(118 days)
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White).
This document pertains to the 510(k) premarket notification for the LOOK™ PTFE Suture (K160744). The information provided focuses on the substantial equivalence of this device to predicate devices concerning its physical characteristics and biocompatibility, as confirmed through performance and biocompatibility testing. It is not a clinical study of an AI-powered device, therefore, many of the requested elements are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the LOOK™ PTFE Suture are based on conformance to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures for tensile strength and needle attachment, as well as adherence to biocompatibility standards.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Suture Diameter | Conforms to USP | All acceptance criteria were met at all testing intervals. |
| Needle Attachment | Conforms to USP | All acceptance criteria were met at all testing intervals. |
| Tensile Strength | Conforms to USP | All acceptance criteria were met at all testing intervals. |
| Shelf Life (5 years) | Maintains USP conformance for tensile strength and needle attachment. | All acceptance criteria were met for the entire shelf life. |
| Biocompatibility Testing | ||
| Cytotoxicity | Pass (according to ISO Elution Method) | All acceptance criteria were met. |
| Intracutaneous Reactivity | Pass (according to ISO Intracutaneous Study in Rabbits) | All acceptance criteria were met. |
| Sensitization | Pass (according to ISO Guinea Pig Maximization Sensitization Test) | All acceptance criteria were met. |
| Endotoxin | Pass | All acceptance criteria were met. |
| Pyrogenicity | Pass (according to Material-mediated Rabbit Pyrogen Test) | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the performance and biocompatibility testing. The testing was conducted internally by Surgical Specialties Corporation, a company based in Mexico. The studies are non-clinical laboratory performance and biocompatibility tests, not human clinical trials. Thus, the concept of "data provenance" in terms of country of origin of patient data or retrospective/prospective human study is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are non-clinical, laboratory-based tests comparing physical properties and biological reactions against established standards (USP monographs, ISO 10993-1). No human "experts" are establishing a "ground truth" in the diagnostic sense; rather, the "ground truth" is defined by the established regulatory and scientific standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple human readers, not for laboratory performance and biocompatibility testing of a medical device's physical properties.
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 is not applicable. This document describes a traditional medical device (suture), not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical medical device (suture), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests were the quantitative specifications defined in the United States Pharmacopeia (USP) monographs for nonabsorbable sutures (specifically USP for diameter, USP for needle attachment, and USP for tensile strength).
The "ground truth" for the biocompatibility tests were the standards and acceptable limits defined in International Standard ISO 10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and testing within a risk management process" and the specific test protocols derived from it.
8. The sample size for the training set
This is not applicable. This document describes a traditional medical device (suture), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable since there is no training set for this type of device.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.