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The GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial svstem and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.

Here's a breakdown of the acceptance criteria and study information for the GPSCath™ Balloon Dilatation Catheter, based on the provided document:

Acceptance Criteria and Device Performance

The document states that the purpose of the Special 510(k) is to revise the Instructions for Use (IFU) to illustrate a new balloon rated burst pressure and compliance table. This implies that the acceptance criteria are related to these physical properties and that the device performance met the new, higher specifications. While the exact numerical values for the original and new rated burst pressures, compliance, and other performance criteria are not explicitly detailed in a table, the document confirms that the device met them.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

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

   • Sample Size: Not explicitly stated in the document. The document mentions "bench top testing" but does not give specific numbers of devices or balloons tested for each criterion.
   • Data Provenance: The studies were "in vitro test data" and "bench top tests." This means the data was generated in a lab setting, not from human or animal subjects. The country of origin of the data is implied to be within the US, as Hotspur Technologies, Inc. is located in Mountain View, CA, and submitted the notification to the FDA.

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

   • This section is not applicable to this type of device and study. The testing for the GPSCath™ Balloon Dilatation Catheter involved physical bench-top performance metrics (e.g., burst pressure, compliance) rather than diagnostic interpretations requiring expert ground truth. The "ground truth" for these tests would be the measured physical properties of the device itself.

3. Adjudication method for the test set:

   • This section is not applicable as the study involved objective physical measurements, not subjective evaluations that would require adjudication.

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:

   • This section is not applicable. The GPSCath™ Balloon Dilatation Catheter is a medical device (a balloon catheter) and not an AI-powered diagnostic system. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

   • This section is not applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant.

6. The type of ground truth used:

   • The "ground truth" for this device's performance assessment was physical measurement against predetermined specifications and applicable standards. For example, a burst pressure test would involve applying pressure until the balloon bursts, and that measured pressure would be compared to the specified rated burst pressure.

7. The sample size for the training set:

   • This section is not applicable. There is no "training set" in the context of this device. The phrase "training set" typically refers to data used to train machine learning models. This product underwent traditional engineering and quality assurance testing.

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

   • This section is not applicable for the same reason as point 7.

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