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The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.

The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.

The provided text describes the submission for a medical device called the "Zoom 6F Insert Catheter." This is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, the "Impress Angiographic Catheter."

Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a catheter) and its performance through bench and laboratory (in-vitro) testing against physical specifications, not algorithm performance. Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for AI test sets, expert consensus for ground truth, MRMC studies, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device as presented.

Description of Acceptance Criteria and Study (for this physical device)

The submission details the design verification and validation testing performed on the Zoom 6F Insert Catheter to demonstrate its substantial equivalence to a predicate device. The "study" here refers to a series of in-vitro bench and laboratory tests, not a clinical trial or an AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table (Table 2) summarizing the performance specifications (acceptance criteria) and the results ("Pass") for the Zoom 6F Insert Catheter.

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

• Sample Size: The document does not specify the exact number of units tested for each attribute. It mentions "Bench and Laboratory (In-vitro) testing." For medical devices, typically this would involve a statistically significant number of samples (e.g., n=3, 5, or more, depending on the test and variation) to ensure reproducibility and reliability, but the exact numbers are not provided in this public summary.
• Data Provenance: The data provenance is "Bench and Laboratory (In-vitro) testing," meaning it was conducted in a controlled lab environment. This is not clinical data, nor attributed to a specific country of origin, retrospective or prospective. It's a physical materials/engineering test.

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

• Not Applicable. For a physical catheter, "ground truth" is established by direct physical measurements according to specified test methods (e.g., measuring dimensions with calipers, applying pressure, observing flow rates). There are no "experts" in the sense of clinical readers or annotators establishing a ground truth for a test set. Engineering and quality control personnel would perform these tests.

4. Adjudication Method for the Test Set:

• Not Applicable. As the tests are objective physical measurements or observations against predefined specifications, there's no need for an "adjudication method" in the context of human interpretation of data. The results are either "Pass" or "Fail" based on comparison to the specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a regulatory submission for a physical diagnostic catheter, not an AI/ML medical device. MRMC studies are relevant for evaluating the impact of AI on human reader performance for diagnostic tasks.

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

• No. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

• Physical Specifications and Engineering Standards. The "ground truth" for these tests is the quantitative and qualitative performance specifications derived from medical device standards (e.g., ISO 10555-1, ISO 80369-7) and internal design requirements. For example, "Effective lengths... within specified tolerances" means the measured length must fall within the defined acceptable range.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set.

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