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The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The Flash-C PTCA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The provided text describes a 510(k) premarket notification for the "Flash-C PTCA Balloon Dilatation Catheter" and does not contain information about a study proving the device meets acceptance criteria.

The document details the device's intended use, its substantial equivalence to predicate devices, and the performance data refers to a list of in-vitro bench testing and biocompatibility testing. These tests are used to confirm the performance characteristics as compared to the predicate device and meet established specifications, rather than proving achievement of specific clinical acceptance criteria in a study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from the provided text, as this type of clinical study was not described.

Here's a breakdown of what can be extracted or inferred based on the context of a 510(k) submission for this type of device:

1. Table of acceptance criteria and the reported device performance:

The document broadly states: "All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use." And "The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs."

However, specific quantitative acceptance criteria and their corresponding reported device performance values are NOT provided in the text. The document only lists the types of tests performed.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the in-vitro or biocompatibility tests.
• Data Provenance: Not specified. These are laboratory bench tests and in-vitro biocompatibility tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the "test set" described consists of in-vitro and biocompatibility testing, not human-read clinical data requiring expert ground truth establishment.

4. Adjudication method for the test set:

• Not applicable for the described in-vitro and biocompatibility testing.

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 MRMC study was done. This device is a PTCA Balloon Dilatation Catheter (a physical medical device, not an AI or imaging diagnostic tool). The provided text does not mention any AI component or human reader interpretation studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the sense of expert consensus, pathology, or outcomes data for clinical performance. The 'ground truth' for the in-vitro and biocompatibility tests would be the established engineering specifications and biological safety standards, respectively.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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