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The HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry configuration. The HHF1 is designed to enhance clinical utility as compared to Open MRI system. The imaging properties of the HHF1 are based on the Altaire imaging properties of the 1.5T magnet.

This FDA submission (K052172) is for a Magnetic Resonance Imaging System (HHF1 MRDD). It is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to a predicate device, rather than submitting a de novo application or PMA which would typically present extensive clinical trial data.

As such, this submission does not contain acceptance criteria or a study proving the device meets those criteria in the way one might expect for a novel or high-risk device requiring significant clinical validation. This type of submission relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device.

Here's a breakdown of why the requested information isn't present in this document and what is provided:

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

• Not Applicable: For a 510(k) submission asserting substantial equivalence for an MRI system, a table of specific acceptance criteria (e.g., specific sensitivity/specificity thresholds for a diagnostic task) and reported device performance against those criteria is generally not required in the same way it would be for a diagnostic AI algorithm or a novel therapy.
• What is provided: The submission states that the HHF1 MRI system's technological characteristics are "similar to the primary predicate Hitachi Altaire MRI System (K050602)" and that "The control and image processing hardware and the base elements of the system software are identical to the predicate device." It also highlights the physical and performance characteristics of MRI in general (high quality anatomical images, differences in image contrast based on T1, T2, proton density, blood flow, etc.). The "performance" being demonstrated here is the ability to produce images comparable to the predicate device, which itself was approved based on its known performance as an MRI.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: There is no specific test set data or clinical study detailed in this 510(k) submission to assess the HHF1's diagnostic performance in a clinical setting. The FDA's review for substantial equivalence in this context focuses on engineering specifications, software validation (which is generally internal to the company and not fully disclosed in the public 510k summary), and comparisons to the predicate device's established performance.

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)

• Not Applicable: Since no specific clinical performance study with a test set is presented, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: As there's no test set described, an adjudication method is not applicable.

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 diagnostic imaging system (MRI), not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is an MRI system, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable: No ground truth data is discussed as there's no clinical performance study presented.

8. The sample size for the training set

• Not Applicable: This device is an MRI system. There is no "training set" in the context of machine learning, as it's not an AI/ML algorithm. The performance is based on the physics of MRI and established engineering principles.

9. How the ground truth for the training set was established

• Not Applicable: As above, there is no training set mentioned.

Summary of the 510(k) Submission's Approach to Demonstrating Safety and Effectiveness:

Instead of presenting new clinical data, this 510(k) relies on substantial equivalence to an existing, legally marketed device (Hitachi Altaire MRI System, K050602). The key arguments for demonstrating safety and effectiveness are:

• Identical Intended Use: The HHF1 MRI system is intended for the same diagnostic purposes (imaging internal structures of the head, body, extremities to provide physiological and clinical information) as the predicate device.
• Similar Technological Characteristics: The device utilizes a 1.5 Tesla superconducting magnet, similar to the predicate. The "control and image processing hardware and the base elements of the system software are identical to the predicate device."
• Established Scientific Concepts: The fundamental scientific principles of MRI (proton density, T1, T2 relaxation times) are well-understood and are the basis for both the new and predicate devices.

The FDA's letter confirms that they have determined the device to be "substantially equivalent" to legally marketed predicate devices, meaning it has been found to be as safe and effective as those devices.

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