(171 days)
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
The Silhouette Instalift device consists of two Stainless Steel Surgical needles and an absorbable implant. The absorbable implant is available in three configurations, each consisting of a single monofilament that holds two bidirectional sets of 4, 6 or 8 cones. Both the monofilament and the cones are made from L- lactide/Glycolide bioresorbable resin material. This device is supplied sterile for single use only.
The provided text describes the Silhouette Instalift device and its 510(k) summary (K163676), which is an amendment to a previously cleared device (K142061). The study described is a clinical study to support an additional implantation technique, which is less invasive.
Here's an analysis based on your request, specifying where information is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter and the 510(k) summary do not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for clinical outcomes (e.g., "a minimum of X% of subjects must report satisfaction"). Instead, the clinical study aims to demonstrate "acceptable performance and safety" with the new technique. The performance is assessed through subject-reported outcomes and objective measurements.
| Acceptance Criteria (Implied) | Reported Device Performance (Clinical Study) |
|---|---|
| Safety: No serious adverse events, unanticipated problems, unanticipated adverse device effects, or deaths. | No serious adverse events, unanticipated problems, unanticipated adverse device effects, or deaths were reported. Adverse events were generally mild, short-duration, and resolved without sequelae. |
| Effectiveness (Subject-Reported Cheek Satisfaction): Positive subject-reported outcomes regarding satisfaction with treatment, demonstrating improvement in cheek satisfaction and age appraisal. | FACE-Q Satisfaction with Cheeks (N=20 Subjects): |
- Symmetry: Mean change of 0.85 (1.23) at Week 12 (from 2.45 to 3.30).
- Smoothness: Mean change of 0.60 (1.31) at Week 12 (from 2.40 to 3.00).
- Attractiveness: Mean change of 1.05 (1.15) at Week 12 (from 2.15 to 3.20).
- Contour: Mean change of 1.25 (1.12) at Week 12 (from 1.90 to 3.15).
- Youthful Fullness: Mean change of 1.20 (1.20) at Week 12 (from 1.95 to 3.15).
All changes were positive, indicating improvement. |
| Effectiveness (Subject-Reported Age Appraisal): Demonstrate a perception of looking younger. | FACE-Q Age Appraisal-VAS (N=20 Subjects): - Mean perceived age change at Week 12 was -3.4 years (5.3) (from +1 year older to -2.4 years younger). |
| Effectiveness (Objective Facial Lift): Demonstrate measurable facial lift. | Amount of Facial Lift in Both Cheeks (N=20 Subjects): - At 12 weeks post-treatment: 80% had ≥ 0.5 mm lift, 35% had ≥ 1.0 mm lift, 25% had ≥ 1.5 mm lift, 20% had ≥ 2.0 mm lift, and 15% had ≥ 2.5 mm lift. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 20 subjects.
- Data Provenance: The document does not specify the country of origin of the data. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The study primarily relies on subject-reported outcomes (FACE-Q questionnaires) and objective measurements by a "Canfield 3D Vectra M3 Face and Neck System." It does not mention expert assessment for establishing ground truth in the traditional sense of diagnostic accuracy.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable. The study described did not involve adjudication by multiple experts for diagnostic assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the clinical performance of the device with a new implantation technique, primarily assessed via patient-reported outcomes and objective measurements, not on the performance of human readers with or without AI assistance.
6. Standalone Performance Study
- The term "standalone performance" typically refers to the performance of an algorithm without human intervention in a diagnostic context. This document describes a clinical study of a medical device (surgical suture), not an AI algorithm. Therefore, a standalone (algorithm only) study was not done in this context.
7. Type of Ground Truth Used
- The "ground truth" for the clinical study's effectiveness was established through:
- Patient-Reported Outcomes (PROs): Using the validated FACE-Q measure for cheek satisfaction and age appraisal.
- Objective Measurements: From a Canfield 3D Vectra M3 Face and Neck System to measure facial lift.
8. Sample Size for the Training Set
- Not applicable. This is a clinical study for a traditional medical device (suture) and an updated implantation technique, not an AI/machine learning device that would typically have a "training set." The device itself (materials, design, manufacturing, sterilization) is stated to be identical to the predicate.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device and study.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.