SnapShot Freeze 2 (SSF 2) is a post processing software, which can be delivered on general purpose computing platforms. SnapShot Freeze 2 is an automated motion correction algorithm designed for use with gated cardiac acquisitions from GE CT scanners to reduce cardiac induced motion artifacts in the whole heart. It is based on the same fundamental algorithm as the predicate product commercially marketed under the name CardIQ Xpress 2.0 with SnapShot Freeze Option (K120910, AKA SSF 1). Same as its predicate device the SSF 2 algorithm works on multi-phase, gated cardiac CT DICOM compatible image data and produces a new image series in which motion artifact is reduced.

AI/ML Overview

The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a table. Instead, it describes internal validation and testing to support the product's substantial equivalence to a predicate device.

However, based on the information provided, here's an attempt to extract relevant details and structure them according to your request, with disclaimers that much of the quantitative information you're asking for (like specific acceptance criteria values and reported performance against them) is not present in the given document.

Device Name: SnapShot Freeze 2
Intended Use: Motion correction of gated cardiac image series.
Indications for Use: Designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.

Overview of Device Performance and Acceptance (as inferred from the document):

The document describes engineering bench testing and a clinical assessment to demonstrate that SnapShot Freeze 2 is "as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnapShot Freeze Option." The main improvement of SnapShot Freeze 2 is its ability to extend motion correction to the "whole heart" beyond just coronary vessels.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a clear table of predefined acceptance criteria with corresponding numerical performance results. However, it mentions qualitative performance improvements and claims of "effective temporal resolution" based on phantom testing.

Feature / Criterion (Inferred from text)	Acceptance Criteria (Not explicitly stated with thresholds)	Reported Device Performance (as stated or inferred)
Motion Correction (Coronary Vessels)	Expected to be equivalent to predicate.	"6x improvement in reducing blurring artifacts of the coronary arteries due to cardiac motion." (Inherited from predicate, reiterated for SSF2)
Motion Correction (Whole Heart)	Demonstrate ability to perform whole heart motion correction.	"Yes, enhancement to the algorithm demonstrates whole heart motion correction."
Effective Temporal Resolution	Maintain or improve upon predicate's resolution.	"29 ms for 0.35 sec/rot gantry speed." (Inherited from predicate)."24 ms for 0.28 sec/rot gantry." (New for SSF2 at faster gantry speed).
Diagnostic Capability of Motion Corrected Images	Images should demonstrate diagnostic utility.	"The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2." (Qualitative statement)
No New Risks/Hazards	Device should not introduce new risks.	"SnapShot Freeze 2 does not introduce any new risks/hazards, warnings, or limitations.""No new hazards were identified, and no unexpected test results were obtained."
Substantial Equivalence	Device must be substantially equivalent to predicate.	"GE Medical Systems believes that the SnapShot Freeze 2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnapShot Freeze Option."

2. Sample Size and Data Provenance for Test Set:

Sample Size for Clinical Assessment: A "representative clinical sample image set of 60 CT cardiac cases."
Data Provenance: The document states this data is "representative of routine clinical imaging from a cardiac acquisition perspective," but "intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases." It does not specify the country of origin, nor explicitly state if it was retrospective or prospective, but the phrasing "representative clinical sample image set" and "routine clinical imaging" suggests it was likely a retrospective collection of existing patient data.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

Number of Experts: Three board certified radiologists.
Qualifications: "Board certified radiologists." No further details on years of experience are provided.

4. Adjudication Method for the Test Set:

The document states, "A representative clinical sample image set of 60 CT cardiac cases... were assessed by three board certified radiologists using 5-point Likert scale."
It does not specify an adjudication method (e.g., 2+1, 3+1 consensus, or independent reading). It only states they "assessed" the cases.

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

No MRMC comparative effectiveness study demonstrating how human readers improve with AI vs. without AI assistance is explicitly described. The clinical assessment was to demonstrate the "diagnostic capability of the motion corrected images by SSF 2," not a direct comparison of human reader performance with and without the tool.

6. Standalone (Algorithm Only) Performance:

The document implies that the effective temporal resolution metrics (29 ms, 24 ms) derived from "mechanical and mathematical cardiac phantom testing" represent the standalone performance of the algorithm in terms of motion correction capability, independent of human interpretation.
The clinical assessment of "diagnostic capability" also evaluates the output of the algorithm, suggesting an evaluation of its quality for diagnostic purposes.

7. Type of Ground Truth Used for the Test Set:

The "ground truth" for the clinical assessment appears to be the expert consensus/assessment of the three board-certified radiologists using a 5-point Likert scale to determine the "diagnostic capability" of the motion-corrected images. No mention of pathology or outcomes data as direct ground truth for image quality/diagnostic utility is made for the 60 clinical cases.

8. Sample Size for the Training Set:

The document does not specify a sample size for the training set. It describes the algorithm's fundamental similarity to its predicate (SSF1) and states that SSF2 "extends the motion correction capability to the whole heart." This suggests the core algorithm was already established, and the "enhancement" for whole-heart motion correction might have involved further development or refinement without explicitly detailing a new, distinct "training set" in this submission summary.

9. How Ground Truth for Training Set was Established:

The document does not describe how the ground truth for any potential training set was established. Given that the algorithm is based on and an extension of a predicate device, it's plausible that the underlying algorithm was developed and validated earlier, and the current submission focuses on the safety and effectiveness of the extended capability.

Summary

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GE Medical Systems, LLC. % Ms. Laura Turner Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188

February 13, 2019

Re: K183161

Trade/Device Name: SnapShot Freeze 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: November 13, 2018 Received: November 15, 2018

Dear Ms. Turner:

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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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.

Michael D. O'Hara
For

Robert Ochs, Ph.D. 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)

K183161

Device Name SnapShot Freeze 2

Indications for Use (Describe)

SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2

510(k) Summary

SnapShot Freeze 2

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GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2

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510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):

Date:	2/4/2019	Laura Turner
Submitter:	GE Medical Systems, LLC3000 North Grandview BlvdWaukesha, WI 53188	Regulatory Affairs Leader
Primary Contact:	Laura Turner	Phone 262-548-4588
	Email: laura.turner@ge.com

Secondary Contacts:	Helen Peng
	Regulatory Affairs Director
	GE Healthcare
	Tel: 262-424-8222
	Email: hong.peng@meg.ge.com

PRODUCT IDENTIFICTION

Device Name:	SnapShot Freeze 2
Regulation number/Product Code	21 CFR 892.1750 Computed tomography x-ray system /JAK
Secondary Regulationnumber/Product Code	21 CFR 892.2050 Picture archiving and communications system/ LLZ
Device Classification	Class II

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Predicate Device Information :

Device Name	CardIQ Xpress 2.0 with SnopShot Freeze Option
Manufacturer	GE Medical System SCS (d.b.a GE Healthcare)
510(k) number	K120910 cleared on June 18, 2012
Regulation number/product Code	21 CFR 892.1750 Computed tomography x-ray system,JAK

Device Description

The device is marketed as SnapShot Freeze 2

Intended Use

SnapShot Freeze 2 is intended to be used for motion correction of gated cardiac image series

Indications for Use

SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.

Technological Characteristic

SSF 2 employs the same fundamentally technology as that of the predicate. The motion correction algorithm fundamentally remains the same, taking the multi-phase temporal enhanced cardiac gated DICOM series, applying motion correction and producing the dramatically motion reduced DICOM dataset. The difference is that the SSF2 extends the motion correction capability to the whole heart beyond the coronary vessels as offered in the predicate.

Comparisons

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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are swirling shapes around the letters. The logo is simple and recognizable, and it is associated with a large and well-known company.

The most notable change in SSF 2 as compared to SSF1 is the ability to extend motion correction capability to the whole heart compared with only coronary vessel motion artifact reduction. This may enable new applications in assessing other structures of the heart that are impacted by motion artifacts.

The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:

Specification/Attribute	Predicate DeviceCardIQ Xpress 2.0 with SnapShotFreeze Option (K120910)	Proposed DeviceSnapShot Freeze 2
Patient Population	Patients referred for a CTcardiovascular examination	Same
Contraindications	None	Same
Platforms	AW workstation, AW Server & CTConsole	AW workstation, AW Server, CTConsole & other platformsincluding cloud-based computingand image processing platforms
Input	3-phase temporal cardiac imageseries	Same
Output	Motion corrected target phaseimage series	Same
Motion Correctionof coronary vessels	Yes – SSF algorithm is capable ofcoronary vessel motion correction	Same
Whole heart motioncorrection	Not Available	Yes, enchantment to thealgorithm demonstrates wholeheart motion correction
Effective TemporalResolution*	6x improvement in reducingblurring artifacts of the coronaryarteries due to cardiac motion.Effective temporal resolution of29 ms for 0.35 sec/rot gantryspeed.	6x improvement in reducingblurring artifacts of the coronaryarteries due to cardiac motion.Effective temporal resolution of29 ms for 0.35 sec/rot gantryspeed.Effective temporal resolution of24 ms for 0.28sec/rot gantry.

*As demonstrated in mechanical and mathematical cardiac phantom testing.

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SnapShot Freeze 2 does not introduce any new risks/hazards, warnings, or limitations.

Determination of Substantial Equivalence

Engineering bench testing was performed to support substantial equivalence and the product performance claims. The testing used a commercially available cardiac motion phantom with linear motion of variable velocity for modeling of the coronary vessels and the whole heart. The testing also used a mathematical phantom to demonstrate effective temporal resolution, coronary motion and whole heart motion correction. The combination of both analyses (from physical and mathematical motion phantoms) is intended to provide further confidence in the capabilities and full extent of the Snapshot Freeze 2 whole heart motion correction.

A representative clinical sample image set of 60 CT cardiac cases, focused on patient populations with elevated heart rate were assessed by three board certified radiologists using 5point Likert scale. This data is representative of routine clinical imaging from a cardiac acquisition perspective, but intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases, in which such an algorithm is most likely to be utilized. The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2.

SnapShot Freeze 2 has successfully completed the required design control testing per GE's quality system. No new hazards were identified, and no unexpected test results were obtained. SnapShot Freeze 2 was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the system:

Risk Analysis
Required Reviews
Design Reviews
Software Development Lifecycle
Testing on unit level (Module verification)
. Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation)

The testing and results did not raise different questions of safety and effectiveness than associated with predicate device using device-based respiratory gating.

The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Conclusion:

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Based on the conformance to standards, development under our quality system, and the engineering and clinical testing provided, GE Medical Systems believes that the SnapShot Freeze 2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnopShot Freeze Option.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.