(305 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Device senses intracranial pressure and drains CSF. | The ACT III Ventricular Catheter, in combination with the ISM-3000 series cable, is equivalent to the predicate device because it has the same intended use. |
| Performance Standard (ICP Monitoring): Compliance with AAMI standards for intracranial pressure monitoring, as modified for air column devices. | "Pressure monitoring system was tested according to AAMI requirements as modified for an air column device. The system passed all testing requirements." |
| Biocompatibility: Use of biocompatible materials suitable for the intended application. | "It uses materials that have been shown to be biocompatible and function well in the intended application." |
| Safety (Parts Integrity): No parts should come loose and be left in the patient. | "Laboratory testing and basic design assure that no parts will come loose and be left in the patient." |
| Ease of Use/Calibration: System is easy to use and does not require a special interface instrument; transducer calibration can be checked at any time. | "The system is easy to use and does not require the use or calibration of an interface instrument between the system and a patient monitor." |
| "Unlike any other self-referencing in vivo ICP monitor now on the market, the calibration of the transducer can be checked at anytime." | |
| Comparative Performance (ICP Waveform): Faithfully follows ventricular value and waveform. (Implied from animal testing) | "Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ventricular value and waveform." |
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.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).