The Presto 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.

Device Description

The Presto is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The Presto 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 4 slices of data simultaneously. The x-ray sub-system features a high frequency generator, xray 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-specd 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. The Presto system consisting of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hitachi Presto Computed Tomography X-ray System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it relies on a comparison to a predicate device. The performance is deemed acceptable because it is "comparable to the predicate device."

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Presto CT)
Dose profile	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
Image noise	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
MTF	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
Slice thickness	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
Sensitivity profile	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
Slice plane location	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
CT dose index	Comparable to predicate device (Hitachi Pronto CT)	Comparable to predicate device
Scan Time	Decreased compared to predicate device (Pronto CT)	Shorter scan time due to 4-slice acquisition
Image output	Essential characteristics unchanged vs. predicate device	No change in essential image characteristics
Safety	No new safety issues compared to predicate device	No new safety issues identified

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of clinical images or patient data. The evaluation described is purely non-clinical, comparing the physical and performance characteristics of the Presto system to its predicate device. Therefore, clinical data provenance is not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the evaluation did not involve human interpretation of images or clinical ground truth establishment by experts. The study focused on technical measurements of the device's physical and performance characteristics.

4. Adjudication Method (for the test set)

This information is not applicable as there was no test set involving human assessment or a need for adjudication.

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

There was no MRMC comparative effectiveness study conducted or described. The device is a CT scanner, not an AI-assisted diagnostic tool in the sense of image analysis software. The evaluation is for the imaging system itself.

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

This concept is not directly applicable in the context of a CT scanner as the "algorithm" is the image reconstruction software integral to the device. The evaluation was of the entire system's performance, which includes the reconstruction algorithms, but it wasn't a separate "standalone algorithm performance" study as typically understood for AI/CAD devices. The non-clinical evaluations (dose profile, image noise, MTF, etc.) assess the output of the system including its algorithms.

7. The type of ground truth used

The "ground truth" for the non-clinical evaluations was based on established physical and engineering measurements and standards as stipulated in 21 CFR 1020.33(c). These involve objective measurements of physical parameters like x-ray output, spatial resolution, noise, and dose, rather than clinical outcomes or pathology. The performance of the Presto was then compared to these objective measurements and, more importantly, to the performance of the predicate device.

8. The sample size for the training set

This information is not applicable. The Presto is a CT scanner, not a machine learning model that requires a "training set" of data in the AI sense. The development and validation of such a system involve engineering design, component testing, and system-level performance verification, not data-driven training.

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

This information is not applicable since there was no training set in the context of a machine learning algorithm.

Summary

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APR 2 1 2004

K040902

HITACHI

HITACHI MEDICAL SYSTEMS AMERICA, INC.

1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel.: 330.425.1313 Fax: 330.425.1410

510(k) Summary

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:	February 24, 2004

Device Name

Device Name:	Computed tomography x-ray system
Trade/Proprietary Name:	Presto
Common Name:	Computed Tomography X-ray System
Classification Name:	System, X-Ray, Tomography, Computed
Classification Number:	Sec. 892.1750

Predicate Device

Predicate Device: Hitachi Pronto CT, 510(k) K014240

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Device Description

Function

The Presto 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 Presto 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 4 slices of data simultaneously. The x-ray sub-system features a high frequency generator, xray 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-specd 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.

Physical and Performance Characteristics

The Presto system consisting of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories. The system performance is similar to the predicate device.

Performance Comparison

Because the Presto and the predicate device are both Hitachi designs, they were subjected to the same non-clinical cvaluations 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 Presto were comparable to the predicate device and support our conclusion that the Presto CT system is substantially equivalent.

Device Intended Use

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Device Technological Characteristics

The Presto CT system acquires data in the same manner as the predicate device. Physically, the Presto is very similar to the predicate device. The key differences are the ability to collect 4 slices in a single scan as well as improvements in overall technology.

The ability to collect 4 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 single slice design, meaning that if an area of 16 mm is to be examined in 2 mm increments, the x-ray tube must scan the patient 8 times, collecting 2 mm of data for each scan, to produce 8 total images. In the Presto's 4 slice design, the system need only to scan 2 times, collecting 8 mm of data during each scan. The x-ray beam is collimated to allow the exposure of 4 slices simultaneously, and the data collection system collects all 4 slices. Since the data collection system processes the data in 2 mm increments, the system produces 8 images as before, but during a shorter time.

The operation of the system is virtually identical to the predicate both systems were produced using the same essential design concepts. The Presto 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 layout was updated.

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

Conclusions

The Presto 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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APR 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hitachi Medical Systems America, Inc. c/o Mr. Daniel Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01779

Re: K040902

Trade/Device Name: Presto Computed Tomography X-ray System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: April 6, 2004 Received: April 7, 2004

Dear Mr. Lehtonen:

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 (sec 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin matters of substantial equivalence of your device to a legally premarket notification. THCPDA intellight of the more 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 If you desire specific advice tor your dones as one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the prosses note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releveloe to promation to the Act may be obtained from the Division of Strail Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Solasmiller Schools. Ida.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

Page 2

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K040902 510(k) Number (if known): Presto Computed Tomography X-ray System Device Name:

Indications for Use:

The Presto Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the The I resto Computed Tonography System a art, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician.

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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.