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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes the 510(k) summary for the Chocolate PTA Balloon Catheter, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metric acceptance criteria in the way typically discussed for AI/ML devices.

The document is a regulatory submission for a medical device (a balloon catheter), and the "performance data" section focuses on bench testing to establish substantial equivalence to predicate devices, rather than meeting quantitative performance metrics against a defined standard.

Therefore, many of the requested sections (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) are not applicable to this type of traditional medical device submission and its associated testing.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in a quantitative format. Instead, it lists the types of in vitro tests performed to demonstrate product safety and effectiveness for substantial equivalence. The "reported device performance" is implicitly summarized by the statement:

"Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use."

The tests performed are:

• Balloon Rated Burst Pressure
• Balloon Inflation and Deflation
• Balloon Fatigue / CS Fatigue
• Catheter Diameter, Balloon Profile and Tip Configuration
• Balloon Compliance
• Trackability, Pushability
• Kink Resistance
• Device Interface Compatibility

There are no specified numerical acceptance thresholds or results provided for these tests in this summary. The goal was to show they "conformed to the requirements for its intended use" and were "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The performance data section refers to "bench testing" (in vitro tests), not clinical studies involving patient data or a test set in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts for a test set in this context. The "ground truth" for these tests would be the established performance specifications for the physical properties of the device.

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

Not applicable. No adjudication method for a test set was mentioned.

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 is a physical medical device, not an AI/ML algorithm that assists human readers.

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 (expert concensus, pathology, outcomes data, etc)

Not applicable in the AI/ML sense. The "ground truth" for the listed in vitro tests would be the predefined engineering specifications and industry standards for medical device performance.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of traditional medical device bench testing.

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

Not applicable. As above, no training set.

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