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Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a MRI and/or CT imaging.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Trajectory Guide Biopsy Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria & Performance: The document only lists the device's trade/device name, regulation number, regulatory class, product code, and indications for use. It does not provide specific performance metrics (e.g., accuracy, precision, success rates) or the numerical acceptance criteria for those metrics.
• Study Details: There is no mention of any specific study conducted to validate the device's performance. All the requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance is absent.
• Purpose of Document: This is a regulatory clearance letter, not a scientific study report or a summary of performance data. Its purpose is to officially state that the device can be marketed in the U.S. because it's deemed "substantially equivalent" to existing devices, implying that detailed performance data was submitted separately in the 510(k) application, but it's not present in this letter.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) submission document or a summary of the performance studies conducted by Image-Guided Neurologics, Inc. for the Navigus Trajectory Guide Biopsy Kit.

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The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.

The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.

Here's an analysis of the provided text regarding the "Better-Bladder™" device's acceptance criteria and studies:

Summary of Device Acceptance Criteria and Performance

Detailed Study Information:

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

   • The document primarily refers to "bench tests" and "individual unit testing" for functional evaluations. Specific sample sizes for these tests are not provided.
   • The data provenance is not explicitly stated (e.g., country of origin). The testing appears to be prospective as it describes evaluations performed on the Better-Bladder™ to demonstrate its performance against predefined criteria and predicate devices.

2. 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 device is a physical medical device (pressure monitoring/blood reservoir) and the "ground truth" for its functional performance (e.g., pressure measurement accuracy, pressure withstand, biocompatibility) is established through objective physical measurements and adherence to engineering/biological standards, not through expert review of data like imaging. Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation is not applicable here. The "experts" involved would be engineers, materials scientists, and quality control personnel following established protocols.

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

   • Again, this device is a physical, non-AI medical device. The "adjudication method" in the context of human interpretation of results (like in clinical trials or image analysis) is not applicable. Objective measurements and adherence to predetermined specifications are used.

4. 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, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, in spirit, a standalone performance was done, as the device's functional integrity and performance were evaluated on its own (bench tests, individual unit tests) against established engineering and biological standards, without human interpretation in the loop as part of its primary function. The device's function is to objectively measure pressure and act as a reservoir, not to process data for human interpretation.

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

   • The "ground truth" for the device's performance is based on objective engineering measurements (e.g., pressure equivalence to invasive methods, maximum pressure withstand, material properties conforming to ISO 10993 Part-1). For comparison, the predicate devices themselves serve as a benchmark for performance.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set" or ground truth for one.

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