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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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The Codman VPV System is designed 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. It is used to adjust the Codman Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.

Not Found

This 510(k) submission (K050739) for the CODMAN® VPV™ System, a Hydrocephalus Valve Programmer, does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the comprehensive study design you are looking for.

Here's an analysis based on the provided document:

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

• Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating "substantial equivalence" rather than specific performance metrics against pre-defined acceptance criteria.
• Reported Device Performance: The document only broadly states: "All test results demonstrated the substantial equivalence of the product to commercially distributed predicate device for the same intended use." No specific performance values (e.g., accuracy, precision) are provided.

Table Placeholder (based on available information):

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

• Sample Size: Not specified. The document only mentions "performance testing (physical and mechanical testing) and in vitro testing" but does not detail the number of devices or tests performed.
• Data Provenance: Not specified. No information on country of origin, or whether the study was retrospective or prospective.

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 Applicable. This type of device (hydrocephalus valve programmer) does not typically involve human expert interpretation for "ground truth" in the way an AI diagnostic algorithm would. The device's function is to adjust a physical valve and confirm the setting, not to interpret medical images or patient data. Its performance would be assessed against the actual physical setting of the valve.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (often radiologists or pathologists) interpret data and their interpretations need to be reconciled to establish a consensus ground truth, especially for AI diagnostic devices. This device does not fall into that category.

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. This device is not an AI diagnostic tool and does not involve human readers for interpretation in the context of an MRMC study. It's a medical instrument used to program a hydrocephalus valve.

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

• Not Applicable / Partially applicable, but not an "algorithm." The "device" in this context is a physical programmer with its internal mechanisms. The performance testing would be of the device itself (its ability to correctly program and confirm settings). There isn't an "algorithm" in the sense of an AI model being independently tested. The "standalone" performance would be the device functioning correctly as designed. The document states "performance testing (physical and mechanical testing) and in vitro testing," which implies testing the device's inherent functionality.

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

• Implied Physical Measurement/Verification: For a device that programs a valve to a selected setting and provides confirmation, the "ground truth" would likely be the actual physical setting of the valve as measured independently or verified by the valve's design specifications. The document mentions that "radiographic imaging will still be required to confirm the selected setting," which suggests real-world verification is part of the clinical use, but not necessarily "ground truth" for the device's internal performance testing. The "in vitro testing" would likely involve comparing the device's reported setting to the actual setting achieved on a test fixture or a valve in a controlled environment.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device and Study Type:

The CODMAN® VPV™ System is an electro-mechanical device for programming hydrocephalus valves. The 510(k) submission for this device relies on demonstrating substantial equivalence to a predicate device (HAKIM PROGRAMMER & TRANSMITTER) through physical, mechanical, and in vitro performance testing. It is not an AI or diagnostic imaging device, so the criteria typically associated with such devices (like expert adjudication, MRMC studies, training/test sets, and detailed performance metrics beyond equivalence) are not relevant or provided in this type of submission. The focus is on the device's ability to mechanically perform its intended function safely and effectively, similar to an existing device.

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