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The ValvuloPro® Valvuloplasty Balloon Catheters are indicated for balvoon aortic valvuloplasty. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation. The effective length of the catheter is 130cm. The y-connector consists of a balloon inflation port and a guidewire lumen. Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. The balloon catheter is supplied sterilized by ethylene oxide (EO) for single use.

AI/ML Overview

The provided document is a 510(k) Summary for the ValvuloPro Valvuloplasty Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies or AI/software performance. Therefore, many of the requested categories related to AI/software performance, clinical studies, and ground truth establishment are not applicable.

Here's the breakdown of the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests conducted and states that "All tests were passed" for each category. It does not provide specific numerical acceptance criteria or detailed performance metrics. Instead, it refers to compliance with established standards (e.g., ISO, internal technical requirements).

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, including specific tests like Hemolysis, Acute Systemic Toxicity, Cytotoxicity, Sensitization, etc.	All tests passed
Sterilization	Sterile with SAL of 10-6 via half-cycle overkill approach, in accordance with ISO 11135:2014.	Achieved required SAL
Packaging Test	Visual inspection, bacteriostasis performance, seal integrity (dye penetration, bubble emission), seal strength.	All tests passed
Balloon Catheter Testing	Guidewire compatibility, channel compatibility, dimensional inspection, compliance, balloon fatigue, RBP, simulated use, flexibility and kink, torque strength, peak tensile strength, leakage, hydratability, corrosion resistance.	All tests passed
Hub Testing	Gauging, stress cracking, liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding.	All tests passed
Other	X-ray detectability, Chemical properties.	All tests passed

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

Test set sample size: Not explicitly stated for each test. The document mentions "Relevant testing was conducted on samples before and after aging to establish device shelf life," indicating multiple samples were used for performance tests.
Data provenance: Not explicitly stated, but the tests are non-clinical, likely conducted in a controlled lab environment by the manufacturer (Dongguan TT Medical, Inc.) or their contracted labs. It is all prospective testing of the manufactured device.

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

Not applicable. This section pertains to clinical studies or expert review of data for AI/software validation. The document describes non-clinical performance and biocompatibility testing against defined standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is relevant for clinical studies or expert consensus on clinical data. Non-clinical tests follow defined protocols and yield objective results.

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:

Not applicable. This device is a physical medical device (balloon catheter), not an AI/software product that assists human readers.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For this type of device, "ground truth" refers to established engineering standards, material properties, and biological safety parameters defined in international standards (e.g., ISO 10993, ISO 11135, ISO 11607) and internal technical specifications. The device's performance is measured against these objective criteria rather than expert consensus on clinical cases.

8. The sample size for the training set:

Not applicable. This refers to machine learning models.

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

Not applicable. This refers to machine learning models.

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