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The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.

After surgical implantation, the Strata Valve provides a non-invasive method to address changing patient needs in the management of hydrocephalus. The unique valve design allows the physician to adjust the pressure/flow performance level by using a magnetic Adjustment Tool included with the Strata® Valve adjustment kit without the need for radiographic confirmation.

The Strata® Handtools, include the Locator Tool, Indicator Tool and Adjustment Tool. Ail three tools are required to set or change the pressure/performance level setting of the Strata® Valve.

Acceptance Criteria and Study Details for Medtronic PS Medical Strata® Valves

Here's a breakdown of the acceptance criteria and the study details as provided in the 510(k) summary for the Medtronic PS Medical Strata® Valves and Handtools:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents acceptance criteria implicitly through the reported performance rather than explicit pre-defined targets. The performance metrics focus on the accuracy of the Indicator Tool in correlating with the x-ray confirmed pressure/performance level setting.

Note: The table in the original document has some unreadable or garbled text under "Concellential" and "DJT". Only the clear percentage values have been included.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document only mentions "Discharge Data" and "ALL IN CORRES Adjustment Data," which refer to categories of observations rather than a specific number of patients or evaluations.
• Data Provenance: The study is referred to as "clinical study data," implying prospective data collection during patient follow-up. The country of origin is not specified, but given the 510(k) submission to the FDA, it is likely that parts or all of the clinical data were collected in the US or in compliance with US regulatory standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the submitted 510(k) summary. The ground truth for valve setting is explicitly stated as "x-ray," but details on who interpreted these x-rays or their qualifications are absent.

4. Adjudication Method for the Test Set

This information is not provided in the submitted 510(k) summary. Given the reliance on "x-ray" as the ground truth, it's possible that a single, definitive x-ray interpretation was used, or if multiple were involved, the adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No. The study described focuses on the correlation between the device's Indicator Tool and x-ray confirmation, not on comparing human reader performance with and without AI assistance. The device in question is a physical medical device (valve and handtools) for hydrocephalus management, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Was it done? No. The device is a mechanical shunt system with external adjustment tools. The "performance" being evaluated is the accuracy of the adjustment tool's indication against an x-ray confirmation of the physical valve's setting. There is no AI algorithm involved for standalone performance evaluation.

7. Type of Ground Truth Used

• Ground Truth: X-ray confirmation of the valve's pressure/performance level setting. The summary explicitly states: "Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray at time of Discharge and during follow-up."

8. Sample Size for the Training Set

This information is not provided as the device is not an AI/ML algorithm that typically requires a distinct "training set." The clinical data described pertains to the performance evaluation rather than the training of an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no mention of a training set for an AI/ML algorithm in the context of this device. The development and verification of the physical valve and tools would likely involve engineering tests, bench testing, and potentially pre-clinical studies, but these are distinct from "training an algorithm." The clinical study data mentioned refers to the human-clinical performance validation.

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The STRATA™ Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool. The tamper resistant design helps ensure that the valve's performance level is not inadvertently changed.

The STRATA™ Valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. This combination enables the valve to maintain intraventricular pressure (IVP) within a normal physiological range, regardless of a patient's CSF flow requirements or body position. Similar to the Hakim Programmable Valve and the Sophysa Pressure Adjustable Valve, the STRATA™ Valve incorporates the following features: (1) valve mechanism (spring biased ball in cone/seat), (2) 316L Stainless Steel spring coils for pressure flow regulation, (3) internal magnet, (4) valve element (ruby), (5) outer jacket (silicone elastomer). Additionally, the STRATA™ Valve incorporates a tamper-resistant internal dis-adjustment mechanism to prevent extreme changes in pressure (i.e., from the highest to the lowest settings) and a strong return spring to stabilize the rotor. The STRATA Valve is available with the BioGlide surface modification, identical to that reviewed under K951258. The product is also provided as part of a shunt configuration equivalent to that reviewed under K900676 and K951258. The shunt consists of the valve and a proximal and distal catheter, equivalent to those reviewed under K792007 and K792005.

The provided text describes a medical device, the Medtronic PS Medical STRATA Valves, and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a "SAFETY AND EFFECTIVENESS SUMMARY" for a 510(k) premarket notification. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study with acceptance criteria for the new device's performance.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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