(90 days)
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proSA shunt can be verified by using the verification instrument but must be confirmed by radiograph (X-ray).
proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf spring and ball mechanism. The pressure setting is magnetically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure. These manual accessories are for external use by the physician. Once verified using the verification instrument the setting must be confirmed with an X-ray. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
I'm sorry, but this document does not contain the detailed information needed to fill out all the sections of your request. This 510(k) summary provides a declaration of substantial equivalence for a medical device (a shunt system), focusing on its design, intended use, and performance testing against established standards.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists the types of performance tests conducted and states that "The results and evaluation conclude that the device is MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 and is substantially equivalent to the predicate devices." It also states "Preclinical testing was performed to demonstrate that the Aesculap Miethke proSA Adjustable Shunt System performs as intended and is safe and effective."
However, it does not provide specific numerical acceptance criteria or the reported device performance values for these tests (e.g., minimum burst pressure, specific flow rates, or MR artifact sizes). It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (e.g., specific thresholds for leak, pressure-flow, overpressure, etc.) | Device performs "as intended" and is "safe and effective." |
| MRI compatibility according to ASTM F 2503 | Device is "MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Preclinical testing was performed..." but does not specify the sample sizes used for any of the tests. It also does not mention the data provenance (country of origin, retrospective/prospective). This is typical for 510(k) summaries which often summarize the testing rather than provide full study details.
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)
This entire section is not applicable or not provided in the document. The testing described is primarily in vitro and physical performance testing of the device itself, not image interpretation or diagnostic accuracy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable or not provided. Adjudication methods are typically relevant for studies involving human interpretation of data, which is not the nature of the preclinical performance testing described here.
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
This is not applicable. This document describes a physical medical device (a shunt system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (Leak, Pressure-Flow, Overpressure, Dynamic Break Strength, Bursting Pressure, Reflux performance, Long Term Stability, Angle dependence, and MRI compatibility), the "ground truth" would be established by engineering standards and physical measurements based on the specified test protocols (e.g., ISO 7197:2006, ASTM F2119, F2182, F2213, F2052, F2503). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set.
§ 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).