(371 days)
MINT™ is indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.
The MINT™ device is a sterile synthetic absorbable surgical suture comprised of polydioxanone, (GHoOJ)n. Polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment of the violet dye is D&C Violet No.2 (21CFR §74.3602). MINT™ is available in a range of gauge sizes and lengths. Each suture has bi-directional barbs along the long axis of the suture monofilament. The MINT™ Synthetic Absorbable PDO suture approximates tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues. Barbed suture lifting is a minimally invasive surgical technique for facial rejuvenation. The MINT™ Product Family includes models which are supplied with needles. For those models supplied with a needle, designated as "Lifting Thread Combined with needle" in the MINT™ Product Family instructions for use, the needle is used to make the insertion point and for threading of the suture in the patient's dermis.
Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:
Device: MINT™ Product Family (Absorbable Polydioxanone Surgical Suture) for mid-face suspension surgery.
Indication: Temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with quantifiable targets for the clinical study. However, the primary effectiveness endpoint and several secondary effectiveness evaluations serve as the de-facto acceptance criteria for clinical efficacy. The reported performance for these criteria is extracted below.
| Acceptance Criteria (Effectiveness Endpoint) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Ratio of subjects showing wrinkle improvement (WSRS: below -1 point) by independent evaluation at 12 weeks post-surgery. | 59 subjects (96.72%) showed improvement (WSRS: below -1 point). The lowest confidence level of 20.95% was greater than 0, indicating superiority. |
| Secondary Effectiveness Evaluation (Independent Evaluators): Ratio of subjects showing improvement (WSRS: below -1 point) at 4, 8, and 24 weeks. | Week 4: 100% (61 subjects) |
| Week 8: 96.72% (59 subjects) | |
| Week 24: 90.16% (55 subjects) | |
| Secondary Effectiveness Evaluation (Testers): Ratio of subjects showing improvement (WSRS: below -1 point) at 4, 8, 12, and 24 weeks. | Week 4: 100% (61 subjects) |
| Week 8: 100% (61 subjects) | |
| Week 12: 100% (61 subjects) | |
| Week 24: 100% (61 subjects) | |
| Mean WSRS Change from Baseline (Independent Evaluators): Statistical significance of decrease in WSRS at 4, 8, 12, and 24 weeks compared to baseline. | Baseline: 3.30 ± 0.45 points. |
| Week 4: -1.56 ± 0.43 points | |
| Week 8: -1.41 ± 0.48 points | |
| Week 12: -1.23 ± 0.41 points | |
| Week 24: -1.20 ± 0.45 points. | |
| Statistically significant difference at all points (p Suture diameter, USP Suture-Needle attachment, and USP Suture tensile strength. Displays superior barb holding strength (20.94 ± 3.93 N) compared to predicate (9.90 ± 0.93 N). | |
| Animal Performance (Absorption): Absorption timeframe. | In vivo absorption occurs between 180-220 days post-implantation (on Monosorb, which is identical to the sutures). |
| Animal Performance (Mechanical Strength): Tensile strength retention. | Tensile strength retention of MINT™ (USP 1) was 44.5% at 6 weeks. Considered approximately 50% at 6 weeks. Unable to be measured at 10 and 12 weeks due to severe degradation. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (Clinical Study): 62 male and female subjects (referred to as "FA set" in results, with 61 subjects for some analyses).
- Data Provenance: Prospective clinical study. The country of origin of the data is not explicitly stated, but the sponsor, Hans Biomed Corporation, is located in the Republic of Korea, suggesting the study may have been conducted there.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Unspecified, but referred to as "independent, blinded assessors" and "blinded evaluators." Also, "testers" (who may or may not be the same as independent evaluators) were involved.
- Qualifications of Experts: Not specified. They are generally referred to as "evaluators" or "assessors."
4. Adjudication Method for the Test Set
The document mentions "Independent, blinded assessors" and that the analysis was based on "blinded evaluator Global Aesthetic Improvement Scale (GAIS) ratings" and "comparing the photos... by blinded evaluators." It also refers to "evaluation of independent evaluators" and "evaluation of testers."
However, no specific adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements between multiple evaluators is described. It implies individual independent ratings were collected and analyzed (e.g., averaging or using individual scores).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done in the sense of comparing human readers' performance with and without AI assistance, as this is a medical device (suture) and not an AI/CADe system for image analysis.
- The clinical study evaluates the device's effectiveness through expert assessment of clinical outcomes (WSRS, GAIS) performed directly on subjects or their photos, not through a reader-AI interaction for diagnosis or interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance was done for the device in the context of its mechanical and biological properties.
- The "non-clinical performance data" (USP compliance, barb holding strength) and "animal performance data" (absorption, mechanical strength in vivo) represent standalone performance assessments of the physical characteristics of the suture itself, without human intervention in the device's inherent function.
- The clinical study then assessed its performance in vivo in human subjects, which is the ultimate "standalone" performance for a medical implant like a suture.
7. The Type of Ground Truth Used (Clinical Study)
- Expert Consensus and Subjective Scales: The primary ground truth for the clinical study was established using validated subjective rating scales like the 5-grade Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). These were applied by:
- Independent, blinded assessors/evaluators.
- Testers (likely clinicians involved in the study).
- The subjects themselves (for GAIS).
- This represents a form of expert assessment/consensus based on observable clinical outcomes, rather than objective pathology or hard outcomes data like mortality.
8. The Sample Size for the Training Set
- Not Applicable. This document describes a medical device (surgical suture), not an AI/Machine Learning model. Therefore, there is no "training set" in the context of machine learning. The clinical study served as the primary evidence for the expanded indication.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable, as there is no training set for an AI/ML model.
§ 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.