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The Clarus Peel-Away Introducer Sheath is a thin-walled, cylindrical device that is placed in position so that it provides a communicating passageway through brain tissue. This is accomplished by fitting the sheath securely over an obturator, advancing both devices through the tissue together as a unit. A hole through the distal tip of the obturator aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The proximal hub on the obturator is rotated, unlocking it from the sheath, and the obturator is removed from the sheath, leaving the sheath alone in the desired position acting to hold the penetrated site in an open condition. The peel away sheath is capable of being pulled apart lengthwise to allow varying insertion depths into brain tissue. The proximal end of the sheath has tab handles that are provided to facilitate grasping and tearing. At this point, a regulatorily cleared device can be inserted through the sheath for patient procedures.

AI/ML Overview

The provided text describes the Clarus Peel-Away Introducer Sheath and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:

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

The acceptance criteria for the Clarus Peel-Away Introducer Sheath were based on demonstrating substantial equivalence to predicate and reference devices, primarily through biocompatibility and mechanical testing. The reported device performance indicates that the device passed all tests and had comparable results to the predicate/reference devices.

Acceptance Criteria Category	Specific Test/Description	Performance/Results
Biocompatibility	Cytotoxicity	Acceptable (demonstrating safety for intended use)
	Sensitization	Acceptable (demonstrating safety for intended use)
	Irritation	Acceptable (demonstrating safety for intended use)
	Systemic Toxicity	Acceptable (demonstrating safety for intended use)
	Hemocompatibility	Acceptable (demonstrating safety for intended use)
	Material-Mediated Endotoxin	Acceptable (demonstrating safety for intended use)
Mechanical Testing	Fluid Patency (Visual inspection for cleanliness and manufacturing quality)	Pass. All devices had comparable results.
	Prolapse Force (Resistance to deformation while advancing distal end into flat plate)	Pass. All devices had comparable results.
	Peak Tensile Force (Measure of inner obturator/dilator and sheath hub per ISO 11070)	Pass. All devices had comparable results.
	Peel Force (Force required to break hub and peel sheath)	Pass. All devices had comparable results.
Overall Equivalence	Comparison of Design, Materials, Construction, Environment of Use	Substantially equivalent to predicate/reference devices

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

The document does not explicitly state the sample sizes used for the biocompatibility or mechanical testing. It mentions "Components of the Clarus Peel-Away Introducer Sheath and predicate devices were tested," implying that multiple units were tested, but no specific numbers are provided.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given this is a 510(k) submission for a medical device, the testing would generally be prospective to generate data for the submission.

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 to the type of device and testing described. The acceptance criteria for this device are based on objective performance characteristics (biocompatibility, mechanical properties) rather than interpretation requiring expert consensus. There were no "ground truth" labels established by experts in the context of image interpretation or diagnostic accuracy studies.

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

Not applicable. As noted above, this device's evaluation relies on objective physical and material property tests rather than diagnostic interpretation requiring adjudication.

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

Not applicable. This device is a physical introducer sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For biocompatibility testing, the "ground truth" is adherence to established international standards (ISO 10993-1) and the successful completion of specific biological tests, with "acceptable" results serving as the ground truth for safety.

For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the performance of predicate devices that are already deemed safe and effective. "Pass" results and "comparable results" to predicates served as the ground truth for performance.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not based on machine learning or AI models that require training data.

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

Not applicable, as there is no training set for this type of device.

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