(136 days)
The OSV II 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 OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.
The provided text describes a 510(k) summary for the OSVII Hydrocephalus Valve. It does not contain information related to a study with acceptance criteria and device performance in the format requested, particularly for AI/ML-based device evaluation. The document focuses on demonstrating substantial equivalence to a previously cleared device (OSV II, K911799) based on design, principle of operation, intended use, materials, and manufacturing process.
The "Safety and Effectiveness" section does not report numerical performance metrics or acceptance criteria in the way that would typically be seen for a new performance claim. Instead, it makes qualitative statements about safety and effectiveness and focuses on the impact of a connector modification.
Below is an attempt to structure the available information, noting where the requested details are not present in the provided text.
Acceptance Criteria and Study for OSVII Hydrocephalus Valve
Summary: The OSVII Hydrocephalus Valve 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a performance study against specific acceptance criteria with numerical outcomes. The "Safety and Effectiveness" section addresses product attributes and the impact of a minor modification but does not provide quantitative performance metrics or acceptance criteria as typically found in studies for AI/ML devices or new performance claims.
1. Table of Acceptance Criteria and Reported Device Performance
As the provided text focuses on substantial equivalence rather than a detailed performance study with defined acceptance criteria and numerical results for the modified device, a table in the requested format cannot be fully generated. The "Safety and Effectiveness" section provides qualitative statements.
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Sterility and non-pyrogenicity | "The OSV II Hydrocephalus Valve is provided sterile and non-pyrogenic." |
| Correlation of modified and unmodified test methods | "The correlation established between the unmodified and modified test methods demonstrated that the modification did not adversely affect the safety or effectiveness of the product." |
| Leakage after connector modification | "The connector modification to the OSV II had been tested for leakage..." |
| Resistance of connections after connector modification | "...and for resistance of the connections at time of manufacturing, after shelf life simulation and after transport and environmental conditions." |
| Operational Stages (Flow Rate vs. Differential Pressure) | The device is designed to operate in three stages: |
- Stage I (Low DP): 5-18 ml/hr flow rate (DP 30-120 mm H2O)
- Stage II (Flow Regulation): 18-30 ml/hr flow rate (DP 120-300 mm H2O)
- Stage III (Pressure Relief): Rapid flow for IVP normalization.
(Note: These are design specifications/operational principles, not reported performance against acceptance criteria from a study for the modified device.) |
2. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "test methods" and "testing" related to the connector modification, implying physical and functional tests were conducted, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission focuses on device characteristics and substantial equivalence, not on expert-adjudicated ground truth for a diagnostic task.
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 a medical device (hydrocephalus valve), not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth." The "ground truth" for this device would relate to its physical and functional performance specifications (e.g., flow rate, pressure regulation, material integrity, sterility) typically established through engineering and biological testing.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. 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).