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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, and infra-popliteal arteries.

The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The product family consists of 0.014" and 0.018" systems that are compatible with 0.014" and 0.018" guidewires, respectively. Overall catheter lengths range from 120-150 cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is constrained by a nitinol constraining structure (CS) which provides fast deflation and uniform re-wrap. Upon deflation, the CS is removed from the vessel along with the balloon catheter. The balloon is available in multiple sizes and contains two radiopaque markers to assist with positioning. The proximal end of the device is a common balloon catheter design of a braided shaft connected to a plastic hub and strain relief. The hub has two ports; the balloon port is used to inflate the balloon and the guidewire port connects to the guidewire lumen.

The Chocolate PTA balloon catheter is intended for single-use only and is provided sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Medtronic Chocolate PTA Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a comprehensive de novo clinical trial with defined acceptance criteria and extensive performance studies.

Therefore, the document does not contain the information typically found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance: The submission focuses on comparing the new device's characteristics to a predicate, not on setting and meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy.
• Sample sizes used for the test set and data provenance: No clinical test set involving patients or human data is described for performance evaluation.
• Number of experts used to establish ground truth or their qualifications: Ground truth establishment is not relevant in this type of submission, as it's about equivalence, not novel performance claims.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic device, nor is it a study comparing human performance with and without the device.
• Standalone (algorithm only) performance: Not applicable as this is a medical device (balloon catheter), not an algorithm or AI.
• Type of ground truth used: Not applicable.
• Sample size for the training set and how ground truth for training set was established: Not applicable, as this is a physical medical device, not an AI/ML algorithm.

What the document does describe in terms of "proving acceptance criteria":

The "acceptance criteria" in the context of this 510(k) submission are not performance metrics for clinical efficacy, but rather the demonstration of substantial equivalence to an existing predicate device. The "study that proves the device meets the acceptance criteria" refers to the various tests and analyses performed to support this equivalence.

Here's an interpretation based on the provided text:

Implicit Acceptance Criteria (for 510(k) Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the modified Chocolate PTA Balloon Catheter is as safe and effective as the predicate device (Chocolate PTA Balloon Catheter K130414) and does not raise new questions of safety or effectiveness. This is demonstrated by showing:

• Identical/Similar Intended Use: The intended use is largely the same, with a minor change in the exclusion of renal arteries.
• Equivalent Technological Characteristics: Key design principles, balloon specifications, and catheter technical specifications remain identical or acceptably similar.
• Biocompatibility: The device is biocompatible and safe for patient contact.
• Sterilization: The sterilization method is unchanged and validated.
• Packaging: Packaging changes do not compromise sterility or device integrity.

The "Study" (Evidence) Proving the Device Meets These Implicit Acceptance Criteria:

The "study" in this context is a compilation of various non-clinical testing and comparisons.

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for 510(k)): Demonstration of substantial equivalence to the predicate device (K130414) for the Chocolate PTA Balloon Catheter. This is assessed by comparing intended use, technological characteristics, and performance data to ensure safety and effectiveness are maintained.
   • Reported Device Performance (as described in the document):
     • Intended Use: "The Chocolate PTA balloon catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries." (Note: this is a slight modification from the predicate, which also included renal arteries). The change does not introduce new safety concerns.
     • Technological Characteristics:
       • Identical: Intended Use (largely), Principle of Operation, Balloon technical specifications (diameters, lengths, materials, markers, burst pressure, nominal pressure, constraining structure material), Catheter technical specifications (lengths, guidewire/introducer compatibility, most materials), Packaging materials, Testing and Compliance to ISO 10993 and ISO 11135-1, Sterilization Method.
       • Similar (with justification for equivalence): Inner Member components (resin changes in outer and inner layers, tie-layer unchanged), IFU specifications (size, stitching), Compliance Card size/artwork, Pouch Label dimensions, Carton Label dimensions.
     • Biocompatibility: Passed required tests per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility). No new or increased biocompatibility concerns.
     • Packaging Validation: Passed packaging validation, packaging aging, and sterilization testing with a worst-case 72-page IFU and eIFU leaflet. No additional risks identified.
     • Sterilization: Successfully completed testing indicated no sterilization process changes required. Sterilization assurance level 10-6 maintained.
     • Performance Equivalence Conclusion: "The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market."

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

   • This document describes non-clinical testing (e.g., biocompatibility testing on material samples, packaging validation on multiple units). It does not specify "sample sizes" in terms of clinical patient populations.
   • Data Provenance: Not explicitly stated, but typical for medical device testing to be conducted at manufacturer facilities or contracted laboratories. No mention of country of origin for any human data (as none was used). The testing is retrospective in the sense that it supports the premarket notification.

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

   • Not applicable. "Ground truth" in the diagnostic sense is not established for this device's performance given the 510(k) pathway. Expert knowledge would be involved in designing and interpreting the engineering and material safety tests, but not in diagnosing conditions.

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

   • Not applicable, as this is not a diagnostic imaging study requiring multi-reader adjudication.

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. This is a physical medical device (balloon catheter), not an AI diagnostic tool.

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

   • No. This is a physical medical device (balloon catheter), not an algorithm.

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

   • Not applicable in the clinical diagnostic sense. The "ground truth" for this submission is based on established engineering principles, material science, validated test methods (e.g., ISO standards), and a comparison to the known performance and safety profile of the legally marketed predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

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

   • Not applicable.

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