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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.

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.

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Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.

The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter

The provided text describes a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device, and its 510(k) submission for clearance. However, it does not contain information about a study that establishes acceptance criteria and proves the device meets those criteria in the context of AI/ML device performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. This process typically involves non-clinical laboratory performance testing to show that the new device (in this case, an additional suture diameter size) performs comparably to the predicate and meets relevant standards (like USP monograph for absorbable sutures).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, acceptance criteria, sample sizes for test/training sets, ground truth, experts, adjudication methods, or MRMC studies. These details are not present in the provided text.

The closest relevant information is about the performance tests conducted to demonstrate substantial equivalence, which primarily involve non-clinical laboratory testing.

Here's what can be extracted from the document:

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

• Acceptance Criteria (Implied): Conformance to the USP monograph for absorbable sutures (as applicable).
• Reported Device Performance: "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device."
• Additional Tests Performed: In vitro post-hydrolysis tensile testing and in vivo resorption testing.

The following questions cannot be answered from the provided text as they pertain to AI/ML device performance studies, which are not described:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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Quill™ PDO Knotless Tissue-Closure Device comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 2 through 3-0 in various lengths affixed to various needle types.

The provided document is a 510(k) summary for a medical device, specifically a surgical suture. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical laboratory performance testing. This type of regulatory submission does not typically include a clinical study with elements like human readers, ground truth consensus, or AI assistance as it's for a physical medical device, not a diagnostic algorithm.

Therefore, many of the requested categories are not applicable to the information contained within this 510(k) submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003 as the acceptance criteria. The specific quantitative acceptance criteria (e.g., minimum tensile strength values) are not provided in this summary.

2. Sample size used for the test set and the data provenance:

This document describes non-clinical laboratory performance testing. It does not mention a "test set" in the context of human or patient data. The testing was likely performed on the suture devices themselves in a laboratory setting. No information on the number of devices tested or data provenance (country of origin, retrospective/prospective) for these laboratory tests is provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a non-clinical, laboratory-based study of a physical medical device. No expert ground truth establishment for a test set is mentioned.

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

Not applicable. This is a non-clinical, laboratory-based study.

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 a non-clinical study for a surgical suture and does not involve human readers, AI, or comparative effectiveness in a diagnostic imaging context.

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

Not applicable. This submission relates to a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical testing of a surgical suture would be defined by the specific measurement standards and methodologies outlined in the USP monograph and FDA guidance documents for tensile strength, needle attachment, and post-hydrolysis performance. These are objective, quantifiable criteria.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is laboratory testing of a physical product, not a machine learning model.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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