(119 days)
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).
3D Amide Proton Transfer (3D APT) is an extension of off-resonance magnetization transfer imaging.
3D APT images display a spatial distribution of amide protons. The RF-shimmed saturation is generated by alternating excitation from the 2 channels of the MultiTransmit system.
3D APT images are obtained by subtracting the saturated image intensity at the 2 mirrored frequency offsets relative to the water frequency (±3.5 ppm). Parameters are optimized to null the difference signal for normal brain tissue.
The provided text, a 510(k) summary for the Philips 3D APT device, does not contain the detailed clinical study information typically required to fully answer the request regarding acceptance criteria and performance studies for an AI/ML medical device.
The document focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T/3.0T R5.3) based on design features, fundamental scientific technology, and indications for use. It mentions "non-clinical performance (verification and validation) tests" that complied with standards and guidance, but these are typically engineering and system validation tests, not clinical performance studies involving a test set, ground truth experts, or MRMC studies that would be relevant for an AI/ML product's clinical performance claims.
The 3D APT device is described as "an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density." It's a software option that "may assist a trained physician in diagnosis and therapy planning." This description suggests it's a tool for imaging acquisition and processing, rather than a diagnostic AI algorithm that independently generates classifications or predictions based on image analysis. Therefore, the type of "acceptance criteria" and "study" would be different than for an AI diagnostic device.
Given these limitations from the provided text, I can only address parts of your request based on what's available and infer what might be relevant for such a device in the absence of explicit AI/ML performance data.
Here's an attempt to answer based on the provided document, highlighting what is not present:
Device: Philips 3D APT (Amide Proton Transfer weighted MRI)
The Philips 3D APT is a software option for Philips Ingenia 3.0T and Ingenia 3.0T CX MR Systems, indicated for use in magnetic resonance imaging of the brain. It's an acquisition and reconstruction technique that derives images reflecting the spatial distribution of amide protons and protein density, intended to assist trained physicians in diagnosis and therapy planning.
Based on the 510(k) summary, the acceptance criteria and study described are not for an AI/ML diagnostic system with a specific performance metric like sensitivity/specificity against a ground truth. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate MRI systems (Ingenia 1.5T/3.0T R5.3) and ensuring the new image acquisition and reconstruction technique functions as intended and safely.
The document mentions "non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards and device-specific guidance." This typically refers to technical validation, image quality assessment (e.g., signal-to-noise ratio, spatial resolution, artifacts), safety (e.g., SAR limits), and functional performance within engineering specifications, rather than clinical efficacy studies in the context of diagnostic accuracy.
Therefore, the requested tables and details on AI/ML-specific performance metrics (e.g., sensitivity, specificity, AUC) and associated clinical study designs (test sets, ground truth methodology, expert adjudication, MRMC studies) are not present in this 510(k) summary. The device appears to be a novel MRI sequence/acquisition method, not a standalone AI diagnostic algorithm performing image analysis.
1. A table of acceptance criteria and the reported device performance
Since this is an MR image acquisition and reconstruction technique, not an AI diagnostic algorithm, the acceptance criteria would relate to imaging quality, consistency, and safety, not diagnostic performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth. The document does not provide a specific table of acceptance criteria and reported performance for these non-clinical tests. It only states: "The results of these tests demonstrate that the proposed 3D Amide Proton Transfer (3D APT) meets the acceptance criteria and is adequate for its intended use."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in terms of clinical cases for diagnostic performance. The "non-clinical performance tests" would likely involve phantoms and potentially a limited number of healthy volunteers for image quality assessment, but details are not provided.
- Data Provenance: Not specified. Again, for non-clinical performance, this would refer to the characteristics of phantoms or human subjects (if any) used for technical validation, not a clinical patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this 510(k) summary, as it describes an MRI acquisition technique, not a diagnostic AI that requires expert-established ground truth for performance evaluation on clinical cases. The "ground truth" for non-clinical performance would be based on physical measurements from phantoms or known parameters of the MR system.
4. Adjudication method for the test set
Not applicable. There's no indication of a clinical test set requiring expert adjudication for ground truth.
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 is not an AI-assisted reading device in the context of MRMC studies. It's a new imaging contrast technique.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is used by humans (trained physicians) for diagnosis and therapy planning. Its "standalone" performance would be its ability to generate the 3D APT images reliably and with sufficient quality, which is covered by the general "non-clinical performance tests" but without detailed metrics in the summary. It's not a standalone diagnostic algorithm in the sense of providing an automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a new imaging sequence like 3D APT, the "ground truth" (in the context of showing it works as intended) would typically involve:
- Physical principles: Confirmation that the sequence correctly applies RF pulses, gradient fields, and signal processing to generate images based on amide proton transfer effects.
- Phantom studies: Using phantoms with known properties to assess image quality, quantitative accuracy (if applicable), and consistency.
- Known physiological effects: Observing expected signal changes in human subjects in areas known to have certain protein densities, though this is for validation of the physics of the sequence, not diagnostic accuracy.
8. The sample size for the training set
Not applicable. This document describes an acquisition and reconstruction technique, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system comes from engineering design, physics principles, and potentially iterative refinement based on phantom and healthy volunteer studies.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI/ML algorithm described in this application.
In conclusion, the 510(k) summary for Philips 3D APT focuses on establishing substantial equivalence and general safety/performance of a new MRI acquisition sequence, rather than the clinical performance metrics of a diagnostic AI/ML algorithm that would involve a detailed test set, expert ground truth, and comparative studies with human readers.
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Philips Medical Systems Nederland B.V. % Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Rd CLEVELAND OH 44143
January 22, 2018
Re: K172920
Trade/Device Name: 3d Apt Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: December 22, 2017 Received: December 26, 2017
Dear Susan Ouick:
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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert A. Ochs, Ph.D.
For
For
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172920
Device Name 3D APT
Indications for Use (Describe)
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging 3D APT K172920
3D APT
Section 005
510(k) Summary
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | September 30, 2017 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary ContactPerson: | Susan QuickRegulatory Affairs SpecialistPhone: (440) 483-2291E-mail: susan.quick@philips.com | |
| Secondary ContactPerson | Jan van de KerkhofSr Manager Regulatory AffairsPhone: +31 6 13300542E-mail: jan.van.de.kerkhof@philips.com | |
| Device Name: | Amide Proton Transfer weighted MRI (3D APT) | |
| Classification: | Classification name: | Magnetic Resonance Diagnosticdevice (MRDD) |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | LNH, LNI | |
| Primary Predicate Device: | Trade name: | Ingenia 1.5T, Ingenia 1.5T S andIngenia 3.0T R5.3 |
| Manufacturer: | Philips Medical SystemsNederland B.V. | |
| 510(k) Clearance: | K163116, January 6, 2017 | |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance DiagnosticDevice (MRDD) | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | LNH, LNI | |
| Product Code: | LNH, LNI | |
| Device Description: | 3D Amide Proton Transfer (3D APT) is an extension of off-resonance magnetization transfer imaging.3D APT images display a spatial distribution of amide protons. The RF-shimmed saturation is generated by alternating excitation from the 2 channels of the MultiTransmit system.3D APT images are obtained by subtracting the saturated image intensity at the 2 mirrored frequency offsets relative to the water frequency (±3.5 ppm). Parameters are optimized to null the difference signal for normal brain tissue. | |
| Indications for Use: | 3D Amide Proton Transfer weighted MRI (3D APT) is a software feature intended for use on Ingenia 3.0T (70cm) and Ingenia 3.0T CX (60cm) MR Systems. It's indicated for use in magnetic resonance imaging of the brain.Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE). | |
| Design Features andFundamental ScientificTechnology: | 3D Amide Proton Transfer (3D APT) is an MR imaging technology where saturation of the water signal using the magnetization transfer effect generates the contrast. Protons bound to macromolecules, specifically amide protons, exchange with the free water pool. Selective narrow-band excitation at the amide proton resonance frequency is used to detect signal differences exclusively associated with the amide protons. This is achieved by a controlled, frequency-selective RF irradiation to saturate protons resonating at +3.5 ppm (the amide proton resonance frequency), and comparing the resulting signal level to that observed when irradiating at -3.5 ppm.The feature consists of:Frequency selective saturation RF pulses (1-2 s duration), alternating between the two channels of the MultiTransmit RF system, at multiple offset frequencies 3D DIXON TSE readout Signal difference calculation between +3.5 ppm and -3.5 ppm to derive the APTw image B0 inhomogeneity correction embedded into the APTw calculation Color scale (rainbow) to display APTw signals between |
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| Substantial Equivalence | The proposed 3D Amide Proton Transfer (3D APT) issubstantially equivalent to the Magnetization Transferfunctionality (MTC and MTR) of the legally marketed primarypredicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia3.0T R5.3 (K163116, January 6, 2017) and has the sameprimary indications for use with respect to the following:• Software feature intended for use on the Ingenia 3.0T(70cm) and Ingenia 3.0T CX (60cm) MR Systems• Use in magnetic resonance imaging of the brain• Consists of an image acquisition and reconstructiontechnique with B0 correction and difference signaldetermination |
|---|---|
| Conclusion: | The proposed 3D Amide Proton Transfer (3D APT) issubstantially equivalent to the legally marketed primarypredicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia3.0T R5.3 (K163116, January 6, 2017) in terms of designfeatures, fundamental scientific technology, indications foruse, and safety and effectiveness. Additionally, substantialequivalence was demonstrated with non-clinical performance(verification and validation) tests, which complied with therequirements specified in the international and FDA-recognized consensus standards and device-specificguidance. The results of these tests demonstrate that theproposed 3D Amide Proton Transfer (3D APT) meets theacceptance criteria and is adequate for its intended use. |
§ 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.