(360 days)
TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. The suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture. The suture may be dyed Logwood Extract, C.175290 conforming to 21 CFR 73.1410. The suture may be provided with or without a standard needle attached.
The provided document is a 510(k) premarket notification for a non-absorbable polyamide surgical suture (TRULON™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design and performance metrics for an AI/device will not be available in this type of document.
The document describes the device, its intended use, and then compares it to two predicate devices, highlighting similarities in material, design, manufacturing, sterilization, labeling, and performance requirements as defined by the United States Pharmacopeia (USP).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with reported numerical device performance in the format typically seen for novel device performance studies. Instead, it states that the device "meets or exceeds USP specifications" for various properties, implying that USP standards serve as the acceptance criteria.
| Acceptance Criteria (USP 26 Specifications) | Reported Device Performance (TRULON™) |
|---|---|
| Extractable color | Meets or exceeds USP specifications |
| Diameter () | Meets or exceeds USP specifications |
| Tensile strength () | Meets or exceeds USP specifications |
| Needle attachment strength () | Meets or exceeds USP specifications |
| Sterility | Meets or exceeds USP specifications |
| Finished suture Length Requirement (95% of stated label length) | Meets or exceeds USP specifications |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to testing performed to USP 26 methods, but the specific sample sizes for these tests are not quantified. The data provenance is also not specified; it is assumed to be from internal testing conducted by SUTURES INDIA PVT.LTD.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. This document is for a physical medical device (suture) and not an AI or diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by physical and chemical properties and performance standards outlined in the USP.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, which are not part of the described testing for a surgical suture.
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
This information is not applicable. This document is for a surgical suture, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document is for a surgical suture, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating compliance is based on United States Pharmacopeia (USP) standards and specifications for non-absorbable surgical sutures. This includes objective measurements of physical and chemical properties.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices like sutures.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes several tests performed on the TRULON™ Non-absorbable Polyamide Surgical Suture to demonstrate its equivalence to predicate devices and compliance with established standards.
- Study Type: The study is not a clinical trial or a typical "performance study" in the context of an AI or diagnostic device. Instead, it's a series of bench tests and material characterization performed according to the methods outlined in United States Pharmacopeia (USP) 26.
- Objective: To demonstrate that the TRULON™ suture "meets or exceeds USP specifications" for various critical properties and is substantially equivalent to legally marketed predicate devices.
- Tests Performed:
- Suture Diameter: Tested according to USP 26, method .
- Suture Length: Tested according to USP 26, ensuring 95% of stated label length.
- Knot Pull Tensile Strength: Tested according to USP 26, method .
- Extractable Color: Tested according to USP 26.
- Needle Attachment Strength: Tested according to USP 26, method .
- Sterility: Tested according to USP 26.
- Biocompatibility: Tested as per ISO 10993 standards. (Note: Specific ISO 10993 tests and results are not detailed, but conformance is stated).
- Result: The conclusion states that the testing "demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices."
The document serves as a 510(k) summary, which is essentially a declaration and summary of evidence supporting substantial equivalence, rather than a detailed report of a formal performance study with raw data and statistical analysis.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(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.