(102 days)
V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
Here's a breakdown of the acceptance criteria and study information for the V-Loc™ 90 Absorbable Wound Closure Device, based on the provided text:
Acceptance Criteria and Device Performance
The provided text details performance evaluations rather than explicitly stating pre-defined "acceptance criteria" with numerical targets. However, the "Results" section indicates the device passed these evaluations by performing comparably to predicate devices or meeting specific standards.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Status / Reported Performance |
|---|---|---|
| In-vitro Performance | Needle Attachment | Meets USP/EP specification. |
| Diameter (non-barbed suture) | Maximum Overage of USP/EP specification as stated in the Instructions for Use. | |
| Tensile Strength (T=0, T=1, T=2 straight pull) | Pass | |
| Barb Holding Strength (T=0, T=1, T=2 simulated barb holding of felt medium) | Pass | |
| In-vivo Performance | Product safety and efficacy (porcine model) | No statistical differences in strength between the barbed control (Quill™ SRS MONODERM) and test devices. |
| The non-barbed control (Biosyn™) was stronger than both barbed devices at T=0 and T=3 days. | ||
| No statistical differences in strength were observed between the non-barbed control and barbed devices at T=10 and T=21 days. | ||
| Strength Loss evaluation (rat model) | Met the label claim of the Biosyn™ suture at T=2 weeks (75% of USP minimum knot pull specification). | |
| Established a strength loss specification of 90% USP minimum knot pull at T=1 week. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or animals.
- For in-vitro tests, the sample size is also not specified.
- For the porcine model, it states "Chronic 21 day study." The number of animals used is not provided.
- For the rat model, it states "degradation over 2 weeks." The number of animals used is not provided.
- Data Provenance: The studies were conducted by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) based in North Haven, CT, USA. The studies themselves are likely proprietary data generated specifically for this 510(k) submission. Therefore, it is prospective data for the purpose of demonstrating device performance. The country of origin of the data generation is implied to be within the US or a facility controlled by the US-based company.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of external experts to establish ground truth for the test set. Performance data appears to be derived from direct physical testing (bench) and biological observation/measurement (animal models) rather than expert interpretation of images or other qualitative data requiring consensus.
4. Adjudication Method for the Test Set
- None explicitly stated. The evaluations are quantitative (e.g., tensile strength, pull force, degradation percentage) based on direct measurement, not on a subjective assessment that would typically require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a surgical suture, and its performance is evaluated through physical and biological property testing.
6. Standalone (Algorithm Only) Performance
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (suture), not an AI algorithm.
7. Type of Ground Truth Used
- The ground truth used is primarily based on:
- Direct Physical Measurements/Specifications: For in-vitro tests such as needle attachment (USP/EP specification), diameter (USP/EP), tensile strength, and barb holding strength.
- Biomechanical Measurements: For in-vivo studies, such as pull force (to assess strength) in the porcine model and knot pull strength in the rat model. This involves objective quantitative data.
- Comparison to Predicate Devices: Performance is often assessed relative to the behavior of established predicate devices (e.g., Quill™ SRS MONODERM, Biosyn™ suture).
8. Sample Size for the Training Set
- Not Applicable. The V-Loc™ 90 Absorbable Wound Closure Device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process would be informed by general engineering principles and material science, not a data-driven training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for it. The device's characteristics are inherent to its design, materials, and manufacturing, which are validated through the performance tests described.
§ 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.