(101 days)
The SafePath Suturing System is intended for use in placement of a silk 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 30 in. length, swaged on 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.
The System Includes:
(2) Suturing Device Pre-loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a ½ circle, 26 mm reverse cutting needle
The provided document describes the SafePath Suturing System, a medical device. Based on the content, the acceptance criteria and the study that proves the device meets those criteria are focused on physical properties and biocompatibility of the suture itself, rather than AI/algorithm performance. There is no mention of an AI component in this device.
Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, human-in-the-loop performance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details) is not applicable to this device.
Here's a breakdown of the acceptance criteria and study information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Standards) | Reported Device Performance |
|---|---|
| Nonabsorbable Sutures - Diameter | Met or exceeded USP criteria |
| Sutures - Needle Attachment | Met or exceeded USP criteria |
| Tensile Strength | Met or exceeded USP criteria |
| Biocompatibility Testing (ISO-10993 Guidance) | |
| Cytotoxicity | Met test criteria |
| Sensitization | Met test criteria |
| Irritation | Met test criteria |
| Systemic Toxicity | Met test criteria |
| Hemocompatibility | Met test criteria |
| Pyrogenicity | Met test criteria |
| Endotoxicity | Met test criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "Physical Testing" and "Biocompatibility Testing," but does not specify the sample sizes used for these tests.
The data provenance is implied to be laboratory testing of the device components, not human or patient data.
- Data Provenance: Laboratory testing of the SafePath Suturing System components (sutures and overall system).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of device physical and biocompatibility testing. Ground truth here refers to established scientific/engineering standards (USP and ISO).
4. Adjudication Method for the Test Set:
Not applicable. Testing appears to be based on adherence to quantitative standards rather than expert consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this type of study is for evaluating diagnostic or interpretive AI systems. The SafePath Suturing System is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this pertains to AI/algorithm performance, which is not relevant to this device.
7. The Type of Ground Truth Used:
- Physical Testing: United States Pharmacopeia (USP) standards for Nonabsorbable Surgical Suture (Diameter, Needle Attachment, Tensile Strength).
- Biocompatibility Testing: FDA Guidance regarding the use of International Standards ISO-10993.
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set.
In summary, the SafePath Suturing System is a traditional medical device, and its acceptance criteria and testing focus on its physical properties, sterility, and biocompatibility in accordance with established medical device standards and regulations. The questions related to artificial intelligence and machine learning performance are not relevant to this specific device.
§ 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.