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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™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture 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 Sizes 1 to 3-0, in various lengths affixed to various needle types.

This document describes the premarket notification (510(k)) for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design.

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 the "test set" in the context of human data or clinical study. The performance testing described is non-clinical laboratory performance testing. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to human subjects is not applicable here.

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

Not applicable. The ground truth for this device's performance is established through non-clinical laboratory testing according to established standards (USP monograph) and direct comparison to predicate devices, not through expert consensus on a test set of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This device is a physical surgical suture, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for this device includes:

• USP Monograph Standards: For tensile strength and needle attachment. These are well-defined, established standards for absorbable sutures.
• Predicate Device Performance Data: For in vitro post-hydrolysis tensile testing, the performance of the predicate devices serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (suture) and does not involve AI or machine learning.

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

Not applicable, as there is no training set for this device.

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

The Quill TM Monoderm TM 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 Sizes 2-0 to 0 in various lengths affixed to various needle types.

This document describes the 510(k) submission for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. The device is an absorbable surgical suture. The submission focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Acceptance Criteria and Device Performance Study Information:

This 510(k) summary does not include detailed acceptance criteria or a "performance table" in the typical sense of a diagnostic device's metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the requirements of the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document for Surgical Sutures. The device's performance is demonstrated by meeting these standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Non-clinical laboratory performance testing was conducted." However, it does not specify the sample size used for the various tests (tensile strength, needle attachment, in vitro post-hydrolysis tensile testing).

The data provenance is non-clinical laboratory testing. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as these concepts are generally not applicable to laboratory performance testing of this nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This type of information is not applicable to this device's submission. The "ground truth" for a surgical suture is defined by established engineering and material science standards (e.g., USP monographs, FDA guidance). Expert review, as in clinical or imaging studies, is not part of establishing the performance for these specific non-clinical tests.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple reviewers assess outcomes or image interpretations. For laboratory performance testing, the results are objectively measured against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on their performance. The Quill™ Monoderm™ device is a surgical suture, not a diagnostic tool requiring human interpretation in this context.

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

This information is not applicable. The device is a physical surgical suture, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing is based on established industry standards and regulatory requirements. Specifically:

• USP monograph for absorbable sutures for tensile strength and needle attachment.
• FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
• The characteristics and performance of the legally marketed predicate devices to which equivalence is claimed.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a surgical suture, not a machine learning model that requires a training set. The performance testing described is for product verification and validation, not for algorithm training.

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

This information is not applicable as there is no training set for this type of medical device submission.

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

The Quill™ Monoderm™ 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 Size 2-0 in various lengths affixed to various needle types.

The provided document is a 510(k) summary for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. It describes the device, its indication for use, and a general statement about performance testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information to fully address all parts of your prompt.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative values or pass/fail thresholds. The document generally refers to conforming to the USP monograph for absorbable sutures and demonstrating substantial equivalence.
• Reported Device Performance: The document states that "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices." No specific performance metrics (e.g., actual tensile strength values, degradation rates) are provided.

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

• Sample Size: Not specified.
• Data Provenance: The document only mentions "testing" and "simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing." It does not specify country of origin, retrospective or prospective nature, or where the testing was conducted.

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 device is a surgical suture, and the performance tests described are mechanical and material characterization studies, not image interpretation or diagnostic studies that would require expert consensus for ground truth.

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

• No. This is not an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• For the non-clinical laboratory performance testing (tensile strength, needle attachment), the "ground truth" would be established by standardized measurement techniques and USP monograph specifications.
• For the simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing, the "ground truth" would be the measured physical properties of the device and the predicate devices, compared against each other.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device that requires a training set. The performance tests are experimental studies, not algorithm training.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary offers a high-level overview of the device and the types of performance testing conducted to support substantial equivalence. It lacks the detailed quantitative data, sample sizes, and specific methodologies that would be required to fully answer most of your detailed questions, particularly those related to clinical studies, AI performance, or expert-adjudicated ground truth, as those concepts do not apply to this type of device and submission.

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