(79 days)
The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.
Vantage 2.0 ExSPECT is a software program which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 1.0 software package, cleared in 510k K943596.
Vantage 2.0 ExSPECT is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage 2.0 ExSPECT device.
Acceptance Criteria and Study Details for Vantage 2.0 ExSPECT
Based on the provided documentation, the Vantage 2.0 ExSPECT is a software program designed to enhance image quality in ADAC Gamma Camera Systems by correcting for attenuation effects, Photopeak scatter, Downscatter, and Resolution Recovery (RR). The 510(k) submission primarily focuses on demonstrating substantial equivalence to its predicate device, Vantage 1.0.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or detailed reported device performance metrics tied to such criteria. The submission focuses on demonstrating that the modifications (Vantage 2.0 ExSPECT) maintain the same indications for use and do not introduce new safety or effectiveness concerns compared to the predicate device (Vantage 1.0).
Implicit Acceptance Criteria:
Given the nature of a 510(k) submission for a software modification, the implicit acceptance criteria would revolve around:
- Maintaining existing image quality and diagnostic utility: The enhanced images from ExSPECT 2.0 should be at least as good as, if not better than, those from Vantage 1.0, without degrading diagnostic information.
- Safety equivalence: The modifications should not introduce new safety hazards (e.g., increased radiation dose, misinterpretation risk).
- Functional equivalence: The system should perform its intended function (producing images depicting anatomical density and correcting attenuation) as effectively as the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Images depict anatomical density and provide enhancement by correcting for attenuation. | "The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient." The device "adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR)." The FDA's substantial equivalence determination implies that these performance enhancements were deemed acceptable and did not raise new questions of safety or effectiveness compared to the predicate device. |
| Maintain indications for use and safety/effectiveness profile of predicate device (Vantage 1.0). | "The Vantage 1.0 and Vantage 2.0 ExSPECT devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter." The FDA's clearance (K971878) confirms that this substantial equivalence was met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size for any test set (e.g., number of patients or images). It only states, "Images were acquired using the protocol outlined in the Vantage user manual."
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective nature of data collection). However, given that it's a 510(k) for a modification to an existing device (Vantage 1.0), it's plausible that the testing involved data typical of SPECT imaging performed on ADAC Gamma Camera Systems, potentially from internal testing or clinical sites where the predicate device was in use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not described or referenced in the provided text. There is no mention of comparing human reader performance with or without AI assistance, nor any effect size provided.
6. Standalone (Algorithm Only) Performance
The document does not explicitly describe a standalone performance study in terms of quantitative metrics. The submission focuses on the software program integrating with existing gamma camera systems to produce enhanced images. The "performance" described is the functionality of the software in correcting for scatter, resolution recovery, and attenuation, which are image processing enhancements rather than a direct diagnostic output that would typically have standalone performance metrics like sensitivity/specificity for a disease.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, for a device that enhances image quality for anatomical density and attenuation correction, ground truth could implicitly refer to:
- Physical phantoms: Used to validate the accuracy of attenuation, scatter, and resolution corrections against known properties.
- Clinical expert consensus: Radiologists or nuclear medicine physicians would visually assess the improved quality and diagnostic utility of the enhanced images compared to unenhanced images or images from the predicate device.
- Quantitative image quality metrics: Such as contrast-to-noise ratio, spatial resolution, or artifact reduction, which can be measured and compared.
The text does not specify which, if any, of these were formally established as ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. This is consistent with the era (1997) and the nature of the device as a software modification for image enhancement, which might not rely on machine learning models requiring explicit "training sets" in the modern sense. The "training" might refer to the development and tuning of the image processing algorithms using various image data.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, how its ground truth was established is also not provided. If the algorithms involved development and tuning, the performance improvement (e.g., better correction of scatter) would have likely been validated against known physics models or simulated data, or visually assessed by experts.
§ 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.