(31 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shelf life stability (18 months) | Results obtained in the stability study were in accordance with the acceptance criteria defined in the protocol and demonstrated continued sterility, package integrity, and device functionality over the 18 months requested. |
| Peak Tensile Force at Break (USP ) | Confirmed compliance at the end of shelf life. |
| Monofilament Diameter (USP ) | Confirmed compliance at the end of shelf life. |
| Swaging Test between Monofilament and (USP ) | Confirmed compliance at the end of shelf life. |
| Sterility (USP ) | Confirmed compliance at the end of shelf life. |
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.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.