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The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.

Silhouette Instalift Sutures are absorbable, sterile sutures. It is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles. All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.

The provided text is a 510(k) summary for a medical device called Silhouette Instalift. It primarily discusses a change to the device's labeling and asserts substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document states:

• "No changes have been made to the intended use or fundamental scientific technology and therefore the supporting information on sterilization, biocompatibility, and clinical data remain unchanged from the original application."
• "The only modification made to the predicate device is the modification to the labelling of the device."

Therefore, I cannot provide the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, or ground truth details, because this information is explicitly stated as unchanged from the original application and is not provided in this specific 510(k) summary document.

To obtain this information, one would need to refer to the original 510(k) applications (K142061 and K163676) mentioned in this document.

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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.

• 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.

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The Silhouette Instalift device is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.

Not Found

The provided text is an FDA 510(k) clearance letter for the Silhouette Instalift device. This document primarily focuses on the device's substantial equivalence to a predicate device and its indications for use. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The 510(k) clearance process often relies on comparison to existing legally marketed devices rather than extensive de novo clinical efficacy studies with specific performance metrics and ground truth establishment in the way one might see for AI/software-as-a-medical-device (SaMD) clearances.

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