(10 days)
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 (Size 4-0) 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.
The provided text is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This type of submission is for medical devices and typically does not involve studies with human readers, AI assistance, or complex ground truth establishment as seen in diagnostic imaging AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing (in vitro and in vivo), material characterization, and compliance with standards.
Therefore, many of the requested fields (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this 510(k) summary.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that "Performance testing (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended." However, it does not explicitly list specific numerical acceptance criteria or the detailed reported device performance in a table format. For 510(k) submissions, the “acceptance criteria” are generally met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device, and the performance testing supports this claim of equivalence.
Table 1: Acceptance Criteria and Reported Device Performance (Inferred)
| Acceptance Criteria (Inferred from Substantial Equivalence and Performance Testing) | Reported Device Performance |
|---|---|
| Material Composition Equivalence: Device materials are comparable to predicate devices and conform to biocompatibility standards. | V-Loc™ 180 is comprised of materials evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of Medical Devices - Part I Evaluation and Testing. (Implied to meet the standard). |
| Technological Characteristics Equivalence: Device is identical in key technological characteristics to the predicate device. | V-Loc™ 180 Absorbable Wound Closure device (Size 4-0) is identical to the predicate device (implied this equivalence was demonstrated). |
| Safety and Effectiveness: Performance testing (in vitro and in vivo) confirms the device is safe and effective for its intended use. | Performance testing (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended (implied that the results met the safety and effectiveness criteria). |
| Intended Use: Device is suitable for soft tissue approximation where an absorbable suture is appropriate. | Indicated for soft tissue approximation where use of an absorbable suture is appropriate. (Implied that performance supports this indication). |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "Performance testing (in vitro and in vivo)" but does not specify sample sizes for these tests, nor does it provide details on data provenance (country, retrospective/prospective). For this type of device, "in vivo" testing typically refers to animal studies rather than human clinical trials for a 510(k).
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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. This is a medical device (suture) submission, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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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. This device is an absorbable suture, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a suture device, "ground truth" would be established through physical and mechanical characterization (e.g., tensile strength, degradation rates) and biological response studies (e.g., biocompatibility) rather than expert consensus on images or pathology. The document indicates that materials were evaluated per ISO 10993-1, which provides standards for biological evaluation.
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The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.