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510(k) Data Aggregation
(96 days)
FasTouch Fixation System
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 hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair.
The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
This document is a 510(k) summary for the Via Surgical Ltd. FasTouch™ Fixation System (K162252). Due to the nature of this submission being a 510(k) for a fixation system (a physical medical device) and not a software-as-a-medical-device (SaMD) or AI/ML-based device, information regarding acceptance criteria and study designs typically associated with AI/ML evaluations (such as sample sizes for test and training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not present.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is an existing FasTouch™ Fixation System (K132698). The performance data cited are for mechanical and functional assessments of the device itself, rather than diagnostic accuracy or clinical effectiveness involving human readers or AI.
Therefore, many of your requested fields will be marked as "Not applicable" or "Not provided in this document" because they pertain to AI/ML device evaluations, which this document does not describe.
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Risk analysis per ISO 14971:2012 | Not explicitly stated, but implies compliance with risk management standards. | Performed and found to be acceptable (device performs as intended, no new safety concerns). |
| Performance Evaluation (BT-114) | Not explicitly stated in this summary. Implies general functional performance. | Performed and found to be acceptable (device performs as intended). |
| Device Cartridge loading and replacement (BT-111) | Not explicitly stated in this summary. Implies proper and reliable operation. | Performed and found to be acceptable (device performs as intended). |
| Fixation strength evaluation (BT 112) | Not explicitly stated in this summary. Implies a minimum required fixation strength. | Performed and found to be acceptable (device performs as intended). |
| Mesh compatibility and Integrity following fixation with the FasTouch Device (BT-113) | Not explicitly stated in this summary. Implies no degradation or damage to mesh. | Performed and found to be acceptable (device performs as intended). |
| Usability/Clinical Utility testing BT-WWH16 | Not explicitly stated in this summary. Implies ease of use and effectiveness in a simulated environment. | Performed and found to be acceptable (device performs as intended). |
Note: The document states that these tests were "the same as those performed and submitted in the original submission using the same acceptance criteria." However, the specific acceptance criteria are not detailed in this 510(k) summary. The overall conclusion is that the device "performs as intended and in a manner that is substantially equivalent to the predicate."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device; the "test set" here refers to mechanical and functional device testing, not a diagnostic or clinical dataset for an AI/ML algorithm. The document does not specify sample sizes for mechanical testing or data provenance beyond the manufacturer being based in Israel.
3. 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. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or pathology) is not relevant for this type of device submission. The "ground truth" for this device would be its mechanical and functional specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or diagnostic studies, not for the mechanical testing of a surgical fixation system.
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
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This document describes a surgical fixation system, not an AI/ML diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to engineering specifications and performance benchmarks for mechanical strength, usability, and compatibility with other materials. It is established through engineering design, material science principles, and established test methods, rather than expert consensus on clinical data or pathology. The document does not explicitly state the specific "type" of ground truth but implies it is based on performance standards for the predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant to its development or validation as described in this 510(k) summary.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant.
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(197 days)
FASTOUCH FIXATION SYSTEM
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.
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