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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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Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Silhouette Lift Sutures are non-absorbable, sterile sutures.

SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polypropylene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.

Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.

All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silhouette Lift Suture, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify the sample size used for the stability study (the test set).

The data provenance is from internal testing conducted by Silhouette Lift Inc. (the manufacturer) as part of their 510(k) submission. The study type is prospective as it's a stability study assessing device performance over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests performed are standardized USP (United States Pharmacopeia) methods for material and sterility properties, which typically rely on laboratory analyses and calibrated equipment rather than expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The assessment of the device's physical and sterility properties is based on objective laboratory measurements against predefined USP standards, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was focused on extending the shelf life of an existing medical device, not on assessing its effectiveness (clinical outcomes) or comparing human reader performance with and without AI assistance. The document explicitly states: "No clinical testing was conducted as part of this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The device is a surgical suture, not an AI software/algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device performance evaluation was based on established USP (United States Pharmacopeia) specifications for surgical sutures and sterility. These are objective, predefined standards for material properties and an absence of microbial contamination.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The context is not machine learning or AI, so there is no "training set." The study is a stability test for a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there is no training set in this context.

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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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Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Silhouette Lift Sutures are non-absorbable, sterile sutures.

SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polvpropvlene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.

Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.

All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.

This document is a 510(k) premarket notification for the Silhouette Lift Suture, which is a medical device used in midface suspension surgery. The purpose of this notification is to demonstrate that the Silhouette Lift device is substantially equivalent to a previously cleared predicate device, the Featherlift Silhouette Suture (K060414), despite a change to its Instructions for Use.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense for a new device's efficacy or safety study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" in this context are implicitly that the modified device remains substantially equivalent to the predicate device, and that the change to the Instructions for Use does not alter its safety, effectiveness, or fundamental scientific technology. The "reported device performance" is a comparative analysis against the predicate device based on specific characteristics.

Below is a table summarizing the comparison for substantial equivalence, which serves as the "performance" data to meet the implicit acceptance criteria of being equivalent.

The key acceptance criterion is that there are no significant differences in the fundamental aspects of the device that would impact safety or effectiveness, outside of the specific change to the Instructions for Use. The study presented here is the comparative analysis, which demonstrates "no difference" across all critical technological characteristics and intended use.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a Special 510(k) where the modification is limited to changes made in the directions for use, and there are "No changes...to the intended use or fundamental scientific technology." Therefore, there is no new test set, clinical data, or sample size provided for a new study in this document. The submission relies on establishing substantial equivalence to the predicate device (K060414) based on its existing clearance.

The data provenance for the original clearance (K060414) is not detailed in this specific document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As noted above, this submission is not presenting new study data requiring ground truth establishment by experts. It's a "Special 510(k)" relying on prior clearance and demonstrating no significant change to the device itself.

4. Adjudication Method for the Test Set

Not applicable, as no new test set is presented.

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

Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. No MRMC study is relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a surgical suture, not an algorithm, so standalone performance is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable to this specific submission, as it relies on substantial equivalence to a predicate device. For the original predicate clearance (K060414), it would have likely involved a combination of bench testing, possibly animal studies, and potentially clinical data (though not always required for Class II devices), with "ground truth" derived from standard surgical practice, material science, and clinical outcomes for similar products.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and no new training set is discussed or implied.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device, and no training set is discussed.

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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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