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The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.

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

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.

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The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.

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.

The Y. JACOBS YOUNG'S THREAD will be available in single use packages, sterile after ethylene oxide (EO) gas sterilization. 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

The provided text describes a 510(k) premarket notification for the "Y. JACOBS YOUNG'S THREAD," an absorbable polydioxanone surgical suture. The document attests to the substantial equivalence of the device to legally marketed predicate devices, rather than detailing a study against specific acceptance criteria for performance in a clinical setting in the way one might for an AI/ML device.

Here's an analysis based on the information provided, focusing on how a medical device's "acceptance criteria" are typically met in a 510(k) submission, particularly for an absorbable suture:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a surgical suture, "acceptance criteria" are generally tied to demonstrating equivalence to predicate devices across various material and mechanical properties, as well as biocompability and sterilization. The document lists the types of performance tests conducted.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes for each of the performance tests (e.g., number of sutures tested for tensile strength). It mentions "characterization testing of the suture design," "tensile strength," "strength retention (biodegradability)," "straight-pull," "barb holding force," "degradation profile," "biocompatibility," and "LAL (endotoxin)."

• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) for a physical medical device (suture), the performance data would typically be derived from in vitro (laboratory) and in vivo (animal, if applicable, or simulation) testing conducted under controlled conditions, often by the manufacturer or authorized testing labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not relevant for the technical performance testing of a surgical suture in a 510(k) submission. The "ground truth" for suture performance is established by standardized testing methods and international standards (e.g., ASTM, ISO standards for surgical sutures).

• For Biocompatibility: The "ground truth" is adherence to ISO 10993 series standards, assessed by toxicologists and other experts in the field.
• For Mechanical Testing: The "ground truth" is defined by the test method and equipment calibration, with results analyzed by engineers and materials scientists.

4. Adjudication Method for the Test Set

Not applicable in the context of physical and material performance testing for a suture. Test results are objectively measured and compared against predefined specifications or predicate device data, not subject to expert adjudication in the same way clinical image interpretation might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are typically used to evaluate the diagnostic or prognostic performance of imaging devices, AI algorithms, or other tools where human interpretation plays a significant role. This submission pertains to a physical surgical suture.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical surgical suture, not an algorithm. Its performance is inherent in its material properties and design, used by a surgeon (human-in-the-loop, but not assisted by this specific device in a way that requires AI/ML evaluation).

7. Type of Ground Truth Used

The ground truth used for the performance evaluation of this surgical suture would be based on:

• Standardized Test Methods and Specifications: Adherence to established industry standards (e.g., for tensile strength, degradation rates, barb holding force).
• Predicate Device Data: The performance of the predicate devices (Quill™ Self-Retaining System and MINT™) serves as the benchmark for demonstrating substantial equivalence.
• Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices.
• Sterility Assurance Levels (SAL): Defined by sterilization standards.

8. Sample Size for the Training Set

Not applicable. The Y. JACOBS YOUNG'S THREAD is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on a design and tested to ensure it meets specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" for an AI/ML algorithm, this question is irrelevant to this device submission. The "ground truth" for manufacturing a suture is the design specification and quality control processes.

Summary of the Study that Proves the Device Meets Acceptance Criteria for a 510(k) Submission:

The provided document describes the basis for a 510(k) clearance, which is demonstrating substantial equivalence to existing legally marketed predicate devices. The "study" here is a series of in vitro and potentially in vivo (non-human) engineering and material science tests.

• Device: Y. JACOBS YOUNG'S THREAD (absorbable polydioxanone surgical suture with barbs).
• Predicate Devices:
  • K080985: Quill™ Self-Retaining System (SRS) (Surgical Specialties Corp.)
  • K130191: MINT™ (Hansbiomed Corp.)
  • K120827: Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) (Angiotech)
• Design: Monofilament PDO suture with uni-directional barbs, dyed with D&C Violet No.2, sterilized by ethylene oxide.
• Intended Use: Soft tissue approximation where an absorbable suture is appropriate.
• Performance Tests Conducted: Biocompatibility, sterilization, shelf-life, characterization testing of suture design, tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile, and LAL (endotoxin).
• Conclusion of the Study (as stated in the document): "Based on the comparison, as well as the information provided in the SE Comparison Table... supported by data found in Sections 11, 14, 15 and 18, we have demonstrated that the Y. JACOBS YOUNG'S THREAD has been shown to be as substantially equivalent for the proposed Intended and Indications for Use as the legally marketed predicate devices."

The entire submission package to the FDA, including the detailed reports of these tests (Sections 11, 14, 15, and 18, which are not provided here), constitutes the "study" demonstrating that the device meets the criteria for substantial equivalence, and thus, "acceptance." The acceptance criteria are, in essence, meeting or exceeding the performance characteristics of the identified predicate devices in relevant tests.

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