SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid.

Device Description

The SmartGrid software is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid. SmartGrid encapsulates an algorithm for estimating and removing scatter from radiographic images. The SmartGrid feature is accessible through DirectView DR Product application software. Users will be able to select SmartGrid processing before an image is acquired, or to change whether SmartGrid processing is applied to a previously acquired image.

AI/ML Overview

The provided text describes the SmartGrid software, which aims to reduce visible x-ray scatter in diagnostic radiographic images. The acceptance criteria and the study proving the device meets these criteria can be extracted from the "Discussion of Testing" section.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The text doesn't explicitly list acceptance criteria in a quantitative table format. Instead, it describes the findings of the study related to image quality. We can infer the acceptance criteria from these reported outcomes.

Acceptance Criterion (Inferred from Study Results)	Reported Device Performance (SmartGrid)
Production of diagnostic quality images.	"SmartGrid processing software produces diagnostic quality images."
Image quality compared to non-grid reference images (at all exposure levels).	"At all exposure levels, SmartGrid processing produced images rated as good as or better than the non-grid reference images."
Diagnostic quality compared to grid reference acquisitions at lower exposures.	"SmartGrid processing software produces images with statistically equivalent diagnostic quality at lower exposures than the grid reference acquisitions."
Image quality after Scatter Factor Estimation and Scatter Correction.	Both SmartGrid and the predicate device "depend on the proper estimation of the scatter-to-primary ratio (SPR) to calculate scatter distribution and perform image enhancement." SmartGrid's performance was found to be substantially equivalent.
Effectiveness of noise suppression.	Both SmartGrid and the predicate device "suppress noise." SmartGrid's performance was found to be substantially equivalent.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The text states that "images of cadaveric specimens and phantoms were acquired and used in the study." It does not specify the exact number of images or cases in the test set.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but the acquisition of "images of cadaveric specimens and phantoms" for the study suggests a prospective acquisition for the purpose of the study, rather than leveraging pre-existing clinical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: The study was conducted as a "radiologist reader study," implying multiple radiologists. The exact number is not specified.
Qualifications of Experts: The individuals are referred to as "Radiologists." Specific experience levels or board certifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The text states that "Radiologists reviewed and rated investigational and reference images (both grid and non-grid), for diagnostic quality, using a Radlex subjective diagnostic rating scale." It does not describe any specific adjudication method (e.g., majority vote, consensus after discussion, or a senior radiologist as tie-breaker) if there were disagreements among readers.

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

MRMC Study: Yes, a "radiologist reader study" was performed, comparing SmartGrid processed images against grid and non-grid reference images. This inherently involves multiple readers (radiologists) reviewing multiple cases (images).
Effect Size of Human Reader Improvement: The study focused on the diagnostic quality of the images produced by SmartGrid, rather than the improvement of human readers with AI assistance.
- It reports that SmartGrid images were rated "as good as or better than the non-grid reference images."
- And "statistically equivalent diagnostic quality at lower exposures than the grid reference acquisitions."
  The study does not quantify how much human readers "improved" in their diagnostic performance when assisted by SmartGrid compared to not using SmartGrid. Instead, it validates the image quality produced by the software.

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

No, the primary study described is a "radiologist reader study," which by definition involves human readers evaluating the images processed by the algorithm. There is no mention of a standalone algorithm performance evaluation without human input in the document.

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

The ground truth was established by expert subjective ratings using a "Radlex subjective diagnostic rating scale." This is a form of expert consensus on image quality rather than an objective clinical truth like pathology or patient outcomes. The text explicitly states that the images were rated for "diagnostic quality."

8. The sample size for the training set

The provided text does not mention the sample size for the training set used to develop the SmartGrid algorithm. The "Discussion of Testing" solely focuses on the performance evaluation study.

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

The provided text does not mention how the ground truth for the training set was established, as it does not discuss the training phase of the algorithm development.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2017

Carestream Health, Inc. % Ms. Diane C. Koetter Sr. Manager, Regulatory Affairs and Quality Systems 150 Verona Street ROCHESTER NY 14608

Re: K163157

Trade/Device Name: SmartGrid Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 13, 2017 Received: March 15, 2017

Dear Ms. Koetter:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'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) K163157

Device Name SmartGrid

Indications for Use (Describe)

"SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid."

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Carestream

"510(k) Summary"

510(k) Owner Name:	Carestream Health, Inc.
510(k) Owner Address:	150 Verona StreetRochester, New York 14608
510(k) Owner Phone:	585-627-6505
510(k) Owner Fax:	585-627-8802
Contact Person & Info:	Diane KoetterSr. Manager, Regulatory Affairs and QualitySystemsdiane.koetter@carestream.com585-627-6505
Date Summary Prepared:	November 8, 2016
Device Trade Name:	SmartGrid
Device Common Name:	Flat Panel Digital Detector System
Classification Name:	Stationary x-ray system
Device Class:	Class II
Device Code:	MQB
Regulation Number:	21 CFR 892.1680
Predicate Device:	FDR D-EVO Flat Panel Detector System (DR-ID600)Manufactured by FujiFilm Medical Systems USA,Inc.510(k) No. – K141765 (October 3, 2014)

Device Description:

The SmartGrid feature is accessible through DirectView DR Product application software. Users will be able to select SmartGrid processing before an image is

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acquired, or to change whether SmartGrid processing is applied to a previously acquired image.

Indications for Use / Intended Use:

The Indications for Use for the SmartGrid Software is:

"SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an antiscatter grid."

Comparison of Technological Characteristics:

SmartGrid Software has the same technological characteristics as the predicate device, FDR D-EVO Flat Panel Detector System (DR-ID600). Both are optional software components that allow for reduction in visible x-ray scatter in radiograph images.

Discussion of Testing:

The performance characteristics and operation of SmartGrid (investigational) were evaluated in a radiologist reader study. It was not possible to obtain the predicate device images. Therefore, images of cadaveric specimens and phantoms were acquired and used in the study.

The SmartGrid software performance was compared against two reference systems. In one reference system, images were acquired with grids at 400 speed exposure (grid reference) and processed with the Carestream DirectView V5.7 software (K060137). In the second reference system, images were acquired without grids at 400 speed exposure (non-grid reference) and processed with the same DirectView V5.7 software.

Radiologists reviewed and rated investigational and reference images (both grid and nongrid), for diagnostic quality, using a Radlex subjective diagnostic rating scale. The results demonstrate:

SmartGrid processing software produces diagnostic quality images.
. At all exposure levels, SmartGrid processing produced images rated as good as or better than the non-grid reference images.
SmartGrid processing software produces images with statistically equivalent . diagnostic quality at lower exposures than the grid reference acquisitions.

Substantial Equivalence:

The proposed predicate device, FDR D-EVO Flat Panel Detector System (DR-ID600), has been found substantially equivalent by FDA through the 510(k) process (K141765) and is legally marketed. Its Indications for Use, though not

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identical to the SmartGrid, convey similar information about the intended use of the device and can therefore be considered for substantial equivalence.

Both devices utilize:

Scatter Factor Estimation
Scatter Correction
Noise Reduction and Image Rendering

Both devices depend on the proper estimation of the scatter-to-primary ratio (SPR) to calculate scatter distribution and perform image enhancement. In both applications, the user can adjust SPR if desired.

Both devices suppress noise.

The predicate device differs from the investigation device in the methods for scatter estimation, scatter distribution and noise control.

The differences between SmartGrid and the predicate device do not affect the intended use of the device or alter the fundamental scientific technology of the device. Performance testing and clinical results support a substantial equivalence determination of the SmartGrid to the FDR D-EVO Flat Panel Detector System (DR-ID600).

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.