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Quill® Nonabsorbable Nylon Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.

The Ouill® Nonabsorbable Nylon Barbed Suture is a monofilament, flexible thread prepared from long chain aliphatic polymers Nylon 6 and Nylon 6,6 (per 21 CFR 878.5020). It is available sterile, dyed black (logwood extract per 21 CFR 73.1410), dyed blue (FD&C Blue No. 2 per 21 CFR 74.3102) or undyed in various suture diameters, lengths and needle configurations in USP Sizes 2, 1, 0, 2-0, 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

The Quill® Nonabsorbable Nylon Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Nylon Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Nylon Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

The Quill® Nonabsorbable Nylon Barbed Suture is a medical device and doesn't involve AI/ML. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

However, based on the provided 510(k) summary, here's an analysis of its acceptance criteria and how the device meets them, focusing on the equivalence established for this type of medical device:

Acceptance Criteria and Device Performance

The acceptance criteria for the Quill® Nonabsorbable Nylon Barbed Suture are established through demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is based on:

• Identical Intended Use: Soft tissue approximation, excluding closure of the epidermis.
• Similar Technological Characteristics: Using barbs to secure tissue, obviating the need for knots.
• Identical Material: Nylon.
• Identical Sterilization and Packaging Methods.

The following table summarizes the comparison:

Study Information (Based on 510(k) Summary)

For non-AI medical devices following the 510(k) pathway, "studies" often refer to comparative analyses, biocompatibility testing (if new materials), and mechanical testing, rather than clinical efficacy trials akin to drug approval or AI model validation studies. The provided document focuses entirely on demonstrating substantial equivalence.

Here's an assessment based on the available information:

1. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here is primarily the comparison against predicate device characteristics.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for equivalence is established by regulatory standards and existing device classifications.
3. Adjudication method: Not applicable.
4. 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, as this is a physical medical device, not an AI/ML algorithm.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used:
   • Regulatory Standards and Predicate Device Data: The "ground truth" for this submission is based on the characteristics, safety, and effectiveness profiles of the legally marketed predicate devices and established regulatory requirements for nonabsorbable surgical sutures (21 CFR 878.5020). The predicates have already demonstrated safety and effectiveness through their prior market clearance.
7. The sample size for the training set: Not applicable, as this is not an AI/ML algorithm device.
8. How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the 510(k) Summary:

The manufacturer, Quill Medical, believes the Quill® Nonabsorbable Nylon Barbed Suture is substantially equivalent to the identified predicate devices based on its design, material, function, and intended use. The key arguments for equivalence are:

• Identical intended use (soft tissue approximation) to all predicates.
• Identical barbed technology for tissue approximation as the Quill® Nonabsorbable Polypropylene Barbed Suture (K052373).
• Identical material (Nylon) to the Nonabsorbable Nylon Surgical Sutures by Surgical Specialties Corp. (K930825) and GramsMed, LLC (K003000), which are well-established materials known to be biocompatible and safe for medical applications.

The FDA's letter (K052900) confirms their review of the submission and their determination that the device is substantially equivalent to legally marketed predicate devices, allowing the device to be marketed. This decision indicates that the FDA agreed with the manufacturer's assessment that the device meets the necessary acceptance criteria through its comparison to the predicates and does not raise new questions of safety or effectiveness.

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Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.

The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament.

The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

The provided document is a 510(k) summary for the Quill® Nonabsorbable Polypropylene Barbed Suture. This type of regulatory submission aims to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and study designs as would be expected for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the detailed information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why the requested information is absent:

• Acceptance Criteria and Reported Device Performance: Instead of performance metrics, the document focuses on comparing the new device's characteristics (materials, technology, intended use) to those of a legally marketed predicate device to establish substantial equivalence.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type & Training Set Details: These are all elements of a clinical effectiveness study or an AI/software performance study. A 510(k) summary for a medical device like this suture typically relies on non-clinical testing (e.g., tensile strength, biocompatibility), material safety, and comparison to a predicate, not clinical trials.

The document does, however, discuss:

• Predicate Devices: The Quill® Nonabsorbable Polypropylene Barbed Suture claims equivalence to:
  • Material/Technological Characteristics: Contour Midface Opposing Unidirectional Threads™ by Surgical Specialties Corp., 510k K050548.
  • Indication for Use based on Technological Characteristics: Quill® Synthetic Absorbable Barbed Suture by Quill Medical, Inc., 510k K051609.
• Intended Use: Soft tissue approximation, excluding closure of the epidermis.
• Basis for Equivalence:
  • Indication for Use: Equivalent to the Quill® Synthetic Absorbable Barbed Suture.
  • Material and Technology: Equivalent to the Contour Midface Opposing Unidirectional Threads™ in product code (GAW), technique of deployment (attached needles), technological characteristic (bi-directional barbs), material (polypropylene, cleared per K904906), sterilization (EO), and packaging.
• Safety and Performance Rationale: The document states, "The difference between the Quill® Nonabsorbable Polypropylene Barbed Suture and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the barbed suture... The device, as designed, is as safe and effective as its predicate devices."

In summary, the provided text does not describe a study with acceptance criteria in the manner requested because it is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting novel clinical performance data against pre-defined acceptance criteria.

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Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue.

The Quill® Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Synthetic Absorbable Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quil® Synthetic Absorbable Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

The Quill® Synthetic Absorbable Barbed Suture is indicated for use in soft tissue approximation. The provided text doesn't explicitly define numerical acceptance criteria for a new device's performance (e.g., specific tensile strength thresholds or degradation rates). Instead, it establishes substantial equivalence based on a comparison to predicate devices, supported by various studies.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit numerical acceptance criteria are not stated for a distinct "new device" but rather for equivalence, the table below reflects the types of performance data used to demonstrate safety and effectiveness relative to predicates.

2. Sample Size for Test Set and Data Provenance:

The provided text does not specify the sample sizes or provenance (country of origin, retrospective/prospective) for the test sets in the biocompatibility data, simulated use evaluation, in vivo barb holding and absorption assessments, in vivo animal studies, or human clinical trials.

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

This information is not provided in the text.

4. Adjudication Method for the Test Set:

This information is not provided in the text.

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

No mention of an MRMC comparative effectiveness study, or human readers improving with/without AI assistance, is made. This is an absorbable suture, not an AI-based diagnostic device.

6. Standalone (Algorithm Only) Performance Study:

Not applicable, as this is a physical medical device (suture), not an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating safety and effectiveness appears to be based on a combination of:

• Biocompatibility standards/testing: Chemical and biological inertness.
• Mechanical and functional performance testing: Demonstrating the physical properties and how the suture functions (barb holding, approximation).
• In vivo observations (animal studies): Direct biological response and functional outcome in living tissue.
• Clinical outcomes (human clinical trials): Safety and efficacy observed in human patients.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device. There is no "training set" in the context of an algorithm.

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

Not applicable, as this is a physical medical device.

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Quill™ Synthetic Absorbable Barbed Sutures are indicated to close easily approximated edges of dermis where use of absorbable sutures is appropriate.

The Quill™ Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths and needle configurations. The Quill™ Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissues. The Quill™ Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface imbedded in the tissues after the surgeon suture pierces the skin and appropriately places the suture within the tissues. The barbs on the Quill suture form an alternative method than knots in conventional suture for holding the two ends of a suture together.

Here's an analysis of the provided text, outlining acceptance criteria and study details for the Quill™ Synthetic Absorbable Barbed Suture:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Ethicon PDS II Suture) rather than explicitly listing acceptance criteria with numerical targets. However, the performance metrics used for comparison serve as de facto acceptance criteria for equivalence.

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

• Sample Size (Clinical): 171 patients (randomized into treatment and control groups). The distribution of numbers between treatment and control is not explicitly stated, but they are described as "balanced."
• Data Provenance: Prospective clinical trial conducted at two sites. The country of origin is not explicitly stated in the provided text.
• Sample Size (Pre-clinical/Animal): Not specified beyond "Animal Surgery Studies."

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

• Clinical Study:

  • Unblinded Assessments: "Forty investigators" enrolled patients and evaluated scars for abnormalities. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but they are implied to be medical professionals performing surgical procedures and follow-ups.
  • Blinded Assessments: "an independent blinded plastic surgeon" evaluated pictures of patients' surgical wounds. The specific number is "an" (singular) independent plastic surgeon. Their years of experience are not specified.

• Pre-clinical Studies: Expertise for biocompatibility, in vivo tensile strength, and barb holding strength would be from laboratory and animal study personnel, but specific numbers and qualifications are not mentioned.

4. Adjudication Method for the Test Set

• Clinical Study:
  • For unblinded assessments by the 40 investigators, no explicit adjudication method is described. It's implied that individual investigators made their assessments.
  • For blinded assessments, a single "independent blinded plastic surgeon" made the evaluations, so there was no multi-reader adjudication process stated for this part of the assessment.
  • Statistical analysis was used to compare the groups, which is a form of adjudicating overall group differences.

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 study was not done.
• This study is for a medical device (surgical suture), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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 AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Clinical Study:
  • Hollander Cosmesis Scale: Used for scar assessment, representing a standardized clinical rating scale. This likely relies on expert observation and clinical judgment.
  • Pain Assessment: Patient-reported or clinician-assessed pain scores.
  • Adverse Events: Clinically observed and reported events.
  • Wound Dehiscence: Clinical observation of wound integrity.
• Pre-clinical Studies:
  • Biocompatibility: Based on standardized tests (ISO Biological Evaluation of Medical Device Standard 10993).
  • Mechanical Properties (Tensile Strength, Barb Holding Strength): Measured using laboratory methods.
  • Absorption Profile: Measured through various analytical techniques in vivo.
  • Animal Surgery: Direct observation of surgical outcomes in animal models.

8. The Sample Size for the Training Set

• Not applicable in the context of an AI device. For this medical device, there isn't a "training set" in the machine learning sense. The development of the suture's design and manufacturing processes would be informed by prior research and engineering principles, but not a data-driven training set.

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

• Not applicable. As above, there's no "training set" for this type of medical device. The "ground truth" for the device's design and initial performance targets would be established through material science research, preclinical testing, and comparison to existing predicate devices.

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