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The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

The Contour Midface Opposing Uni-Directional Threads are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture material. The 45 centimeter length incorporates a Uni-directional-barbed design with center of the thread being smooth for a distance of a nominal two inches. The Threads will be supplied with 7 inch needles attached to both ends. The needles are made of 400 series stainless steel. The threads are supplied sterile for single use.

The provided text is a 510(k) summary for a medical device called "The Contour Midface Opposing Uni-Directional Threads." This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not available in this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary in the format of a table with specific pass/fail criteria and performance results. 510(k)s often rely on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than meeting predefined, quantifiable acceptance criteria for novel performance.

However, the document mentions "Physical testing was conducted on the thread to USP 27 for tensile strength." This implies that the device met the tensile strength requirements specified in USP 27 for its material (polypropylene suture). Without access to USP 27, the specific criteria and the exact reported performance cannot be detailed.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "Bench and animal evaluations have demonstrated the device to be safe and effective." However, it does not provide details about the sample sizes used for these evaluations.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This device is a surgical suture. Its "ground truth" performance would typically be assessed through physical material testing (e.g., tensile strength), biocompatibility evaluations, and potentially animal studies for safety and effectiveness in a biological context, rather than expert interpretation of data like in an AI/diagnostic device study. The document does not mention any expert consensus in this regard.

4. Adjudication method for the test set

Not applicable/Not specified. See explanation above.

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 document describes a surgical suture, not an AI or diagnostic device designed for human reader interpretation. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (suture), not an algorithm.

7. The type of ground truth used

The implicit "ground truth" for this device would be established through:

• Material Specifications: Adherence to USP (United States Pharmacopeia) standards for polypropylene sutures, specifically for tensile strength ("Physical testing was conducted on the thread to USP 27 for tensile strength.").
• Biocompatibility: Demonstrated through "Bench and animal evaluations."
• Performance in vivo: Demonstrated through "animal evaluations" for safety and effectiveness.
• Substantial Equivalence: The primary "truth" demonstrated in a 510(k) is that the device is as safe and effective as a legally marketed predicate device.

8. The sample size for the training set

Not applicable/Not specified. This is not an AI/ML device that requires a training set. If "training set" refers to data used to inform the design or initial development, the document doesn't provide such details.

9. How the ground truth for the training set was established

Not applicable/Not specified. See explanation above.

Summary of Device and Performance Information Found:

• Device Name: The Contour Midface Opposing Uni-Directional Threads
• Intended Use: For use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
• Material: Clear, nonabsorbable, sterile, surgical strand of USP size 2-0 polypropylene suture material.
• Technological Characteristics: Polypropylene material is commonly used in medical applications and proven biocompatible. Has "Uni-directional-barbed design with center of the thread being smooth for a distance of a nominal two inches."
• Performance Data Mentioned: "Physical testing was conducted on the thread to USP 27 for tensile strength." "Bench and animal evaluations have demonstrated the device to be safe and effective."
• Substantial Equivalence Claimed to: Contour Extended Length Threads (K041593) for intended use. States "The Contour Midface Opposing Uni-Directional Thread uses the same suture material shown to have tensile strength and biocompatibility suitable for this application."

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