(79 days)
Aurolab nonabsorbable Silk suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.
This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.
This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.
The provided document is a 510(k) summary for Aurolab's nonabsorbable Silk sutures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data as typically seen in AI/ML device submissions.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Based on USP Standards) | Reported Device Performance (as stated) |
|---|---|---|
| Material Properties | Diameter meets USP specifications | Meets USP standards |
| Mechanical Properties | Tensile strength meets USP specifications | Meets USP standards |
| Device Integration | Suture-needle attachment meets USP specifications | Meets USP standards |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly mentioned. The document states that "tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture-needle attachment." USP monographs specify testing methods, which include sample sizes (e.g., 10 suture strands for specific tests), but the exact number of samples tested by Aurolab is not provided in this summary.
- Data Provenance: The tests were conducted internally by Aurolab in India. The data is retrospective in the sense that the summary is presenting results of tests already completed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable to the provided document. The "ground truth" for this medical device (nonabsorbable silk suture) is established by adherence to recognized industrial standards, specifically the United States Pharmacopoeia (USP). Experts in this context would be laboratory technicians and quality control personnel performing the physical and mechanical tests, not clinical experts establishing a medical "ground truth."
4. Adjudication Method
Not applicable. Performance is determined by objective measurements against predefined USP specifications, not by expert adjudication of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI/ML devices where human interpretation is involved. For a surgical suture, the effectiveness is demonstrated through mechanical and material property testing and clinical use experience (not detailed in this summary).
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable. This is a medical device (surgical suture), not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device is based on United States Pharmacopoeia (USP) standards and specifications for nonabsorbable silk sutures. These are objective, measurable physical and chemical properties.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
Summary of Acceptance Criteria and Study Design for the Suture:
The study conducted to demonstrate the substantial equivalence of the Aurolab nonabsorbable Silk sutures was a bench testing study focused on characterizing the physical and mechanical properties of the suture.
- Acceptance Criteria: The primary acceptance criteria were that the device's diameter, tensile strength, and suture-needle attachment met the specifications outlined in the United States Pharmacopoeia (USP) for nonabsorbable silk sutures.
- Study Design:
- Objective: To establish technical equivalency with predicate devices (Ethicon silk nonabsorbable sutures).
- Methodology: Performance tests were conducted in accordance with USP methodologies.
- Results: The tests performed showed that Aurolab devices meet USP standards and are technically equivalent to the predicate devices.
- Conclusion: Based on these tests, the device was deemed substantially equivalent to legally marketed predicate devices.
§ 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.