(82 days)
The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.
The Certas Programmable Valve System is designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular pressure and drainage of CSF. The Therapy Management System allows the user to non-invasively adjust the opening pressure setting before and after implant. The Certas Programmable Valve will be available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters. The Certas Programmable Valve includes the same legally marketed accessories that are available with the Hakim Programmable Valve. The Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position. The BACTISEAL catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Codman Certas Programmable Valve System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes pre-clinical testing for the Codman Certas Programmable Valve System. While it doesn't explicitly state quantitative "acceptance criteria" values in a table, it lists the types of tests performed and the general outcome.
| Acceptance Criterion (Test Performed) | Reported Device Performance |
|---|---|
| Leak Testing | Performs as intended, safe and effective. |
| Pressure-Flow Testing | Performs as intended, safe and effective. |
| Overpressure Testing | Performs as intended, safe and effective. |
| Bursting Pressure Testing | Performs as intended, safe and effective. |
| Dynamic Break Strength Testing | Performs as intended, safe and effective. |
| Long-Term Stability Testing | Performs as intended, safe and effective. |
| Puncture Testing | Performs as intended, safe and effective. |
| MRI Translational Attraction (ASTM F2052) | MR Conditional in a 3 Tesla MRI system. |
| MRI Torque (ASTM F2213) | MR Conditional in a 3 Tesla MRI system. |
| MRI Artifact (ASTM F2119) | MR Conditional in a 3 Tesla MRI system. |
| MRI Heating (ASTM F2182) | MR Conditional in a 3 Tesla MRI system. |
| Biocompatibility (ISO 10993-1, FDA G95-1) | All materials meet requirements. |
| Sterilization (ISO 17665 Part 1 & 2, 11737) | Sterility assurance level of 10^-6^ achieved. |
| Overall Substantial Equivalence | The Certas Valve and Certas Therapy Management System are substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the pre-clinical tests or details on the provenance of data (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench or laboratory-based, as is common for pre-clinical performance evaluations of medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set. The tests described are primarily objective, quantitative engineering and materials tests (e.g., pressure-flow, strength, MRI compatibility, biocompatibility, sterility) rather than clinical evaluations requiring expert interpretation of outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective pre-clinical evaluations, not interpretive clinical assessments that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes pre-clinical (bench) testing to demonstrate substantial equivalence based on performance characteristics, materials, and principles of operation. It does not mention any clinical studies, MRMC studies, or human reader performance evaluations.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical medical implant and associated management system, not an AI algorithm. The performance evaluation is for the physical device itself.
7. Type of Ground Truth Used
The "ground truth" for the pre-clinical tests would be the established scientific and engineering standards and methodologies defined by the cited ISO and ASTM standards. For example, for sterility, the ground truth is a sterility assurance level of 10^-6^. For MRI compatibility, the ground truth is the criteria defined by ASTM F2503 for "MR Conditional."
8. Sample Size for the Training Set
Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" of the device itself refers to its design and manufacturing processes based on engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical medical device, not an AI/ML algorithm. The "ground truth" for its development would be based on established engineering principles, material science, and prior knowledge from predicate devices and relevant standards.
§ 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).