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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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POLYS YN™ Polyglycolic Acid (PGA) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures.

PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0.

This document describes the 510(k) summary for the PolySynTM (PGA) Surgical Suture. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically for additional diameter sizes (USP Size 7-0 through 10-0).

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the PolySynTM (PGA) Surgical Suture are conformity to the USP monograph for absorbable sutures and demonstration of substantial equivalence to predicate devices through various performance tests.

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

The document does not explicitly state the specific sample sizes for each test in the non-clinical laboratory performance testing. It generally refers to "performance testing."

The data provenance is from non-clinical laboratory performance testing. The country of origin of the data is not explicitly stated, but it is implied to be generated by the applicant, Surgical Specialties Corporation, in the United States (given their address). The data is retrospective testing done to support the 510(k) submission.

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

Not applicable. This device is a surgical suture, and the evaluation is based on non-clinical laboratory performance testing against established standards (USP monograph) and predicate device characteristics, not on expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on objective laboratory measurements against predefined specifications and comparisons to predicate device data, not on subjective assessments requiring adjudication.

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 device is a surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a traditional medical device (surgical suture), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for evaluation is based on:

• USP (United States Pharmacopeia) monograph for absorbable sutures: These are established, scientifically vetted standards for the physical and performance characteristics of surgical sutures.
• Predicate device characteristics: These are the established performance parameters of the legally marketed devices (K965162 and K022269) to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a traditional medical device (surgical suture) and does not involve machine learning or AI, thus no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for it.

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Quill™ MONODERM™ device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The Quill™ Monoderm™ Knotless Tissue-Closure Device is a sterile, synthetic absorbable tissue approximation device that 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 bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Sizes 0 to 5-0, in various lengths affixed to various needle types.

The provided text describes a 510(k) premarket notification for a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device (PGA-PCL). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria in the manner typical for AI/ML-based devices.

Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, standalone performance, training set details, or expert ground truth establishment) are not applicable to the information contained in this submission.

Here's an analysis of the provided text in relation to your questions, focusing on the available information:

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

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 specify sample sizes for the performance tests (USP monograph, in vitro tensile, in vivo resorption). It also does not provide details about the provenance of the data, such as country of origin or whether the studies were 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)

This type of information is not relevant or provided for this device type (a surgical suture). Ground truth, in the context of this device, would be defined by standardized chemical and physical tests rather than expert interpretation of data.

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

Not applicable to the type of device and testing described. Performance was assessed via laboratory and in-vivo testing, not through adjudication of expert opinions.

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 surgical suture, not an AI/ML-based diagnostic device where MRMC studies would be relevant.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance would be established through:

• Physical and chemical standards: As defined by the USP monograph for absorbable sutures.
• Direct measurement: Of properties like tensile strength and resorption rates in vitro and in vivo.
  The "ground truth" is objective measurement against established standards and comparisons to the predicate device, not expert consensus or pathology in the typical sense.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set as this is not an AI/ML device.

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MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ (PGA-PCL) Surgical Suture, structured according to your request:

Acceptance Criteria and Study for Monoderm™ (PGA-PCL) Surgical Suture

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in terms of individual sutures tested. The reference is to "performance testing" being conducted. The data provenance is implied to be from non-clinical laboratory testing conducted by the company, Surgical Specialties Corporation, likely in the USA (given the company's address and FDA submission). The nature of the testing suggests it is prospective in the sense that the new Monoderm™ (PGA-PCL) suture was manufactured and then subjected to these tests to evaluate its properties.

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

This information is not provided in the document. The "ground truth" for suture performance is typically established by physical and chemical properties measured against established standards (like the USP monograph), rather than expert human interpretation of images or other subjective data. Therefore, expert consensus in the traditional sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human review of subjective data, typically in diagnostic imaging or clinical trials where expert consensus is needed. For product performance testing of a physical device like a suture, the assessment is based on measured physical properties against predefined specifications, not human adjudication of subjective findings.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a physical surgical suture, not an AI device.

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

No, a standalone study (in the context of an algorithm) was not done. This submission is for a physical surgical suture.

7. The Type of Ground Truth Used

The ground truth used for evaluating the suture's performance is based on:

• Established standards and specifications: Specifically, the USP monograph for absorbable sutures.
• Comparative data against a legally marketed predicate device: "in vitro post-hydrolysis tensile testing" to demonstrate substantial equivalence. This implies that the predicate device's performance characteristics served as a reference "ground truth" for comparison.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This submission is for a physical medical device (suture) and does not involve an algorithm or AI model that requires a training set.

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

This information is not provided and is not applicable as there is no training set for an algorithm in this context.

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The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.

The provided text describes a 510(k) premarket notification for a medical device called the TranQuill barbed device, an absorbable surgical suture. The focus of the documentation is to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The documentation mentions "Non-clinical laboratory performance testing," but does not provide specific sample numbers for each test (e.g., number of sutures tested for tensile strength).
• Data Provenance: The testing was "Non-clinical laboratory performance testing," indicating it was conducted in a controlled lab environment. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it pertains to benchtop testing rather than clinical data.

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

• Not applicable. This device is a surgical suture, and the evaluation focused on non-clinical laboratory performance testing to establish substantial equivalence to a predicate device. It did not involve a test set requiring expert interpretation or ground truth establishment in the context of diagnostic or screening performance.

4. Adjudication Method for the Test Set:

• Not applicable. As the study involved non-clinical laboratory performance testing of physical characteristics, there was no need for an adjudication method as would be used in studies involving subjective expert opinions or diagnostic interpretation.

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

• No, an MRMC study was not done. This type of study is typically performed for diagnostic or screening devices to assess human reader performance with and without AI assistance. The TranQuill device is a surgical product, not a diagnostic tool requiring interpretation by multiple readers.

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

• Not applicable. The device is a physical surgical suture, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm.

7. Type of Ground Truth Used:

• Objective Measurement and Standards Compliance: The "ground truth" for this evaluation was based on objective measurements and adherence to established standards and predicate device performance.
  • USP monograph for absorbable sutures: This serves as a "ground truth" or standard for tensile strength.
  • Predicate device characteristics: The performance of the predicate device (Quill Synthetic Absorbable Barbed Suture, Quill™ Self-Retaining System (SRS) comprised of PDO) served as the comparative "ground truth" for barb holding strength and post-hydrolysis tensile testing.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical device (suture), not an AI/ML algorithm that requires a training set. The evaluation focuses on physical and mechanical properties.

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

• Not applicable. As there is no training set for a physical device, this question is not relevant.

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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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Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue. They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.

The provided text describes the performance tests conducted for the Polypropylene Surgical Suture and Quill™ Polypropylene Knotless Tissue-Closure Devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the devices conform to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures regarding diameter and tensile strength.

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

The document does not specify the exact sample sizes used for the non-clinical laboratory performance testing. It only mentions that "Non-clinical laboratory performance testing was conducted." The data provenance is implied to be retrospective as it involves testing of manufactured devices to confirm adherence to existing standards and comparison to predicate devices, rather than a prospective study to generate new clinical data. The country of origin for the data is not explicitly stated but is implied to be in the USA given the FDA context.

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

This information is not applicable as the ground truth for these non-clinical performance tests is established by adherence to a standardized monograph (USP) and direct physical/chemical testing, not by expert interpretation or consensus.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical laboratory performance testing. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical laboratory performance study, not a clinical study involving human readers.

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

This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical performance tests is based on established industry standards and physical/chemical properties, specifically:

• The USP (United States Pharmacopeia) monograph for nonabsorbable sutures for diameter and tensile strength.
• Chemical characterization and biological risk assessment to evaluate chemical equivalency.

8. The Sample Size for the Training Set:

This information is not applicable as the study described is a non-clinical performance test for a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above (no training set for a physical medical device).

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Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. 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 Size 0 in various lengths affixed to various needle types.

The provided text describes a medical device, the Quill™ Polypropylene Knotless Tissue-Closure Device, and its regulatory submission. It does not contain information about a study with acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a substantial equivalence determination by the FDA, primarily relying on performance testing against existing standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with defined acceptance criteria for such metrics.

Therefore, I cannot provide the requested information based on the given text. The document focuses on:

• Device Description: A sterile, synthetic nonabsorbable tissue-closure device with barbs and a loop design, made of polypropylene.
• Indications for Use: Soft tissue approximation, excluding epidermis closure.
• Substantial Equivalence Claims: Based on material composition and intended use being identical to a predicate barbed suture, and design being identical to other knotless tissue-closure devices.
• Performance Tests: Non-clinical laboratory testing to confirm compliance with USP monograph for nonabsorbable sutures regarding tensile strength and needle attachment, performed according to FDA's Class II Special Controls Guidance Document: Surgical Sutures.

Since the device is a surgical suture, the "acceptance criteria" discussed are related to physical and mechanical properties (tensile strength, needle attachment) rather than diagnostic performance metrics (e.g., sensitivity, specificity) expected in studies involving AI algorithms or human reader performance.

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

The QuillTM 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 0, 2-0 and 3-0 in various lengths affixed to various needle types.

This 510(k) submission describes a Quill™ PDO Knotless-Tissue Closure Device, Variable Loop Design (Polydioxanone), which is an absorbable surgical suture. The device is a sterile, synthetic absorbable tissue-closure device comprised of polyester [poly (p-dioxanone)], with uni-directional barbs and a welded primary and secondary loop design at the distal end. It is available in diameter Size 0, 2-0, and 3-0 in various lengths affixed to various needle types.

The submission focuses on demonstrating substantial equivalence to a predicate device (K113744 Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size -0-) by confirming that the new device, which differs only in suture diameter, meets established performance standards for absorbable sutures.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the new device has "the same design and materials as the Quill™ PDO Knotless Tissue-Closure Device predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter." This implies the acceptance criteria for these performance aspects are to meet or exceed the performance of the predicate device and the general USP standards.

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

The document specifies "Non-clinical laboratory performance testing was conducted." It also mentions "Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing."

• Sample Size: The document does not explicitly state the sample size used for the non-clinical laboratory performance testing or the in vitro post-hydrolysis tensile testing.
• Data Provenance: The tests are described as "non-clinical laboratory performance testing" and "in vitro," indicating they were conducted in a laboratory setting, likely by the manufacturer, Angiotech. There is no information regarding the country of origin of the data or whether the data was retrospective or prospective in the context of animal or human studies, as these were material and mechanical property tests.

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

This type of information is not applicable to this submission. The "ground truth" for this medical device (surgical suture) is established by adherence to recognized standards for material properties (e.g., USP monograph) and performance measures like tensile strength and needle attachment, rather than expert interpretation of images or clinical outcomes that require expert consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of ambiguous cases (e.g., diagnostic imaging). For non-clinical, laboratory-based material property testing, the "ground truth" is determined by objective measurements and reference to 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

Not applicable. This submission is for a surgical suture, not an AI-assisted diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.

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

Not applicable. This submission is for a surgical suture, not an algorithm or AI device.

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

The "ground truth" in this context is based on:

• Established Standards: Primarily the USP monograph for absorbable sutures.
• Mechanical and Material Properties: Objective measurements of tensile strength, needle attachment, and in vitro post-hydrolysis tensile strength.
• Predicate Device Performance: The new device's performance was compared to that of the legally marketed predicate device (K113744) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train machine learning models. This submission is for a surgical suture, not an AI or machine learning device.

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

Not applicable. As stated above, there is no training set for this type of device submission.

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