(85 days)
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.
| 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.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.