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510(k) Data Aggregation
V-Loc™ 180 Absorbable Reload: The V-Loc™ 180 absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ 180 absorbable reloads are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
V-Loc™ PBT Non-Absorbable Reload: The V-Loc™ PBT non-absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ PBT non-absorbable reloads are indicated for soft tissue approximation.
Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices
The provided text describes a 510(k) premarket notification for surgical suture reloads. It does not contain information about an AI/ML powered medical device, therefore the response will focus on the details that ARE available related to the performance testing of the suturing devices, primarily to establish substantial equivalence with predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study:
Acceptance Criteria and Device Performance
The acceptance criteria for the V-Loc™ 180 Absorbable Reload and V-Loc™ PBT Non-Absorbable Reload are based on demonstrating substantial equivalence to predicate devices through various performance tests. The document highlights the following standards and tests:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance and Compliance |
|---|---|
| USP Monograph for Sutures (33, NF 28, 2010) Physical Test Diameter | Compliance with this standard indicates the suture diameter meets specified requirements. The document states "Performance testing has been performed... This testing verifies that the V-Loc™ 180 Absorbable Reload and the V-Loc™ PBT Non-Absorbable Reload are substantially equivalent to the predicate devices." |
| USP Monograph for Sutures (33, NF 28, 2010) Physical Test Needle Attachment | Compliance with this standard indicates the needle attachment strength meets specified requirements. The document states "Performance testing has been performed... This testing verifies that the V-Loc™ 180 Absorbable Reload and the V-Loc™ PBT Non-Absorbable Reload are substantially equivalent to the predicate devices." |
| Needle Attachment (Bench Top & In Vivo) | Demonstrated performance to establish substantial equivalence. Specific quantitative results are not provided but the successful completion of these tests supports the claim of equivalence. |
| Insertion / Removal Forces through Port Cannula (Bench Top & In Vivo) | Demonstrated performance to establish substantial equivalence. Specific quantitative results are not provided. |
| Tensile Strength (Bench Top & In Vivo) | Demonstrated performance to establish substantial equivalence. Specific quantitative results are not provided. |
| Barbed Suture Holding Strength (Bench Top & In Vivo) | Demonstrated performance to establish substantial equivalence. Specific quantitative results are not provided. |
| Tissue Passage (Bench Top & In Vivo) | Demonstrated performance to establish substantial equivalence. Specific quantitative results are not provided. |
| Biocompatibility | "All component materials... have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices, according to their intended use." Also, "These materials have also been previously cleared in predicate devices for the identical intended use." |
| Technological Characteristics (Indications, Labeling, Materials, Performance) | The implantable portions are "identical to the predicate V-Loc™ Wound Closure Devices in terms of indications, labeling, materials, performance, and technology." Modifications (braided leader, ferrule) utilize "previously-cleared" needles and materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the benchtop and in vivo performance tests. It mentions "Performance testing has been performed" which implies tests were conducted, but specific numbers of devices, animals, or test conditions are not detailed.
Data provenance is not specified beyond indicating "bench top and in vivo tests." There is no mention of country of origin or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The submission is for surgical sutures, not an AI/ML powered device that requires expert review for ground truth establishment. The performance tests are largely objective measurements against defined standards (like USP monographs) or comparisons to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of human-in-the-loop assessments or expert interpretations that would require an adjudication method. The testing focuses on physical and biological properties.
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
This information is not applicable. This submission is for surgical sutures and related devices, not an AI/ML system. There are no "human readers" or "AI assistance" being evaluated in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established scientific and regulatory standards or the documented performance of the predicate devices.
- USP Monograph for Sutures (33, NF 28, 2010): These serve as the ground truth for physical properties like diameter and needle attachment.
- Predicate Devices: The V-Loc™ 180 Absorbable Wound Closure Device (K091087 and K082662), V-Loc™ Non-Absorbable Wound Closure Device (PBT) (K103052), Endo Stitch™ Endoscopic Suturing Device (K934738), SILS™ Stitch (K090419), and USSC Non-absorbable Sutures (K955747) serve as the ground truth for establishing "substantial equivalence" in terms of material composition, intended use, indications, labeling, and performance characteristics.
- ISO 10993-1: Biological Evaluation of Medical Devices: This standard serves as the ground truth for biocompatibility assessments.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The development of sutures and devices involves design, material selection, and manufacturing processes, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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