(119 days)
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):
| Acceptance Criteria (Not explicitly stated) | Reported Device Performance |
|---|---|
| e.g., Accuracy of pressure setting | Achieved substantial equivalence to predicate device. |
| e.g., Reliability of adjustment | Achieved substantial equivalence to predicate device. |
| e.g., Confirmation of selected setting | Achieved substantial equivalence to predicate device. |
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.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).