The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.

Device Description

The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration).

The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Analogic CT6485 and CT12885 Computed Tomography (CT) systems. It details the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not specify explicit "acceptance criteria" in a numerical or target performance metric for image quality. Instead, it refers to fulfilling requirements of various consensus standards and demonstrating performance comparable to predicate devices. The reported device performance is described qualitatively as meeting these standards and the images being of diagnostic quality.

Acceptance Criteria (Implicit)	Reported Device Performance
Non-clinical Performance:
Fulfill requirements of FDA consensus standards (21CFR §1020.30, §1020.33)	CTXX85 scanners "fulfilled the requirements" of the listed standards (e.g., IEC61223-2-6, IEC61223-3-5, IEC 60601-2-44, NEMA PS 3.1 - 3.20, IEC 60601-1-3, NEMA XR 25, NEMA XR 28, IEEE Std. 3333.2.1, IEC 62366, IEC 60825).
Image Quality: Assess MTF, low contrast detectability, noise, CT number accuracy, uniformity,	"Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body. ... The results of these tests demonstrate that the proposed device performs as intended."
Image Quality: Evaluate iterative reconstruction algorithm performance	"Testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm. The results of these tests demonstrate that the proposed device performs as intended."
Biocompatibility: Patient-contacting accessories comply with standard requirements	"The patient contacting accessories comply with the biocompatibility standard requirements."
Electrical Safety & EMC: Compliance with standards	"Electrical safety testing is compliant with the following standards: AAMI/ANSI/ES 60601-1, IEC 60601-1-2."
Software Verification & Validation: Compliance with FDA guidance and EN IEC 62304	"Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance... The CTXX85 CT Scanner complies with EN IEC 62304 Medical Device Software Life-Cycle Processes."
Clinical Performance:
Diagnostic quality of reconstructed images (FBP and LISA)	"Sample clinical images... were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality."
Demonstrate substantial equivalence to predicate devices (Siemens Somatom Definition AS and Somatom Definition Edge)	"The performance results of scanning and image reconstruction is comparable as demonstrated in verification and validation testing... The result of all conducted testing was found acceptable to support the claim of substantial equivalence." and "The proposed CTXX85 CT Scanners are substantially equivalent to the predicate Siemens Somatom Definition AS and Somatom Definition Edge CT Scanners."

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 document mentions "sample clinical images of the brain, chest, abdomen and extremity," but does not specify the exact number of images or cases used in the clinical evaluation.
Data Provenance: Not specified. It's unclear if the clinical images were retrospective or prospective, or their country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: "a board-certified radiologist" (singular).
Qualifications of Experts: "board-certified radiologist." No further details on years of experience or subspecialty.

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

Adjudication Method: None specified. The text only states that a single board-certified radiologist evaluated the images.

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: No, an MRMC comparative effectiveness study was not performed. The study description focuses on confirming diagnostic quality by a single reader and benchmarking against physical phantom measurements.
Effect Size: Not applicable, as no MRMC study was conducted.

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

Standalone Performance: The non-clinical performance testing on phantom models directly assesses the algorithm's performance without human interpretation (e.g., MTF, low contrast detectability, noise, CT number accuracy). This can be considered a form of standalone performance evaluation for image quality metrics.
- "Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body."
- "Testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm."

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

Non-clinical (Image Quality): The ground truth for image quality metrics (MTF, noise, etc.) is established by the physical properties of the phantom models and expected system performance based on established engineering principles and physics.
Clinical (Diagnostic Quality): For the clinical images, the ground truth was expert opinion/assessment by "a board-certified radiologist" confirming "diagnostic quality." This is a subjective assessment rather than a definitive ground truth like pathology.

8. The sample size for the training set

Training Set Sample Size: Not specified. The document does not mention the training of the LISA algorithm or any other components, nor does it provide a sample size for a training set. The focus is on the performance of the device as a whole.

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

Training Set Ground Truth: Not specified. Since the training set sample size and details of the training itself are not provided, how its ground truth was established is also not mentioned.

Summary

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February 13, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Analogic Corporation % Ms. Karen Provencher Sr. Regulatory Affairs Specialist 8 Centennial Drive PEABODY MA 01960

Re: K172058

Trade/Device Name: CT6485, CT12885 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 29, 2018 Received: January 30, 2018

Dear Ms. Provencher:

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

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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,

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) K172058

Device Name CT6485, CT12885

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image contains the logo for Analogic. The logo features the word "analogic" in a blue sans-serif font, with the "a" in lowercase. Above and to the right of the word is a blue sphere with a white sine wave running through it. Below the word "analogic" is the tagline "Innovative Solutions for Life" in a smaller blue font.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

l. Submitter: Analogic Corporation 8 Centennial Drive Peabody, MA 01960
Tel: (978) 326-4668 Fax: (978) 977-6808 Contact: Karen Provencher Sr. Regulatory Affairs Specialist E-mail: kprovencher@analogic.com

Date Prepared: January 29, 2018

ll. Device Names / Common Names / Classification Names:

Trade Name: CT6485, CT12885 Common Name: Computed Tomography (CT) Scanner Classification Name: Computed Tomography X-Ray System Product Code: JAK Class: 11 Regulation Number: 21 CFR §892.1750 Classification Panel: Radiology

III. Identification of Predicate or Legally Marketed Devices:

The predicate devices are Class II per 21 CFR §892.1750, with product code JAK: Siemens Somatom Definition AS - K103127 (03/04/2011) Siemens Somatom Definition Edge - K120579 (05/23/2012)

IV. Device Description:

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The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

V. Indications / Intended Use:

VI. Comparison of Technological Characteristics with the Predicate Device:

Summary of Similarities

The indication for use and intended use of the proposed CTXX85 CT Scanners are equivalent to the predicate device scanners Siemens Somatom Definition AS and Somatom Definition Edge.

The overall system technology and principles of operation are equivalent.

The performance results of scanning and image reconstruction is comparable as demonstrated in verification and validation testing.

The following list of features are available in all proposed and predicate systems: radiation dose control, in room start, remote gantry tilt, rear gantry keypads, adaptive filtration for noise reduction, spiral scanning, artifact reduction algorithms, slice doubling, DICOM, MPR (multi-planar reconstruction), MIP/MinIP (maximum/minimum intensity projection), 3D shaded surface display, 3D volume rendering, bolus trigger, iterative

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reconstruction, Cardiac Imaging with Gated ECG Monitor and CT Angiography.

Summary of Differences

The differences between the proposed CTXX85 CT Systems and the predicate devices are in the design of the subsystems. The resulting effect of these differences do not impact the performance or image quality as demonstrated in verification and validation testing. The differences in design are summarized below:

. Gantry Design – The proposed and predicate devices have gantry designs with an x-ray tube fixed opposite from the detector that rotates around the patient. The difference between the proposed systems and the predicate device is in the operation of the electromechanical components that allow the transfer of power and data from the stationary to rotating structure.
Gantry & Table Design The overall dimensions, weight and . gantry aperture are different in the proposed devices.
. Method for slice doubling – the proposed CTXX85 CT Scanners use a reconstruction software approach while the predicate device uses X-ray tube focal spot deflection to produce a similar effect.
X-Ray Tube the methods for heat dissipation are different. ●

VII. Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Test/Performance Testing - Bench:

Bench testing was performed and the CTXX85 scanners fulfilled the requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33 which are applicable to Computed Tomography X-Ray Systems, 21 CFR 8892.1750:

IEC61223-2-6 - Evaluation & Routine Testing in Medical Imaging Departments - Part 2-6: Constancy Tests - Imaging Performance of Computed Tomography X-Ray Equipment

IEC61223-3-5 - Medical Electrical Equipment - Part 2-44: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography

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IEC 60601-2-44 - Medical Electrical Equipment - Part 2-44: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography

NEMA PS 3.1 - 3.20 - Digital Imaging & Communications in Medicine (DICOM) Set

IEC 60601-1-3 - Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance -Collateral Standard Radiation Protection in Diagnostic X-Ray Equipment

NEMA XR 25 - Computed Tomography Dose Check

NEMA XR 28 - Supplemental Requirements for User Information and System Function Related to Dose in CT

IEEE Std. 3333.2.1 - IEEE Recommended Practice for Three Dimensional Medical Modeling

IEC 62366 - Consolidated version medical devices - application of usability engineering to medical devices

IEC 60825 - Safety of laser products - Part 1: Equipment classification and requirements

Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body.

Testing to the above-mentioned standards were performed on the proposed CTXX85 devices. Additionally, testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm. The results of these tests demonstrate that the proposed device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

Biocompatibility:

The main CTXX85 units are not patient contacting. However, there are several system accessories (patient table CT slicker cushion, head holder, wedge knee pad, table top and patient restraints) which are patient contacting and categorized per Section 5.2 and Table A1 of AAMI/ANSI/ISO 10993-1 as Surface Contact: Skin, Duration: Limited <24hr. The patient contacting accessories comply with the biocompatibility standard requirements.

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Sterilization:

There are no sterilization requirements associated with the CTXX85 CT Scanners.

Electrical Safety & Electromagnetic Compatibility (EMC):

Electrical safety testing is compliant with the following standards:

AAMI/ANSI/ES 60601-1: Medical electrical equipment Part . 1: General requirements for basic safety and essential performance
. IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. The CTXX85 CT Scanner complies with EN IEC 62304 Medical Device Software Life-Cycle Processes. The submission contains performance data which demonstrates conformance to special controls for medical devices containing software.

Animal Testing:

Not applicable – animal testing was not required to support substantial equivalence to the predicate device.

Clinical Studies:

Sample clinical images of the brain, chest, abdomen and extremity, reconstructed via FBP and LISA with different strengths were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality.

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VIII. Conclusion:

The proposed CTXX85 CT Scanners are substantially equivalent to the predicate Siemens Somatom Definition AS and Somatom Definition Edge CT Scanners (K103127 and K120579). The differences between the proposed and predicate devices do not impact the safety and effectiveness of the proposed device. Performance testing presented in the submission supports that the proposed device is substantially equivalent to the legally marketed predicate devices.

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.