(15 days)
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. - The GEMINI produces attenuation and non-attenuation 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 transmission images of these areas: "XX" 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 by trained health professionals: "The RET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
The GEMINI hybrid PET/CT system is a combined positron emission tomography and X-ray computed tomography scanner. This system uses the ADAC ALLEGRO PET system, K003434, and the Marconi MX8000-v5.0 CT, K010817. The GEMINI integrates the two systems on a single workstation to allow straightforward planning and system operation. The PET and the MX8000 CT system gantries remain intact as major subsydent components fabricated within a common integrated housing. It can be used in any procedures, which have been clinically conducted in a separate CT system end/or a PET system. No modifications have been made to either system, which would affect system performance.
The provided document is a 510(k) summary for the GEMINI PET/CT system. It does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the GEMINI system is and what it's used for (combining PET and X-ray computed tomography for imaging).
- Comparison to Predicate Devices: Stating that the GEMINI is similar to existing GE CT-PET and ECAT CT-PET systems.
- System Performance Test (General): This section mentions that the component CT system (MX 8000) and PET system (ALLEGRO) meet certain performance standards (21 CFR 1020.30-33 for CT, NEMA-NU2 for PET) and that "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." It also states the GEMINI complies with voluntary safety and effectiveness standards.
- Conclusion: The device is substantially equivalent to predicate devices.
Missing Information:
The document lacks the specific details required to complete many sections of your request, such as a table of acceptance criteria with measured device performance, sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Based on the provided text, here is what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| CT System (MX 8000 v.5.0): Compliance with Performance Standards in 21 CFR 1020.30 - 33. | "The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 CFR 1020.30 -- 33." (Confirms compliance, but specific performance metrics are not detailed). |
| PET System (ALLEGRO): Performance measured according to NEMA-NU2 standard. Evaluate image quality in terms of noise texture and contrast using clinical phantoms and protocols. | "ALLEGRO system performance was measured according to the NEMA-NU2 standard." "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." (Confirms methods used, but specific performance metrics - e.g., spatial resolution, sensitivity, noise reduction values - are NOT provided). |
| GEMINI System (Overall): Compliance with voluntary standards for safety and effectiveness (IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2) and demonstration of minimized hazards (electrical, mechanical, radiation). | "The GEMINI complies with voluntary standards for safety and effectiveness... and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized." (Confirms compliance, but specific test results are not detailed). |
| Substantial Equivalence: Similar intended use, technological comparison, and system performance to predicate devices (GE CT-PET K010641, EXACT CT-PET K002715). | "The GEMINI Imaging System is substantially equivalent to the predicate devices... based upon similar intended use, technological comparison, and system performance." (This is the ultimate conclusion, not a specific performance metric). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "clinical phantoms" for the ALLEGRO PET system but does not provide a number or mention human subject data for testing the combined GEMINI system's performance metrics.
- Data Provenance: Not specified for any performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document states that the system produces images for "interpretation by trained health professionals," but it does not describe how ground truth was established for any performance evaluation.
4. Adjudication method for the test set
- This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study mentioned. The document describes a medical imaging device (PET/CT scanner) rather than an AI-enabled diagnostic algorithm. There is no mention of AI or reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No standalone algorithm performance provided. This document describes a hardware imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. The document mentions "clinical phantoms" for PET system evaluation, implying a known simulated pathology or reference standard for those tests, but the specific type of ground truth for a test set is not detailed for the integrated system.
8. The sample size for the training set
- Not applicable / Not specified. This document describes a medical imaging hardware system. If any internal algorithms were developed, their training data is not discussed.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As above, this information is not relevant to or provided in the context of this 510(k) for a hardware imaging system.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.