(21 days)
The MoniTorr ICP™ system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequestly emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the current MoniTorr ICPTM systems is being replaced with a vent that will allow better drainage of the CSF to the drainage bag and will better resist occlusion after contact with CSF. The antimicrobial media chosen for the vent is not compatible with the current method of sterilization, therefore, an alternate sterilization method, ethylene oxide has been chosen to sterilize the entire line of MoniTorr ICP™ systems. A vented cap will be used in place of the current closed end cap to allow flow of gas through the patient line. Additionally, the fluid path from the burette to the drainage bag has been enlarged and the current sampling sites are being replaced with needleless sampling sites.
The provided text describes a 510(k) premarket notification for the MoniTorr ICP™ External CSF Drainage and Monitoring System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as would be typical for new, high-risk devices or software algorithms.
Therefore, many of the requested categories for AI/software-based studies (like sample sizes for test sets, ground truth establishment for training, MRMC studies, standalone performance) are not applicable to this particular device submission. The "study" mentioned here refers to basic engineering and biological compatibility testing to ensure safety and functionality of the modified components and new sterilization method.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Goal / Intended Performance) | Reported Device Performance (Safety Testing) |
|---|---|
| Sterility (of the entire line of systems) | Systems have been shown to be sterile and non-pyrogenic. |
| Non-pyrogenicity | Systems have been shown to be sterile and non-pyrogenic. |
| Antimicrobial vent resistance to occlusion | Antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels. |
| Microbial retention of antimicrobial vent | Antimicrobial media subjected to an aerosol challenge with B. diminuta yielded a microbial retention of 10⁷. |
| Tensile strength of bonded components | Tested for tensile strength of bonded components. (Explicit performance value not given, but successful testing implies meeting an internal standard.) |
| Pressure and leakage | Tested for pressure and leakage. (Explicit performance value not given, but successful testing implies meeting an internal standard.) |
| Drainage effectiveness | Tested for drainage. (Explicit performance value not given, implies effective and improved drainage due to modifications.) |
| Package integrity | Tested for package integrity. (Explicit performance value not given, implies maintaining sterility and protection.) |
| Reduction of needlestick injuries | Needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for these safety tests (e.g., how many vents were tested for occlusion, how many systems for sterility). The data provenance is not mentioned, as these are likely internal lab tests rather than clinical data from a specific country. They are prospective tests conducted on the modified device components.
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/diagnostic imaging device where expert ground truth is typically established. The "ground truth" here is determined by objective laboratory measurements and biological analyses (e.g., microbial retention, sterility tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of imaging/clinical data, which is not relevant to the described engineering and biological safety tests.
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 device is an external CSF drainage and monitoring system, not an AI-assisted diagnostic or interpretation tool. No human reader studies were conducted for this type of 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.)
The "ground truth" for the tests described is based on objective laboratory measurements and established scientific standards for sterility, microbial retention, physical integrity (tensile strength, pressure/leakage), and functional performance (drainage, occlusion resistance). For example, sterility is a binary outcome determined by microbial culture. Microbial retention is a measurable percentage.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
Not applicable.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).