(361 days)
TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . 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. It will be available with and with out a standard needle attached.
Here's an analysis of the provided document regarding the acceptance criteria and study for the TRUSILK™ Non-absorbable Silk Surgical Suture:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for TRUSILK™ Natural Nonabsorbable Silk Surgical Suture relies on equivalence testing to predicate devices and adherence to United States Pharmacopeia (USP) specifications. The acceptance criteria essentially are to meet or exceed the performance specified by USP 26 for various characteristics, matching the predicate devices.
| Acceptance Criteria (Based on USP 26) | Reported Device Performance (TRUSILK™) |
|---|---|
| Extractable color (Official Monograph) | Meets Official Monograph of USP 26 |
| Diameter (Performance requirements defined in USP 26 ) | Meets performance requirements defined in USP 26 |
| Tensile strength (Performance requirements defined in USP 26 ) | Meets performance requirements defined in USP 26 |
| Needle attachment (Performance requirements defined in USP 26 ) | Meets performance requirements defined in USP 26 |
| Sterility (Official Monograph) | Meets Official Monograph of USP 26 |
| Suture Length | Meets or exceeds USP specifications |
| Knot Pull Tensile Strength | Meets or exceeds USP specifications |
| Needle Attachment Strength | Meets or exceeds USP specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for testing each of the USP 26 criteria (e.g., how many sutures were tested for diameter, tensile strength, etc.). It only states that the testing was performed, and the device "meets or exceeds USP specifications."
- Sample Size: Not explicitly stated for individual tests.
- Data Provenance: The device is manufactured by Sutures India Pvt. Ltd. in Bangalore, India. The testing would have been conducted as part of their submission process, presumably at their facilities or a contracted lab. The data is retrospective in the sense that the tests were completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or provided in a 510(k) submission for a surgical suture. The "ground truth" for the performance of a surgical suture is established by the well-defined, objective, and quantitative specifications set forth in recognized standards like the United States Pharmacopeia (USP). These standards outline the methods and acceptable ranges for physical and performance characteristics. Therefore, expert consensus in the clinical sense is not used to establish the "ground truth" for these measurements.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is determined by objective, measurable criteria defined in USP standards, not by human interpretation requiring adjudication.
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. This is a submission for a physical medical device (surgical suture), not an AI/software as a medical device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/software device.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is based on USP 26 specifications for natural nonabsorbable silk surgical sutures. This includes:
- Defined ranges for diameter.
- Minimum requirements for tensile strength.
- Minimum requirements for needle attachment strength.
- Qualitative and quantitative criteria for extractable color and sterility.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.