(98 days)
The Model MCT-1 EXF is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and threedimensional images. The device is operated and used by physicians, dentists, and x-ray technologists.
The MCT-1 EX F is an X-ray CT using the limited cone beam. MCT-1 EX F makes diagnosis be possible due to its high resolution three dimensional images for small diagnosis be possible add to the extremely complex morphology of the hard tissue of the head and neck region. High resolution images are obtained in the same short period as that of the Panoramic Radiology. Low X-ray radiation dosage is realized and the overall system structure is assembled to be compact unit. The J.MORITA. MFG. CORP. has manufactured the MCT-1EX as the original model of such kind of X-ray scanner, and modify the device for MCT-1 EX F by replacing the image receptor , XII for FPD ( Flat Panel Detector).
The provided 510(k) summary for the "3D Accu-I-tomo XYZ Slice View Tomograph MCT-1 EX F" is a submission for a modified device, primarily claiming substantial equivalence to a previously cleared device (MCT-1 EX, K030450) by replacing the image receptor. Therefore, the information provided focuses on demonstrating equivalence rather than establishing new performance criteria through a standalone study with acceptance criteria.
The submission does not contain specific acceptance criteria or an explicit study proving performance against such criteria in the way one might expect for a de novo device or a device claiming entirely new capabilities. Instead, it relies on the predicate device's established safety and effectiveness and notes that the technological change (replacement of the image receptor) does not raise new issues of safety or effectiveness.
However, based on the provided text, we can infer how "performance" is addressed within the context of demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance (Inferred)
| Performance Aspect (Inferred "Acceptance Criteria") | Reported Device Performance |
|---|---|
| Imaging Technology | Replacement of X-ray image intensifier (XII) with Flat Panel Detector (FPD) |
| Image Resolution | "High resolution three-dimensional images for small diagnosis be possible" |
| Imaging Speed | "High resolution images are obtained in the same short period as that of the Panoramic Radiology." |
| X-ray Radiation Dosage | "Low X-ray radiation dosage is realized" |
| Safety Testing | VDE tested and certified for CE marking with CB report on MCT-1 EX F (NOTE-2) |
| Overall Performance | "Identical" to predicate device MCT-1EX (as per "Substantial Equivalent comparison summary table") |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a separate test set or sample size used for a performance study.
- The primary justification for equivalence relies on the technological similarity and the minor modification of the image receptor.
- Data Provenance: Not applicable in the context of specific a clinical performance study. The device itself is manufactured by J. Morita Mfg. Corp.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No expert review or ground truth establishment for a specific test set is described. The submission focuses on technical equivalence rather than a clinical performance study requiring expert adjudication of ground truth.
4. Adjudication Method for the Test Set
- Not applicable. As there is no described test set or expert review, no adjudication method is mentioned.
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. An MRMC study was not conducted or mentioned. This device is a CT imaging system, not an AI/CAD device for diagnostic assistance. The focus is on the imaging hardware itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is an imaging device, not an algorithm. Therefore, a standalone algorithmic performance study is not relevant to this submission.
7. The Type of Ground Truth Used
- Not applicable. The submission does not describe a performance study that uses "ground truth" in the clinical sense (e.g., pathology, outcomes data, or expert consensus) for assessing diagnostic accuracy. The safety and effectiveness are established by demonstrating substantial equivalence to the predicate device, which presumably was evaluated via standard methods for CT scanners (e.g., image quality metrics, dose measurements) when it was originally cleared.
8. The Sample Size for the Training Set
- Not applicable. This device is an imaging hardware system, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth.
§ 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.