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The Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures.

The Mongoose Angiographic Catheter is a single-use, sterile, non-pyrogenic disposable intravascular catheter for use in angiographic procedures. The Mongoose Angiographic Catheter is intended for adult and pediatric patients of all ages.

The Mongoose Angiographic Catheter is available in 3.3 F, 4.0 F and 5 F sizes. These catheters are available in effective lengths ranging from 35-135 cm and a variety of distal end shapes. The distal tip, soft tube and shaft of Mongoose Angiographic Catheters are manufactured with radiopaque barium sulfate to aid in device visualization under fluoroscopy. Catheters have a hydrophilic coating and are reinforced with wire braiding. Side holes are available to disperse the contrast medium.

An inserter is made available as an accessory to the Mongoose Angiographic Catheters with a pigtail distal configuration. The inserter facilitates insertion of the angiographic catheter into an introducer.

The provided text describes a 510(k) summary for the "Mongoose Angiographic Catheter," which is a diagnostic intravascular catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving device performance are not applicable based on the provided text. The document details non-clinical (bench) testing to establish substantial equivalence.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as would be typical for a clinical performance study. Instead, the "acceptance criteria" for this 510(k) submission are that the device demonstrates substantial equivalence to existing predicate devices by having the same intended use and similar technological characteristics, and importantly, not raising new questions of safety and effectiveness.

The "reported device performance" is a summary of non-clinical testing confirming that the Mongoose Angiographic Catheter meets established standards and internal requirements, thereby demonstrating it is as safe and effective as its predicates.

The study that "proves" the device meets the acceptance criteria is the sum of non-clinical performance testing and the demonstration of substantial equivalence to predicate devices.

Information Not Applicable/Provided for a Clinical Study

Based on the provided text, the following information, typically found in a clinical study report proving device performance, is not applicable or not provided as this submission is for a 510(k) based on substantial equivalence through non-clinical testing.

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

   • Not applicable as no clinical test set is described. The "test set" comprised physical units of the device subjected to bench testing. The provenance of that bench testing (where it was done) is implied to be by the manufacturer or their contracted labs.

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

   • Not applicable. There's no clinical test set requiring expert ground truthing.

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

   • Not applicable.

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:

   • Not applicable. This device is an angiographic catheter, not an AI or imaging diagnostic tool.

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

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

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

   • For the non-clinical tests, the "ground truth" would be objective measurements and adherence to specified engineering tolerances and international standards. For example, tensile strength measured against a predefined acceptable range, or sterility confirmed by standard microbiological methods.

7. The sample size for the training set:

   • Not applicable. There is no algorithm or AI component requiring a training set mentioned.

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

   • Not applicable.

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