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The All'InCath 035M PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The All'InCath 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media.

This catheter is not for use in coronary arteries.

The All'InCath 035M PTA Balloon Dilatation Catheter (All'InCath 035M) is a sterile single use dilatation balloon and contrast injection catheter.
The All'InCath 035M is an over the wire (OTW) catheter compatible with 0.035" (0.89mm) guidewire.
The proximal end of the catheter includes a three ports hub connected to the three lumens of the shaft: the port provided with a stopcock valve is used for angiographic contrast injection, the straight entry port allows access to the distal tip of the catheter for guidewire insertion, and the last port is used for balloon inflation/deflation.
Contrast is injected into the vascular system through three holes in the contrast lumen proximal to the balloon and marked by a radiopaque marker.
The balloon is mounted at the distal end of the catheter.
The balloon has two radiopaque markers indicating the dilating section of the balloon and aid positioning the balloon relative to the lesion. The tip of the catheter is made of a soft radiopaque tubing.

This document is a 510(k) Premarket Notification for the All'InCath 035M PTA Balloon Dilatation Catheter. It is a medical device submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. This type of document is not an AI/ML study, it's a submission for a medical device. Therefore, the questions related to AI/ML study parameters (like sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment for AI/ML) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical medical device based on the provided text, as well as information about the types of studies conducted for its safety and performance.

Acceptance Criteria and Reported Device Performance (Physical Device)

The document primarily focuses on demonstrating substantial equivalence based on in vitro performance tests and a pre-clinical study in an animal model. The acceptance criteria are generally implied as meeting established standards and not raising different questions of safety and effectiveness compared to predicate devices.

Study Information (Pertaining to the Physical Device)

1. Sample sizes used for the test set and data provenance:

   • In vitro tests: The specific number of devices/samples tested for each in vitro performance criterion (dimensional verification, burst pressure, fatigue, etc.) is not explicitly stated in this summary. These tests are typically performed on a statistically significant sample size to ensure reproducibility and reliability, but the exact numbers are not detailed here.
   • Biocompatibility tests: Similarly, specific sample sizes (e.g., number of animals for in vivo biocompatibility components or number of samples for in vitro components) are not detailed. These are typically done according to the requirements of ISO 10993.
   • Pre-clinical study: The sample size (number of porcine models) for the in vivo pre-clinical study is not specified in the document.
   • Data Provenance: The document states the pre-clinical study was conducted in a porcine vascular model. No country of origin for the data is explicitly mentioned for the studies, but the submitter is "NexStep Medical, 7-9 Place Saint Bernard 21000 Dijon France" and the contact person is in Minneapolis, MN, USA. The studies themselves are retrospective to the submission date.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a medical device submission based on physical and biological performance, not an AI/ML image-based study requiring expert ground truth in the traditional sense. The "ground truth" for device performance comes from direct measurements (in vitro) and observed biological/physiological responses (in vivo animal model) against predefined engineering and biological standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for an AI/ML study, which is not what this document describes.

4. 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 type of study relates to AI/ML software.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance relies on engineering specifications, physical measurements (e.g., balloon dimensions, burst pressure), biological standards (e.g., biocompatibility per ISO 10993), and direct observation/measurement of device behavior in a controlled in vitro environment and an in vivo animal model. There is no "pathology" or human "outcomes data" presented for specific patients, as this is a pre-market submission, not a clinical trial report on human subjects.

7. The sample size for the training set: Not applicable. This pertains to AI/ML models.

8. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML models.

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