(60 days)
Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications.
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.
The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sutralon device:
This document is a 510(k) summary for a medical device called Sutralon, which is a non-absorbable synthetic polyamide suture. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and efficacy through extensive clinical trials.
Therefore, the type of "study" described here is primarily focused on bench testing to meet established industry standards, rather than a clinical study with human patients, AI, or expert readers.
Here's the information extracted and organized according to your request:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Standards) | Reported Device Performance (Sutralon) |
|---|---|
| Diameter (USP Standards) | Meets USP standards |
| Tensile Strength (USP Standards) | Meets USP standards |
| Suture-Needle Attachment (USP Standards) | Meets USP standards |
Notes:
- The document explicitly states that "Performance tests to demonstrate substantial equivalency" were conducted "according to methods presented in United States Pharmacopia (U.S.P.)".
- The results show that "SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document only mentions "SutraTec devices tested."
- Data Provenance: Not explicitly stated, however, the tests were conducted to meet United States Pharmacopia (U.S.P.) standards, implying adherence to US-recognized methodologies and specifications for medical devices. The nature of the tests (diameter, tensile strength, suture-needle attachment) suggests they are laboratory-based bench tests rather than data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on objective, measurable physical properties (diameter, tensile strength, attachment strength) as defined by established USP standards. The "ground truth" is the USP specification itself, not a consensus of human experts interpreting images or clinical data.
4. Adjudication method for the test set:
- Not applicable. As the "ground truth" is defined by objective USP standards for physical properties, there is no need for expert adjudication. Measurements are taken directly against the specified limits.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with or without AI assistance. This device is a surgical suture, and its performance is evaluated by physical characteristics, not diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an AI algorithm. Its performance is based on the physical properties of the suture material.
7. The type of ground truth used:
- Established Industry Standards/Specifications: The ground truth for performance evaluation is derived from the United States Pharmacopia (U.S.P.) standards for suture diameter, tensile strength, and suture-needle attachment.
8. The sample size for the training set:
- Not applicable. This document describes the testing of a physical medical device (suture) against established standards. There is no AI model or algorithm that requires a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is irrelevant to the Sutralon 510(k) submission.
§ 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.