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The CODMAN® VPV™ System is designed for use only with CODMAN® HAKIM™ Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to non-invasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and provides confirmation of the valve adjustment, without the need for radiographic imaging when an "Adjustment Complete" message is displayed.

The CODMAN® VPV™ System (VPV) is an accessory (multiple use) indicated for use only with the CODMAN® HAKIM Programmable Valve, in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The system is comprised of the program unit, transmitter unit, a power cord, carrying case, and ultrasound gel. The VPV System allows the clinician to noninvasively increase or decrease the valve setting to meet the patient's particular clinical needs.

The provided text is a 510(k) Premarket Notification for the CODMAN® VPV™ System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way modern AI/ML device submissions typically do.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This document is a regulatory submission for a medical device that predates the widespread use of AI/ML in medical devices and the associated requirements for rigorous performance studies as requested in the prompt.

Here's what can be extracted and what cannot:

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

• Not present. The document states that "Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing." However, specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) and numerical performance results are not provided. The entire premise of this 510(k) is that the new device is "identical" to a previously cleared VPV device (K050739) and "substantially equivalent" to another device (Medtronic's PS Medical Strata® Valves) in terms of indications for use and labeling.

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

• Not present. No information about a "test set" or "data provenance" is included.

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)

• Not present. No ground truth establishment is described, as the evaluation method emphasizes physical/mechanical testing and equivalence to existing devices, not clinical performance metrics based on expert assessments.

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

• Not present.

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

• Not present. This is not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable / Not present. This device is a system for non-invasively adjusting and confirming settings on programmable valves, not an AI algorithm.

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

• Not present.

8. The sample size for the training set

• Not present.

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

• Not present.

Summary based on the provided text:

The CODMAN® VPV™ System is seeking clearance as substantially equivalent to a predicate device (CODMAN® VPV™ System, K050739) and another device (Medtronic's PS Medical Strata® Valves and Handtools, K040943). The basis for this equivalence is "performance testing (physical and mechanical testing) and in vitro testing." The document explicitly states: "The CODMAN VPV System is identical to the currently marketed predicate VPV device (K050739) in terms of physical characteristics, programming and procedure."

There is no mention of AI/ML, clinical studies with human readers, or performance metrics like sensitivity, specificity, or accuracy that would require a ground truth established by experts. The focus is on the device's physical and functional equivalence to already cleared devices.

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