BIOELAST 5-0 SUTURE, MODEL 500100

• K Number: K072470
• Device Name: BIOELAST 5-0 SUTURE, MODEL 500100
• Manufacturer: ENTRIGUE SURGICAL, INC.
• Date Cleared: 2007-11-16 ( 73 days)
• Product Code: NWJ
• Regulation Number: 878.4494
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K163013 , K913865

Intended Use

BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description

BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.

AI/ML Overview

The provided text describes a 510(k) summary for the BioElast™ 5-0 Suture. It details the device, its indications for use, and a general statement about safety and performance, but it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Specifically, the document states: "Results of bench and in-vivo testing demonstrate that the BioElast™ 5-0 Suture is biocompatible and substantially equivalent in function to the predicate devices."

This statement indicates that testing was performed and that the device was found substantially equivalent to predicate devices (Tepha, Inc., TephaFLEX® Absorbable Suture and Ethicon, Inc., PDS*II). However, it does not provide:

1. A specific table of acceptance criteria and reported device performance. The document only gives a general statement of meeting certain benchmarks through substantial equivalence.
2. Details about sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. This is typically for AI-powered diagnostic devices, not sutures.
6. Information about standalone algorithm performance. Again, this is for AI-powered diagnostic devices.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Given the nature of the device (a surgical suture) and the context of a 510(k) summary for a Class II medical device, the "acceptance criteria" here are generally implied by the regulatory standard of substantial equivalence to existing legally marketed predicate devices. This means that the new device performs as intended and is as safe and effective as the predicate devices, based on comparative bench and in-vivo testing.

Therefore, I cannot populate the requested table and detailed information as the provided text does not contain that level of detail for a medical device study typical of AI/diagnostic tools.

Regulation Number and Section

§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).