(139 days)
The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries
The Dunamis Force DFX Sutures are sterile single use sutures are used in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries. The technical design configuration for both USP Size 2 and Size 5 are as follows:
USP Size 2 (metric 5)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile.
USP Size 5 (metric 7)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile
Materials:
Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter.
Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None
Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.
The provided text is a 510(k) summary for the Dunamis Force DFX Suture. It states that the device is identical to a legally marketed predicate device (Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Sutures, K063778) except for brand name, part number, and "manufactured for" indication on the labeling. As such, the Dunamis Force DFX Suture leverages the testing and established performance of the predicate device.
Given this context, the request for acceptance criteria and a study proving the device meets those criteria, along with details like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not directly applicable to this specific submission. This is because the device's substantial equivalence is established by its identical specifications to a previously cleared product, rather than new, independent performance testing for the Dunamis device itself.
Therefore, the following information is derived from the context of substantial equivalence to the predicate device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on USP for non-absorbable sutures and ISO 10993-1 for biocompatibility) | Reported Device Performance (Leveraged from Predicate K063778) |
|---|---|
| Meets USP requirements for non-absorbable sutures (except for diameter) | Specifications are identical to predicate device, which met these requirements. |
| Biocompatibility in accordance with ISO 10993-1 | Specifications are identical to predicate device, which met these requirements. |
| Stability testing | Specifications are identical to predicate device, which met these requirements. |
| Tensile strength, knot strength, and other relevant mechanical properties as per USP | Specifications are identical to predicate device, which met these requirements. |
| Sterility | Specifications are identical to predicate device, which met these requirements. |
2. Sample size used for the test set and the data provenance
The document states, "Because the sutures are manufactured to the same specifications as those cleared in K063778, data provided in K063778 may be leveraged to support equivalence, including testing in accordance to the USP for non-absorbable sutures, biocompatibility testing performed in accordance with ISO 10993-1, and stability testing. No additional testing was performed on the contract-manufactured product."
Therefore, specific sample sizes and data provenance for the Dunamis device are not provided as its performance is inferred from the predicate device (K063778). The provenance of the predicate device's data would be from its original submission. This would be retrospective for the Dunamis submission.
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 as no new performance testing with a 'test set' was conducted for the Dunamis Force DFX Suture to establish a new ground truth. The device demonstrates equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no new performance testing with a 'test set' requiring adjudication was conducted for the Dunamis Force DFX Suture.
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
This information is not applicable. This device is a surgical suture, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device (K063778) on which the Dunamis device's performance is based, the "ground truth" would be established by standardized laboratory testing methods as specified in the USP for non-absorbable sutures and ISO 10993-1 for biocompatibility. These are objective engineering and biological measurements, not expert consensus or pathology in the typical sense.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device requiring a training set.
§ 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.