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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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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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The use of MPS (or MPS-T) 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 a second or third parameter may be deemed useful in optimum patient management.

MPS- Oxiport is a system capable of draining CSF, sensing ICP and receiving two monitoring probes such as oxygen or temperature. MPS stands for Multiple Parameter System. The system consists of bolt, a bolt insert and a ventricular catheter. A slidable insert is common on the catheter at the factory. After the catheter is situated in a ventricle, the insert is moved down the catheter and into the throat of the bolt. The insert has an o-ring that forms a seal with the bolt. It also has two guide tubes. The guide tubes allow the surgeon to place probes such as an oxygen or temperature sensor in the insert has a fixation element that joins the insert to the bolt and three pigtails with Toughy-Borst fittings to fix the monitoring probes and the ventricular catheter to the insert.

The provided document is a 510(k) premarket notification for the MPS-Oxiport device, which is an intracranial pressure (ICP) monitoring device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data to prove performance against specific acceptance criteria.

Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the way one would expect for a more complex or novel device requiring rigorous clinical validation. Instead, it relies on demonstrating that its characteristics are similar enough to existing, legally marketed devices.

Here's an analysis based on the information provided, highlighting the absence of some requested elements due to the nature of a 510(k) submission for a substantially equivalent device:

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

This document does not present a formal table of "acceptance criteria" and "reported device performance" with quantitative metrics (e.g., accuracy, precision) as would be found in a clinical study report for a new device. Instead, it compares the device's characteristics to predicate devices to demonstrate equivalence.

The "acceptance criteria" here are implicitly that the MPS-Oxiport device's characteristics are sufficiently similar to the predicate devices or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is the description of the MPS-Oxiport's physical and functional characteristics.

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 does not describe a clinical study with a test set of patients/data to evaluate algorithmic performance. It's a medical device submission based on substantial equivalence to existing devices, relying on engineering comparison and functional descriptions rather than clinical data from a "test set."

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. There is no "test set" of data requiring expert-established ground truth in this submission.

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

• Not Applicable. There is no "test set" of data requiring adjudication in this submission.

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

• No. This is not an AI-assisted device, nor does the submission describe an MRMC study.

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. No ground truth data (in a clinical study sense) is presented as the basis for device validation. The "ground truth" for the submission is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

• Not Applicable. As above, no training set or associated ground truth.

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The use of a ACT III Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.

The ACT III Ventricular Catheter consists of a 10 Fr. ventricular catheter in combination with an external pressure transducer. The catheter has two lumens. One lumen drains CSF. The second lumen transmits ICP from the brain to the external transducer by means of an air tube within the lumen. The air tube communicates with a flaccid bladder on the distal end of the catheter. The bladder's volume and internal pressure change according to P1 V = P2 V2. The catheter's proximal end terminates in a piston with an o-ring. The piston is joined to an external transducer. The pressure seen by the bladder/catheter/transducer mirrors the pressure in the brain.

The CSF drainage function is provided by a dedicated lumen within the catheter. The CSF drainage function is typical of ventricular catheters. The length of the catheter fenestrated with radial holes is the same length as that provided by a conventional drainage catheter. The active drainage length of the catheter is preserved by mounting the bladder on the side of the catheter on a segment not penetrated by radial holes.

The technique used to place a ventricular catheter is the same as that used to place a conventional ventricular catheter. Once the distal end of the catheter is placed in the brain, the proximal end of the catheter is placed in the sheath of a trocar and tunneled beneath the scalp in a forward direction. The proximal end of the catheter is bifurcated in order to separate the air lumen and drainage lumen.

It is desirable to keep the size of the proximal end of the catheter small and thereby minimize the diameter of the trocar sheath passed beneath the scalp.

The size of the proximal end of the catheter has been minimized by the use of a tube-within-a-lumen design. In this design, a dedicated air tube is inserted into a lumen which, to distinguish it from the drainage lumen, will be referred to hereafter as the second lumen. The air tube is bonded to the distal end of the second lumen. The tube then exits the sidewall of the second lumen near the proximal end of the catheter. This construction allows the air tube to separate from the main catheter without the use of a molded bifurcation. As will be seen in the drawings, the concept provides a proximal configuration much smaller than a conventional molded bifurcation.

Once tunneled beneath the scalp, the air tube is pneumatically connected the transducer. The transducer is mounted within a special transducer housing that features a cylinder designed to engage the catheter's piston. The bladder is activated when the piston on the end of the air tube is placed in the cylinder. Connecting the piston to the cvlinder causes the air in the cylinder to be injected into the bladder. The bladder air is restored once per shift by removing and replacing the transducer housing. The transducer is incorporated into to a standard patient monitoring cable. The cable can be connected to a patient monitor without the need for a special intermediate instrument.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACT III Ventricular Catheter, structured according to your requested information.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 2001/2002, which predate many of the detailed reporting requirements for AI/ML devices specified in your request (e.g., MRMC studies, detailed training set information, specific expert qualifications for ground truth). Therefore, some information may not be directly available or applicable in the provided text.

Acceptance Criteria and Device Performance Study for ACT III Ventricular Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a specific number for a clinical "test set" as one might expect for a modern AI/ML device. The testing described is primarily laboratory testing and an animal study.
  • For the animal study: "Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ventricular value and waveform." The number of pigs is not specified.
  • For laboratory testing: "Pressure monitoring system was tested according to AAMI requirements as modified for an air column device. The system passed all testing requirements." The number of test instances or samples is not specified.
• Data Provenance:
  • Animal Study: Animal model (pig).
  • Laboratory Testing: Conducted in a laboratory setting.
  • Both are prospective as experimental tests performed for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

• The concept of "experts establishing ground truth" in the context of human interpretation for a test set (common in AI/ML performance studies) is not applicable to this device and its testing.
• Ground truth for the described tests was established through:
  • Direct physiological measurement in the animal model.
  • Engineering and metrological standards in the laboratory setting for pressure monitoring.
• The device's intended use specifies placement "by a qualified neurosurgeon," implying their expertise in clinical application, but not in establishing ground truth for device performance testing in this context.

4. Adjudication Method for the Test Set

• Not applicable. As the device is a sensing and drainage catheter, the "test set" here refers to physical and physiological performance evaluation, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC comparative effectiveness study is not applicable to this device. This is a medical device for intracranial pressure monitoring and CSF drainage, not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance.

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

• This question is not directly applicable in the context of an intracranial pressure monitoring catheter. The "performance" being evaluated is the physical and electrical function of the catheter system itself, independent of a human's interpretation of its output in an "algorithm only" sense. The device is the "standalone" entity in its functional testing.

7. The Type of Ground Truth Used

• Physiological measurements: In the animal study, the "ventricular value and waveform" served as the physiological ground truth that the device was compared against.
• Engineering and metrology standards: For the pressure monitoring system, the AAMI requirements, modified for an air column device, provided the objective ground truth against which the system's performance was measured.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (catheter) and does not involve AI/ML algorithms that require a "training set."

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

• Not applicable. As there is no AI/ML component, there is no "training set" or corresponding ground truth establishment in this context.

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The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston.

A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap.

The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system.

The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.

Here's a breakdown of the acceptance criteria and study information for the ACT II MP ICP Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a clinical study related to this specific modification (the MP version).

The text mentions:

• "Animal test data of the subject device vs. a ventricular catheter shows the device faithfully follows the ventricular pressure and waveform and that the bolt is securely anchored in the skull." This implies animal testing was conducted.
• "Laboratory testing has shown that the ACT II MP ICP Monitoring System... are safe in the following areas: Mechanical integrity; Biocompatibility." This refers to laboratory tests, not human clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study described is primarily animal and laboratory testing, not a human clinical trial where expert-established ground truth would be relevant in the same way (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described animal and laboratory testing, an adjudication method like 2+1 or 3+1 (typically used in human reader studies for diagnostic accuracy) would not be applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a medical monitoring system, not an AI diagnostic tool primarily aimed at improving human reader performance.

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

This is not applicable as the device described is a physical intracranial pressure monitoring system and associated components, not a software algorithm.

7. Type of Ground Truth Used

Based on the text, the ground truth for the performance evaluation comes from:

• Physiological measurements in animal models (e.g., actual ventricular pressure and waveform).
• Laboratory test results (e.g., mechanical integrity tests, biocompatibility tests against ISO standards).
• Consensus standards (AAMI performance standards for accuracy).

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above (not an AI/ML algorithm).

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