(10 days)
The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.
The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.
This appears to be a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the typical sense of a de novo or PMA submission.
Therefore, many of the requested sections (2-9) about sample size, ground truth, expert adjudication, MRMC studies, and training sets are explicitly not applicable to this type of submission document as they are not typically required or included. The "study" mentioned here is primarily one of non-clinical device performance comparison and adherence to industry standards, not a clinical trial.
Here's the information extracted and interpreted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Safety Standards | |
| UL 60601-1 | Meets UL 60601-1 Standard |
| CAN/CSA C22.2 No. 601-1 | Meets CAN/CSA C22.2 No. 601-1 Standard |
| EMI Standards | In Compliance with EMI Standards |
| Performance Standards | |
| NEMA NU 1-2001 (Uniformity) | Meets NEMA NU 1-2001 Standard |
| NEMA NU 1-2001 (Linearity) | Meets NEMA NU 1-2001 Standard |
| NEMA NU 1-2001 (Resolution) | Meets NEMA NU 1-2001 Standard |
| Non-Clinical Performance | |
| Linearity of thyroid gland phantom images | Deemed to be excellent |
| Resolution of thyroid gland phantom images | Deemed to be excellent |
| Uniformity of thyroid gland phantom images | Deemed to be excellent |
| Overall Effectiveness (compared to similar devices) | Provides effective results as expected from similar devices in the marketplace. |
| Substantial Equivalence to Predicate Device (Inter Medical Gamma Camera System Model CX 250 C Plus) | Characteristics compare substantially with the predicate device in materials, technology, and functional methodology. Differences do not affect safety and effectiveness. Operates in a manner substantially equivalent and performs as well as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission details non-clinical performance and substantial equivalence based on technical specifications and phantom studies, not a clinical test set with patient data in the typical sense.
- The "test set" for performance was likely phantom images, though the specific number of phantom images or type of phantoms is not detailed.
- The data provenance mentioned relates to adherence to international safety and performance standards (UL, CAN/CSA, NEMA) and comparison to a legally marketed predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).
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)
- Not Applicable. No ground truth established by external experts is described for a clinical test set. The assessment of "excellence" for phantom images (linearity, resolution, uniformity) would have been determined internally by MEDX, Inc. engineers or quality assurance personnel against the NEMA standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication method is 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
- Not Applicable. No MRMC study or AI component is mentioned. This device is a traditional gamma camera system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device (gamma camera) with associated software (NuQuest™). Its performance is inherently linked to its operation, not a standalone algorithm in the AI sense. The "standalone" performance here refers to the device's technical specifications and adherence to NEMA standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Performance Testing: The ground truth for performance testing (linearity, resolution, uniformity) was based on physical phantom measurements and adherence to NEMA NU 1-2001 industry standards.
- For Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence was the technical specifications and proven performance of the predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device requiring a training set in that context. The device and its software (NuQuest™ based on IM512P) have a history of prior FDA clearances (K945792, K961104), indicating established functionality rather than a recently trained algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).