Search Results

Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.

The provided text describes a 510(k) submission for the Codman BACTISEAL™ Barium Striped Catheters. The substantial equivalence was based on performance and in-vitro testing. It does not contain information about a study that would produce acceptance criteria and device performance in the way described in the prompt (e.g., using a test set, ground truth, expert opinions, or MRMC studies). The provided document is a regulatory submission for substantial equivalence.

Therefore, many of the requested fields cannot be extracted directly from this document.

However, I will extract what is available and indicate when information is not present.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: Not specified (presumably from laboratory studies, but country and retrospective/prospective status are not mentioned).

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 as this document refers to physical and in-vitro performance testing, not studies requiring expert ground truth in a clinical or diagnostic image analysis context.

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

• Not applicable (see point 3).

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. This type of study (MRMC for AI assistance) was not done, as the device is a physical catheter, not an AI diagnostic tool.

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

• No. This is not an algorithm, but a physical medical device.

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

• For the physical and in-vitro testing, the "ground truth" would be the established performance metrics and specifications for the predicate devices and general standards for medical devices (e.g., material strength, antibacterial efficacy measurements in lab conditions). The document highlights "laboratory studies" for antibacterial properties.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device that requires a training set.

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

• Not applicable (see point 8).

Ask a specific question about this device