AIR Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest being imaged, contrast agents may be used.

Device Description

AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images. AIR Recon DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AIR Recon DL:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the desired improvements and non-inferiority claims of the AIR Recon DL feature. The reported device performance demonstrates how these criteria were met.

Acceptance Criteria Category	Specific Criteria (Implicit from Claims)	Reported Device Performance (as stated in the document)
Image Quality - Noise Reduction	Equivalent or better Apparent Signal to Noise Ratio (SNR)	133 out of 133 cases showed equivalent or better apparent SNR.
Image Quality - Sharpness	Equivalent or better sharpness	133 out of 133 cases showed equivalent or better sharpness.
Image Quality - Lesion Conspicuity	Equivalent or better lesion conspicuity for pathological cases	123 out of 124 cases with pathology showed equivalent or better lesion conspicuity.
Impact on Quantitative Measurements	Does not adversely affect accuracy of quantitative measurements (e.g., contrast pharmacokinetics, lesion sizes, brain volumetry).	Strong agreement between measurements made using conventional and AIR Recon DL images.
Scan Time Reduction	Image quality maintained or improved even with reduced scan time.	For 22 image pairs with shorter scan times (AIR Recon DL) vs. longer scan times (conventional), AIR Recon DL images were rated as better or equivalent image quality in all cases.
Artifacts	Does not significantly change the appearance of motion artifacts.	Sample images show AIR Recon DL does not significantly change the appearance of motion artifacts.
Overall Radiologist Preference	Radiologists prefer AIR Recon DL images over conventional images.	Radiologists preferred AIR Recon DL images over conventional images in 99% of evaluations.
Non-clinical Performance (Phantoms)	Improved SNR, sharpness; maintained low contrast detectability; ADC maps not adversely impacted.	Nonclinical testing passed defined acceptance criteria; demonstrated improved SNR and sharpness, maintained low contrast detectability, and no adverse impact on ADC maps.

2. Sample Size and Data Provenance

Test Set Sample Size: 133 cases.
- 129 patient cases
- 4 healthy subjects
Data Provenance:
- Country of Origin: Not explicitly stated, but "10 different clinical sites" suggests a multi-center study, and "a GE Healthcare facility" could indicate a US or international site. Given the FDA submission, it's highly likely to include US data.
- Retrospective or Prospective: Not explicitly stated, but the description "images acquired across a variety of pulse sequences and anatomies" and involvement of "10 different clinical sites" could imply a retrospective collection for the reader study, where images were pre-collected. However, without explicit mention, it's not definitive. The phrasing "acquired from the same acquired raw data" suggests a paired comparison based on existing data.

3. Number of Experts and Qualifications

Number of Experts: Three radiologists.
Qualifications: "Radiologists" implies medical doctors specialized in radiology. No further specifics on years of experience or subspecialty were provided.

4. Adjudication Method for the Test Set

The adjudication method appears to be 2+1 (or 3/3 agreement is ideal, but 2 out of 3 for consensus is common).
"Each image pair was evaluated independently by three radiologists."
"The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of apparent signal to noise ratio (133 out of 133 cases), sharpness (133 out of 133 cases), and lesion conspicuity (123 out of 124 cases with pathology)."
"The radiologists reading the images also indicated a preference for the AIR Recon DL images over conventional images in 99% of the evaluations."
This indicates that the claims are based on the collective agreement or majority opinion of the three readers for each case. The exact decision rule (e.g., simple majority, unanimous) is not stated, but the high consistency (e.g., 133/133, 123/124) implies strong agreement or effective resolution.

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

Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was done.

Comparison: Radiologists compared AIR Recon DL images to conventional images (without AIR Recon DL) reconstructed from the same acquired raw data.
Effect Size of Human Reader Improvement: The study demonstrates a significant preference and improvement in perceived image quality attributes by human readers when using AIR Recon DL assisted images compared to conventional images.
- Preference: Radiologists preferred AIR Recon DL images over conventional images in 99% of evaluations. This indicates a strong positive effect on reader perception and diagnostic confidence.
- Qualitative Improvement:
  - Equivalent or better SNR in 100% of cases (133/133).
  - Equivalent or better sharpness in 100% of cases (133/133).
  - Equivalent or better lesion conspicuity in ~99.2% of pathological cases (123/124).
- Enablement of Shorter Scans: For shorter scan time acquisitions, AIR Recon DL images were rated as better or equivalent image quality in 100% of 22 image pairs, which suggests human readers are able to maintain or even improve their assessment quality despite reduced acquisition time. Overall, the effect size is very large and consistently positive across all measured subjective criteria.

6. Standalone (Algorithm Only) Performance

The document describes "nonclinical testing" on phantoms, which represents a form of standalone testing where the algorithm's output is directly measured against predefined physical criteria:

"AIR Recon DL has undergone phantom testing to evaluate the feature and its impact on image quality, including SNR, sharpness, and low contrast detectability."
"The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability."
"ADC maps were not adversely impacted by the use of AIR Recon DL."
This evaluates the algorithm's effect on image characteristics absent human interpretation of clinical cases.

7. Type of Ground Truth Used

The study primarily used expert consensus (radiologist agreement) as the ground truth for evaluating image quality attributes (SNR, sharpness, lesion conspicuity, overall preference) and the impact of the algorithm.
For the "presence of pathology" in the test set, it's assumed that this was either identified beforehand from clinical reports or pathology (e.g., biopsy results) or by consensus among the evaluating radiologists prior to their evaluation of the AI-enhanced images. However, the exact source of ground truth for pathology presence/absence isn't detailed, only that 124 cases "with pathology" and 9 cases "without pathology" were included.

8. Sample Size for the Training Set

9. How Ground Truth for Training Set was Established

The document states: "Both the proposed AIR Recon DL and the predicate device use neural networks that have similar architecture, and were trained using similar methods and data."
The method for establishing ground truth for the training set is NOT explicitly detailed. Typically, for deep learning reconstruction, the "ground truth" during training often refers to high-quality, fully sampled MR images (or images from a prior, high-quality reconstruction method) that the AI attempts to match or improve upon, rather than a clinical diagnosis per se. The goal during training would be to generate images that are less noisy and sharper while preserving underlying anatomical and pathological information, learned by comparing "corrupted" (e.g., undersampled, noisy) inputs to "clean" reference images.

Summary

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June 8, 2022

GE Medical Systems, LLC % Glen Sabin Regulatory Affairs Director 3200 N Grandview Blvd. Waukesha, Wisconsin 53188

Re: K213717

Trade/Device Name: AIR Recon DL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: Mav 9, 2022 Received: May 10, 2022

Dear Glen Sabin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213717

Device Name

AIR Recon DL

Indications for Use (Describe)

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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K213717

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	6 June 2022
Submitter:	GE Medical Systems, LLC3200 N. Grandview Blvd.Waukesha, WI 53188
Primary Contact:	Glen SabinRegulatory Affairs DirectorPhone: 262 894-4968Email: Glen.Sabin@GE.com
Secondary Contact:	Andrew MendenSenior Regulatory Affairs ManagerPhone: 262 308-5719Email: Andrew.Menden@GE.com
Device Trade Name:	AIR Recon DL
Common / Usual Name:	MR System
Classification Name:Regulation Number:Primary Product Code:	Magnetic Resonance Diagnostic Device21 CFR 892.1000LNH
Predicate Device:510(k) Number:Device Name:Manufacturer:	K193282SIGNA PremierGE Medical Systems, LLC
Reference Devices:510(k) Number:Device Name:Manufacturer:	K202238SIGNA ArtistGE Medical Systems, LLC

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Device Description:

This 510(k) submission has been triggered by a modification to AIR Recon DL to expand its compatible pulse sequences to include PROPELLER and 3D Cartesian acquisitions.

Indications for Use:

The Indications for Use statement for the proposed device is provided below:

AIR™ Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest beinq imaged, contrast agents may be used.

Comparison of Technological Characteristics:

The proposed AIR Recon DL software feature that is the subject of this 510(k) is similar to the feature of the same name included in the predicate SIGNA Premier, K193282. The predicate device used deep learning convolutional networks to remove noise and ringing from certain 2D Cartesian acquisitions. The proposed AIR Recon DL has been modified to be compatible with PROPELLER and selected 3D Cartesian acquisitions. Both the proposed AIR Recon DL and the predicate device use neural networks that have similar architecture, and were trained using similar methods and data.

The proposed AIR Recon DL is intended for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. The AIR Recon DL feature included in the predicate device was intended for use with only GE Healthcare 3.0T systems. However, the same alqorithm described in the predicate device (K193282) is also cleared for use in GE Healthcare 1.5T systems (SIGNA Artist - K202238), and 7.0T systems (SIGNA 7.0T - K211118).

Summary of Nonclinical Testing:

AIR Recon DL has undergone phantom testing to evaluate the feature and its impact on image quality, including SNR, sharpness, and low contrast detectability. For PROPELLER acquisitions, analysis was also performed to compare Apparent

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Diffusion Coefficient (ADC) maps calculated from images using AIR Recon DL to those calculated from conventional images.

The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability. AIR Recon DL was also able to maintain image SNR and did not sacrifice sharpness for images acquired with a reduced scan time. ADC maps were not adversely impacted by the use of AIR Recon DL. The nonclinical testing passed the defined acceptance criteria and did not identify any adverse impacts to image quality or other concerns related to safety and performance.

Summary of Clinical Testing:

A reader evaluation study was performed on images acquired across a variety of pulse sequences and anatomies. The study involved 133 cases as summarized below:

Source of data:

129 patient cases from 10 different clinical sites

4 cases from healthy subjects obtained at a GE Healthcare facility

Equipment used:

GE Healthcare 1.5T MR systems: 51 cases

GE Healthcare 3.0T MR systems: 82 cases

Protocols used:

3D acquisitions: 92 cases

PROPELLER acquisitions: 41 cases

Anatomical coverage:

Body (breast, abdomen, and pelvis): 42 cases

Cardiac: 10 cases

Neuro (head, neck, and spine): 57 cases

Musculoskeletal (shoulder, wrist, hip, knee, and ankle): 24 cases

Use of exogenous contrast:

With Contrast: 31 cases

Without Contrast: 102 cases

Presence of pathology:

With pathology: 124 cases

Without pathology: 9 cases

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Readers were asked to compare the AIR Recon DL images to conventional images (without AIR Recon DL) reconstructed from the same acquired raw data. Each image pair was evaluated independently by three radiologists. The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of apparent signal to noise ratio (133 out of 133 cases), sharpness (133 out of 133 cases), and lesion conspicuity (123 out of 124 cases with pathology). The radiologists reading the images also indicated a preference for the AIR Recon DL images over conventional images in 99% of the evaluations.

Evaluations were also made of AIR Recon DL images from shorter scan time acquisitions and images without AIR Recon DL taken with longer scan times. Despite the shorter scan times, the AIR Recon DL images were rated as better or equivalent image quality for all 22 image pairs.

Sample images involving the presence of motion and other common artifacts were evaluated both with and without the AIR Recon DL feature. The sample images show that AIR Recon DL does not significantly change the appearance of motion artifacts.

Additionally, images were evaluated to confirm that the use of AIR Recon DL does not adversely affect the accuracy of quantitative measurements such as contrast pharmacokinetics, lesion sizes, and brain volumetry results. The analysis showed strong agreement between measurements made using conventional and AIR Recon DL images.

Conclusions Drawn from Performance Testing:

The nonclinical and clinical testing demonstrated that AIR Recon DL satisfies the product claims of improved SNR and image sharpness, and can enable shorter scan times while preserving SNR and image sharpness.

The proposed AIR Recon DL software feature has been developed under GE Healthcare's quality system and is at least as safe and effective as the earlier version of AIR Recon DL in the legally marketed predicate device. The performance testing did not identify any new hazards, adverse effects, safety concerns, or performance concerns that are significantly different from those associated with MR imaging in general.

Therefore, GE Healthcare believes that AIR Recon DL is substantially equivalent to the predicate device and is safe and effective for its intended use.

Regulation Number and Section

§ 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.