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The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of intracranial pressure and/or drainage of CSF in the subdural space. The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of intracranial pressure in the subdural space.

The HS900DS device is a dual lumen catheter, the outer lumen is for drainage of CSF, the inner lumen is a gas filled path connected to a bladder/balloon. The bladder is inserted into the space where pressure is to be measured. The distal end of the gas filled lumen is connected to a pressure transducer, which provides a measurement of the pressure in the lumen. The H800S is similar to the H900DS except it only contains the pressure sensing lumen.

This looks like a 510(k) submission for a medical device, which is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. For such submissions, detailed studies proving acceptance criteria are often not explicitly detailed in the summary but rather referenced or summarized. The provided text primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a standalone study with acceptance criteria and results in the typical academic format.

However, I can extract the relevant information and structure it to the best of my ability based on the provided text, making assumptions where the text is implicit.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its "substantial equivalence" to the predicate device and compliance with relevant standards. The text states:

"The models are substantially equivalent to the predicate tunneled catheters because they use the same physical characteristics, use the same pressure sensor which meets the requirements of AAMI NS28 1988 Intracranial Pressure Monitoring Devices and they allow external zeroing of pressure. They use the same materials. all of which have been shown to be biocompatible and to function well in the intended application."

Therefore, the acceptance criteria are primarily demonstrating equivalence to the predicate and meeting the AAMI NS28 standard for intracranial pressure monitoring devices.

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

The provided text does not explicitly describe a separate "test set" or a standalone clinical study with a specified sample size for the Hummingbird Subdural catheters. Instead, the submission relies on the concept of "substantial equivalence" to an existing predicate device (K013705). This typically means that rather than conducting new clinical trials for the specific device, the manufacturer refers to the established safety and effectiveness of the predicate device and demonstrates that the new device shares similar design, materials, and operational principles.

Therefore, there is no direct information on:

• Sample size used for a specific test set.
• Country of origin of data for a specific study.
• Whether the data would be retrospective or prospective (as no new clinical study validating the device meeting acceptance criteria is described).

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

This information is not mentioned in the provided text. As the submission relies on substantial equivalence and compliance with a standard (AAMI NS28), it does not detail a process of establishing ground truth by expert consensus for a new dataset.

4. Adjudication Method for the Test Set

This information is not mentioned in the provided text, as a specific test set requiring adjudication is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is described in the provided text. The submission focuses on the performance of the device itself (measuring ICP and draining CSF) rather than assessing human reader performance with or without AI assistance. Therefore, there is no effect size reported for human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This submission is for a medical device (catheter) that directly performs a measurement and/or drainage, not an algorithm. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable here. The performance described is the device's inherent capability to measure pressure and drain fluid.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is implicitly established by its adherence to the AAMI NS28 1988 Intracranial Pressure Monitoring Devices standard and its equivalence to the predicate device, which would have had its performance validated against established methods for measuring intracranial pressure. For biocompatibility, the ground truth is established by the materials' proven track record and testing for biocompatibility.

8. Sample Size for the Training Set

This information is not applicable as the device is hardware (catheter) with a physical mechanism for sensing pressure, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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