(188 days)
VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate
The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs distributed along the suture with a barb size of 0.567mm. The device is designed with small bi-directional barbs along the long axis of the suture monofilament to prevent sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots after tissue approximation. It is available in diameter size USP 0 through 4-0 in various lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA suture is sterilized by ethylene oxide gas and packed each set in a poly bag.
The provided text describes a 510(k) premarket notification for a medical device called "VIOLA barbed suture". It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for market clearance.
Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (Not Explicitly Stated, but Implied by Conformance) | Reported Device Performance |
|---|---|---|
| Non-clinical Laboratory Performance Testing | ||
| USP 40-NF35:2017 Tensile Strength | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| In vitro Barb Holding Strength | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| Suture Diameter | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| Suture-Needle Attachment | Conformance to FDA's Class II special controls guidance | Conforms to FDA guidance |
| In vitro Post-Hydrolysis Tensile Testing | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Needle Tensile | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Elasticity | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Bending Strength | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Surface Structure | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Pull-out Test | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Endotoxin Level Testing | Acceptance criteria for endotoxin levels | Will be performed on each batch of product |
| Biocompatibility Testing | ||
| ISO 10993 Biological Evaluation of Medical Device | Conformance to ISO 10993 and FDA's Class II special controls guidance | Performed in accordance with ISO 10993 and FDA guidance for sutures |
Note: The document states that "All of the testing results met the acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. Instead, it refers to conformance with standards and substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical or biocompatibility testing. These studies are typically laboratory-based and would not involve human participants in the same way as clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The studies performed are non-clinical, benchtop, and biocompatibility tests, which do not involve expert interpretation or ground truth establishment by clinical experts in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which is not the case for the non-clinical and biocompatibility testing described.
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
No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic or assistive devices involving human readers (e.g., radiologists, pathologists). The VIOLA barbed suture is a physical surgical device, and its evaluation does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done for the device itself through the non-clinical laboratory tests and biocompatibility tests. These tests assess the physical and biological properties of the suture in isolation, without human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests (tensile strength, barb holding strength, diameter, attachment strength, etc.), the "ground truth" is established by physical measurements and adherence to established industry standards and regulatory guidance (USP monographs, FDA special controls guidance, ISO 10993). In essence, the ground truth is defined by the specified physical and chemical properties and performance characteristics required for absorbable surgical sutures.
8. The sample size for the training set
This information is not applicable and not provided. The VIOLA barbed suture is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As mentioned above, the device is not an AI/ML algorithm, and therefore there is no "training set" or "ground truth for the training set" in that context.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.