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The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid. The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains barium sulfate for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document, K233448, is an FDA 510(k) clearance letter for the Integra LifeSciences Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set. Based on the content of this letter, the device in question is a physical medical device (catheter) and not an AI/software device.

Therefore, the request for information related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics (such as multi-reader multi-case studies, ground truth establishment for training/test sets, sample sizes for image data, and expert adjudication), is not applicable to this document.

The document describes the changes made to an existing device (Bactiseal EVD Catheter Sets) as:

• Labeling changes: Updating MRI labeling to state MR Safe and administrative updates/harmonized symbols.
• New supplier for clindamycin hydrochloride: The antimicrobial impregnated into the catheter.

The studies mentioned are non-clinical (bench testing and engineering analysis) to demonstrate equivalence to the predicate device despite these changes.

Here's a summary of the relevant "acceptance criteria" and "study that proves the device meets the acceptance criteria" as described in the document for this non-AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated in terms of number of units tested, but it refers to "production equivalent devices" for performance testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This pertains to an AI/software device requiring human expert annotation/ground truth. For this catheter, the "ground truth" is adherence to established industry standards (USP) and internal test methods for drug performance and other material characteristics.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical data review for AI/software devices. Testing was based on established laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not applicable. This type of study is for evaluating observer performance with and without AI assistance for clinical interpretations. The current 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, not applicable. This applies to AI/software performance.

7. The Type of Ground Truth Used:

• For drug equivalency and effectiveness: USP standards and monograph, internal test methods.
• For biocompatibility: Assessment against known materials and established literature/standards.
• For physical characteristics: Engineering analysis and comparison to predicate device specifications.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no "training set" or need for ground truth establishment in this context.

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