(46 days)
PCH-2500 (PaX-i) 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. 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 (PaX-i) 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-(PaX-i) can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), one cephalometric scan type (Xmaru2301CF) and two flat panel one shot ceph sensors (1210SGA and 910SGA). PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the new component (910SGA sensor) as this is a Special 510(k) submission primarily addressing changes to an existing device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is a Special 510(k) for PCH-2500 (PaX-i), primarily introducing a new cephalometric sensor (910SGA). The acceptance criteria for this sensor are implicitly set by its equivalence to the predicate device and the performance of other sensors within the PCH-2500 (PaX-i) system, as well as general performance standards for dental X-ray imaging.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate/Standards) | Reported Device Performance (PCH-2500 (PaX-i) with 910SGA) |
|---|---|---|
| Technical Specifications | ||
| Pixel Resolution | ≥ 3.9 lp/mm (matching 1210SGA predicate sensor) | 3.9 lp/mm |
| Pixel Size | 127 x 127 μm (matching 1210SGA predicate sensor) | 127 x 127 μm |
| Image Receptor Type | Amorphous silicon TFT with scintillator (matching 1210SGA) | Amorphous silicon TFT with scintillator |
| Safety | Compliance with IEC 60601-1 and related standards | All test results were satisfactory |
| EMC | Compliance with IEC 60601-1-2 | All test results were satisfactory |
| Performance | Compliance with IEC 61223-3-4 and IEC 61223-3-5 | All test results were satisfactory |
| Image Quality | Image quality comparable to predicate device (K113672) for diagnostic information of oral and maxillofacial anatomy | Expert review of image comparisons showed substantial equivalence to predicate device. |
| DICOM Conformance | Compliance with NEMA PS 3.1-3.18 (DICOM Set) | Meets the provisions of NEMA PS 3.1-3.18 |
| Non-clinical Performance | Satisfactory performance according to FDA Guidance for Solid State X-ray Imaging Devices | Performed and satisfactory |
| Clinical Considerations | Satisfactory considerations according to FDA Guidance for Solid State X-ray Imaging Devices | Performed and satisfactory |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the "test set" (i.e., the images used for the expert review). It only mentions "image comparisons for both devices." The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified for the images used in the expert review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states an "expert review of image comparisons" was conducted, but it does not specify the number of experts used or their qualifications.
4. Adjudication Method for the Test Set
The document mentions an "expert review," but it does not describe an adjudication method (e.g., 2+1, 3+1). It implies a consensus or comparison against a standard, but no specific method is outlined.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, the document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The evaluation primarily focused on demonstrating substantial equivalence to a predicate device through technical specifications, safety/EMC testing, and an expert review of image comparisons. There is no mention of human readers improving with AI assistance, as this is an imaging device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not directly applicable in the context of this submission. The device is an X-ray imaging system, not an algorithm. Its performance is evaluated as an imaging system, which inherently produces images for human interpretation. The "non-clinical and clinical consideration report for the new SSXI detector, 910SGA" would assess the detector's capability to produce diagnostic images, effectively acting as its standalone performance.
7. The Type of Ground Truth Used
The ground truth for the "image comparisons" was established through expert review. This implies a comparison of diagnostic quality and features between images produced by the new 910SGA sensor and the predicate device's sensors. The ultimate "ground truth" for dental X-ray images is typically the clinical diagnosis or assessment derived by a qualified professional from those images.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is a hardware submission, not a machine learning algorithm submission, so a traditional "training set" as understood in AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
§ 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.