(107 days)
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. The Medtronic M2 Adjustment Tool is used in conjunction with Strata® handtools.
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. External adjustment of the valve prevents the need for an invasive revision procedure. To adjust the operating pressure of the valve, the adjustment tool is used in close proximity to the valve to move the rotor within the valve.
This document is a 510(k) summary for the Medtronic M2 Magnet Adjustment Tool. It appears to be a submission for regulatory clearance rather than a detailed study report. Therefore, much of the requested information regarding acceptance criteria, device performance studies, and ground truth establishment is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) summary generally focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and clinical performance study results with quantitative metrics.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. The document does not describe any specific test set or data used for performance evaluation in the way a clinical study report would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the 510(k) summary. No details about expert involvement for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set:
This information is not provided in the 510(k) summary. There is no mention of an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological comparison, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only):
No, a standalone (algorithm only) performance study was not done, or at least not described in this 510(k) summary. The device is a physical magnetic adjustment tool, not an algorithm.
7. Type of Ground Truth Used:
This information is not applicable as there is no mention of a performance study with a "ground truth" using the given device. The device itself is a tool for adjusting an existing medical implant.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical tool, not an AI/ML algorithm that would typically have a "training set."
9. How Ground Truth for the Training Set Was Established:
This information is not applicable/not provided. As explained above, there is no training set for this type of device.
Summary of Device Acceptance/Clearance based on the document:
The Medtronic M2 Magnet Adjustment Tool was cleared by the FDA based on substantial equivalence to predicate devices (adjustment tools for Medtronic PS Medical® Strata® Valve and Shunt Assemblies, specifically K012052, K033850, and K042465).
The submission argues that the materials of fabrication, intended use, and fundamental scientific technology of the M2 Magnet Adjustment Tool are the same as the previously reviewed and cleared magnet adjustment tools for the Strata Valve and Shunt Assemblies. The FDA reviewed the 510(k) premarket notification and determined that the device is substantially equivalent for the stated indications for use (non-invasively adjusting the Strata-type Valve when a stronger magnet is warranted by the surgeon, in conjunction with Strata® handtools).
In essence, the "acceptance criteria" here is the legal standard of "substantial equivalence" to a legally marketed predicate device, rather than specific quantitative performance metrics from a new clinical study.
§ 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).