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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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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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