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Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

The CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s. This 510(k) is to have these identical Class II products cleared for use in an MRI environment.

This 510(k) pertains to MRI Patient Positioning Devices, which are Class II devices intended to support and position patients during an MRI. The submission is for identical products previously cleared under other 510(k)s, now seeking clearance for use in an MRI environment.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Key Finding: The provided document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, particularly in the context of performance metrics or clinical outcomes. This submission is a 510(k) Premarket Notification for Substantial Equivalence, which primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical performance studies.

The document highlights the device's classification as Class II and its regulatory pathway via substantial equivalence to previously cleared predicate devices. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the acceptance criteria are met by demonstrating equivalence to existing products, rather than through novel performance testing.

Therefore, many of the requested details about acceptance criteria and study particulars are not present in this type of submission.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices in terms of intended use, design, materials, and safety for use in an MRI environment. The document implies that the device is identical to previously cleared devices but is now seeking specific clearance for MRI compatibility.
   • Reported Device Performance: The document does not provide quantifiable performance metrics or a study demonstrating specific device performance against a set of numerical acceptance criteria. The "performance" is implicitly demonstrated through the device's classification as "identical Class II products cleared for use in an MRI environment" (implying safety and functionality within that environment, likely based on material compatibility and design).

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices for intended use and safety in MRI environment.	The device (MRI Patient Positioning Devices) is deemed substantially equivalent to the listed predicate devices (e.g., K950866 MEDTEC Inc, Hip Fix; K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices; K060737 SINMED Positioning Devices; K973842 MEDTEC Inc, Carbon Fiber Conformal Couch Top). The FDA's letter explicitly states a finding of substantial equivalence based on the provided 510(k) premarket notification. The devices are described as "identical Class II products cleared for use in an MRI environment," suggesting that their design, materials, and functionality are consistent with existing, cleared MRI-compatible positioning devices, thereby meeting the safety and efficacy standards for their intended use in MRI.
   Compliance with general controls and relevant special controls (if any) for Class II devices.	The FDA letter reminds the submitter of compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and potential additional controls for Class II devices. The act of receiving the 510(k) clearance implies that the information submitted satisfies these regulatory requirements for market entry.

2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a test set or data provenance for a clinical performance study. The substantial equivalence is based on comparing the new device's characteristics to cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

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 a passive patient positioning device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This submission does not involve ground truth determination for performance evaluation. The "ground truth" equivalent would be the established safety and efficacy profiles of the predicate devices.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning product and does not involve a training set.

9. How the ground truth for the training set was established: Not applicable. As above, no training set is involved.

In summary: This 510(k) submission is for a medical device that demonstrates substantial equivalence to existing products. The information provided does not detail clinical performance studies with specific acceptance criteria, test sets, or ground truth establishment typically associated with novel or high-risk devices or software. The "acceptance" is the FDA's determination of substantial equivalence, allowing the device to be marketed.

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Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.

This 510(k) submission (K080072) is for "MRI Patient Positioning Devices" and focuses on demonstrating substantial equivalence to previously cleared devices. The core of the submission revolves around proving the safety and effectiveness of these devices for use in an MRI environment, as they were previously Class I exempt and are now being cleared for MRI use.

The document does not provide a typical "study" with specific acceptance criteria and reported device performance in the way one might expect for an AI/software device or a diagnostic device. Instead, the "study" is a series of tests to ensure MRI compatibility and safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to the physical devices themselves. The sample size would be the number of physical MRI Patient Positioning Devices tested for MRI compatibility. This number is not disclosed in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven study.

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

Not applicable. "Ground truth" in the context of device performance for physical products like patient positioning devices (especially for MRI compatibility) typically involves engineering tests, material compatibility assessments, and MRI safety protocols, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive test set requiring adjudication.

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

Not applicable. This is not a diagnostic device or an AI assistant for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's main claim (MRI safety) would be established through:

• Engineering Standards and Test Results: Compliance with recognized MRI safety standards (e.g., ASTM F2503 for "MR Safe," "MR Conditional," "MR Unsafe"). These standards outline specific tests for magnetic attraction, RF-induced heating, image artifact, etc.
• Material Compatibility: Assessment of the materials used in the devices for their magnetic properties and potential for heating in an MRI environment.
• Regulatory Compliance: Meeting the requirements of the FDA for safe medical devices.

The document only states "These products have been tested to demonstrate that they can be safely used in an MRI environment," implying these types of tests were performed.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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