(89 days)
To obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.
The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected Positron Emission Tomography images for non-uniform attenuation.
Here's a breakdown of the acceptance criteria and study information for the CoDe AC: Attenuation Correction System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for artifact reduction). However, the overarching acceptance criterion is demonstrating substantial equivalence to the predicate device, VTransACT option for the Apex VariCam (K980659), in terms of safety and effectiveness.
| Acceptance Criteria Category | Specific Metric (Implied) | Acceptance Threshold (Implied) | Reported Device Performance |
|---|---|---|---|
| Image Uniformity | Degree of uniformity in PET images after attenuation correction | No significant difference compared to predicate | Delivers more uniform images than regular coincidence imaging without attenuation correction. Comparison to VTransACT images shows no significant difference. |
| Safety | No new safety concerns raised | Adherence to existing safety standards for similar devices and design features | Sealed and shielded source, manually activated, no electro-mechanical shutter, self-powered LED, well-collimated, integral part of septa collimator. |
| Effectiveness (General) | Ability to produce attenuation-corrected PET images | Substantially equivalent to predicate | Stated as substantially equivalent to the VTransACT option. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Bench data and Clinical data" were used, but no specific number of cases or patients is given for the clinical data.
- Data Provenance: Not explicitly stated. However, the manufacturer is ELGEMS Ltd., located in Tirat Hacarmel, Israel, suggesting the data may have originated from Israel. It is not specified if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- Was an MRMC study done? It is not explicitly stated that an MRMC comparative effectiveness study was performed. The phrasing "Comparison to VTransACT images shows no significant difference" suggests a comparison, but not necessarily with human readers involved or an MRMC design.
- Effect size of human reader improvement: This is not applicable as an MRMC study with human readers assessing improvement with human-AI assistance is not mentioned. The device's primary function is to correct images, not to directly assist human interpretation in a comparative effectiveness study of the AI system itself.
6. Standalone (Algorithm Only) Performance
- Was a standalone performance study done? Yes, implicitly. The statement "Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference" refers to the performance of the device's algorithm in generating corrected images. It is assessing the algorithm's output directly.
7. Type of Ground Truth Used
The ground truth used for image uniformity and attenuation correction is implicitly based on:
- Comparison to a legally marketed predicate device (VTransACT): The "no significant difference" claim implies that the VTransACT's corrected images served as a de-facto "ground truth" or a benchmark for acceptable performance.
- Improvement over uncorrected images: The statement "delivers more uniform images than regular coincidence imaging system without attenuation correction" suggests that the physical reality of non-uniform attenuation and its correction served as the ground truth against which uniformity was assessed. This would likely involve phantom studies (bench data) where the true attenuation is known or controlled.
8. Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Given the nature of an attenuation correction system (a signal processing and image reconstruction task), the "training" might involve developing algorithms to correct known physical phenomena rather than training on a large dataset with expert-labeled ground truth in the same way an AI diagnostic system would. However, the document does not elaborate on the development or training process.
§ 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.