(197 days)
The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
The FasTouch Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate fixation of prosthetic material to soft tissue in laparoscopic or open surgical procedures such as ventral hernia repair. The FasTouch Fixation System is disposable, single-use system.
The Via Surgical's FasTouch Fixation System is designed to be inserted through a laparoscopic port sleeve but may be used during open surgical procedures as well. The FasTouch Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).
The provided document describes the Via Surgical FasTouch Fixation System and its premarket notification (510(k)) submission to the FDA (K132698). However, it does not contain the level of detail requested in the prompt regarding specific acceptance criteria, reported performance values, or detailed study methodologies that would typically be found in a clinical trial report or a comprehensive validation study.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Identical intended use.
- Similar fixation technology and fastener design/material.
- Similar technological characteristics (trigger handle, penetration depth, spring load firing mechanism, shaft length).
- Same principle of operation and similar materials.
The document states that minor technological differences were tested and do not raise new questions of safety and effectiveness.
Here's an attempt to extract and describe the information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or provide a table of performance metrics. The performance is summarized as "safe and effective" and "substantially equivalent" to predicate devices. The listed tests are qualitative or comparative:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functionality | |
| Cartridge loading and replacement (BT-011) | Demonstrated (implied successful operation) |
| Performance Evaluation (BT-014) | Demonstrated (implied successful operation) |
| Fixation Strength | |
| Fixation strength evaluation (BT-012) | Demonstrated (implied sufficient strength, potentially comparable to predicates) |
| Mesh Compatibility | |
| Mesh compatibility and Integrity following fixation (BT-013) | Demonstrated (implied compatible with various market-cleared meshes and maintains integrity) |
| Deployment/Clinical Use | |
| Animal study for deployment and fixation with surgeons feedback | Positive feedback, demonstrated safe and effective deployment and fixation |
| Clinical usability test | Device found safe and effective for its intended use |
| Overall Comparison | |
| Substantial Equivalence | Concluded to be substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for "test sets" in the context of statistical validation for AI/algorithm performance. The studies mentioned are:
- Bench Testing (BT-011, BT-012, BT-013, BT-014): No sample sizes are provided.
- Animal Study: No sample size is provided. Data provenance is not explicitly stated (e.g., country), but it would likely be a controlled laboratory environment. Retrospective/prospective is not specified, but animal studies are typically prospective.
- Clinical Usability Test: No sample size is provided. Data provenance is not explicitly stated. Retrospective/prospective is not specified; usability tests are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided for any of the studies mentioned. The animal study involved "surgeons' feedback," but their number and specific qualifications are not detailed. Clinical usability also implies expert opinion but no specifics are given.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device described is a surgical fixation system, not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The comparison is against predicate devices, not human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The FasTouch Fixation System is a physical surgical device, not an algorithm.
7. Type of Ground Truth Used
For the physical device, "ground truth" would relate to its mechanical and functional performance, as well as its biological interaction.
- Mechanical/Functional Bench Tests: Ground truth would be defined by engineering standards, measurement results (e.g., force, integrity), and successful operation as per design specifications.
- Animal Study: Ground truth would be based on successful deployment, effective fixation in living tissue, and potentially histological assessment of tissue response. "Surgeons feedback" serves as expert assessment of performance.
- Clinical Usability Test: Ground truth would be the assessment of usability, safety, and effectiveness by medical professionals (surgeons or similar) during simulated or actual use cases, validating the device's practical application.
8. Sample Size for the Training Set
Not applicable. As a physical device, there isn't a "training set" in the context of machine learning algorithms. The development and refinement of the device would involve engineering design, prototyping, and iterative testing, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see point 8). Development and testing would rely on engineering principles, material science, and pre-clinical evaluations to guide design improvements.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.