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

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2017

Silhouette Lift, Inc. % Mr. Brian Young Health Policy Associates, Inc 690 Canton Street Suite 302 Westwood, Massachusetts 02090

Re: K163676

Trade/Device Name: Silhouette Instalift Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: May 18, 2017 Received: May 19, 2017

Dear Mr. Young:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163676

Device Name Silhouette Instalift

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitted by:	Silhouette Lift, Inc.A Sinclair Pharma Company1 Technology Drive, Suite F211Irvine, CA 92618
Contact Person:	Brian YoungVice-President Regulatory Affairs/Quality AssuranceHealth Policy Associates, Inc.Phone: (781) 329-2993Fax: (781) 329-2968Email: byoung@healthpolicyassociates.com
Date Prepared	June 15, 2017
Trade Name:	SILHOUETTE INSTALIFT
Common Name:	Absorbable surgical suture
Classification Name:	Absorbable poly(glycolide/l-lactide) surgical suture
Regulation Number:	21 CFR 878.4493
Classification Product Code:	GAM
Device Classification:	II

Predicate Device:

The predicate is the original Silhouette Instalift device cleared under 510(k) number K142061 on April 24, 2015.

Device Description:

This device is supplied sterile for single use only.

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Indications for Use:

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

Intended Use:

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

Technological Characteristics (comparison to Predicate Device):

The subject Silhouette Instalift device is identical to the original 510(k) cleared predicate except that the instructions for use have been modified to include an additional optional implantation technique. The additional technique is less invasive and provides clinicians greater flexibility in the treatment of their patients.

Performance Testing Summary:

Nonclinical Testing:

The design, materials, manufacturing and sterilization processes are the same as the original predicate version of the device. No additional bench testing was required to support substantial equivalence of this labeling change.

Clinical Testing:

A prospective, clinical study was performed to assess treatment with Silhouette Instalift without use of a permanent, monofilament, anchor suture. In this study, 20 subjects were assessed pretreatment, and compared to 1. 8. and 12 weeks following treatment.

Subjects responded positively to subject-reported outcomes questions regarding their satisfaction with treatment. There was an improvement in cheek satisfaction and age appraisal through 12 weeks post-treatment using the validated patient-reported outcome FACE-O measure. Additional details are provided in the Tables below:

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1 = Very Dissatisfied; 2 = Somewhat Dissatisfied; 3 = Somewhat Satisfied; 4 = Very Satisfied
Question	Mean (SD)
	EnrollmentN=20	Week 8N=20	Change	Week 12N=20	Change
a. How symmetric (similar)your cheeks look?	2.45(1.05)	3.20(0.83)	0.75(1.29)	3.30(0.80)	0.85(1.23)
b. How smooth yourcheeks look?	2.40(0.99)	3.00(0.92)	0.6(1.54)	3.00(0.86)	0.60(1.31)
c. How attractive yourcheeks look?	2.15(0.99)	3.00(0.79)	0.85(1.46)	3.20(0.70)	1.05(1.15)
d. The contour (outline) ofyour cheeks?	1.90(0.91)	2.95(0.83)	1.05(1.23)	3.15(0.75)	1.25(1.12)
e. The youthful fullness ofyour cheeks?	1.95(1.00)	3.00(0.97)	1.05(1.39)	3.15(0.75)	1.20(1.20)

Table 1: FACE-Q Satisfaction with Cheeks (N=20 Subjects)

Compared to enrollment. Wilcoxon Signed Rank test.

Table 2: FACE-Q Age Appraisal-VAS (N=20 Subjects)

Question	YearsMean (SD)
	Enroll-mentN=20	Week 8N=20	Change	Week 12N=20	Change
How many years youngeror older do you think youlook compared to youractual age?	+1(6.9)	-2.9(4.1)	-3.9(5.3)	-2.4(3.5)	-3.4(5.3)

Compared to enrollment. Wilcoxon Signed Rank test.

Canfield 3D Vectra M3 Face and Neck System was used in the post-treatment period to measure clinical results.

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Timepoint	N (%); N=20
	≥ 0.5 mm	≥ 1.0 mm	≥ 1.5 mm	≥ 2.0 mm	≥ 2.5 mm
Pre-Treatment(Visit 2)	10 (50%)	2 (10%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
1 Week Post-Treatment(Visit 4)	20 (100%)	16 (80%)	9 (45%)	1 (5%)	0 (0.0%)
8 Weeks Post-Treatment(Visit 6)	17 (85%)	10 (50%)	6 (30%)	2 (10%)	0 (0.0%)
12 Weeks Post-Treatment(Visit 7)	16 (80%)	7 (35%)	5 (25%)	4 (20%)	3 (15%)

Table 3: Amount of Facial Lift in Both Cheeks (N=20 Subjects)

The adverse events reported during the study were generally mild, of short duration, and resolved without sequelae. There were no serious adverse events, unanticipated problems, unanticipated adverse device effects, or deaths.

Substantial Equivalence:

The subject device utilizes the same design, materials, manufacturing and sterilization processes as the original predicate version of the device. The modified labeling technique was evaluated in a clinical study which demonstrated acceptable performance and safety thereby supporting a finding of substantial equivalence.

Regulation Number and Section

§ 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.