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Blue Max 20 Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The proposed Blue Max™ -20 Balloon Dilatation catheter is an over-the-wire catheter with two lumens indicated for percutaneous transluminal angioplasty of narrowed or obstructed vessels in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The provided text describes a 510(k) premarket notification for the "Blue Max™ -20 Balloon Dilatation Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the information provided primarily revolves around in vitro functional testing and biocompatibility testing, not human clinical trials or AI-based performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states these tests were "performed" but does not provide specific numerical acceptance criteria (e.g., "burst pressure must exceed X psi") or the exact results obtained from these tests. The conclusion simply states that based on the testing, the device is "safe and effective for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for any of the in vitro or biocompatibility tests.
• Data Provenance: The tests would have been performed by Boston Scientific Corporation or their designated testing facilities. The country of origin of the data is not explicitly stated beyond the manufacturer being in Natick, MA. These are laboratory tests, not human data, so "retrospective or prospective" does not apply in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable to the studies described. The "ground truth" for in vitro functional and biocompatibility tests is typically established through standardized protocols and validated measurement techniques, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• This is not applicable to the studies described, as "adjudication method" usually refers to resolving discrepancies in expert interpretations of data in clinical or image-based studies.

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. An MRMC study was not described. This device is a physical medical device (balloon catheter), not an AI algorithm or an imaging device requiring human reader interpretation, so AI assistance is not relevant here.

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

• Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

• For the in vitro functional tests, the ground truth would be based on engineering specifications and established test methodologies to assess physical performance characteristics (e.g., burst pressure, inflation time, bond strength).
• For biocompatibility tests, the ground truth would be based on validated biological endpoints as defined by ISO standards and regulatory guidelines (e.g., cell viability, irritation response, systemic toxicity).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning study. The device itself is manufactured. There isn't a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" for this type of medical device.

In Summary:

The K972357 submission for the Medi-tech Blue Max™ -20 Balloon Dilatation Catheter demonstrates safety and effectiveness primarily through in vitro functional testing and biocompatibility testing to establish substantial equivalence to predicate devices. It does not involve AI, human clinical trials with patient outcomes, or expert-adjudicated ground truth as would be seen in diagnostic device or AI software submissions. The provided document lists the types of tests performed but lacks specific numerical acceptance criteria or detailed results. The FDA's letter confirms substantial equivalence based on the submitted information.

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