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These shunts (Clearview® Intracoronary Shunts) are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.

Clearview® Intracoronary Shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. The sizes of the shunts are indicated on the tag. These shunts are starile, nonpyrogenic, disposable and single use only.

The provided text describes a 510(k) summary for the Medtronic Clearview® Intracoronary Shunts. This document is for a medical device that has been modified, specifically a change in the radiopaque material from organic barium sulfate to synthetic barium sulfate. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on your request:

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

• Biocompatibility testing of the material showed acceptable results.
• Suture pull test of the material showed acceptable results. |
  | No change to technological characteristics | Confirmed: "The technological characteristics have not changed from the predicate device." |
  | No change to operating principle | Confirmed: "No change to the operating principle was made." |
  | No change to design features | Confirmed: "No design features have changed." |
  | Shelf life not impacted | Confirmed: "Shelf life has not been impacted by the change." |
  | Substantial equivalence to predicate device | Concluded: "Medtronic has demonstrated that the Clearview® Intracoronary Shunts are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness." |

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

The document primarily describes bench testing (non-clinical) for demonstrating substantial equivalence. It does not provide specific sample sizes for the "test set" for X-ray, biocompatibility, or suture pull tests. The provenance of this data (e.g., country of origin) is not mentioned. Given it's bench testing, it would be prospective data generated for the purpose of this submission. No clinical testing was conducted or required.

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)

This section is not applicable as the study involved bench testing of material properties, not clinical data requiring expert review or establishment of ground truth in a diagnostic sense.

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

This section is not applicable as the study involved bench testing of material properties, not clinical data requiring adjudication by experts.

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, an MRMC comparative effectiveness study was not done. This device is a medical shunt, not an AI-powered diagnostic tool, and the submission does not involve human readers interpreting images.

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

No, a standalone (algorithm only) performance study was not done. This device is a medical shunt, not an algorithm.

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

The "ground truth" for the bench testing would be established by the definitions and standards of the specific tests conducted:

• For X-ray: radiopacity equivalence against a control or predefined standard.
• For Biocompatibility: compliance with ISO standards for biological evaluation of medical devices.
• For Suture pull test: meeting predefined mechanical strength specifications.

8. The sample size for the training set

This section is not applicable as the document describes a 510(k) submission for a physical medical device, not a machine learning model, hence there is no "training set."

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

This section is not applicable as there is no training set for a machine learning model.

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