from the given text.
However, I can extract information regarding the device's acceptance criteria and performance based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from USP Monograph for Synthetic Absorbable Sutures) | Reported Device Performance (CAPROLON®) |
|---|---|---|
| Diameter | Meets U.S.P requirements | Meets U.S.P requirements except for minor variations |
| Tensile Strength | Meets U.S.P requirements | Meets U.S.P requirements |
| Needle Attachment | Meets U.S.P requirements | Meets U.S.P requirements |
| Resorption Profile | N/A (evaluated from in-vitro/in-vivo testing and published data) | Evaluated and determined to be acceptable |
| Stability | N/A (testing completed) | Testing completed and results acceptable |
| Biocompatibility | In accordance with ISO 10993-1 | Supported by testing on the final subject device or design/process equivalent devices |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document. The text only mentions "the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph." Specific numbers of sutures tested for each characteristic (Diameter, Tensile strength, Needle attachment) are not provided.
- Data Provenance: The testing was conducted by Resorba Medical GmbH as part of their 510(k) submission. The document doesn't specify country of origin for the raw data, but the company is based in Germany. The testing appears to be conducted specifically for this submission, implying a prospective nature in the context of this regulatory filing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the evaluation of a surgical suture against USP standards. "Ground truth" in this context refers to the defined parameters and methods set forth by the USP, which are established by expert consensus over time within the pharmaceutical and medical device industries. The testing itself is quantitative and objective, not reliant on expert interpretation for its results.
4. Adjudication method for the test set:
- Not applicable in the context of quantitative USP testing. Results are compared directly against predefined numerical and qualitative standards from the USP monograph.
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:
- This query is not applicable. The document is about a surgical suture, not an AI or algorithm-based diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This query is not applicable. The document is about a surgical suture, not an AI or algorithm.
7. The type of ground truth used:
- The "ground truth" used for this device's performance evaluation comprises the United States Pharmacopeia (USP) Monograph for Synthetic Absorbable Sutures and ISO 10993-1 for Biocompatibility. These are established, validated, and legally recognized standards that define acceptable performance characteristics for medical devices like surgical sutures.
8. The sample size for the training set:
- This query is not applicable. The document describes a physical medical device (suture) and its performance testing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- This query is not applicable as there is no AI algorithm or training set discussed.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.