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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.

AI/ML Overview

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.

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Summary from Text)
Biocompatibility: Device material is safe for biological contact.	Biocompatibility data provided.
Functional Performance (Simulated Use): Device performs as intended in simulated surgical conditions.	Simulated use evaluation provided.
Barb Holding & Absorption: Barbs effectively hold tissue, and suture degrades as expected.	Results of in vivo barb holding and absorption assessments provided. Degrades or dissolves over time in tissue. Barbs imbed in tissues.
In Vivo Performance (Animal Studies): Device is safe and effective in living organisms.	Results of in vivo animal studies provided.
Clinical Performance (Human Studies): Device is safe and effective in human use.	Human clinical trial results provided.
Technological Characteristics: Comparable technique of deployment and tissue approximation mechanism.	Subcuticular placement: needle captures a precise bite on each side of the incision. Bi-directional barbs along the long axis of the suture monofilament catch and cinch to approximate the tissue without the need for a knot, similar to an interrupted suture. This is compared to: Contour Midface Opposing Uni-directional Thread (needle placement/introducer, opposing unidirectional cogs) and Insorb™ Absorbable Staple (mechanically placed, cleats of u-shaped staple).
Material Safety: Material is as safe as predicate device.	Equivalent in material to predicate (Quill® Synthetic Absorbable Barbed Suture, K042075). Polydioxanone is well-characterized.

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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K Number

K042075

Device Name

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

Manufacturer

QUILL MEDICAL, INC.

Date Cleared

2004-10-26

(85 days)

Product Code

NEW

Regulation Number

878.4840

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Intended Use

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

Device Description

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.

AI/ML Overview

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.

Parameter	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Quill™ Synthetic Absorbable Barbed Suture)
Material Composition	Poly (p-dioxanone) (matching predicate)	Poly (p-dioxanone)
USP Sizes	9-0 to 2 (predicate range, device is within this range for its available sizes)	2-0 to 2
Oversized Diameter	Yes (matching predicate)	Yes
Tensile Strength Equivalence	Comparable to predicate for specific USP sizes (e.g., Quill Size 2-0 ≅ USP Size 4-0, Quill Size 0 ≅ USP Size 3-0, Quill Size 2 ≅ USP Size 0)	Quill Size 2-0, Quill Size 0, Quill Size 2 (matched to predicate sizes)
Approximation Method	Knots (predicate) - Note: This is a key difference, addressed by clinical equivalency of function.	Barbs
Absorption Profile (% Remaining at Time)	0 months: 100%
2 months: ~100%
4 months: ~100%
6 months: ~26% (Predicate values are the benchmark)	0 months: 100%
2 months: ~101%
4 months: ~94%
6 months: ~18%
Strength Retention Profile (% Strength at Time)	0 week: 100%
2 week: ~70%
4 week: ~50%
6 week: ~25% (Predicate values are the benchmark)	0 week: 100%
2 week: ~81%
4 week: ~79%
6 week: ~42%
Biocompatibility	Non-toxic, non-hemolytic, non-irritating, non-pyrogenic, non-allergenic, non-sensitizing, non-cytotoxic, non-reactive, and biocompatible (matching predicate expectations based on ISO 10993)	Data presented demonstrate that Quill PDO Sutures are non-toxic, non-hemolytic, non-irritating, non-pyrogenic, non-allergenic, non-sensitizing, non-cytotoxic, non-reactive and biocompatible.
In Vivo Tensile Strength Loss	Losing tensile strength during the critical wound healing period (e.g., roughly 30% at 2 weeks, 50% at 4 weeks, 75% at 6 weeks for predicate)	Approximately 20% lost in two weeks; 20% lost in four weeks; 60% lost in six weeks.
Barb Holding Strength	Sufficient to approximate tissues during the critical wound period (predicate does not have barbs, so this is a unique functional criterion for the Quill™ device)	Decreases slightly after implantation, remains relatively constant for approximately four weeks after implantation and retains sufficient tensile strength to approximate tissues during the critical wound period.
Absorption Time	Similar hydrolytic degradation and absorption profile as predicate (e.g., completely absorbed by 6 months).	Approximately 5% dissolved in two months; 50% dissolved in four months; most of the suture mass dissolved in six months.
Clinical Outcomes (Scars)	No clinically significant or statistical difference from control group using Hollander Cosmesis scale	No clinically significant or statistical difference in overall Hollander Cosmesis scores (unblinded & blinded) or individual components.
Clinical Outcomes (Pain)	Balanced at observation intervals, no clinically significant or statistical differences from control group.	Balanced at observation intervals, no clinically significant or statistical differences.
Clinical Outcomes (AEs)	Distribution balanced, no statistically significant difference from control group.	Distribution balanced, no statistically significant difference.
Wound Dehiscences	No full wound dehiscences (expected outcome for both groups)	No full wound dehiscences were noted.

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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