(36 days)
The Medtronic PS Medical Strata™ II Valve and shunt assemblies with and without BioGilde are shunt components designed to provide continued 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 the pressure/flow performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
The PS Medical Strata II Valve is an adjustable Valve designed for noninvasive pressure-flow adjustment.
The provided text is a 510(k) summary for the Medtronic PS Medical® Strata II Valve™ and Shunt Assemblies. It states that the device is substantially equivalent to a predicate device and relies on that equivalence rather than providing a detailed study with specific acceptance criteria and performance data for the new device.
Therefore, many of the requested details about a specific study proving the device meets acceptance criteria are not available in this document.
Here's an assessment based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical criteria within this document. The basis for acceptance is substantial equivalence to legally marketed predicate devices. | The document states that the Strata II Valve and Shunt Assemblies are substantially equivalent to the predicate devices (Medtronic PS Medical Strata and Strata NSC Valve and Shunt Assemblies). This implies that its performance, characteristics, and intended use are considered to be the same as the cleared predicate devices. |
Explanation: The 510(k) summary explicitly states: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Strata II Valve and Shunts with and without BioGlide are the same as the previously reviewed and cleared Strata and Strata NSC Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata products based upon the predicate and currently marketed devices."
This indicates that the "acceptance criteria" were met by demonstrating that the new device is fundamentally the same as its legally marketed predicate, rather than through new, independent performance studies with their own defined numerical acceptance thresholds.
Study Details (Based on available information in the document)
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing data comparing the Strata II to specific acceptance criteria is described. The approval is based on substantial equivalence to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground-truthing is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 applicable. This is not an AI-assisted diagnostic device, but a physical medical implant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the new device's independent evaluation. The "ground truth" for its acceptance is its demonstrated similarity to previously cleared devices.
- The sample size for the training set: Not applicable. This is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 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).