Search Results

The Philips Gyroscan INTERA (Release 7) series are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique crosssectional images, spectroscopic images and/or spectra, based upon 'H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

The new Philips MRDD being the successor of Gyroscan NT (Rel.6), is the Release 7 series called the Gyroscan INTERA series. The Gyroscan INTERA is based on the same platform as its predicate device Gyroscan NT (re.K980645) with the same technological characteristics and intended use.

The provided text is a 510(k) Summary for the Philips Gyroscan INTERA (Release 7 series) MRI system. It asserts substantial equivalence to a predicate device, the Philips GYROSCAN NT Release 6 series. However, it does not contain a study that proves the device meets specific acceptance criteria.

Instead, the document focuses on demonstrating that the new device has "the same intended use" and "the same technological characteristics" as its cleared predicate device, and that its "safety parameters" and "General Safety and effectiveness" remain the same. This is typical for a 510(k) submission seeking substantial equivalence, rather than a de novo approval requiring a full clinical performance study against specific acceptance criteria.

Therefore, many of the requested information points, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth information for a new study, are not present in this document.

Here's what can be extracted based on the provided text, with a clear indication of what is not available:

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in this document. The document asserts that the safety and effectiveness of the Gyroscan INTERA Release 7 are implicitly proven by its substantial equivalence to the predicate device, the GYROSCAN NT Release 6, which was previously cleared. There are no explicit acceptance criteria or comparative performance measures presented for the Philips Gyroscan INTERA (Release 7 series) itself beyond the statement of equivalent safety and effectiveness.

2. Sample size used for the test set and the data provenance

• Not applicable/Not provided. No separate "test set" for performance evaluation is described for the Gyroscan INTERA (Release 7 series) in the context of specific performance metrics. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. No new ground truth establishment process for a performance study is described.

4. Adjudication method for the test set

• Not applicable/Not provided. No test set or adjudication process 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

• No, an MRMC comparative effectiveness study was not done. This device is a Magnetic Resonance Diagnostic Device (MRDD), not an AI-based diagnostic aid that would typically involve a "human readers improve with AI vs without AI assistance" study. The submission focuses on hardware and software updates to an existing MRI platform.

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

• Not applicable/Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent in its image generation capabilities for a trained physician to interpret.

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

• Not applicable/Not provided for a new study. The intended use statement mentions that "These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis." This implies that the 'ground truth' for an MRI system's utility is diagnostic information derived by a physician. However, no specific ground truth for a new performance evaluation is detailed here.

8. The sample size for the training set

• Not applicable/N/A. This document describes a medical device (MRI scanner), not a machine learning algorithm that requires a "training set" in the conventional sense.

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

• Not applicable/N/A.

Summary of Device and Regulatory Context (Based on the document):

• Device Name: Philips Gyroscan INTERA (Release 7 series)
• Predicate Device: Philips GYROSCAN NT Release 6 series (FDA ref. K980645)
• Intended Use: "The Philips Gyroscan INTERA (Release 7) series have the same intended use as its predecessor and predicate device Gyroscan NT Release 6. The Gyroscan INTERA systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis."
• Basis for Approval: Substantial Equivalence to the predicate device. The document explicitly states: "The Gyroscan INTERA (Release 7 series) is substantially equivalent to the predicate device Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645." This means the new device is considered as safe and effective as the predicate device without needing new, extensive clinical studies demonstrating performance against novel acceptance criteria. The enhancements are primarily focused on user-friendliness, patient comfort, and faster image reconstruction/processing, without altering the fundamental diagnostic capability or safety profile compared to the predicate.

Ask a specific question about this device