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510(k) Data Aggregation
(103 days)
StrataMR guider tool
Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.
The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMRTM valve can by modified by the StrataMR adjustment tool.
The original StrataMR adjustment tools, including handheld locator, and adjustment tool, are designed to allow the user to determine the pressure/performance level setting of StrataMR valves and adjust the setting when needed. In this 510(k) submission, Medtronic is proposing to add an additional component, guider tool, to the StrataMR adjustment tools, to improve the method to reliably adjust the StrataMR valve, cleared in K152700.
The provided text details the acceptance criteria and the study conducted for the Medtronic StrataMR™ Valves and Shunts (Guider Tool), specifically focusing on the addition of a new "guider tool" component.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical: | Non-Clinical: |
| - When the rotor foot is placed on top of an MRI resistance wall, use of the guider tool can remove the rotor foot from the wall and position it to a pressure-level-setting well after the adjustment procedure. | Met. The tests varied the configuration to represent a worst-case scenario involving misalignment and off-centering, demonstrating the modified StrataMR adjustment tool met the performance specification. |
| - Use of the guider tool will not inadvertently change the pressure level setting. | Met. Design verification and validation studies demonstrated that the modified StrataMR adjustment tool meets the functional requirement of adjusting the pressure level setting of StrataMR and that use of the guider tool did not inadvertently change the setting. |
| Human Factors: | Human Factors: |
| - Validate that under simulated use conditions, users can adjust the setting of the StrataMR valve with the new guider tool together with the existing adjustment tools. | Met. 14 clinician users (neurosurgical personnel like attending neurosurgeons, residents, physician assistants, or clinical staff with experience managing StrataMR or Strata-type valves) successfully performed 84 adjustment cycles (6 per evaluator) on plastic anatomical model heads with imitation skin, demonstrating users can adjust the setting. |
| - Validate that the rotor foot does not reside on an MRI resistance wall at the end of the adjustment procedure when using the guider tool. | Met. The design validation study's goal was to confirm this, and the conclusion states that the studies demonstrated the modified StrataMR adjustment tool met the functional requirement, implying this condition was met through successful adjustment. |
| Biocompatibility: | Biocompatibility: |
| - The guider tool withstands cleaning with warm water and mild detergent without exhibiting cracking or removal of marking. | Met. Design verification study was conducted to demonstrate this. No new biocompatibility testing was conducted as the guider tool's patient-contacting material is identical to the predicate device, leveraging previous biocompatibility testing (ISO 10993-5: cytotoxicity, ISO 10993-10: irritation and skin sensitization, ISO 10993-11: systemic toxicity). |
| Packaging: | Packaging: |
| - The packaging can protect the device from damage during transportation, and the product passes functional requirements after transportation simulation. | Met. Transportation study was conducted to demonstrate this. The only difference in packaging was the addition of the guider tool and an updated foam insert. |
2. Sample sizes used for the test set and the data provenance
- Non-Clinical Test Set: 29 guider tools were used in conjunction with 29 StrataMR valves.
- Human Factors Test Set: 14 clinician users performed a total of 84 adjustment cycles (6 adjustments per evaluator).
- Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "verification and validation testing" and "design validation study," indicating a prospective nature for the data generation; it was specifically generated to test the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Non-Clinical: The ground truth for this testing (e.g., whether the rotor foot was correctly positioned, whether the setting inadvertently changed) appears to be established through direct observation and measurement based on engineered specifications and worst-case scenarios, rather than expert interpretation of images or clinical outcomes. No specific "experts" for ground truth establishment were mentioned beyond the design and testing engineers/personnel.
- Human Factors: 14 clinician users served as "evaluators" performing the tasks. Their qualifications were described as "neurosurgical personnel (attending neurosurgeons, residents, physician assistants, or clinical staff) with experience managing StrataMR or Strata-type valves." They were the "users" in a simulated setting, and their ability to successfully manipulate the device constituted the "ground truth" for usability.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- No explicit adjudication method (like 2+1 or 3+1 for discordant reads) is mentioned for either the non-clinical or human factors testing. The non-clinical testing appears to be objective pass/fail against predetermined mechanical and functional criteria. The human factors study seems to rely on the direct performance of the evaluators.
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 MRMC or comparative effectiveness study involving human readers improving with AI assistance was performed. This device is a mechanical tool (guider tool for a shunt valve adjustment) and not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a mechanical medical device, not an algorithm. The "standalone" performance would be equivalent to the non-clinical testing of the tool's mechanical function, which was indeed performed without human interaction, focusing on its ability to correctly guide the adjustment given various conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical: Engineering specifications and functional requirements (e.g., rotor foot correctly positioned in a well, no inadvertent change in setting). This is a functional/physical ground truth.
- Human Factors: Successful completion of the adjustment task by qualified users in a simulated environment. This is a usability/performance ground truth.
8. The sample size for the training set
- Not applicable. This device is a mechanical tool with no AI/ML component; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this mechanical device.
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