Search Results
Found 3 results
510(k) Data Aggregation
(175 days)
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
The provided document is a 510(k) Summary for a medical device (WEGO-PDO Barbed Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.
Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning performance metrics for an AI or imaging device.
The document describes pre-market notification for a surgical suture, not an AI or imaging device. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections clearly state the types of tests performed (primarily material and sterility standards, with no clinical study included). The "SE Comparison" table compares the proposed suture device to predicate suture devices based on physical characteristics, material properties, and regulatory standards, not diagnostic performance.
To answer your prompt, you would need a document related to the clearance or approval of an AI/imaging medical device, which would detail its performance study, acceptance criteria (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, and expert involvement. This document does not provide such information.
Ask a specific question about this device
(90 days)
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 <151>) | 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 <861>) | Complies with the diameter requirement listed in USP <861>. |
| Tensile Strength (USP <881>) | Complies with the tensile requirement listed in USP <881>. |
| Needle Attachment (USP <871>) | Meets the requirements defined in USP <871>. |
| 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 <85>) | 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.
Ask a specific question about this device
(132 days)
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE is undyed and uncoated.
The proposed device is composed of suture and needle.
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes.
WEGO-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
This document describes the premarket notification for the WEGO-PTFE surgical suture, asserting its substantial equivalence to a predicate device. It includes information on non-clinical testing performed to establish this equivalence, but no clinical study was conducted. Therefore, the device does not have acceptance criteria based on clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a premarket notification for a surgical suture claiming substantial equivalence to a predicate device, the "acceptance criteria" are based on compliance with recognized standards and biocompatibility, rather than clinical performance metrics. The "reported device performance" refers to the results of non-clinical tests demonstrating this compliance.
| Acceptance Criteria (Compliance with Standard) | Reported Device Performance (WEGO-PTFE Test Results) |
|---|---|
| USP 39-NF 34:2016 Nonabsorbable Surgical Suture | Complies with the requirements |
| USP 39-NF 34:2016 <861> Sutures Diameter | Complies with the requirements |
| USP 39-NF 34:2016 <871> Sutures Needle Attachment | Complies with the requirements |
| USP 39-NF 34:2016 <881> Tensile Strength | Complies with the requirements |
| ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | Conforms to the requirements |
| ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | Conforms to the requirements |
| ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | Conforms to the requirements |
| ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Conforms to the requirements |
| ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Conforms to the requirements |
| USP <85> Bacterial Endotoxins Limit | Complies with the requirements |
| ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials | Complies with the requirements |
| ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | Complies with the requirements |
| ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | Complies with the requirements |
| ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | Conforms to the requirements |
| ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Complies with the requirements |
| Shelf life stability (Product performance and Package integrity) | Supported by test reports for three years, two years, one year, and six months |
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 specify the sample sizes used for each of the non-clinical tests. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly stated in terms of country of origin, but the submitting company is "Foosin Medical Supplies Inc., Ltd." located in Weihai, Shandong, China. The studies are non-clinical, likely laboratory-based, and therefore not categorized as retrospective or prospective in the human study sense.
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. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., USP, ISO, ASTM), not by expert consensus on clinical cases. The tests themselves are designed to measure against predefined physical and biological parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical study or expert-based evaluation of a test set for performance was conducted. The tests are laboratory procedures with defined pass/fail criteria based on 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
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a surgical suture, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a surgical suture, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced standards (e.g., USP for tensile strength and diameter, ISO for biocompatibility categories). These standards provide quantifiable criteria that the device must meet.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned or implied as this is a physical medical device and not an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
Ask a specific question about this device
Page 1 of 1