(127 days)
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
| Acceptance Criteria (Set by USP and FDA Guidance) | Reported Device Performance (Summary) |
|---|---|
| Conformance to USP for nonabsorbable surgical suture | Meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and USP 41. |
| Biocompatibility | Meets requirements in accordance with ISO 10993-1. |
| In-vitro and in-vivo resorption | Demonstrated substantial equivalence to predicate devices. |
| Suture diameter | Conforms to methods outlined in USP 41. |
| Suture length (95% of stated label length) | Meets or exceeds the performance requirements defined in USP for "Suture Length Requirement". |
| Knot pull tensile strength | Meets or exceeds the performance requirements defined in USP for "Tensile Strength" . |
| Needle attachment strength | Meets or exceeds the performance requirements defined in USP for "Needle Attachment" . |
| Extractable color | Conforms to methods outlined in USP 41. |
| Sterility | Conforms to methods outlined in USP 41. |
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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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.