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510(k) Data Aggregation
(90 days)
Wego-Stainless Steel
The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
The provided document is a 510(k) summary for the "WEGO-STAINLESS STEEL" surgical suture, in which the manufacturer asserts substantial equivalence to a predicate device (Surgical Stainless Steel Suture K170767). The document describes non-clinical tests conducted to support this claim, but it does not describe an AI/ML powered device, nor does it detail acceptance criteria related to AI/ML performance, or comparative effectiveness studies of AI vs. human readers.
Therefore, the requested information regarding AI/ML acceptance criteria, study details, expert involvement, and MRMC studies cannot be extracted from this document, as it is outside the scope of a traditional medical device (surgical suture) 510(k) submission.
However, I can provide the available information regarding the non-clinical tests performed to demonstrate substantial equivalence for the surgical suture:
Acceptance Criteria and Device Performance (for Non-Clinical Tests of Surgical Suture)
The acceptance criteria for the "WEGO-STAINLESS STEEL" surgical suture were based on compliance with established international and pharmacopeial standards. The reported device performance indicates that the proposed device met these standards.
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance / Compliance |
|---|---|
| Biocompatibility (based on ISO 10993 series): | |
| Cytotoxicity (ISO 10993-5) | No cytotoxicity. (Complies with ISO 10993) |
| Skin Sensitization (ISO 10993-10) | No skin sensitization. (Complies with ISO 10993) |
| Intracutaneous Reactivity Test (ISO 10993-10 implied) | No intracutaneous reactivity. (Complies with ISO 10993) |
| Acute Systemic Toxicity Test (ISO 10993-11) | No systemic toxicity. (Complies with ISO 10993) |
| Genotoxicity (ISO 10993-3) | No genotoxicity. (Complies with ISO 10993) |
| Pyrogenicity (USP ) | No potential febrile reaction. (Complies with ISO 10993) |
| Muscle Implantation Study (ISO 10993-6) | No reaction to the tissue. (Complies with ISO 10993) |
| Subchronic Toxicity Study (ISO 10993-11 implied) | No systemic toxicity. (Complies with ISO 10993) |
| Hemolysis Test (Direct Contact) (ASTM F756-17) | No Hemolysis. (Complies with ISO 10993) |
| Hemolysis Test (Indirect Contact) (ASTM F756-17) | No Hemolysis. (Complies with ISO 10993) |
| Physical and Performance Characteristics (based on USP standards): | |
| Suture Diameter (USP ) | Complies with the diameter requirement listed in USP . |
| Tensile Strength (USP ) | Complies with the tensile requirement listed in USP . |
| Needle Attachment (USP ) | Meets the requirements defined in USP . |
| Sterilization & Packaging: | |
| Sterility Assurance Level (SAL) | $1.0\times10^{-6}$ (Met standard) |
| Sterilization Process Validation (ISO 11137-1, ISO 11137-2) | Verified (Radiation sterilization selected as equivalent to predicate's radiation option) |
| Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15) | Tested over 1-5 years shelf life. (Compliance implied by "Product performance test reports" and "Package integrity test reports") |
| Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-15) | Tested over 1-5 years shelf life. (Compliance implied by "Product performance test reports" and "Package integrity test reports") |
| Other: | |
| Standards for Nonabsorbable Surgical Suture (USP 41-NF 36:2018) | Proposed device complies with USP requirements. |
| Bacterial Endotoxins Test (USP ) | Tested. (Compliance implied by "Product performance test reports" and being listed as a non-clinical test) |
| Shelf Life (Product performance and Package integrity) | Product performance test reports (one years, two years, four years and five years) and Package integrity test reports (one year, two years, three years, four years and five years) were performed. (Compliance supports proposed shelf life) |
The subsequent questions are related to AI/ML device studies and are not applicable to this document, as it concerns a conventional surgical suture.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical tests on a physical device, not an AI/ML model.
- 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): Not applicable. Ground truth for AI/ML is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. No clinical study was included, and this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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