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Use of the CODMAN EDS 3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

The EDS 3 system is designed to collect cerebral spinal fluid (CSF) and other fluids of similar physical characteristics from a patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP).

The provided document is limited in detail regarding the specific acceptance criteria and study data for the CODMAN® EDS 3™ CSF External Drainage System. The document states that the fundamental scientific technology of EDS 3 is the same as EDS II and that "Bench testing was performed for the EDS 3 system. The modified device was deemed acceptable according to the acceptance criteria; therefore, the safety and efficacy of the product was not affected." However, the exact acceptance criteria and the detailed results of this bench testing are not provided.

Therefore, much of the requested information cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only states that the device was "deemed acceptable according to the acceptance criteria."

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 available in the provided text. The term "bench testing" suggests a controlled laboratory environment, but details about sample size or data origin are absent.

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 available in the provided text. The testing appears to be bench testing, not clinical human-based evaluation requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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 and not available in the provided text. The device is a CSF external drainage system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not available in the provided text. The device is a physical system, not an algorithm. Bench testing would assess its standalone mechanical and fluid dynamic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated. For bench testing of a medical device, the "ground truth" would typically refer to established engineering and medical standards for fluid dynamics, biocompatibility, and mechanical integrity, rather than clinical outcomes or expert consensus on images.

8. The sample size for the training set

This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm.

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