(21 days)
The Low Flow OSV II Hydrocephalus Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
The Precision Flow OSV II and the modified Low Flow OSV II hydrocephalus valve systems are implantable devices for controlled cerebrospinal fluid drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
This document describes a 510(k) premarket notification for the Low Flow OSV II Hydrocephalus Valve. The submission focuses on demonstrating substantial equivalence to a previously cleared device, the Precision Flow OSV II Hydrocephalus Valve, rather than presenting a de novo study with acceptance criteria and performance data in the context of AI/software.
Therefore, many of the requested categories related to AI/software performance studies, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable to this document. The information provided is about a physical medical device.
However, I can extract the relevant information by interpreting "acceptance criteria" and "device performance" in the context of device modification and substantial equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for intended use. | - Provided sterile and non-pyrogenic. |
- Performance testing reflects shelf life simulation and environmental conditions.
- Review of clinical experiences and published scientific literature supports the rationale for the additional flow regulation rate.
- "The modifications do not affect... new issues of safety and effectiveness." |
| Effectiveness: Device is effective for intended use. | - Maintains controlled cerebrospinal fluid drainage from ventricles to peritoneal cavity or other appropriate drainage site. - Variable resistance valve maintains a drainage rate constant within the physiological range of intracranial pressure.
- Designed to address needs of patients requiring a lower drainage rate.
- "no new issues of... effectiveness." |
| Substantial Equivalence: Similar in function and intended use. | - Substantially equivalent to the unmodified OSV II (Precision flow OSV II) Hydrocephalus Valve (K971799). - Design, materials of composition, and principle of operation remain the same as the predicate device.
- Modifications involve an additional flow regulation rate to provide lower drainage for specific patient needs. |
| Biocompatibility: Materials are compatible with the body. | - (Implied, as materials of composition remain the same as the predicate device, which would have been assessed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document refers to "review of clinical experiences and of published scientific literature" but does not detail specific study designs, sample sizes, or data provenance. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device and bench testing.
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 is not a study requiring expert ground truth for a test set in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device modification is largely based on:
- Predicate Device Performance: The established safety and effectiveness of the Precision Flow OSV II Hydrocephalus Valve (K971799) serves as the primary benchmark.
- Bench Testing: "Performance testing has been performed on The Low Flow OSV II Hydrocephalus Valve reflecting shelf life simulation and environmental conditions." This testing would verify the physical characteristics and flow rates.
- Clinical Literature/Experience: "A review of clinical experiences and of published scientific literature supports the rationale for this additional flow regulation rate which is designed to address the needs of patients who require a lower drainage rate." This implies that existing medical knowledge and clinical need define the appropriateness of a lower flow rate.
8. The sample size for the training set
Not applicable. This is not an AI/software device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software 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).