1. to produce cross-sectional images of the hunan body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
tadiopliatinaccunears within the things a suy produced by x-ray transmission from the same axial plane 2) taken at different angles,
taken at different angles,
to create attenuation maps from the x-ray data to correct the PET images, and 3)
to creat anchuation maps from the A tay images after reconstruction to produce images with both 4) anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can aid to diagnosis when used by a qualified physician.

Device Description

The SceptreP3 combines the technologies of a multi-slice x-ray computed tomography system, rne Socker 3 comments on computed tomography scanner, and a DICOM compliant image workstation into an integrated system that uses the PET and CT data to produce cross-sectional images of the body at various angles.

The system is made up of 4 discrete sub-systems that are independently marketed under unique 510(k) clearances. The sub-system models are:
CT - Presto
PET - ECAT ART-LSO PET System
Workstation - Sceptre-VS (AVIA)
Patient Table - PET/CT Patient Handling System (PHS)

The SceptreP3 system consisting of a CT gantry, a PET gantry, operator's workstation, patient handling system (table), high-frequency x-ray generator, and accessories. The system performance is identical to the predicate devices.

AI/ML Overview

The provided text is a 510(k) summary for the SceptreP3 PET/CT system. It does not include a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a novel AI device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, meaning its performance is considered comparable because it uses established technologies.

Here's a breakdown of the information that can be extracted or inferred from the document, and where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or image quality metrics) in the way one would see for a new diagnostic algorithm. The primary "acceptance criteria" here is substantial equivalence to predicate devices.
Reported Device Performance: The document explicitly states: "The system performance is identical to the predicate devices." and "The evaluation results of the SceptreP3 are comparable to the predicate devices and support our conclusion that the Sceptre PET/CT system is substantially equivalent."

Since the device is a combination of existing, already cleared sub-systems, its performance is considered a direct reflection of those predicate devices. There are no new performance metrics reported for the combined system beyond its functionality for image acquisition, reconstruction, display, and fusion.

Table (based on the provided text's approach):

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices	"The SceptreP3 system is technologically equivalent in concept, function, and performance to the predicate devices.""The system performance is identical to the predicate devices.""The evaluation results of the SceptreP3 are comparable to the predicate devices and support our conclusion that the Sceptre PET/CT system is substantially equivalent."Functionality mirrors predicate devices (CT, PET, Workstation).
Ability to produce cross-sectional images (PET)	Fulfilled (based on predicate PET sub-system - ECAT ART-LSO PET System; K003241)
Ability to produce cross-sectional images (CT)	Fulfilled (based on predicate CT sub-system - Presto; K040902)
Ability to create attenuation maps from x-ray data for PET	Fulfilled (explicitly stated as an intended use and functional capability)
Ability to combine CT and PET images (co-register)	Fulfilled (explicitly stated as an intended use and functional capability)
Safety and Effectiveness for Indicated Use	"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 devices."

Information Not Present in the Document:

The following requested items are typically associated with performance studies for novel devices or AI algorithms. Since this submission relies on substantial equivalence of combined, previously cleared components, these details are not provided:

2. Sample size used for the test set and the data provenance: Not applicable/Provided. No specific "test set" for performance evaluation of the combined system is described beyond the inherent performance of the predicate devices. The submission does not detail data provenance for such a test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. There is no mention of a test set requiring expert ground truth establishment for novel performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Provided.

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: Not applicable/Provided. This device is an imaging system, not an AI-assisted diagnostic tool in the modern sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Provided. This is an integrated hardware/software system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Provided.

8. The sample size for the training set: Not applicable/Provided. This device is not an AI/ML algorithm that undergoes a "training" phase in the context of the submission provided.

9. How the ground truth for the training set was established: Not applicable/Provided.

Summary of Study (Based on 510(k) Substantial Equivalence):

The "study" for the SceptreP3 system, as described in the 510(k) summary, is a demonstration of substantial equivalence to existing, legally marketed predicate devices.

Methodology: The manufacturer combined four independently cleared sub-systems (CT, PET, Workstation, Patient Table). The core argument is that each sub-system retains its original performance and technological characteristics, and the integration introduces no new questions of safety or effectiveness. Minimal software changes were made to allow for integrated control and data transfer.
Proof: "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 devices." This implies internal testing and analysis confirmed the integrated system operates as expected without introducing new hazards, primarily by verifying the functionality of the interface and combined operation to ensure it aligns with the performance of its cleared components. The specific details of this "testing" are not provided in this summary but would have been part of the full 510(k) submission.

In essence, the "study" is a regulatory comparison rather than a performance efficacy study against clinical ground truth, typical for devices building upon pre-existing technologies.

Summary

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KOHL4NS

SEP 1 7 2004

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:	June 11, 2004

Device Name

Device Name:	Computed tomography x-ray system, Emission computedtomography system
Trade/Proprietary Name:	SceptreP3
Common Name:	Computed Tomography X-ray System, Emissioncomputed tomography system
Classification Name:	System, X-Ray, Tomography, ComputedSystem, Tomography, Emission Computed
Classification Number:	Sec. 892.1750Sec. 892.1200

Predicate Devices

	Hitachi Medical	K040902
ECAT EMERGE PET	CTI PET Systems	K003241
PET/CT Patient HandlingSystem (PHS)	CTI PET Systems	K023768
Sceptre-VS (AVIA)Workstation	Hitachi Medical	K021314

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Device Description

Introduction

The system is made up of 4 discrete sub-systems that are independently marketed under unique 510(k) clearances. The sub-system models are:

Sub-System	Model	Manufacturer	510(k)
CT	Presto	Hitachi Medical	K040902
PET	ECAT ART-LSO PET System	CTI PET Systems (CPS)	K003241
Workstation	Sceptre-VS (AVIA)	Hitachi Medical	K021314
Patient Table	PET/CT Patient Handling System (PHS)	CTI PET Systems (CPS)	K023768

Scientific Concepts

The CT sub-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, 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 (opinal) boat ates 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 PET sub-system uses partial ring LSO detector technology, where the detectors rotate around the patient and collect emission data from the injected radiopharmaceutical.

The computer workstation (AVIA™) initiates data acquisition and processes the resultant images. The images are stored, printed, and archived as required. CT data is used to create attenuation correction maps for the PET images as well as for standard CT image display. The workstation is also capable of fusing CT and PET images into one display to show both anatomical and physiological data. The workstation is based on current PC technology using the Windows™ operating system.

Physical and Performance Characteristics

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Performance Comparison

Because the SceptreP3 simply combines freestanding CT and PET systems, its performance mirrors the predicate devices. There are no fundamental performance changes to the CT and PET sub-systems, nor the image workstation. The only change allows the workstation to the control PET data collection, request motion of the PHS and to automatically receive the image data from the CT and PET sub-systems.

The evaluation results of the SceptreP3 are comparable to the predicate devices and support our conclusion that the Sceptre PET/CT system is substantially equivalent.

Device Intended Use

The SceptreP3 system is intended to be used:

l ) to produce cross-sectional images of the human body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
1. to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles,
1. to create attenuation maps from the x-ray data to correct the PET images, and
1. to combine (co-register) the CT and PET images after reconstruction to produce images with both anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Technological Characteristics

The CT and PET sub-system are functionally identical to their predicate devices. Physically, the SceptreP3 combines the two gantries under one cover and uses a new patient table, called a Patient Handling System (PHS). The PHS is identical to the predicate PHS device.

The operation of the system is virtually identical to the predicates because the operating software on the CT and PET subsystems is largely unchanged. The key differences are the ability to initiate PET data collection and control the PHS from the AVIA workstation. This necessitated minor changes to the CT and PET sub-systems to allow them to accept commands from the A VIA. The PHS design allows the table pallet to extend through the CT aperture into the PET aperture. Gantry controls provide the same features as the CT predicate, but the control layout was modified to accommodate the new covers.

Despite these differences, the SceptreP3 system is technologically equivalent in concept, function, and performance to the predicate devices.

Conclusions

The SceptreP3 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 devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

SEP 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hitachi Medical Systems America, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K042428

Trade/Device Name: SceptreP3 PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

. II

Regulatory Class: II Product Code: 90 KPS and JAK Dated: September 7, 2004 Received: September 8, 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 for ass station 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 (PMA), 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.

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 sadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogh manone of your device of your device of your device to a legally premarket notincation. The PDF anishing sites on 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 If you desire specific acrise as your he 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 and please note the regulation entitled, "Misbranding Other of Compliance at (201) 22th Part 807.97) you may obtain. Other general by releveloc to promative includious (et the Act may be obtained from the Division of Small mormation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 14andraorerors, International address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Broughton

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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Labels	Values
510(k) Number (if known):	K042428
Device Name:	SceptreP3 PET/CT System

Indications for Use:

The SceptreP3 system is intended to be used:

1. to produce cross-sectional images of the hunan body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
tadiopliatinaccunears within the things a suy produced by x-ray transmission from the same axial plane 2) taken at different angles,
taken at different angles,
to create attenuation maps from the x-ray data to correct the PET images, and 3)
to creat anchuation maps from the A tay images after reconstruction to produce images with both 4) anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can aid to diagnosis when used by a qualified physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Layson

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

Prescription Use $\checkmark$

Over-the-Counter Use

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.