BBX™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic outcome assessment.

Device Description

The BBX-PET Scanner is a Positron Emission Tomography (PET) system to image the distribution of injected positron emitting radiopharmaceuticals into live humans or animals. The BBX-PET Scanner produces images that represent the internal distribution of radioactivity in the head. The BBX-PET Scanner is comprised of two parts; the Gantry containing detectors and electronics, and the Universal Console that contains the computer workstation. These two parts are connected to each other using optical fiber and an USB cable. The detector assembly is composed of scintillation crystal Lutetium Fin-Silicate (LFS) and light detector photomultiplier. These detectors are arranged on the surface of a cylindrical shell with the diameter of 29 cm in the Gantry. Various electronic circuits are used to process and digitize the signals of these detectors and process the data and store in the computer of the Universal Console for image reconstructions and display.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BBX-PET Scanner. It outlines the device description, indications for use, comparison to a predicate device, and performance data required for substantial equivalence. However, the document does not contain details about acceptance criteria or a comparative clinical study involving human readers (MRMC study) or a standalone AI algorithm performance study.

The performance data sections focus on:

Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
Software Verification and Validation Testing: Classified as "moderate" level of concern, following FDA guidance for software in medical devices.
Performance Testing - Bench: Compliance with NEMA NU-2:2012 for PET scanners, including spatial resolution, scatter fraction, sensitivity, accuracy, and image quality using phantoms. This is an objective measurement of the device's technical specifications.
Performance Testing - Clinical Effectiveness: "Sample images from three clinical cases using the BBX™-PET Scanner were provided." This is a very limited dataset for general clinical effectiveness and does not constitute a rigorous clinical study demonstrating diagnostic accuracy or improvement in human reading performance.

Therefore, based on the provided text, I cannot populate the requested table and details for a multi-reader multi-case (MRMC) study or a standalone AI performance study. The document only describes the device's technical performance and very limited clinical imaging data.

Despite the lack of information for the specific questions related to AI acceptance criteria and study designs, I will summarize what is present in the document regarding the device's "acceptance criteria" (technical performance) and the "study" (bench and limited clinical image review) that proves it meets those criteria:

Summary of Device Performance and Supporting Data (as per the provided document):

The BBX-PET Scanner's acceptance criteria primarily revolve around its technical performance as measured by industry standards for PET scanners and general regulatory compliance. The "study" demonstrating this involves bench testing with phantoms and review of a very small number of clinical images.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Standard / Guidance)	Reported Device Performance / Compliance
Electrical Safety	IEC 60601-1: 2005 (Third Edition)	Complies
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 ed 4.0 (2014-02)	Complies
Software Level of Concern	FDA Guidance for Software Contained in Medical Devices (CDRH, 2005) - "Moderate"	Software verification and validation conducted; classified as "moderate" level of concern.
PET Performance (Bench)	NEMA NU-2:2012 (Performance Measurements of Positron Emission Tomography) for:	Test results indicate compliance with predetermined specifications and applicable standards for all listed parameters.
	1. Spatial Resolution	Complies
	2. Scatter Fraction, Count Losses, and Randoms Measurement	Complies
	3. Sensitivity	Complies
	4. Accuracy: Corrections for Count Losses and Randoms	Complies
	5. Image Quality, Accuracy of Corrections	Complies
Clinical Effectiveness	FDA Guidance for Submission of Premarket Notifications for Emission Computed Tomography Devices (CDRH, 1998) Section IX.F.	Sample images from three clinical cases provided; "supported the clinical effectiveness."

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

Test Set (Clinical): "Sample images from three clinical cases"
Data Provenance: Not explicitly stated, but implied to be from clinical use of the BBX-PET Scanner. The document does not specify country of origin or whether cases were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable / Not Stated: The provided information does not describe any expert review process for establishing ground truth, as the clinical evidence relies on "sample images" rather than a formal diagnostic study. The primary "ground truth" for the device's technical performance is established by NEMA NU-2:2012 phantom measurements.

4. Adjudication Method for the Test Set:

Not Applicable / None Stated: No explicit adjudication method is mentioned for the limited clinical images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, not specified in the provided text. The document describes bench testing and the submission of "sample images from three clinical cases," but not a formal MRMC study comparing human readers with and without AI assistance.

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

Not Applicable / No AI algorithm is described as part of this device. The BBX-PET Scanner appears to be a hardware device for PET imaging, not an AI-powered diagnostic algorithm. The software mentioned is for data acquisition, processing, and display, not for automated interpretation or diagnosis.

7. The Type of Ground Truth Used:

For technical performance (bench testing): Physical phantom measurements following NEMA NU-2:2012 guidelines serve as the objective ground truth.
For clinical effectiveness: The "sample images from three clinical cases" are presented to "support" clinical effectiveness, but the method for establishing diagnostic ground truth (e.g., pathology, clinical follow-up, or expert consensus) for these specific cases is not described.

8. The Sample Size for the Training Set:

Not Applicable / Not Stated: This device is a PET scanner, not an AI algorithm that would typically have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Stated: As above, this concept does not apply to the type of device described.

Conclusion based solely on the provided document:

The FDA 510(k) clearance for the BBX-PET Scanner was based on its substantial equivalence to a predicate device (NeuroPET K091269), demonstrated through:

Comparison of technological characteristics, noting similar intended use and core PET principles.
Compliance with electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2) standards.
Software verification and validation as per FDA guidance for a "moderate" level of concern.
Performance testing against NEMA NU-2:2012 standards using phantoms, confirming its technical capabilities (spatial resolution, sensitivity, etc.).
Submission of "sample images from three clinical cases" to support clinical effectiveness, which is a very limited form of clinical evidence and not a comprehensive diagnostic study.

The document does not suggest the device incorporates AI for image interpretation or diagnosis, nor does it describe any clinical studies (e.g., MRMC or standalone) that would establish diagnostic performance or enhancement of human reader performance.

Summary

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March 17, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Prescient Imaging, LLC % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd WARREN NJ 07059

Re: K210450

Trade/Device Name: BBX-PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: February 12, 2021 Received: February 16, 2021

Dear Mr. Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210450

Device Name BBX™ -PET Scanner

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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K210450

SECTION 5- 510(K) SUMMARY

I. SUBMITTER INFORMATION

Submitter Prescient Imaging LLC., 12569 Crenshaw Blvd Hawthorne, CA-90250

Farhad Daghighian, Ph.D. & Jeffrey Chou Contact Person 12569 Crenshaw Blvd, Hawthorne CA-90250 Phone: (310) 428-4101 ceo@prescientimaging.com Date 03/10/2020

II. DEVICE IDENTIFICATION

Trade/ Proprietary Name	BBX™-PET Scanner
Common Name	PET Scanner
Classification Name	Emission computed tomography system
21 CFR Reference	892.1200
Classification	Class II
Panel	Radiology
Product Code	KPS

III. IDENTIFICATION OF PREDICATE DEVICE

Predicate Device

NeuroPET

510(k) number: K091269

Applicant: PhotoDetection Systems, Inc.

This predicate has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

BBX™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapuetic planning and therapeutic outcome assessment.

Both the subject and predicate device have the same intended use for obtaining positron emission tomography (PET) images of parts of the human body that fit in its patient aperture. Also, their field of views are very similar and suitable for brain imaging.

The few minor differences between the BBX-PET and the predicate device do not alter the intended use of the device nor do they affect the safety and effectiveness of the BBX-PET relative to the predicate.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both scanners are Positron Emission Tomography systems used to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings. The PET Scanners both produce images that represent the internal distribution of radioactivity in the head or other body parts that fit in the similar field of view. At a high level, the subject and predicate devices are based on the following same technological elements:

The PET detectors are arranged on a cylindrical shell with inner diameter of 29 cm vs. 31 cm.
. The detectors detect gamma rays that are emitted by radioactivity placed inside this cylinder.
. The detectors consist of scintillators and photomultipliers.
. The detectors detect the gamma rays and the coincidence events are formed based on timing, energy and position of detection of the annihilation photons in the detectors.
. Software acquires, displays and transfers these images to a networkserver.
. Both PET scanners use calculated attenuation correction method.

The following technological differences exist between the subject and predicate devices:

. BBX-PET scintillators are lutetium fine-silicate (LFS), optically coupled to solid- state photomultipliers.
The predicate device uses detectors consisting of blocks of 16x10 Csl(Na) scintillators, attached to photomultiplier tubes.

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

i. Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the BBX™-PET scanner. The system complies with the IEC 60601-1: 2005 (Third Edition) + COOR.1:2006 + CORR.2:2007 + A1:2012 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

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for electrical safety and the IEC 60601-1-2 ed 4.0 (2014-02) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests for EMC.

ii. Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (CDRH, 2005)." The software for this device was considered as a "moderate" level of concern, since a malfunction or a latent design flaw might lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that might lead to minor injury.

iii. Performance Testing - Bench

Performance testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff," Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems" Section IX.C.2. (CDRH, 1998).

Performance of the BBX™-PET Scanner has been tested by Prescient Imaging LLC according to NEMA NU-2:2012 - Performance Measurements of Positron Emission Tomography. The testing performed include:

1. SPATIAL RESOLUTION
1. SCATTER FRACTION, COUNT LOSSES, AND RANDOMS MEASUREMENT
1. SENSITIVITY
1. ACCURACY: CORRECTIONS FOR COUNT LOSSES AND RANDOMS
1. IMAGE QUALITY, ACCURACY OF CORRECTIONS

Test results indicate that BBX™- PET Scanner complies with its predetermined specification and the applicable standards.

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Performance Testing - Clinical Effectiveness iv.

Clinical effectiveness was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff," Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and Nuclear Tomography Systems" Section IX.F. (CDRH, 1998).

Sample images from three clinical cases using the BBX™-PET Scanner were provided.

VIII. CONCLUSIONS

The data support the safety of the device and the hardware and software verification and validation demonstrate that the BBX™-PET Scanner should perform as intended in the specified use conditions. The sample images from three clinical cases supported the clinical effectiveness of the BBX™-PET Scanner. Based upon performance data, BBX™-PET Scanner is substantially equivalent to the predicate device.

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.