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The use of a Trilogy system by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from one or more parameters may be deemed useful in providing optimum patient management.

This submittal covers a device that allows the placement of a ventricular catheter and up to three probes through one bolt. The pressure sensor is an air-based system that has a deformable chamber. The pressure in the chamber mirrors ICP. It is transmitted to an external transducer. The submittal also includes several procedure accessories, a device that sets the proper length of a probe to be inserted into the Trilogy, a tripod that indicates the correct drill angle, a series of tubes that fit on the shank of the bolt that cause the distal end of the bolt to stop when it reaches the inner table, an improved drill bit stop and an improved pump that injects air into the catheter's sensing system.

This document is a 510(k) premarket notification for a medical device called Trilogy. It describes modifications to an intracranial pressure monitoring device and its accessories. However, the provided text does not contain a study that proves the device meets specific acceptance criteria.

The document primarily focuses on describing device modifications and evolutionary changes to the existing MPS Oxiport and MPS Oxiport Plus devices. It mentions that "The ability of the sensor to work in parenchymal tissue is described in K003905," referring to a previous 510(k) submission, but the details of that study or its acceptance criteria are not included here. The current submission is a 510(k) for changes to an already approved device, suggesting that the focus is on demonstrating substantial equivalence rather than a de novo clinical trial with specific performance Acceptance Criteria.

Therefore, I cannot provide the requested table or answer most of the questions because the document does not report any acceptance criteria or the results of a study designed to prove the device meets those criteria.

Here's what can be extracted based on the provided text, and where the information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information/Not Applicable based on document:

2. Sample size used for the test set and the data provenance: Not mentioned. No test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No test set or ground truth establishment is described.
4. Adjudication method: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The document describes a device, not a diagnostic AI.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not mentioned. The document describes a physical medical device and its components, not an algorithm.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does describe:

• Submitted by: InnerSpace
• New Device Names: Trilogy
• Predicate Device: K072379 MPS Oxiport Plus
• Device Modifications:
  • Three probe capability: Added a third probe channel to the manifold, requiring a 10% larger bolt diameter to accommodate it. The guidance system was re-engineered using two thin-wall tubes instead of a single injection-molded part, maintaining similar brain volume displacement.
  • Pressure Sensor: Moved the sensor higher on the catheter to avoid entering the ventricle, addressing the "slit ventricle problem" and allowing readings in parenchymal tissue. States that the ability of the sensor to work in parenchymal tissue is described in K003905.
• Evolutionary Modifications (Entered For The Record):
  • Air Injection System: Modified to remove residual air before injecting new air, ensuring a consistent starting air charge and correcting ICP readings regardless of initial ICP.
  • Drill Angle Tripod: A tripod device to help surgeons visualize the correct drill angle for burr holes before drilling. It does not control the drill during the process.
  • Drill Stop: Redesigned to be a two-piece assembly with an integrated spacer, simplifying its use and increasing likelihood of surgeon compliance. It allows the drill bit to advance through the skull but not beyond.
  • Bolt Stop: Tubes of defined lengths are provided to match skull thickness, ensuring the bolt is screwed in to the proper depth without the surgeon needing to count turns.
  • Probe Length Measuring Tube: A system using a measuring tube and T-B fitting to consistently set the length of a probe inserted into the brain.

In conclusion, this document is a regulatory submission describing design changes and evolutions of a medical device, not a report of a study with specific acceptance criteria and performance data for those criteria.

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The use of a Hummingbird HUMV-500 or HUMV-500MR by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.

The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen. An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter.

This document pertains to a 510(k) premarket notification for a medical device, specifically the InnerSpace Hummingbird HUMV-500 and HUMV-500MR, which are intracranial pressure monitoring devices. It is a submission to the FDA for market clearance and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML performance evaluation.

The document describes modifications to existing predicate devices and ensures the safety and effectiveness of the new models through comparison to predicate devices and testing related to MRI compatibility and physical properties. It does not involve a study with acceptance criteria in the context of diagnostic or classification performance metrics (e.g., sensitivity, specificity, AUC) that would be applicable to AI/ML devices.

Therefore, many of the requested fields cannot be populated as they are related to performance studies of AI/ML algorithms, which are not present in this regulatory submission.

Here is an attempt to address the request based only on the provided text, while acknowledging the limitations for AI/ML related questions:

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

The document does not explicitly define "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" reported relates to physical characteristics and compatibility.

• MPS 8.1 Fr: 3.46 x $10^{-3}$ Sq. in. (Camino Large 2: 1.96 x $10^{-3}$ Sq. in.)
• MPS 9.0 Fr: 4.91 x $10^{-3}$ Sq. in. (Camino Large 1: 2.37 x $10^{-3}$ Sq. in.)
  (MPS catheters have a larger drainage lumen due to polyurethane construction allowing thinner walls, compared to predicate silicone catheters.)

Manifold Port Diameters:

• Modified Device Port 1: .056" (Same as Approved device Port 1)
• Modified Device Port 2: .063" (Larger than Approved device Port 2: .056")
  (Port 2 enlarged to accommodate larger flow/dialysis probes.) |
  | Material Strength | Catheter body made of polyurethane, which is "stronger than silicone." |
  | Continuous Pressure | New "Continuous Pressure" model has a modified cage design with a partition to isolate the sensing bladder from pressure changes due to clogged inlet holes, eliminating the need to stop CSF drainage for true ICP reading. |
  | MRI Compatibility | Hummingbird HUMV-500MR:
• Thermocouple placed in a removable probe to be removed prior to MRI.
• Bolted component (HUMV-500MR) found to be "MR Conditional" as defined by ASTM F2503 using 1.5T and 3.0T MR systems.
  (Catheter and manifold are plastic and MRI safe without the probe.) |
  | Indications for Use | Substantially equivalent to predicate devices, used for direct measurement of intracranial pressure, CSF drainage, and relevant parameter monitoring, with additional indication for MRI compatibility for the -MR model. |

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

Not applicable. This document describes physical device characteristics and MRI compatibility testing, not performance on a "test set" of diagnostic data. The MRI testing for the bolt (ASTM F2503) would have involved specific test methods and conditions but not a "sample size" in the context of data points for AI/ML evaluation.

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)

Not applicable. This is not an AI/ML device requiring expert ground truth for a diagnostic test set.

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

Not applicable. This is not an AI/ML device evaluation.

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 is not an AI-assisted diagnostic device.

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)

Not applicable. Ground truth, in the context of AI/ML, refers to definitively correct labels for data. For this device, "ground truth" would be the physical properties measured against engineering specifications or established standards (e.g., ASTM F2503 for MRI compatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

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

Not applicable.

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