The APEX XL-4 is a Gamma Camera - SPECT Imaging System. It is intended to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823. The detector electronics, mechanical components, software, and the manufacturing specifications of the applicant system (the APEX XL-4) are substantially equivalent to the CardioSPECT SC, the legally marketed device.

AI/ML Overview

The provided document for K033001 describes the Photon2 APEX XL-4, a gamma camera - SPECT imaging system. This 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance criteria through a new clinical study. Therefore, the information requested about specific acceptance criteria, device performance tables, sample sizes for test sets, expert involvement, and comparative effectiveness studies as typically presented for AI/ML device submissions is not applicable in this context.

This 510(k) relies on demonstrating that the new device has substantially equivalent specifications, safety, effectiveness, and intended use as the legally marketed predicate device, the NC Systems, Inc. CardioSPECT SC (K021823). The document primarily focuses on comparing technical specifications and intended use.

Here's a breakdown of what can be extracted from the document based on your request, with an emphasis on what is not present:

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

Not Applicable. This type of table is typically found in submissions for novel devices or those with new performance claims where specific metrics (e.g., sensitivity, specificity, AUC) are being established against a defined ground truth. For a substantial equivalence claim for a gamma camera, the acceptance criteria are generally met by demonstrating that the device meets existing performance standards and is comparable to the predicate device across various technical and functional specifications. The document states: "The conclusion of tests performed and clinical images obtained demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC)." However, no specific performance metrics or acceptance criteria are presented in a table form.

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

Not Applicable/Not Provided. The document does not describe a specific "test set" in the context of an AI/ML algorithm evaluation. The "tests performed and clinical images obtained" mentioned are likely part of the validation process to ensure the device performs as expected and similarly to the predicate, but detailed information about the number of patients/cases, their origin, or study design (retrospective/prospective) is not provided.

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)

Not Applicable/Not Provided. Since there's no described "test set" and ground truth establishment in the context of AI/ML performance evaluation, there's no mention of experts or their qualifications for this purpose.

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

Not Applicable/Not 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. This device is a gamma camera hardware system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.

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

Not Applicable. This is a hardware device; no standalone algorithm performance is being evaluated.

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

Not Applicable/Not Provided. As there is no "test set" requiring ground truth for performance evaluation in the AI/ML sense, no specific type of ground truth is mentioned. The comparison is based on the technical specifications and functional equivalence to the predicate device.

8. The sample size for the training set

Not Applicable/Not Provided. This is not an AI/ML device, so there is no "training set."

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

Not Applicable/Not Provided.

Summary of the study that proves the device meets the acceptance criteria (as understood in a 510(k) for a hardware device):

The "study" presented is primarily a comparison of specifications and intended use between the APEX XL-4 and its predicate device, the NC Systems, Inc. CardioSPECT SC (K021823). The document states:

"The intended use of the applicable components in the two devices is identical."
"The specifications for each device are compared in Section C." (This section is referenced but not provided in the input, but implies detailed technical comparison).
"The labeling for each device are equivalent."
"The conclusion of tests performed and clinical images obtained demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC)."

This demonstrates that the device achieves substantial equivalence by meeting the implied "acceptance criteria" of being functionally and technically similar to a device that has already been cleared by the FDA for safety and effectiveness. The proof is in the direct comparison of the new device to the predicate across various attributes including design, materials, performance claims, and intended use as outlined in Section 6.0 "Determination of Substantial Equivalence." There is no detailed clinical study described with patient cohorts or statistical performance endpoints in the provided text.

Summary

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Ko33001

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14350 S.W. 142nd Ave., Micomi, FI. 33186 Phone: 305-234-0836

SECTION G 510(K) SUMMARY

21CFR 807.92

1.0 Introduction

DEC 2 4.2003

This 510(k) Premarket Notification has been prepared to demonstrate that the APEX XL-4, manufactured by Photon2, is substantially equivalent to the NC Systems, Inc. CardioSPECT SC which has previously been reviewed and approved via the 510(k) premarket notification process (K021823).

Submitter Identification 2.0

2.1 Applicant Name & Address. Transphoton Corporation (dba Photon") 14350 S.W. 142nd Avenue Miami, FL 33186 Phone: 305-234-0836 305-234-2398 Fax:
2.2 Contact Person:

Scott Jennings IBIS, Inc. 37 Electric Avenue Lunenburg, MA 01462 Phone: 978-985-2532 978-582-4544 Fax:

2.3 Manufacturing Site: Mediso, Ltd. Alsotorokvesz 14 H-1022 Budapest, Hungary
2.4 Date of Submission: September 30, 2003

3.0 Device Identification

3.1 Device Proprietary Name: Photon2 APEX XL-4
3.2 Common Name: Gamma Camera - SPECT Imaging System

3.3 Classification Name Emission Computed Tomography System (ECT)

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3.4 Classification Panel: Radiological

3.5 Regulatory Class Class II

3.6 Regulation Number: 21CFR 892.1200

3.7 Product Code: 90KPS

Identification of Equivalent Device 4.0

4.1 Predicate Device 510(k) Number: K021823

4.2 Predicate Device Identification:

Proprietary Name: NC Systems, Inc. CardioSPECT SC Device Name (common): Gamma Camera-SPECT Gamma Camera Classification Name: Emission Computed Tomography System (ECT) Regulation Number: 21CFR 892.1200 Regulatory Class: II Product Code: 90KPS

4.3 Predicate Device Description:
The predicate device, NC Systems, Inc. CardioSPECT SC, is a device with components that have substantially equivalent specifications, safety, effectiveness, and intended use as the Photon2 APEX XL-4:
The CardioSPECT SC is a scintillation detector, NaI, system with . PMT light gathering capacity. The CardioSPECT SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on the detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The CardioSPECT SC is capable of both Planar (Class I) and SPECT or ECT (Class II) operation. The acquisition/processing computer is an approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation.
The detector electronics, mechanical components, software, and the . manufacturing specifications of the applicant system (the APEX XL-4) are substantially equivalent to the CardioSPECT SC, the legally marketed device.
Detailed specifications for the predicate device are provided in Section . く.

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Intended Use 5.0

The intended use of the APEX XL-4 is to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823.

Determination of Substantial Equivalence 6.0

The APEX XL-4 Interface has been compared to the corresponding components of the legally marketed CardioSPECT SC System and been determined to be substantially equivalent:

The intended use of the applicable components in the two devices is . identical.
The specifications for each device are compared in Section C. .
The labeling for each device are equivalent. Refer to Section D. .
The conclusion of tests performed and clinical images obtained . demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC). Refer to Section E.

Thus, we conclude that the APEX XL-4 is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2003

Transphoton Corporation % Mr. Scott Jennings IBIS, Inc. 37 Electric Avenue LUNENBURG MA 01462 Re: K033001 Trade/Device Name: APEX XL-4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 24, 2003 Received: September 30, 2003

Dear Mr. Jennings:

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 (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 (OS) 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) 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 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 Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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510(k) Number (if known):	K 03 30 01
Device Name:	APEX XL-4

Indications For Use:

The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera

images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Lyman

(Division Sign-510kl N

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Usc

(Optional Formal 1-2-96)

Regulation Number and Section

N/A