(53 days)
The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Region: Shoulder and adjacent regions
Nuclei Excited: Hydrogen
The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below.
The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The HFO Shoulder Coil consists of a cup-shaped, plastic enclosure containing three coil elements for receiving of RF signals from the shoulder and adjacent region. The enclosure is placed on patient's shoulder for imaging. The enclosure contains tuning and decoupling electronics circuitry and preamplifiers. The coil enclosure has a cable attached to it and the cable connector is plugged into the system connector on the patient table. The cable provides the coil with supply and control voltages and transfers the received RF signals to the system. The cable connector contains coil interface circuitry for the system.
Here's an analysis of the provided 510(k) submission for the Philips Medical Systems HFO Shoulder Coil, based on the information available:
The provided document is a 510(k) summary for a Magnetic Resonance (MR) specialty coil, not a diagnostic AI device or software. Therefore, many of the requested sections related to AI performance criteria, ground truth, and clinical study designs (like MRMC or standalone performance) are not applicable to this type of submission.
This submission focuses on demonstrating substantial equivalence to a predicate device for hardware components used in an existing MR system. The "performance" in this context refers to the coil's ability to produce quality MR images within the existing safety and efficacy profile of the MRI system it's used with.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
As this is a hardware accessory (MR coil) and not an AI or diagnostic software, explicit "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC are not presented in this document. The primary acceptance criteria for such a device would revolve around:
- Safety: Meeting established safety standards for MRI coils (e.g., SAR, static field, time-varying magnetic fields, acoustic noise) when integrated with the specific MRI system.
- Functionality: Correct operation, successful image acquisition.
- Image Quality: Producing images comparable to or better than previously cleared coils for the same anatomical region, enabling diagnostic interpretation.
- Substantial Equivalence: Alignment with the design, materials, and intended use of a legally marketed predicate device.
| Acceptance Criteria (Implied for MR Coils) | Reported Device Performance |
|---|---|
| Safety: No change to existing safety specifications (static field, time-varying magnetic fields, SAR, acoustic noise) of the Philips HFO (1.0T) Panorama system. No additional potential hazards compared to currently marketed, receive-only coils. | "The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system. The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils." (Section 2.3 Safety Information) |
| Intended Use: Consistent with the existing indications for use of the cleared High Field Open (1.0T) Panorama system for producing interpretable MR images of the shoulder and adjacent regions using Hydrogen nuclei. | "The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system... The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Region: Shoulder and adjacent regions, Nuclei Excited: Hydrogen." (Section 2.2 Intended Use) The general system indications for use describe the production of images useful for diagnostic determination when interpreted by a trained physician. While not explicitly stated as "performance metrics," the implication is that the coil would facilitate this existing performance. |
| Substantial Equivalence: Demonstrated equivalence to a legally marketed predicate device. | "The HFO Shoulder Coil is substantially equivalent to the Invivo Corporation Shoulder Array Coil Set QSC-127-INT." (Section 2.4 Conclusion). This equivalence is based on similar technology, intended use, and safety profile. |
Study Proving Acceptance Criteria:
The document explicitly states: "The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system." and "The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils." This implies that testing (likely in-house engineering and phantom testing, and possibly animal or human subject scanning for image quality assessment, though not detailed in this summary) was conducted to verify that the coil operates within the established safety envelope of the MRI system and produces diagnostically acceptable images. The primary "study" here is the comparison to the predicate device and verification against established MRI safety standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. For an MR coil, "test set" would typically refer to phantom data, cadaver data, and/or small numbers of healthy volunteer or patient scans. This document does not provide details on the number of subjects or phantom scans.
- Data Provenance: Not specified. Testing would likely be conducted by the manufacturer, Philips Medical Systems, in Finland (where the coil is manufactured) or at a Philips testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: For an MR coil, the concept of "ground truth" for diagnostic accuracy is not directly applied in the same way as for AI software. The "truth" is established by the accepted physics and engineering principles of MRI, and the output is images that trained radiologists use for diagnosis, not a primary diagnostic output from the device itself. While image quality would be assessed, it's typically done by trained MR physicists or radiologists ensuring the images are suitable for interpretation, rather than establishing a specific "ground truth" for a diagnostic outcome.
4. Adjudication Method for the Test Set
- Not Applicable: As there's no clinical "ground truth" being established in the traditional sense for diagnostic performance, an adjudication method isn't relevant here.
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, Not Applicable: This device is an MR coil, not an AI or diagnostic software. Therefore, an MRMC study comparing human reader performance with or 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
- No, Not Applicable: This is an MR coil, not an algorithm, so a standalone performance study as described is not relevant.
7. The Type of Ground Truth Used
- Implicit Engineering and Clinical Acceptability: The "ground truth" for an MR coil is its ability to:
- Adhere to safety specifications (e.g., quantifiable SAR measurements, electromagnetic compatibility).
- Produce images with expected signal-to-noise ratio, uniformity, and artifact levels (often assessed against phantom standards and clinical expert opinion on diagnostic utility).
- Maintain the diagnostic capability of the overall MRI system.
- Not Applicable in the sense of expert consensus, pathology, or outcomes data for a specific diagnosis, as the coil itself does not provide a diagnosis.
8. The Sample Size for the Training Set
- Not Applicable: This is a hardware component. There is no "training set" in the context of machine learning or AI. Hardware design and development involve extensive engineering, simulation, and testing, but not training data for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: No training set as described for AI/ML.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.