(30 days)
PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dentists, dental assistants, x-ray technicians and other professionals who are licensed by the law of the State in which he or she practices to use the device.
PaX-Duo3D Plus (PCT-5000), a dental radiographic imaging system, consists of dual image acquisition modes; panorama, and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Duo3D Plus (PCT-5000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic dental x-ray system based on CMOS X-ray detector.
The PaX-Duo3D Plus (PCT-5000) device introduces new cone beam CT sensors (Xmaru0712CF, Xmaru1215CF Plus, Xmaru1215CF Master Plus). The study supporting its substantial equivalence to the predicate device, PaX-Duo3D Plus (K102102), focused on demonstrating similar performance characteristics.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and adherence to safety and performance standards, rather than defining specific diagnostic performance acceptance criteria for a novel AI algorithm. The performance of the new sensors is evaluated against the predicate device's established performance through non-clinical and clinical considerations.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Safety | IEC 60601-1 (A1+A2, 1995) | All test results satisfactory |
| IEC 60601-1-1 (2001) | All test results satisfactory | |
| IEC 60601-1-3 (Ed. 1, 1994) | All test results satisfactory | |
| IEC 60601-2-7 (1998) | All test results satisfactory | |
| IEC 60601-2-28 (Ed. 1, 1993) | All test results satisfactory | |
| IEC 60601-2-32 (Ed. 1, 1994) | All test results satisfactory | |
| IEC 60601-2-44 (Ed. 2, 2002) | All test results satisfactory | |
| EMC | IEC 60601-1-2 | All test results satisfactory |
| Non-clinical Performance | FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" | Non-clinical performance report provided; considered similar to predicate. |
| Clinical Performance | FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" | Clinical consideration report provided; considered similar to predicate. |
| Image Quality / Acceptance Testing | IEC 61223-3-4 | All test results satisfactory |
| IEC 61223-3-5 | All test results satisfactory | |
| Interoperability | NEMA PS 3.1-3.18, DICOM Set | Meets provisions |
2. Sample size used for the test set and the data provenance:
The document mentions "nonclinical and clinical consideration" and an "expert review of image comparisons" for both devices. However, no specific sample size for a test set (e.g., number of patients or images) is explicitly stated. The data provenance (country of origin, retrospective or prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The text refers to an "expert review of image comparisons." However, the number of experts used is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience") provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The adjudication method used for the "expert review of image comparisons" is not explicitly stated.
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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described for the device. The study primarily focuses on demonstrating substantial equivalence of the new hardware through technical specifications and expert review, not on AI-assisted diagnostic improvement. Therefore, no effect size for human reader improvement with AI assistance is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is an X-ray imaging system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply in this context. The performance described relates to the image acquisition capabilities of the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "expert review of image comparisons" mentioned, the ground truth was based on expert review/consensus comparing images from the new device with those from the predicate device. The document does not mention pathology or outcomes data for this comparison.
8. The sample size for the training set:
As this is a hardware device submission and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned in the document.
9. How the ground truth for the training set was established:
Since there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not applicable or described.
In summary, the provided document is a 510(k) summary for a dental X-ray imaging system. The study described focuses on demonstrating the device's adherence to safety and performance standards and its substantial equivalence to a predicate device through non-clinical testing and an expert review of image comparisons, rather than evaluating the diagnostic performance of an AI-powered system with specific acceptance criteria related to disease detection or measurement.
§ 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.