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510(k) Data Aggregation
(10 days)
GEMINI 16
The device is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). The device produces attenuation and nonattenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. The device can provide CT data suitable for use in attenuation correction.
The device is a combination Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner that can be utilized in both conventional, fixed installations or mobile environments. The system integrates the two system operator consoles into a single workstation to allow straightforward planning and system operation. The individual PET and the CT gantries remain intact as major subsystem located within a common integrated housing. It can be used in clinical protocols and procedures, which have been clinically conducted in a separate CT system and/or a PET system. The system is intended for use primarily as a clinical whole body oncology scanner with high-end multislice CT capability and high-end GSO based PET performance. It mechanically separates to allow for the greater flexibility for above three operation modes.
Here's an analysis of the provided text regarding the Gemini 16 device's acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the Gemini 16 does not specify quantitative acceptance criteria for its performance. Instead, it refers to compliance with established standards. The reported "device performance" is primarily articulated as meeting these technical and safety standards, and being "substantially equivalent" to predicate devices.
| Acceptance Criteria (Reference to Standard) | Reported Device Performance |
|---|---|
| Radiation Safety: | |
| 21 CFR 1020.30 (Performance standards for ionizing radiation emitting products) | Compliance and certification achieved. Radiation safety product report to be filed. |
| 21 CFR 1020.33 (Computed Tomography Equipment) | Compliance and certification achieved. Radiation safety product report to be filed. |
| Electrical and Mechanical Safety: | |
| IEC 60601-1 series (Applicable standards) | Adherence and certification achieved. |
| Imaging Performance: | |
| NEMA NU-2 standard | Device performance measured in accordance with this standard. |
| Clinical Efficacy (Implied): | |
| Substantial equivalence to predicate devices: Gemini (K013521) and Mx8000 IDT (K012009) | Achieved through similar intended use, technological comparison, and system performance. Performance improvements noted for decreasing patient scan time and improving attenuation correction speed compared to the predicate Gemini system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific sample size for a test set or the provenance of any data. The evaluation relies on compliance with technical standards and a comparison to predicate devices, rather than a clinical study with a distinct test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no reported clinical study with a test set requiring expert-established ground truth. The evaluation focuses on technical performance and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no reported clinical study with a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on technical safety and performance, and substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This information is not applicable in the context of this device. The Gemini 16 is a medical imaging system (a PET/CT scanner), not an AI algorithm. Its performance is inherent to its hardware and software functioning, which is evaluated against established physical and safety standards (NEMA NU-2, IEC, CFR). The "algorithm only" concept typically applies to software-based diagnostic aids.
7. The Type of Ground Truth Used
The "ground truth" for the Gemini 16's evaluation is primarily based on:
- Compliance with published technical standards: NEMA NU-2 for imaging performance, 21 CFR 1020.30 & 1020.33 for radiation safety, and IEC 60601-1 series for electrical and mechanical safety.
- Comparison to predicate devices: Establishing "substantial equivalence" based on intended use, technological comparison, and system performance as defined by the aforementioned standards.
8. The Sample Size for the Training Set
This information is not applicable. The Gemini 16 is a physical imaging device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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