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Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.

This document is a 510(k) summary for the Geomed Vascular Dilators, a surgical instrument. It is NOT for an AI/ML powered device, therefore most of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not detailed in this summary. The summary states that "Acceptance criteria were met for all tests performed," implying that the device successfully passed these tests.

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

The document does not specify the sample sizes for the individual tests (tensile strength, dimensional verification, cleaning, sterilization, drying time). The data provenance is not explicitly mentioned but can be inferred as internal testing performed by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, as part of their 510(k) submission. These are device performance tests, not clinical studies with human data.

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

This information is not applicable as this is not a study involving human interpretation of data or a clinical study. The "ground truth" for these tests would be established by engineering specifications, validated cleaning protocols, and sterilization standards.

4. Adjudication method for the test set

This information is not applicable for device performance testing. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in observations or diagnoses.

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

This information is not applicable. The device is a physical surgical instrument (vascular dilator), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the device performance tests, the "ground truth" is based on:

• Engineering specifications and standards: For tensile strength and device dimensions.
• FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015): For cleaning and sterilization validation.
• Established industry standards for sterilization and drying: For sterilization and drying time validation.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model being trained.

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

This information is not applicable. There is no "training set" for this type of device submission.

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