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The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.

The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.

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

• Sample Size for Test Set: Not applicable. This submission describes testing for substantial equivalence of a physical medical device, not a diagnostic algorithm with a "test set" of data. The "testing" refers to functional and biocompatibility tests on the physical catheter system.
• Data Provenance: Not applicable. The "data" are results from engineering and biocompatibility tests, not clinical data from patients.

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

• Not applicable. This is not an AI/ML diagnostic device where ground truth is established by experts for a test set.

4. Adjudication method for the test set

• Not applicable.

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 not an AI-assisted device.

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

• Not applicable. This is a physical medical device (balloon catheter).

7. The type of ground truth used

• The "ground truth" for this device's acceptance would be derived from:
  • Engineering specifications and standards: For functional tests (e.g., balloon inflation/deflation times, burst pressure, trackability).
  • ISO 10993-1 Biocompatibility Standards: For chemical and biological safety.
  • Predicate Device Characteristics: For comparison of design, materials, and intended use to establish substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr cylinder.

The provided 510(k) Premarket Notification for the CVSi™ Peripheral Balloon Catheter System outlines functional and biocompatibility testing, but it does not include the detailed performance metrics, acceptance criteria, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) that would typically be associated with AI/ML device evaluations. This document describes a traditional medical device submission, focusing on equivalence to predicate devices rather than AI performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies for an AI device cannot be extracted from this document.

However, based on the information provided, here's what can be stated:

Acceptance Criteria and Device Performance (Limited Information for AI/ML)

Since this is a submission for a traditional medical device (a balloon catheter system), not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the AI/ML context (e.g., sensitivity, specificity, AUC) is not applicable here.

The document states that:

• Functional Performance Testing: "All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended."
• Biocompatibility Evaluation: "The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."

Table of Acceptance Criteria and Reported Device Performance (as far as can be inferred for a traditional device):

Study Details (Applicable to Traditional Device, Not AI/ML)

As this is not an AI/ML device, the following points are addressed in the context of a traditional medical device submission for substantial equivalence:

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

   • The document mentions "Human clinical experience collected in conformance with an IDE study and additional case studies" and "Data from animal studies conducted in conformance with GLP regulations and additional animal studies."
   • Sample sizes for these studies are NOT provided.
   • Data Provenance: Not explicitly stated, but clinical and animal studies would typically be conducted in a prospective or retrospective manner specific to the study design. The country of origin is not mentioned.

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

   • Not applicable for this type of device submission. The "ground truth" for a balloon catheter is its physical performance and biological safety, assessed through engineering tests and biocompatibility panels, and clinical outcomes for human studies, not expert consensus on image interpretation.

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

   • Not applicable for a traditional medical device. Adjudication methods are relevant for subjective data interpretation, typically in AI/ML performance evaluation.

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:

   • No, an MRMC comparative effectiveness study was NOT done (or at least not reported in this context). This is a traditional device, not an AI-assisted diagnostic tool. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

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

   • Not applicable. This device is a physical medical instrument, not a standalone algorithm.

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

   • For functional testing: Engineering specifications and measurements; adherence to physical performance parameters.
   • For biocompatibility: ISO 10993 standards and laboratory test results.
   • For clinical/animal studies: Patient outcomes, physiological measurements, and histological findings (for animal studies) would form the basis of "ground truth" for safety and effectiveness comparisons.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device.

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