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The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy.

The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. The indications and intended use for of the P.D. Access™ / SmartNeedle® Device are the same as predicate devices manufactured by CardioVascular Dynamics (the SmartNeedle").

The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices.

This 510(k) notification describes the P.D. Access™ / SmartNeedle® Device, a vascular access device intended for monitoring blood flow. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Testing of the P.D. Access™ / SmartNeedle® Device included dimensional, strength, ultrasonic performance and biocompatibility testing. These tests demonstrated that the all items tested were within specification tolerances. There were no failures during these tests."

However, the specific quantitative "acceptance criteria" and "reported device performance" are not detailed in this summary. The summary only provides a qualitative statement of compliance. For example, it doesn't list a specific "strength tolerance" in Newtons and then a "reported strength" of X Newtons.

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

The document does not specify the sample sizes used for the dimensional, strength, ultrasonic performance, or biocompatibility tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not applicable and not provided. The study described focuses on device performance against engineering specifications (dimensional, strength, ultrasonic, biocompatibility) rather than a diagnostic performance where expert ground truth would be required.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided, as the testing was against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. The device is a vascular access device with a monitoring function (audible blood flow). Its effectiveness is judged by meeting engineering specifications and being substantially equivalent to predicate devices, not by radiologists' diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" as it applies to AI algorithms is not relevant here. This is a physical medical device. The "ultrasonic performance" testing would be considered the standalone performance of its monitoring capability. The document states this performance was within specification tolerances.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described would be the pre-defined engineering specifications for dimensions, strength, ultrasonic output characteristics, and biocompatibility standards. These are objective measures rather than expert consensus, pathology, or outcomes data in the typical sense of diagnostic performance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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