(13 days)
This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multi-slice CT scanner.
The PCA-8000A consists of an integrated multi-slice CT system and a Positron Emission Topography Scanner. This system uses CT images to correct for non-uniform attenuation of the PET images. CT images and PET images are integrated to provide localization of emission activity. This system is capable of imaging with all available PET tracers and CT contrast agents. The system will display anatomical and functional information via the integrated graphical display system. The CT portion of the system can be used as a standalone head and whole body CT system.
The provided text is a 510(k) Pre-market Notification for the Toshiba America Medical Systems, Inc. PCA-8000A Mark II PET/CT System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, much of the requested information about acceptance criteria and study details is not present in this document.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" discussed is primarily about meeting general safety standards and having similar technological characteristics and intended uses.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study or a test set of data (e.g., patient scans) used to evaluate the device's performance against specific acceptance criteria. Therefore, information on sample size and data provenance is not available.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Since no specific performance study on a test set is described, there's no mention of experts establishing ground truth or their qualifications.
4. Adjudication Method
As no specific performance study is detailed, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a MRMC comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI vs. without AI assistance. This device is a PET/CT scanner, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study for an algorithm without human-in-the-loop performance. The device is a medical imaging system that produces images for human interpretation.
7. Type of Ground Truth Used
No ground truth is explicitly mentioned as being used for performance evaluation, as no specific performance study is detailed with quantitative outcomes.
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of an algorithm's development. This is a medical imaging device, and the focus is on hardware and integrated software capabilities, not on a machine learning algorithm trained on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is also not applicable or present in this document.
Summary of what the document does state regarding acceptance or equivalence:
- Conformance to Standards: "All portions of this device have been designed and manufactured in accordance with the requirements of the applicable portions of ISO 60601 and its collateral standards." and "All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this device, will be met... Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-44. - Medical Device Safety standards."
- Substantial Equivalence: The primary "proof" relies on demonstrating that the PCA-8000A Mark II has "the same indications for use as the predicate device and utilizes technologies and materials that are similar in nature." The predicate devices are listed as GE Discovery VCT (K050559) and Toshiba, TSX-201A, Aquilion LB (K050458).
Essentially, this 510(k) submission establishes that the new device is safe and effective by showing that it is fundamentally the same as devices already legally marketed, in terms of technology, intended use, and adherence to relevant safety standards, rather than presenting a novel performance study against specific clinical acceptance criteria.
§ 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.