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The Contour Necklift Thread™ is indicated for use in Necklift Surgery. The Necklift Contour Threads are specifically indicated for use to fixate and elevate the subdermis to the deep fascia of the retromastoid area.

The Contour Necklift Threads™ are a clear, non-absorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture. The 25 centimeter length thread incorporates a unidirectional barbed section 10 centimeters long from the distal end. The Threads will have a 7 inch straight needle attached to the distal end and a 26 mm curved needle attached to the proximal end. The threads are supplied sterile for single use.

This 510(k) summary describes a medical device, the Contour Necklift Threads™, and asserts its substantial equivalence to existing predicate devices. However, it does not contain a traditional "study" in the sense of a clinical trial or a performance study with defined acceptance criteria and reported results.

Instead, the submission relies on the following to demonstrate safety and effectiveness:

Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than specific, quantified acceptance criteria and reported numerical results in a table format.

Study Details (or lack thereof)

Since a traditional study with a test set, experts, and statistical analysis is not described, the following information is not present in the document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as detailed performance study data is not provided. The document mentions "bench and animal evaluations" but no specifics on sample sizes, design, or results are given.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 thread, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "bench and animal evaluations," the ground truth would likely be direct measurements (e.g., tensile strength, force to remove) and histological assessment for biocompatibility. For the claim of equivalence to "Gold Standard Surgical Procedure," the ground truth is established clinical practice and historical outcomes data for Prolene™ sutures in necklifts.
7. The sample size for the training set: Not applicable, as there's no machine learning algorithm involved.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Substantiation Approach:

The submission for the Contour Necklift Threads™ relies primarily on demonstrating substantial equivalence to already legally marketed predicate devices (Contour Midface Threads™, Contour Browlift Threads™, and Prolene™ Sutures). The key arguments are:

• Material Equivalence: The Contour Necklift Threads™ are made of the same polypropylene material as the predicate devices, which is a common and proven biocompatible material in medical applications.
• Technological Characteristics Equivalence: The polypropylene material has "proven to be biocompatible," and "Bench and animal evaluations have demonstrated the device to be safe and effective," with these characteristics being "the same for Surgical Specialties Corporation's Contour Threads as presented in the predicate 510(k)'s."
• Performance Testing: Physical testing for tensile strength (USP 27), force required to remove after implantation, and biocompatibility (ISO 10993) was conducted. While no specific numerical results are provided in this summary, the implication is that these tests met acceptable standards consistent with the predicate devices.
• Indications for Use Equivalence (with anatomical site variation): The necklift indication, while a different anatomical site than midface or browlift applications, is argued not to change the fundamental safety and effectiveness of the device given the material and design.
• Equivalence to Established Surgical Standard: The device's material (Prolene™ suture) is directly linked to a "Gold Standard Surgical Procedure for Necklift in the last 2 decades."

In essence, the "study" proving the device meets acceptance criteria is a demonstration that the new device is fundamentally the same as or very similar to previously cleared devices that have already been proven safe and effective through their own regulatory clearances and long-standing clinical use. No new, independent clinical study with a specific test set, ground truth experts, or statistical outcome metrics is detailed in this 510(k) summary.

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