(79 days)
Aurolab 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 nonabsorbable 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 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 coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.
The provided text describes a 510(k) summary for a Nylon Suture manufactured by Aurolab. The study focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and the performance results related to the device itself (the suture), even though it's not an AI device.
Here's the information based on the provided text, with clarifications where AI-specific details are not applicable:
Acceptance Criteria and Device Performance for Aurolab Nylon Suture
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Set by USP Standards) | Reported Device Performance (Aurolab Nylon Suture) |
|---|---|
| Meets USP standards for Diameter | Aurolab device tested meets USP standards |
| Meets USP standards for Tensile Strength | Aurolab device tested meets USP standards |
| Meets USP standards for Suture-Needle Attachment | Aurolab device tested meets USP standards |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the testing of diameter, tensile strength, and suture-needle attachment. It mentions that tests were conducted "according to methods presented in United States Pharmacopoeia (U.S.P)".
Data Provenance: Not explicitly stated beyond "tests according to methods presented in United States Pharmacopoeia (U.S.P)". The manufacturer is Aurolab, located in India. The studies were likely performed internally or by a contracted lab. The study appears to be a bench study to assess physical properties, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical device (suture), and its performance was assessed against established physical standards (USP) through laboratory testing, not through expert review of data.
4. Adjudication method for the test set
Not applicable. The assessment was based on objective measurements against USP standards, not subjective 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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The ground truth used was United States Pharmacopoeia (U.S.P) standards for physical properties of sutures, specifically:
- Diameter
- Tensile Strength
- Suture-Needle Attachment
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI/ML algorithm. The "ground truth" for the performance evaluation was established by the USP standards themselves.
§ 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.