(753 days)
SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.
The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.
This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.
Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document highlights the following non-clinical performance criteria and testing for the sutures:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| USP Nonabsorbable Sutures - Diameter | Met or exceeded USP criteria |
| USP Sutures - Needle Attachment | Met or exceeded USP criteria |
| USP Sutures - Tensile Strength | Met or exceeded USP criteria |
| Biocompatibility - Cytotoxicity | Met test criteria |
| Biocompatibility - Sensitization | Met test criteria |
| Biocompatibility - Irritation | Met test criteria |
| Biocompatibility - Systemic Toxicity | Met test criteria |
| Biocompatibility - Hemocompatibility | Met test criteria |
| Biocompatibility - Pyrogenicity | Met test criteria |
| Biocompatibility - Endotoxicity | Met test criteria |
2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.
4. Adjudication method for the test set: Not applicable as this is a non-AI/ML device.
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 as this is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.
7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).
8. The sample size for the training set: Not applicable as this is a non-AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.
The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the 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.