The NLS128 [NExCT 7] system is intended to be used for x-ray computed tomography applications that produce cross sectional images for anatomy that can be imaged in the system aperture. The NExCT 7 is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age.

Device Description

The NExCT 7 system is essentially a higher slice, higher speed, stationary version of our predicate NL4000 BodyTom CT system. It has comparable detector coverage (80 mm), speed (0.25s) and features as the Toshiba Aquilion ONE Vision. It is a high resolution, 128 row, 78 cm aperture, 50cm field of view, Computed Tomography System. The stationary gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and patient table with stepper drive translation system. The Power Distribution Unit is a UL listed device. The display/control console consists of a commercial off the shelf (COTS) computer and monitor. The system control software is a modification to the BodyTom software. The system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. In addition the system complies with the Medical Imaging Technology Alliance (MITA) Smart Dose standard to optimize and manage radiation dose delivery. This includes radiation protection measures such as the MITA Dose Check Standard and the MITA Access Control Standard.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to fully answer all parts of your request regarding acceptance criteria and performance studies. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, functionality, and technology, rather than presenting a comprehensive clinical or standalone performance study of the NExCT 7.

Here's what can be extracted and what cannot:

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

The document mentions that "Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA."

However, it does not provide specific numerical acceptance criteria for these metrics nor the reported performance values for the NExCT 7. It only states that these tests were conducted and that the system "performs as well in its intended use as devices currently on the market."

Acceptance Criteria (e.g., max noise, min resolution)	Reported Device Performance
Not specified in the document	Not specified in the document

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

The document refers to "phantom image quality tests." This implies that the test set consisted of phantoms, not human patient data. Therefore, questions about country of origin and retrospective/prospective data are not applicable. The sample size for the test set (number of phantoms or scans performed) is not specified.

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)

For phantom studies, ground truth is typically established by physical measurements and the known properties of the phantom, not by expert human readers. Therefore, the number and qualifications of experts for ground truth establishment are not applicable to this type of study as described.

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

Since ghost data, the adjudication method is not applicable.

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

The document does not mention any MRMC comparative effectiveness study involving human readers or AI assistance. The study described is a technical phantom study to evaluate image quality. Therefore, this information is not provided.

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

The document describes "phantom image quality tests" which suggests a standalone technical performance evaluation of the CT system itself (the NExCT 7). These tests are typically conducted without human interpretation as part of the primary measurement, focusing on intrinsic image quality metrics. However, it's not an "algorithm" in the sense of an AI algorithm, but rather the imaging system's performance. So, a standalone technical performance study was done for the imaging device, but not specifically for a separate AI algorithm within it.

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

For the phantom studies, the ground truth would be based on the objective physical properties and known characteristics of the phantoms used for image quality assessment (e.g., a phantom designed to have a certain density, or containing objects of known size and contrast).

8. The sample size for the training set

This document describes a CT system (hardware). It is not an AI software algorithm that typically requires a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As there is no training set mentioned for this hardware device, this question is not applicable.

In summary:

This 510(k) summary primarily addresses the substantial equivalence of a new CT imaging system (NExCT 7) to existing predicate devices based on technical specifications and phantom image quality tests. It does not delve into clinical performance studies with human subjects, AI performance, or detailed acceptance criteria with specific numerical performance metrics. The evidence presented focuses on demonstrating that the device meets general safety standards and produces image quality comparable to predicate devices through technical evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.

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

December 23, 2014

NeuroLogica Corporation A Subsidiary of Samsung Electronics Co., Ltd % Ninad Gujar Regulatory Affairs Manager 14 Electronics Avenue Danvers, Massachusetts, 01923, USA

Re: K142697

Trade/Device Name: NExCT 7 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 19, 2014 Received: September 22, 2014

Dear Ninad Gujar,

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 devicerelated 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/ResourcesforYou/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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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)

K142697

Device Name NExCT 7

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY For NeuroLogica Corporation A Subsidiary of Samsung Electronics Co., Ltd NLS128 [NExCT 7] Computed Tomography System

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

(1) Submitter: NeuroLogica Corporation A Subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers, MA 01923

Establishment Registration number: FDA #3004938766

Primary Contact: Mr. Ninad Gujar Regulatory Affairs Manager Telephone: 978-564-8503 Fax: 978-564-8677 E-mail: ngujar@neurologica.com
Secondary Contact: Mr. Donald Fickett Vice President of Regulatory Affairs and Quality Systems Telephone: 978-564-8523 Fax: 978-564-8677 E-mail: dfickett@neurologica.com

Date this summary was prepared: September 19, 2014

(2) Device Name:

Trade Name	: NEXCT 7
Device Model	: NLS128
Classification Name	: Computed Tomography X-ray System
Product code	: JAK
Device classification	: Class II (per 21 CFR § 892.1750)

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(3) Predicate device(s):

The legally marketed devices to which substantial equivalencies are being claimed are as follows:

NeuroLogica Corp., NL4000 BodyTom® Computed Tomography System. . This predicate device was cleared under premarket Notification K102677. This is the predicate used for the bulk of comparison of design and labeling.
Toshiba America Medical Systems, Inc., Aquilion ONE Vision, TSX-. 301C/1, v4.90. This predicate device was cleared under premarket Notification K122109. This predicate is being used for comparison of detector coverage and rotational speed characteristics.

Both the predicate devices have the same intended use as the new device but different technological characteristics. NeuroLogica NL4000 BodyTom (K102677) is the primary predicate device.

Device Description: (4)

(ട) Intended Use:

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(6) Comparison of Technological Characteristics with the predicate device:

NeuroLogica Corporation believes that the NExCT 7 system, for its intended use, is of comparable type in design, material, functionality, technology and is substantially equivalent to the following cleared predicate devices: NeuroLogica BodyTom ref: K102677 and Toshiba America Medical Systems Aquilion ONE Vision, ref: K122109.

Similarities

Material: The NExCT 7 uses similar material to the above listed . scanners such as solid state detectors, x-ray generator, slip ring, data acquisition ICs, rotational bearing, and motion control systems.
Design: The NExCT 7 is similar in general design principle to both the above listed CT systems. Specifically, it shares most of the control system designs and features of the NeuroLogica BodyTom and has the rotational speed (0.25s) and detector coverage (80 mm) comparable to the Toshiba Aquilion ONE Vision.

Differences

■ Mobile vs. Stationary

The difference between NExCT 7 and the primary predicate BodyTom is that the BodyTom is a mobile scanner and the proposed is a stationary scanner. Mobile scanners require battery power, cannot tilt, and do not have translating patient tables. But these differences are covered by the similarities to the Aquilion scanner which is stationary, with tilt, with translating patient table, and wall power.

. Detector Coverage

The proposed scanner has 80mm of detector coverage, which is more coverage than the BodyTom predicate (40mm), but less than the Aquilion predicate (160mm).

■ Gantry Rotational Speed

The maximum rotational speed of the proposed NExCT 7 system (0.25sec) is only marginally faster than the Aquilion predicate (0.275sec). This does not affect the overall safety and effectiveness as the proposed scanner complies and passed all of the referenced IEC mechanical safety tests.

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(7) General Safety and Effectiveness Concerns:

All components of the NExCT 7 system that are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR §1020.30 and §1020.33 are certified to meet those requirements. An initial report as per 21 CFR §1002.10 will be filed with the Center for Device and Radiological Health (CDRH). To minimize electrical, mechanical and radiation hazards, NeuroLogica adheres to recognized and established industry practices.

NExCT 7 system is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485 requirements. The device is in conformance with the applicable parts of the following FDA Recognized Consensus Standards:

AAMI/ANSI ES60601-1, (IEC 60601-1), Medical Electrical Equipment -■ Part 1: General Requirements for Safety; Amd. C1: 2009, Amd. 2: 2010 (3"d Ed.)
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility. Requirements and Test (30 Ed.)
. 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 (Ed. 2.1)
IEC 60601-2-28, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (2nd Ed.)
. IEC 60601-2-44, Medical Electrical Equipment- Part 2-44: Particular Requirements for Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography (3rd Ed.)
IEC 60825-1, Safety of Laser Products – Part 1: Equipment Classification and Requirements (2nd Ed.)
. NEMA XR 25 (2010) Computed Tomography Dose Check
ISO 14971:2007. Medical devices - Application of risk management to medical devices
IEC 61223-2-6, Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment (2nd Ed.)

In addition, the risk management analysis identified potential hazards which were controlled and mitigated during development of NExCT 7. The verification/ validation testing ensured the safety and effectiveness of NExCT 7. Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA.

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8) Conclusion

Based upon the above considerations, NeuroLogica Corporation, subsidiary of Samsung Electronics Corporation, believes that the NExCT 7 Computed Tomography System is of comparable type in design, material, functionality, technology and is, for its intended use, substantially equivalent to the following cleared predicate devices: NeuroLogica BodyTom CT (K102677) and Toshiba Aquilion ONE Vision, TSX-301C/1, v4.90 (K122109).

Use of the NExCT 7 Computed Tomography System does not result in any new potential safety risks. The equipment performs as well in its intended use as devices currently on the market.

Regulation Number and Section

N/A