(29 days)
Combination of whole-body positron emission tomography (PET) scanning with a diagnostic quality computed tomography scanner. Intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images which depict the anatomical distribution of radioisotopes within the human body. The integrated il produced in intended to provide an enhancement to the emission images by compensating for the attenuation of byothing intended to provide registration of anatomical and physiological images to localize the radioisotope activity in the patient anatomy. The CT or PET scanner may be used independently.
The Positrace / Discovery VI PET/CT scanner is a whole-body scanner primarily intended for oncology applications. It consists of a patient table, PET scanner, CT scanner, UNIX workstation, monitor, keyboard, mouse, modem, and network interface.
The provided material, K012775, describes the GE Positrace/Discovery VI PET/CT Dual Mode Oncology Scanner. This submission is a 510(k) premarket notification for a new version of an existing device, the Positrace Dual Mode PET/CT Oncology System (K001681).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for K012775 does not include explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a previously cleared predicate device (Positrace Dual Mode PET/CT Oncology System, K001681).
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device must be of a comparable type, substantially equivalent to the currently marketed predicate device (Positrace scanner K001681), have the same technological characteristics, be comparable in key safety and effectiveness features, use the same basic design, and have the same intended uses. | "The Positrace / Discovery VI is of a comparable type and substantially equivalent to the currently marketed Positrace scanner. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, and has the same intended uses as the predicate device." |
| "The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards." | ||
| "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed Positrace scanner. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance." | ||
| Clinical Performance | No specific clinical performance metrics (e.g., diagnostic accuracy) were required or provided for this 510(k) submission. | "Clinical Tests: None required." |
2. Sample Size Used for the Test Set and Data Provenance
Since "Clinical Tests: None required" is explicitly stated, there was no specific clinical test set used with a defined sample size. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no clinical tests were required, no experts were used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical test set was used, no adjudication method was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or reported. The submission explicitly states "Clinical Tests: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware imaging system (PET/CT scanner), not an AI algorithm. Therefore, the concept of a "standalone performance" for an algorithm is not applicable in this context. The evaluation focuses on the safety and performance of the hardware and its output, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used
No ground truth derived from clinical data (e.g., pathology, outcomes data, expert consensus) was used for this K012775 submission, as clinical tests were not required. The "ground truth" for the submission's acceptance was the demonstration of substantial equivalence to the predicate device, relying on the predicate's established performance and the new device's compliance with safety standards and manufacturing quality systems.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of an AI/algorithm. This device is a physical diagnostic imaging system.
9. How the Ground Truth for the Training Set Was Established
As there was no training set for an AI/algorithm, this question is not applicable.
§ 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.