FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Y . JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of absorbable polydioxanone (PDO) suture. Y. JACOBS YOUNG'S THREAD consists of:

absorbable polydioxanone (PDO) suture
absorbable PLGA cone with each suture
disposable polycarbonate hub which has no patient contact

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Y. Jacobs Young's Thread," which is an absorbable polydioxanone surgical suture. The document establishes substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with outcome metrics.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, as typically seen with performance-based devices, is not applicable in this context for the Y. JACOBS YOUNG'S THREAD based on the provided document.

Instead, the document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This means that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's how the provided information relates to your questions, noting where the information is not present or not applicable for this type of submission:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense for this 510(k) submission. This document does not present specific quantitative acceptance criteria or performance metrics for the Y. JACOBS YOUNG'S THREAD in the way a clinical study would for efficacy/accuracy. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices.
The document states: "The data presented in this 510(k) encompasses biocompatibility, sterilization, shelf-life, and characterization testing of the suture design." However, no specific performance values or acceptance limits for these tests are provided in the public summary. The conclusion is a general statement of equivalency.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document states that "biocompatibility, sterilization, shelf-life, and characterization testing" was done, but it does not specify sample sizes for these tests or the data provenance.
Given this is a 510(k) for a surgical suture, the "test set" would typically refer to the samples used in these non-clinical tests (e.g., number of sutures tested for tensile strength, degradation profile, etc.).

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)

Not Applicable. This type of information is relevant for studies involving human interpretation or diagnosis, such as imaging or AI algorithms. For a surgical suture, "ground truth" would be established through objective laboratory testing (e.g., material analysis, strength testing) rather than expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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 specific to AI-assisted diagnostic devices, which is not the nature of a surgical suture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is specific to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the direct sense of diagnostic ground truth. For a surgical suture, "ground truth" for non-clinical testing would be established through validated laboratory methods and standards for material properties, tensile strength, degradation rate, biocompatibility, and sterility. The document refers to "characterization testing" which implies such objective measurements.

8. The sample size for the training set

Not Applicable. This is an AI-specific term. For a physical device like a suture, there isn't a "training set" in the machine learning sense. The development of the suture would involve materials science and engineering, with "training" referring to iterative design and testing.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary for Y. Jacobs Young's Thread based on the provided document:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Y. JACOBS YOUNG'S THREAD to existing predicate devices. This is a regulatory pathway that relies on showing the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. It does so by referencing:

Identical Indications for Use: "The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate." (Page 2 & 3)
Similar Material Composition: Absorbable PDO with D&C Violet No.2 (suture), PLGA (cone), Polycarbonate (hub). These are compared to the predicate devices' materials. (Page 3 & 4)
Similar Design: Knotless design with barbs, similar to the "QuillTM Self-Retaining System (SRS)" and "MINTTM" predators. (Page 4)
Performance Data: The submission includes "biocompatibility, sterilization, shelf-life, and characterization testing of the suture design." (Page 4) However, specific quantitative results from these tests are not detailed in this public summary document. The absence of specific performance metrics and acceptance criteria for these tests means the document does not allow for a table of "reported device performance against acceptance criteria" for the Y. JACOBS YOUNG'S THREAD itself. The substantial equivalence argument implies that these tests were sufficient to show the device performed comparably to, and as safely and effectively as, the predicate devices.

Summary

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.