(26 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 510(k) summary for the K091346 device states that "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device." However, it does not provide specific acceptance criteria or detailed results of this testing.
Therefore, I cannot fulfill all parts of your request with the given information.
Here's a breakdown of what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. For mechanical devices like shunts, typical acceptance criteria would involve flow rates, pressure settings, material biocompatibility, cyclic fatigue, and sterility.
- Reported Device Performance: The document only makes a general statement: "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device." No specific numerical performance metrics are provided.
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 in the given 510(k) summary. The document mentions "bench testing," which implies laboratory-based tests rather than clinical trials with human 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)
- This information is not applicable/provided. The device is a mechanical shunt system, not an AI or diagnostic imaging device that requires human expert review for establishing ground truth on a test set. The testing would involve engineering and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. Adjudication methods are typically used in clinical studies or AI performance evaluations involving subjective human assessment, which is not the case here.
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
- This information is not applicable/provided. The device is a mechanical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a mechanical device like this would be established through engineering specifications, material standards, and performance benchmarks set by the manufacturer based on regulatory requirements and industry standards for cerebrospinal fluid shunts. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
- This information is not applicable/provided. This is a physical device, and the concept of a "training set" is relevant for AI/machine learning models, not for traditional medical device bench testing.
9. How the ground truth for the training set was established
- This information is not applicable/provided for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through bench testing of a mechanical shunt system. It does not contain the detailed performance metrics, test methodologies, or clinical study design information (like expert ground truth or sample sizes for AI/diagnostic studies) that your questions are geared towards. For such detailed information, one would typically need to review the full 510(k) submission, which is often much more extensive than the publicly available summary.
§ 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).