(48 days)
Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which 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.
Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. 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 Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.
The provided text describes a 510(k) summary for the Codman Hakim Shunt Systems. It focuses on adding a dimensional modification (a silicone platform) to existing predicate valves within the system.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as formal acceptance criteria. | "Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use." |
| Implicit acceptance criterion: Technological characteristics of the proposed device are the same as the predicate devices, with the addition of a dimensional modification. | "The technological characteristics of the proposed device are the exact same as the predicate device." (This refers to the core function and technology, not the new dimensional modification itself.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The study type is "bench testing," which typically involves laboratory testing of the device itself rather than patient data.
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. The study was bench testing, not a clinical study requiring expert ground truth for patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing, not a clinical study involving adjudication of interpretations.
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
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (shunt system), not an AI-powered diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device, not an algorithm. Bench testing would assess the device's performance in a standalone laboratory environment.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For bench testing, the "ground truth" would be engineering specifications, performance standards, or established physiological parameters that the device is designed to meet. The document states that the testing "supports the safety and effectiveness of the proposed device for its intended use," implying adherence to established performance benchmarks for shunt systems.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm that requires a training set.
§ 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).