(64 days)
The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.
After surgical implantation, the Strata Valve provides a non-invasive method to address changing patient needs in the management of hydrocephalus. The unique valve design allows the physician to adjust the pressure/flow performance level by using a magnetic Adjustment Tool included with the Strata® Valve adjustment kit without the need for radiographic confirmation.
The Strata® Handtools, include the Locator Tool, Indicator Tool and Adjustment Tool. Ail three tools are required to set or change the pressure/performance level setting of the Strata® Valve.
Acceptance Criteria and Study Details for Medtronic PS Medical Strata® Valves
Here's a breakdown of the acceptance criteria and the study details as provided in the 510(k) summary for the Medtronic PS Medical Strata® Valves and Handtools:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document presents acceptance criteria implicitly through the reported performance rather than explicit pre-defined targets. The performance metrics focus on the accuracy of the Indicator Tool in correlating with the x-ray confirmed pressure/performance level setting.
| Metric (Implied Acceptance Standard) | Reported Device Performance |
|---|---|
| Correlation between Indicator Tool pressure/performance level setting and x-ray at Discharge | 98.6% |
| Correlation between Indicator Tool pressure/performance level setting and x-ray for ALL IN CORRES Adjustment Data | 98.8% |
Note: The table in the original document has some unreadable or garbled text under "Concellential" and "DJT". Only the clear percentage values have been included.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document only mentions "Discharge Data" and "ALL IN CORRES Adjustment Data," which refer to categories of observations rather than a specific number of patients or evaluations.
- Data Provenance: The study is referred to as "clinical study data," implying prospective data collection during patient follow-up. The country of origin is not specified, but given the 510(k) submission to the FDA, it is likely that parts or all of the clinical data were collected in the US or in compliance with US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the submitted 510(k) summary. The ground truth for valve setting is explicitly stated as "x-ray," but details on who interpreted these x-rays or their qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the submitted 510(k) summary. Given the reliance on "x-ray" as the ground truth, it's possible that a single, definitive x-ray interpretation was used, or if multiple were involved, the adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The study described focuses on the correlation between the device's Indicator Tool and x-ray confirmation, not on comparing human reader performance with and without AI assistance. The device in question is a physical medical device (valve and handtools) for hydrocephalus management, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No. The device is a mechanical shunt system with external adjustment tools. The "performance" being evaluated is the accuracy of the adjustment tool's indication against an x-ray confirmation of the physical valve's setting. There is no AI algorithm involved for standalone performance evaluation.
7. Type of Ground Truth Used
- Ground Truth: X-ray confirmation of the valve's pressure/performance level setting. The summary explicitly states: "Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray at time of Discharge and during follow-up."
8. Sample Size for the Training Set
This information is not provided as the device is not an AI/ML algorithm that typically requires a distinct "training set." The clinical data described pertains to the performance evaluation rather than the training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no mention of a training set for an AI/ML algorithm in the context of this device. The development and verification of the physical valve and tools would likely involve engineering tests, bench testing, and potentially pre-clinical studies, but these are distinct from "training an algorithm." The clinical study data mentioned refers to the human-clinical performance validation.
§ 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).