(17 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™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated 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 device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided document is a 510(k) Premarket Notification for a medical device, specifically a balloon catheter. However, it does not contain specific acceptance criteria or a detailed study report that would typically describe device performance against such criteria.
Instead, the document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, and lists general types of tests performed. It lacks quantitative data, statistical analyses, or detailed methods for establishing ground truth or expert involvement as requested in the prompt.
Therefore, I cannot fulfill most of your request directly from the provided text. I will outline what information is available and explicitly state what is missing.
Summary of Available Information (and Missing Information):
This document is a 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It declares substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. The document lists general types of tests performed but does not provide specific acceptance criteria, quantitative results, or detailed study methodologies.
Here's an breakdown based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document mentions "conformance to the requirements for its use as a PTA dilatation balloon catheter" but does not define these requirements quantitatively (e.g., "burst pressure must exceed X psi in Y% of samples").
- Reported Device Performance: No specific quantitative performance data is reported. The document lists types of tests performed (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) and states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance..." However, no numerical results, ranges, or pass/fail rates are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence.
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 / Not specified. This type of information (expert consensus for ground truth) is relevant for studies involving imaging or diagnostics where subjective interpretation is key. For a physical medical device like a balloon catheter, "ground truth" would typically refer to objective physical properties measured against engineering specifications, not expert interpretation of data. The document does not describe any human-read data or ground truth establishment relevant to expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically used in clinical trials or studies where human readers or experts are evaluating outcomes, often in cases of disagreement. This is not relevant for the types of physical device tests mentioned (tensile, burst, etc.).
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
- No. This is definitively stated as "No". An MRMC study is relevant for diagnostic or AI-assisted devices that involve human interpretation of cases. This document is for a physical interventional medical device and does not involve AI or diagnostic interpretation in its reported testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is definitively stated as "No". Similar to point 5, this is not an AI-driven device, so standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical tests mentioned (burst, tensile, etc.), the "ground truth" would be established by engineering specifications and validated testing methodologies (e.g., measuring pressure at which a balloon bursts, force required for tensile failure). The document does not specify these in detail, but it's implied that standard physical testing methods were used. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable / Not specified. This device does not involve AI/machine learning, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As there is no training set, this question is not applicable.
§ 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).