(18 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance PTA Dilatation Catheter is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
The ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including illac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) submission for the ATB™ Advance PTA Dilatation Catheter. It outlines the device's indications for use, its classification, and a list of tests performed to demonstrate its safety and effectiveness. However, it does not include detailed acceptance criteria or the specific results that prove the device meets these criteria in a structured format as requested. It only broadly states that the test results "provide reasonable assurance that the device has been designed" for its intended purpose.
Therefore, for many of the requested points, the information is not available in the provided text.
Here is an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document lists several tests performed but does not specify acceptance criteria or quantitative performance results. It generally states that "The results of these tests provide reasonable assurance that the device has been designed."
| Test Type | Acceptance Criteria (Not provided in text) | Reported Device Performance (No specific data provided) |
|---|---|---|
| Tensile tests | Not specified | General assurance of design adequacy |
| Balloon inflation/deflation | Not specified | General assurance of design adequacy |
| Balloon burst tests | Not specified | General assurance of design adequacy |
| Balloon compliance | Not specified | General assurance of design adequacy |
| Balloon fatigue tests | Not specified | General assurance of design adequacy |
| Balloon profile | Not specified | General assurance of design adequacy |
| Balloon burst within a stent | Not specified | General assurance of design adequacy |
| Balloon fatigue within a stent | Not specified | General assurance of design adequacy |
2. Sample sizes used for the test set and the data provenance
- Sample sizes: Not specified in the provided text for any of the listed tests.
- Data provenance: Not specified. Based on the nature of a 510(k) submission for a medical device prior to market, these would typically be lab-based engineering and bench tests, not clinical studies with human data. Therefore, country of origin related to patient data is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are engineering and bench tests, not studies requiring expert clinical interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies or studies involving human assessment of data, not for the engineering tests described.
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 a medical device (dilatation catheter) and the tests are for its physical properties, not an AI-based diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For the engineering tests listed (tensile, burst, fatigue, etc.), the "ground truth" would be established by physical measurements and engineering specifications, rather than expert consensus, pathology, or outcomes data. For example, a burst test would determine the actual pressure at which a balloon bursts, and this would be compared against a pre-defined engineering specification.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for the type of tests described.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this type of medical device submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).