Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
vatech A9 (Model : PHT-30CSS)
vatech A9 (Model : PHT-30CSS) is intended to produce panoramic, cone beam computed tomography, or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
vatech A9 (Model : PHT-30CSS) is an advanced 3-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), and CBCT scan imaging capabilities into a single system. vatech A9 (Model : PHT-30CSS), a digital radiography imaging system, is specially designed to take X-ray images of patients on the chair and assist dentists. Designed explicitly for dental radiography, vatech A9 (Model : PHT-30CSS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of the head, neck, oral surgery, implant, and orthodontic treatment.
Here's an analysis of the acceptance criteria and study information for the Vatech A9 (Model: PHT-30CSS) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list numerical acceptance criteria in a table format. Instead, it states that the device's performance was compared to a predicate device and international standards. The general acceptance criterion appears to be "equivalent or better than the predicate device" in terms of image quality and meeting relevant international standards for X-ray systems.
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|
| Image Quality: Equivalent or better than the predicate device (Green16/Green18, K170066) in terms of Contrast, Noise, CNR, and MTF, for CBCT, PANO, and CEPH images. | "The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device." (Applies to Contrast, Noise, CNR, MTF in CT; also stated for PANO/CEPH/CBCT images generically) |
| Dosimetry Performance (DAP): For Panoramic mode, dose to be in line with the predicate device. For Cephalometric mode, DAP measurements to be the same as the predicate device under identical conditions. For CBCT mode, similar performance to the predicate device considering FOV differences. | Panoramic Mode: "The mA setting for the subjective device was increased to be in line with the DAP of the predicate device in the Normal Panoramic mode." |
| CEPH Mode: "The CEPH mode for the subject device and the predicate device has the same FDD... the same DAP measurement under the same X-ray exposure conditions." | |
| CBCT Mode: "the outcome result confirmed that the CBCT mode for both devices performed similarly." | |
| Compliance with International Standards: Meeting requirements of 21 CFR Part 1020.30, 1020.33, IEC 61223-3-5,IEC 60601-1:2005+AMD1:2012(Edition 3.1), IEC 60601-1-3:2008+AMD1:2013 (Edition 2.1), IEC 60601-2-63:2012+AMD1:2017 (Edition 1.1), IEC 60601-1-2:2014 (Edition 4), NEMA PS 3.1-3.18. | "The acceptance test was performed according to the requirements of 21 CFR Part 1020.30. 1020.33 and IEC 61223-3-5..." |
| "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005+AMD1:2012(Edition 3.1), IEC 60601-1-3:2008+AMD1:2013 (Edition 2.1), IEC 60601-2-63:2012+AMD1:2017 (Edition 1.1) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2014 (Edition 4)." | |
| "The vatech A9 (Model : PHT-30CSS) conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set." | |
| Software: "Moderate" level of concern, with existing cleared viewing programs. | "Software verification and validation were conducted and documented as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern..." |
| "vatech A9 (Model: PHT-30CSS) provides the following imaging viewer programs; -2D Image viewing program: EzDent-i(K202116) -3D Image viewing program: Ez3D-i(K200178)" | |
| X-Ray Source (D-054SB): Specifications (max rating, emission & filament characteristics) equivalent to the predicate device's D-052SB. | "The specification for both D-054SB and D-052SB x-ray source (tube) is the same as confirmed by the maximum rating charts, emission & filament characteristics." |
| Detector (Xmaru1404CF-PLUS): Previously cleared. | "The subject device is equipped with the Xmaru1404CF-PLUS detector which has been cleared with previous 510k submissions, PCH-30CS (K170731)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample size (number of images or cases) used for the performance testing or image quality evaluations. It mentions that "the same test protocol was used to test the performance of the subject and the predicate device for comparison."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that the testing involved comparing the subject device with a predicate device and was conducted in a laboratory, it appears to be bench testing/non-clinical performance testing rather than testing on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions that "PANO/CEPH/CBCT images from the subject and predicate device are evaluated in the Image Quality Evaluation Report." However, it does not specify the number of experts who performed this evaluation, nor does it provide their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the image quality evaluation or performance testing. It simply states the images "are evaluated."
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 described or indicated. The evaluation mentioned is an "Image Quality Evaluation Report" comparing the subject and predicate device, but it doesn't detail a study involving multiple human readers to assess improvement with or without AI assistance. The device is an X-ray imaging system, not an AI diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable in the typical sense for this device. The Vatech A9 is itself an imaging device, an X-ray system, not an AI algorithm that generates a diagnosis or interpretation in a standalone manner. Its performance (image quality, dose) is evaluated as a standalone system. The software components (viewing programs EzDent-i and Ez3D-i) are also cleared, indicating their standalone functionality in displaying images.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation appears to be based on:
- Physical Measurements and Standards: For Contrast, Noise, CNR, MTF, and Dosimetry (DAP), these are objective physical measurements taken with phantoms or test protocols.
- Comparison to a Predicate Device: The performance of the subject device was directly compared to the performance of the legally marketed predicate device (Green16/Green18, K170066) using the "same test protocol."
- Expert Evaluation: For the "Image Quality Evaluation Report," the "ground truth" implicitly relies on expert subjective assessment of the images, although details are missing.
8. The Sample Size for the Training Set
The document does not describe a training set. This is because the device is a medical imaging hardware system (CT X-ray system), not an AI algorithm that requires a training set for machine learning. The viewing software (EzDent-i, Ez3D-i) is separate and was cleared through previous 510(k) submissions.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an AI algorithm.
Ask a specific question about this device
Page 1 of 1