(70 days)
The Codman BACTISEAL™ EVD Catheter Set is 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.
Codman BACTISEAL™ EVD Catheter Sets are manufactured from radiopaque silicone rubber which is then impregnated with rifampicin and clindamycin hydrochloride in order to render the device resistant to colonization of most gram positive organisms.
The provided text does not contain information about "acceptance criteria" in the traditional sense of performance metrics for an AI/device, nor does it detail a study proving the device meets such criteria with the specific elements requested (sample sizes, ground truth establishment, expert qualifications, etc.).
Instead, this document is a 510(k) summary for a medical device called the "Codman BACTISEAL™ EVD Catheter Sets," which is a ventricular catheter. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with human readers or an algorithm.
Here's a breakdown of what is available based on your request, and what is not:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document states that "All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use." However, it does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance statistics. The testing performed was related to "performance and in vitro testing" and "biocompatibility studies," which are general categories.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "clinical data" but gives no details about the sample size, type of study (retrospective/prospective), or data provenance.
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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 provided. The concept of "ground truth" as typically applied to AI performance evaluation is not relevant here, as this is a physical medical device. The "clinical data" mentioned would likely refer to outcomes in patients, but no details are given about how these outcomes were assessed or by whom.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This is not applicable to the type of device and testing described.
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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:
- Not provided. This is not an AI device, and no MRMC study is mentioned. The device itself is a catheter, not an imaging or diagnostic tool that would be used by human readers to interpret results.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document refers to "clinical data" and "biocompatibility studies." For a device like a catheter, "ground truth" would relate to its physical performance (e.g., drainage effectiveness, material integrity) and patient outcomes (e.g., infection rates, CSF diversion success, reduction in intracranial pressure). It's implied that these aspects were evaluated, but the specific methods for establishing "ground truth" (e.g., how infection was confirmed, how CSF drainage was measured accurately) are not detailed.
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The sample size for the training set:
- Not provided. This is not an AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not provided. Not an AI device, so no training set or associated ground truth.
Summary of available information regarding device testing:
The device's safety and effectiveness were evaluated through:
- "extensive performance and in vitro testing"
- "biocompatibility studies in accordance with ISO10993-Part 1"
- "clinical data"
The purpose of this testing was to demonstrate substantial equivalence to legally marketed predicate devices, specifically:
- Codman BACTISEAL™ Catheters
- Codman External Drainage Ventricular Catheter Set
- Cook Inc. SPECTRUM® Ventricular Catheter
The basis for substantial equivalence was "similarity to the predicate devices in intended use, materials, design, and dimensions," in addition to the testing results. The text does not elaborate on specific acceptance criteria or detailed study methodologies beyond these general categories.
§ 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).