(29 days)
The Strata NSC Burr Hole Valves and Shunt Assemblies are shunt components 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 Strata NSC Burr Hole Valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.
The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured of silicone elastomer and polypropylene. The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure flow adjustment.
The provided text is a 510(k) summary for the PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria and device performance results as typically found for new device approvals or AI/software-as-a-medical-device submissions.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable (N/A) because the submission is for a device based on substantial equivalence to existing technology, rather than a novel device requiring a de novo clinical performance study against specific metrics.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device is substantially equivalent to predicate devices. | Medtronic Neurosurgery states the device is manufactured of identical materials, and has the same intended use and fundamental scientific technology as the predicate devices: |
- Medtronic PS Medical Strata NSC Valve and Shunt Assemblies (K038850)
- Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without BioGlide (K042465)
- PS Medical CSF Flow Control Valve, Burr Hole (K831678) |
| Safety and Effectiveness | Based on the technological comparison and substantial equivalence to legally marketed predicate devices, the device is considered safe and effective. |
| Primary Design Function | 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 valve allows non-invasive adjustment without radiographic confirmation. |
| Material Composition | Manufactured of silicone elastomer and polypropylene; identical to predicate devices. |
2. Sample size used for the test set and the data provenance
- N/A. This submission is based on substantial equivalence to predicate devices, not a clinical study on a test set. There is no mention of a test set or data provenance in the context of device performance evaluation against specific metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. No test set or ground truth establishment by experts is described for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method is described.
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
- N/A. This device is a fluid shunt, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a hardware medical device (a shunt valve), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground truth, in the context of this 510(k) submission, is implied by the established safety and effectiveness of the legally marketed predicate devices. The "truth" is that the core technology and functional performance are already proven and therefore the new device, being substantially equivalent, is also considered safe and effective. No specific ground truth data for a novel performance evaluation is mentioned.
8. The sample size for the training set
- N/A. No training set is described, as this is not an AI/machine learning device. The design, materials, and functional principles are based on existing, proven technologies.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set described.
§ 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).