(75 days)
The black silk braided nonabsorbable sutures, USP, are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The black silk braided nonabsorbable sutures, USP, manufactured by Johnson & Johnson Medical (China) Ltd. can be braided, coated with wax, dyed black (Logwood), available in a range of gauge sizes and lengths, and attached to stainless steel needles of varying types and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mersilk® Black Silk Braided Non-absorbable suture:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from USP XXIIII and other regulations) | Reported Device Performance |
|---|---|
| Suture diameter requirements (USP XXIIII) | Meets or exceeds USP specifications. |
| Suture length requirements (USP XXIIII) | Meets or exceeds USP specifications. |
| Knot pull tensile strength requirements (USP XXIIII) | Meets or exceeds USP specifications. |
| Needle attachment strength requirements (USP XXIIII) | Meets or exceeds USP specifications. |
| Additive (Logwood) content (Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3) | In conformance with the requirement addressed in Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3. Additionally, Logwood and coating wax are proved to be nontoxic. |
| Labeling compliance (USP XXIIII) | Complies with the specific requirement of USP XXIIII. |
| Symbol on packaging compliance (ISO/TR 15223) | Complies with the requirements of ISO/TR 15223 Medical Devices-Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied. |
| Sterilization validation and monitoring (corporate and international regulations) | Process of gamma sterilization, implemented by contract sterilizer, is validated and approved in conformance to corporate and international regulations. The gamma sterilization is approved and monitored according to established procedures. |
| Incoming material, in-process material, and finished goods acceptance/rejection criteria | Established procedures define the criteria of acceptance and rejection for incoming material, in process material and finished goods. The requirements are stricter than or in conformance to that of USP. |
| Biocompatibility (proven non-toxic) | Additives including Logwood and coating wax, are proved to be nontoxic. (Mentioned under "Performance Data" and "Performance and section 7.0 Biocompatibility"). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "various testing and clinical study contained in this submission," but does not explicitly state the sample size for the test set used to demonstrate adherence to USP XXIIII standards (suture diameter, length, knot pull tensile strength, needle attachment strength) or for the biocompatibility testing.
The data provenance is retrospective, as the testing was conducted on manufactured products to demonstrate compliance with established standards. The manufacturer is Johnson & Johnson Medical (China) Ltd., indicating the data would originate from China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of a clinical diagnostic study. The ground truth for the physical and chemical properties of the suture (e.g., diameter, strength, content) is established by conformance to established industry standards like USP XXIIII and ISO/TR 15223. For biocompatibility, it's stated that the additives are "proved to be nontoxic," implying testing against accepted toxicological standards, but details on the experts involved in interpreting such tests are absent.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation is based on objective, quantifiable measurements against pre-defined specifications from USP and other regulatory standards, not on subjective expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and an AI's impact on their performance is measured. This submission is for a surgical suture, a physical medical device, where performance is measured by objective physical and chemical properties, not by human interpretation of data aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in essence, standalone performance was assessed. The device's characteristics (diameter, length, strength, additive content) were tested directly against the USP and other regulatory specifications. There is no "human-in-the-loop" component for the performance evaluation of the suture itself; its performance is independently verifiable.
7. The Type of Ground Truth Used:
The primary type of ground truth used is established industry and regulatory standards.
- USP XXIIII (United States Pharmacopeia): For physical properties like suture diameter, length, knot pull tensile strength, and needle attachment strength.
- Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3: For additive (Logwood) content.
- ISO/TR 15223: For symbols on packaging.
- Corporate and international regulations: For sterilization validation.
- Biocompatibility testing: Proving non-toxicity, which implies testing against accepted toxicological protocols.
8. The Sample Size for the Training Set:
Not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing processes are validated, and quality control procedures are established, but these are not equivalent to training an AI model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm. For the manufacturing and quality control aspects, the "ground truth" for ensuring product quality is established through validated processes, established procedures for acceptance/rejection criteria, and adherence to regulatory standards (like USP) for incoming materials, in-process materials, and finished goods.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.