(43 days)
The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.
The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of:
- A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software.
- NuQuest™ Nuclear Medicine Computer and related . software.
The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software.
The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software.
This is a 510(k) summary for a gamma camera system, which means it evaluates the substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics in the context of a de novo study is not present in this document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The provided document describes a 510(k) submission, where the primary "acceptance criterion" is substantial equivalence to a predicate device. This is a regulatory pathway, not a performance study against predefined numerical targets.
-
Acceptance Criteria (Implicit for 510(k)): The device, MEDX NuQuest™ - InteCam™ SPECT 37-75 System, must demonstrate that it is as safe and effective as the predicate device (Siemens Integrated ORBITER™ Gamma Camera System) and has the same intended use. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.
-
Reported Device Performance: The document does not provide specific performance metrics (e.g., spatial resolution, sensitivity, processing speed) of the MEDX NuQuest™ system in comparison to the predicate. Instead, it focuses on the modifications made to a remanufactured Siemens device and the integration of previously cleared components (NuQuest™ Nuclear Medicine Computer and IM512P imaging software). The implication is that by using a modified version of a Siemens device and cleared components, the performance is at least equivalent.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device "Performance" (via Substantial Equivalence Claim) |
| :------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Substantially equivalent to predicate device | The MEDX NuQuest™ - InteCam™ SPECT 37-75 System is substantially equivalent to the Siemens Integrated ORBITER™ Gamma Camera System. |
| Same Intended Use and Indications for Use | The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals, which is the same as commonly accepted uses for gamma cameras. |
| Differences do not raise new questions of safety/effectiveness | The device consists of a modified (remanufactured) Siemens Digitrac™ Orbiter™ Gamma Camera (with its gantry) and a previously cleared NuQuest™ Nuclear Medicine Computer (K953255) with previously cleared imaging software (IM512P, K945792). The modification involved replacing low-voltage circuit boards in the Siemens device to operate with the new computer and software. This implies that the core imaging hardware (detector) is a known design, and the modifications are primarily in the control and processing electronics, which are covered by the cleared components. No new safety or effectiveness concerns are indicated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a substantial equivalence claim based on modifications to an existing device and integration of pre-cleared components, extensive clinical test sets with patient data are often not required if the changes are deemed non-significant to safety and effectiveness. The focus would typically be on technical verification and validation, possibly using phantom studies, rather than a clinical dataset for performance evaluation against ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as a formal clinical study with a ground truth assessment by experts for a test set is not described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as a formal clinical study with adjudication is not described.
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
An MRMC comparative effectiveness study is not mentioned and would not typically be performed for a 510(k) submission for a gamma camera system claiming substantial equivalence, especially one based on modifications and integration of pre-cleared components. This device is a primary imaging acquisition and processing system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device itself is the "standalone" imaging system. While it has algorithms for image processing and analysis (as indicated by the "processing, display and analysis" function and the cleared IM512P software), the 510(k) does not detail specific algorithm performance studies or metrics as it focuses on the substantial equivalence of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since a specific clinical performance study against ground truth is not described, this information is not provided. The ground truth for proving substantial equivalence usually revolves around technical specifications and engineering validation of the modified components and integrated system to ensure they perform equivalently to the predicate and comply with relevant standards.
8. The sample size for the training set
This information is not provided. The device is a gamma camera system, and while it uses software and processing, it's not described as a machine learning/AI classification algorithm that would require a "training set" in the common sense of AI development for diagnostic tasks. The software it uses (IM512P) was previously cleared, indicating its development and validation occurred prior to this submission.
9. How the ground truth for the training set was established
This information is not provided as no training set (in the AI/ML context) is described for this specific 510(k) submission.
§ 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.