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510(k) Data Aggregation
(243 days)
The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive or synthetic arteriovenous dialysis fistulae.
The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon. The device is compatible with 0.18" guidewires.
This document is a 510(k) Summary for the FLEX™ Scoring Catheter. It does not describe a study to prove acceptance criteria in the typical format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, animal testing, and cadaveric studies.
Therefore, the requested information elements such as sample sizes for test sets (in the context of an AI/ML model), number of experts for ground truth, adjudication methods, MRMC studies, or training set details are not applicable in this document's context, as it's not evaluating an AI/ML algorithm.
However, I can extract the acceptance criteria (performance requirements) and the reported performance based on the information provided regarding the functional and safety testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Requirement (Acceptance Criteria Mentioned) | Reported Device Performance / Assessment |
|---|---|
| General Requirements for Intravascular Catheters (ISO 10555-1) | Device underwent bench testing and met these requirements. |
| Biocompatibility Testing (ISO 10993-1) | Device underwent testing and met these requirements. Biological evaluation followed Part 1 of ISO 10993-1. |
| Sterilization Validation Testing (ISO-11135-1) | Device underwent testing and met these requirements. Sterilization is via Ethylene Oxide, and validation followed ISO 11135-1. |
| Simulated Use Testing | Performed and demonstrated the FLEX device meets user needs and intended use. |
| Clinical Performance (In Vivo GLP animal testing & Cadaveric Studies) | Performed and demonstrated the FLEX device meets user needs and intended use. The conclusion states that "bench testing and pre-clinical animal studies demonstrate that none of the technical differences raise any new questions of safety and effectiveness." |
| Material/Design Properties | The device has the same intended use, principles of operation, and similar design features (as detailed in the technical comparison table with the predicate device). |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects for performance evaluation.
- For bench testing: "representative samples of the device underwent bench testing." The exact number of samples is not specified.
- For In Vivo GLP animal testing / Cadaveric studies: Conducted, but specific sample sizes are not provided in this summary.
- Data Provenance: These are pre-clinical studies (bench, animal, cadaveric). No indication of specific country of origin, but generally, GLP (Good Laboratory Practice) studies follow international standards. These would be prospective studies (designed and conducted specifically for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device approval based on substantial equivalence, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering and biological performance standards, verified through testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device submission.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" in this context is the established engineering standards, biological safety standards, and functional performance requirements. These are verified through various tests, including:
- Compliance with ISO 10555-1 (General Requirements for Intravascular Catheters), which sets performance specifications.
- Compliance with ISO 10993-1 (Biological evaluation of medical devices), focusing on biocompatibility.
- Compliance with ISO 11135-1 (Sterilization of Health Care Products).
- Verification against user needs and intended use through simulated use, animal, and cadaveric studies.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
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