(29 days)
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.
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.
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.
§ 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.