(127 days)
PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.
PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.
This document is a 510(k) summary for a medical device called PERMATAPE™ SUTURE. The document details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here is the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it refers to industry standards and predicate device comparisons.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| USP Tensile Strength for Surgical Sutures | PERMATAPE™ Suture's performance was tested per USP Tensile Strength for Surgical Sutures. |
| Conformance to FDA's Special Controls Guidance document for Surgical Sutures | The device follows FDA's Special Controls Guidance document for Surgical Sutures. |
| Bacterial endotoxin testing requirements | The proposed device met requirement of bacterial endotoxin testing. |
| Substantial equivalence to predicate devices in intended use, materials, sterilization method, and technological characteristics. | Based on similarities, the PERMATAPE™ suture has been shown to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The document describes a physical medical device (surgical suture), not a software or AI/ML device that would typically involve test sets of data. The testing mentioned (USP Tensile Strength, bacterial endotoxin) would involve physical samples of the suture, but the sample sizes for these tests are not specified, nor is the "data provenance" as it would apply to data in an AI context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this document. This is a physical medical device submission, not an AI/ML device where "experts" would establish ground truth for a test set. The "ground truth" for a suture would be its physical properties, which are measured using standardized methods.
4. Adjudication method for the test set
This information is not applicable to this document. Adjudication methods like "2+1, 3+1" are relevant for AI/ML device studies where discrepancies in expert labels or model predictions need resolution. For a physical device, performance is measured against established standards.
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 to this document. An MRMC study is relevant for AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical suture, which does not involve human "readers" or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this document. The device is a surgical suture; it is not an algorithm and does not have "standalone" performance in the context of AI.
7. The type of ground truth used
For the physical characteristics of the suture, the "ground truth" is established by adherence to established industry standards and test methods, specifically:
- USP Tensile Strength for Surgical Sutures
- FDA's Special Controls Guidance document for Surgical Sutures
- Requirements for bacterial endotoxin testing
8. The sample size for the training set
This information is not applicable and not provided. This is a physical medical device, not an AI/ML device requiring a "training set" of data in the common sense. The manufacturing process of the suture is the "training" in a very loose analogy, but it's not a data-driven training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As explained above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for the manufacturing process would be established by quality control procedures and specifications for materials and manufacturing methods, but these details are not provided in this regulatory summary.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.