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510(k) Data Aggregation
(7 days)
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.
This document is a 510(k) summary for a medical device called the "V-Loc™ 180 Absorbable Wound Closure Device." It outlines the device's description, intended use, and its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Testing | Not applicable (no change to the device from the predicate). The device is "identical to the predicate device." |
| Biocompatibility | Materials evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of Medical Devices - Part I Evaluation and Testing. (Implicitly, the device met these criteria, as it received 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states: "Performance testing is not applicable as there has been no change to the V-Loc™ 180 absorbable wound closure device." This means there was no new performance study conducted with a test set for this 510(k) submission. The device's approval is based on its substantial equivalence to a predicate device (K082662 - V-loc™ 180 Absorbable Wound). Therefore, information on sample size, test set data provenance, and ground truth for a new test set is not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no new performance study with a test set was conducted for this 510(k). The device's performance relies on the previous evaluation of the identical predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no new performance study with a test set was conducted for this 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The FDA clearance is based on substantial equivalence, not a comparative effectiveness study showing improvement with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical wound closure device, not an AI algorithm, so the concept of standalone performance for an algorithm is irrelevant here.
7. Type of Ground Truth Used
Not explicitly stated for this 510(k). The device's performance is established by its identity to a predicate device, which would have undergone its own testing and established its efficacy through appropriate methods (e.g., in vitro, in vivo, or clinical studies) prior to its own approval. The biocompatibility for the materials was evaluated against ISO 10993-1:2003.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device, not an AI algorithm.
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(195 days)
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.
The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
The input document is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This document does not describe the acceptance criteria or results of a study in the format requested. It is a regulatory submission outlining the device description, indications, and substantial equivalence to predicate devices, but lacks detailed performance data with specific acceptance criteria and study results. Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.
Specifically, the "Performance Data" section merely states: "Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended." This general statement does not provide the specific metrics, criteria, or study outcomes needed to answer your request.
To fulfill your request, I would need a document that includes:
- A table or section explicitly listing acceptance criteria for various performance metrics (e.g., tensile strength, absorption rate, knot security, biocompatibility).
- Detailed results of the studies performed to demonstrate compliance with these criteria.
- Information on sample sizes, data provenance, ground truth establishment, expert qualifications, and study designs (e.g., standalone, MRMC) if applicable.
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