(99 days)
PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.
PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometire and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric 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 and cephalometric dental x-ray system based on CMOS X-ray detector. The proposed device is available with two X-ray generator options.
- A pair of CT sensor and Pano sensor are assembled together, back to back, and fixed mechanically to the rotating X-ray gantry, facing the X-ray tube from the opposite side. Based on the choice of a modality, between CT and panorama, the mechanically attached sensors rotate automatically so an appropriate type of sensor is facing the X-ray tube for exposure.
- The type of CT sensor attached to the equipment determines the model name. The model name, PHT-6500, refers to the equipment mounted with Xmaru0712CF, and Xmaru1215CF Plus SSXI detector whereas PHT- 60 CFO model refers to the equipment mounted with Xmaru1215CF Master Plus and Xmaru1524CF Master Plus SSXI detector.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PHT-6500 (PHT-60CFO) dental computed tomography X-ray system:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a Special 510(k) submission, which means the device is an upgraded version of a legally marketed predicate device with the same indications for use and technical characteristics. Therefore, the primary "acceptance criterion" is proving substantial equivalence to the predicate device (K122606). The performance testing focuses on demonstrating that the new components or changes do not negatively impact safety or effectiveness, and in some cases, show improvement or equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K122606) | The new device is stated to be "identical to the predicate device in its indications for use, performance, materials, safety characteristics, image viewing program and accessory components." (Page 5) |
| Technological Characteristics | "The fundamental technological characteristics of the subject and predicate device were the same." (Page 5) |
| Safety (IEC Standards Compliance) | Safety tests were conducted for each generator according to IEC standards (IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44). "All test results were satisfactory." (Page 6-7) |
| EMC (IEC Standard Compliance) | EMC testing conducted in accordance with IEC 60601-1-2. "All test results were satisfactory." (Page 6-7) |
| Radiation Control (CFR Standards Compliance) | Manufacturing facility conforms with 21 CFR 1020.30, 31, and 33. (Page 6) |
| Image Quality (MTF, DQE, NPS) for New Detectors | "Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is equal or better than that of the predicate device and there is no significant difference in efficiency and safety." (Page 6) |
| CT Image Evaluation (IEC Standards Compliance) | Acceptance test and CT image evaluation report performed according to IEC 61223-3-4 and IEC 61223-3-5. (Page 7) |
| Clinical Image Evaluation (for each X-ray generator) | "A separate clinical image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the performance of a radiographic imaging device." (Page 7). "A separate image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the quality of radiographic images and imaging performance of the device." (Page 6) |
| DICOM Conformance | Meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. DICOM Conformance Statement unchanged from predicate. (Page 6-7) |
| Biocompatibility | Biocompatibility evaluation report identical to predicate device. (Page 7) |
| Image Viewing Software Validation | Image viewing SW validation reports identical to predicate device. (Page 7) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific human "test set" sample size or data provenance (country of origin, retrospective/prospective) in the context of clinical performance evaluation directly. The emphasis is on non-clinical testing and expert evaluation of images.
- Non-clinical testing: This involved evaluating physical characteristics like MTF, DQE, and NPS for the new detectors and X-ray generators. No patient data is typically involved in these tests.
- Clinical image evaluation: This was "performed for each X-ray generator" (Page 6, 7), but the number of cases or patients, or their origin, is not specified. Given the nature of a Special 510(k) and the statement about "no significant difference in efficiency and safety," it's likely this involved expert review of a limited set of images rather than a large-scale clinical trial with a defined patient cohort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document mentions "qualified individuals employed by the sponsor" evaluating laboratory and clinical performance testing (Page 5), and "a separate clinical image evaluation is performed for each X-ray generator" (Page 7). However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any clinical image evaluations. Given the focus on demonstrating equivalence and the lack of detail on reader studies, it's highly probable that a formal, multi-reader adjudication process as seen in AI efficacy studies was not conducted or deemed necessary for this Special 510(k).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the provided text. The document refers to clinical image evaluations to assess the X-ray generator's effect on image quality, but it does not describe a study comparing human readers with and without AI assistance or any other comparative effectiveness study. This type of study is more common for devices claiming enhanced diagnostic performance or AI integration, which is not the primary focus of this Special 510(k) (which focuses on an upgraded version of an existing device).
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 "standalone (algorithm only)" performance like in AI devices does not apply in the same way. The performance is intrinsically linked to the hardware generating the images. The non-clinical tests (MTF, DQE, NPS) could be considered "standalone" in that they evaluate the physical imaging components themselves, separate from a human interpreter.
7. The Type of Ground Truth Used:
For the non-clinical tests (MTF, DQE, NPS), the "ground truth" would be objective physical measurements and established engineering standards.
For the "clinical image evaluation," the ground truth is most likely based on expert consensus/opinion regarding diagnostic image quality, comparing images from the upgraded device to those from the predicate device or a reference standard, to ensure no degradation in diagnostic utility. The document's statement about "diagnostic image quality of new sensors is equal or better" (Page 6) suggests this. There is no mention of pathology or outcomes data being used for ground truth.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an upgraded X-ray hardware system, there is no mention of a training set in the context of AI model development.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set for an AI algorithm, this question is not applicable to the provided document.
§ 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.