The ECLOS Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.

Device Description

The ECLOS is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The ECLOS system consists of a gantry, operator's workstation, patient table, highfrequency x-ray generator, and accessories.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the KD 71806 ECLOS Computed Tomography system, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Physical Characteristics	System consists of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories.	The ECLOS system consists of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories. (Stated as similar to predicate device).
Performance Metrics	Equivalent or similar performance to predicate device (Hitachi PRESTO CT, K040902) across various imaging parameters.	"The evaluation results of the ECLOS were comparable to the predicate device and support our conclusion that the ECLOS CT system is substantially equivalent."
	Specific non-clinical evaluations as stipulated in 21 CFR 1020.33(c), including: dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index.	The ECLOS and predicate device were subjected to "the same non-clinical evaluations as stipulated in 21 CFR 1020.33(c). Evaluations include: dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index."
Technological Equivalence	Acquire data in the same manner as the predicate device.	The ECLOS CT system acquires data in the same manner as the predicate device.
	Operation of the system virtually identical to the predicate.	The operation of the system is virtually identical to the predicate because both systems were produced using the same essential design concepts. The ECLOS operating system software is essentially the same, as well as the user interface.
Safety and Effectiveness	System is safe and effective for the indicated use.	"Testing has proven that the system is safe and effective for the indicated use."
	No new safety issues compared to the predicate device.	"Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate device."

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify a test set sample size in terms of patient images or specific test cases.
- The evaluations were "non-clinical evaluations," suggesting the use of phantoms or laboratory-based testing rather than clinical patient data.
- Data Provenance: Not explicitly stated as retrospective or prospective, but the focus on non-clinical evaluations suggests a controlled laboratory environment rather than a clinical trial. The country of origin is not specified, but the applicant is Hitachi Medical Systems America, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the use of human experts to establish ground truth for image data. The evaluations were non-clinical, focusing on objective performance metrics of the hardware and software without human interpretation as the primary endpoint.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None reported. The evaluation relies on direct measurement and comparison of physical and technical performance parameters against a predicate device and regulatory standards (21 CFR 1020.33(c)) rather than subjective expert adjudication.
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:
- No MRMC comparative effectiveness study was done. This device is a foundational CT imaging system, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The entire evaluation is inherently "standalone" in the sense that it assesses the intrinsic physical and technical performance of the CT system itself (e.g., dose profile, image noise, MTF) without a human-in-the-loop diagnostic task being the primary endpoint. The device's output is intended to "provide an aid to diagnosis when used by a qualified physician," but the performance metrics are about the image quality and physical properties of the system, not the diagnostic accuracy of an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by objective physical measurements and engineering specifications as defined in regulatory standards (21 CFR 1020.33(c)). Parameters like dose profile, image noise, MTF, slice thickness, etc., are measured directly from the system's output or test phantoms, not from clinical pathology or expert consensus on patient images.
The sample size for the training set:
- Not applicable / Not specified. This device is a CT scanner, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Its design and validation rely on engineering principles, physics, and comparison to a predicate device, rather than learning from a large dataset.
How the ground truth for the training set was established:
- Not applicable. As the device does not use a training set for machine learning, there is no ground truth established in this manner. The "ground truth" for its development and validation would be adherence to scientific and engineering principles, and performance matching established physical standards and predicate device characteristics.

Summary

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KD 71806

AUG 2 8 2007

Submitter Information

SUBMITTER:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (330) 425-1410
CONTACT:	Douglas J. Thistlethwaite
DATE:	06/19/2007

Device Name

CLASSIFICATION NAME:	Computed tomography x-ray system
CLASSIFICATION NUMBER:	Sec. 892.1750
TRADE/PROPRIETARY NAME:	ECLOS
PREDICATE DEVICE(S):	Hitachi PRESTO CT, 510(k) K040902

Device Intended Use

The ECLOS Computed Tomography system is an x-ray imaging device that produces cross-sectional image of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.

Device Description

Function

The ECLOS is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.

Scientific Concepts

The ECLOS system uses "third generation" CT technology, where the x-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The x-ray sub-system features a high frequency generator, x-ray tube, and collimation system that produces a fan beam x-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the x-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a computer workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

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Physical and Performance Characteristics

The ECLOS system consists of a gantry, operator's workstation, patient table, highfrequency x-ray generator, and accessories. The system performance is similar to the predicate device.

Performance Comparison

Because the ECLOS and the predicate device are both Hitachi designs, they were subjected to the same non-clinical evaluations as stipulated in 21 CFR 1020.33(c). Evaluations include: dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index.

The evaluation results of the ECLOS were comparable to the predicate device and support our conclusion that the ECLOS CT system is substantially equivalent.

Device Technological Characteristics

The ECLOS CT system acquires data in the same manner as the predicate device. Physically, the ECLOS is very similar to the predicate device. The key differences are the ability to collect 16 slices in a single scan as well as improvements in overall technology.

The ability to collect 16 slices in a single scan allows overall scan time to be decreased but does not change the essential characteristics of the finished images. The predicate is a 4 slice design, meaning that if an area of 32 mm is to be examined in 2 mm increments, the x-ray tube must scan the patient 4 times, collecting 2 mm of data for each scan, to produce 16 total images. In the ECLOS's 16 slice design, the system need only to scan 2 times, collecting 32 mm of data. The x-ray beam is collimated to allow the exposure of 16 slices simultaneously, and the data collection system collects all 16 slices. Since the data collection system processes the data in 2 mm increments, the system produces 16 images as before, but during a shorter time.

The operation of the system is virtually identical to the predicate because both systems were produced using the same essential design concepts. The ECLOS operating system software is essentially the same, as well as the user interface. The patient table design is the same, with the exception that the weight limit was increased somewhat. Gantry controls provide the same features as the predicate, but the control lavout was updated.

Despite these differences, the ECLOS CT system is technologically equivalent in concept, function, and performance to the predicate device.

Conclusions

The ECLOS CT system has been developed and validated according to applicable standards. Testing has proven that the system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 2 8 2007

Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371

Re: K071806

ECLOS Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 20, 2007 Received: July 2, 2007

Dear Mr. Thislethwaite:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if K071806 known): ECLOS Computed Tomography X-ray System Device Name:

Indications for Use:

Prescription Use × AND/OR

Over-the-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhary

(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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.