(105 days)
PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-2500 can be equipped with three dedicated sensors, each for two X-ray modalities : panoramic (Xmarul 501CF), cephalometric scan type (Xmaru2301CF) and oneshot ceph sensor type (1210SGA). PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging option based on the customer's diagnostic needs.
Here's a breakdown of the acceptance criteria and study information for the PCH-2500 device, based only on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device. This type of document is designed to demonstrate substantial equivalence to an already legally marketed device, not necessarily to provide a comprehensive clinical study report proving efficacy against a specific set of clinical acceptance criteria. Therefore, much of the requested information (like specific performance metrics for acceptance criteria, sample sizes for test/training sets, expert qualifications, and MRMC study details) is not present in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for PCH-2500 primarily focuses on demonstrating substantial equivalence to the predicate device, PaX-Flex3D, by comparing technical characteristics and performance specifications. There are no explicit "acceptance criteria" for diagnostic accuracy or clinical outcomes stated. Instead, the performance is presented as meeting certain technical specifications.
| Characteristic | Acceptance Criteria (from predicate/technical standards) | Reported Device Performance (PCH-2500) |
|---|---|---|
| Indications for Use | PCH-2500 is a digital extra-oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. Operated by licensed professionals. | Same as Acceptance Criteria |
| Performance Specification | Panoramic and cephalometric imaging capability (similar to predicate, excluding CT) | Panoramic and cephalometric imaging capability |
| Tube Voltage | 50-90 kV (predicate) | 50-90 kV |
| Tube Current | 4-10 mA (predicate) | 4-10 mA |
| Focal Spot Size | 0.5 mm (predicate) | 0.5 mm |
| Exposure Time | 9-24 s (predicate) | Max 20.2 s |
| Total Filtration | 2.8 mmAl (predicate) | 2.8 mmAl |
| Pixel Resolution (Panoramic) | 5 lp/mm (predicate) | 5 lp/mm |
| Pixel Resolution (Cephalometric - scan type) | 5 lp/mm (predicate) | 5 lp/mm |
| Pixel Resolution (Cephalometric - one shot type) | N/A (predicate lacked this specific mode/sensor) | 3.9 lp/mm |
| Pixel Size (Panoramic) | 100 x 100 µm (predicate) | 100 x 100 µm |
| Pixel Size (Cephalometric - scan type) | 100 x 100 µm (predicate) | 100 x 100 µm |
| Pixel Size (Cephalometric - one shot type) | N/A (predicate lacked this specific mode/sensor) | 127 x 127 µm |
| Safety, EMC, Performance Standards | Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2, NEMA PS 3.1-3.18, DICOM Set, IEC 61223-3-4, IEC 61223-3-5. | All test results were satisfactory. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical performance evaluation (e.g., number of patients/images used to assess diagnostic accuracy). The non-clinical performance and clinical consideration report for the SSXI detector (1210SGA) is "provided separately in this submission," but details are not given here.
The data provenance for the device performance testing mentioned (e.g., electrical, mechanical, EMC, acceptance tests according to IEC standards) would be from in-house engineering and testing as per standard regulatory requirements, likely conducted in Korea Republic (manufacturer's country). No clinical trial data is detailed. The expert review of image comparisons is mentioned, but without specifics of the dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text mentions an "expert review of image comparisons" for both the PCH-2500 and the predicate device. However, it does not specify the number of experts, their qualifications, or how they established a "ground truth" for a test set. This review seems to be part of the substantial equivalence argument, likely comparing image quality or diagnostic utility rather than rigorously establishing a ground truth for a clinical condition.
4. Adjudication Method for the Test Set
Since the text does not detail a clinical test set with specific ground truth establishment, no adjudication method (e.g., 2+1, 3+1) 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
No MRMC comparative effectiveness study is mentioned or implied. The PCH-2500 is a digital X-ray imaging system, not an AI-powered diagnostic tool, and the submission predates widespread clinical AI in radiology.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. The PCH-2500 is a hardware imaging device, not a standalone algorithm.
7. The Type of Ground Truth Used
For the technical performance aspects, the "ground truth" is adherence to established technical standards (e.g., IEC, NEMA) and the performance of the predicate device. For potential image quality assessments by experts (implied by "expert review of image comparisons"), the ground truth would inherently be expert opinion/consensus on image quality and diagnostic features. Pathology or outcomes data are not mentioned as being used for ground truth.
8. The Sample Size for the Training Set
Not applicable/Not provided. As this is an X-ray imaging system, there isn't a "training set" in the machine learning sense. Any calibration or factory testing would involve proprietary methods not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. See point 8.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.