Search Results

DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is available in different colors and may be provided with or without an attached needle(s).

This document is a 510(k) summary for the DemeTECH DemeFORCE Nonabsorbable Surgical Suture. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for an AI/ML algorithm or diagnostic tool. Therefore, much of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted or inferred from the provided text, focused on the non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each non-clinical test. It states "Non-clinical testing was conducted on the device... to prove conformance to the requirements of USP." The provenance of the data is from in-house non-clinical testing performed by DemeTECH Corporation, as described in the "Non-Clinical Tests Performed" section. It is not retrospective or prospective patient data from a specific country, but rather laboratory testing of the device itself.

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

This information is not applicable to this type of submission. Ground truth in this context refers to established standards (USP monographs, ISO 10993) and the results of laboratory tests. There is no mention of human experts establishing ground truth for a "test set" in the context of imaging or diagnostic evaluations.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "test set" is the physical device being tested against predefined technical standards.

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 is for a surgical suture and does not involve AI, human readers, or diagnostic interpretation.

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

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

7. The type of ground truth used

The ground truth used for the non-clinical tests were:

• Established standards: United States Pharmacopeia (USP) monographs for nonabsorbable surgical sutures (specifically USP 41), and FDA's Special Control Guidance Document: Surgical Sutures.
• International standards: ISO 10993-1 for biocompatibility.
• Predicate device characteristics: For demonstrating substantial equivalence in areas like in-vitro and in-vivo resorption.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

Ask a specific question about this device