(158 days)
PHT-65LHS is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, 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.
Green16 / Green18 (Model: PHT-65LHS) is an advanced 5-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, 3D MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system. PHT-65LHS, a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists and ENT specialists. PHT-65LHS is a complete digital X-ray system equipped with imaging viewers, 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 head, neck, oral surgery, implant and orthodontic treatment. PHT-65LHS can also acquire 2D diagnostic image data in conventional panoramic and cephalometric modes.
The provided text is a 510(k) Summary for the Vatech Green16/Green18 (Model: PHT-65LHS) dental X-ray system. It describes the device, its intended use, and compares it to a predicate device (Green Smart, PHT-35LHS) to establish substantial equivalence.
However, the document does not describe a study that proves the device meets specific acceptance criteria related to a device's performance in analyzing medical images or making diagnostic predictions (e.g., an AI/ML device). Instead, it describes:
- Acceptance criteria for the imaging system itself: This refers to the fundamental image quality metrics (like MTF, DQE, NNPS, Contrast, Noise, CNR) and safety standards required for an X-ray imaging device to be cleared by the FDA for its intended purpose (producing panoramic, cephalometric, or 3D digital X-ray images).
- Performance data comparing the new device to a predicate device: This is to show that the new device's imaging capabilities are equivalent to or better than a previously cleared device.
Therefore, many of the requested items (e.g., sample size for training/test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI/ML) are not applicable to this document as it pertains to the clearance of an imaging hardware system, not an AI/ML-driven diagnostic device.
Here's a breakdown of what can be extracted and what is not present, based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Performance Parameter | Acceptance Criteria (Implied: Equivalent or Better than predicate) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|---|
| PHT-65LHS Detectors (Xmaru1314CF & Xmaru1515CF) | ||
| Mod. Transfer Function (MTF) | Equivalent to Xmaru1404CF-Plus (predicate) | Similar resolution performance at all spatial frequencies |
| Detective Quantum Efficiency (DQE) | Equivalent to Xmaru1404CF-Plus (predicate) | At low spatial frequency (~0.5 lp/mm), Xmaru1314CF & Xmaru1515CF: 49% (4x4binning) vs. Xmaru1404CF-Plus: 52% (4x4binning). However, overall "similar" performance claimed. |
| Normalized Noise Power Spectrum (NNPS) | Equivalent to Xmaru1404CF-Plus (predicate) | Similar image quality at all spatial frequencies |
| Pixel Resolution (CT&PANO) | Equivalent to predicate (5 lp/mm -2x2 binning detector spec, 2.5 lp/mm -4x4 binning system spec) | Identical for 2x2 binning. Same diagnostic image quality as predicate using 4x4 binning. |
| Pixel Size (CT&PANO) | Equivalent to predicate (99 µm -2X2 binning, 198 µm - 4X4 binning) | Identical |
| Pixel Resolution (CEPH) | Equivalent to predicate (5 lp/mm-Non binning, 2.5 lp/mm -2x2 binning) | Identical |
| Pixel Size (CEPH) | Equivalent to predicate (100 um- Non binning, 200 um -2X2 binning) | Identical |
| CT Image Quality (measured with iterative reconstruction algorithm) | Adherence to IEC 61223-3-5 standard; Equivalent or Better than predicate | Demonstrated "equivalent or better" general image quality |
| Contrast | Equivalent or Better than predicate | Achieved |
| Noise | Equivalent or Better than predicate | Achieved |
| CNR | Equivalent or Better than predicate | Achieved |
| MTF | Equivalent or Better than predicate | Achieved |
| Dosimetric Performance (DAP) | Equivalent to predicate under same exposure conditions | CEPH/PANO: same. CBCT: FOV 5x5 mode equivalent. |
| General Image Quality (Clinical judgment) | Equivalent or Better than predicate | Demonstrated "equivalent or better" |
2. Sample size used for the test set and data provenance:
- The document mentions "Non-Clinical Test results" and "Clinical consideration and image quality evaluation report" but does not specify sample sizes for these tests.
- Data provenance (country of origin, retrospective/prospective) is not mentioned beyond the manufacturer being VATECH Co., Ltd. in Korea.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable as this is not an AI/ML diagnostic device requiring expert-established ground truth for a test set. The "Clinical consideration and image quality evaluation report" implies human evaluation, but details are absent.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size:
- Not applicable. This is not an AI/ML CAD device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an X-ray imaging system, not an algorithm, so its "standalone" performance is its fundamental imaging capability, which is reported via metrics like MTF, DQE, NNPS.
7. The type of ground truth used:
- For the technical performance of the imaging system, the "ground truth" is established by physical phantoms and measurement protocols defined by international standards (e.g., IEC 61223-3-5).
- For "Clinical consideration and image quality evaluation," the "ground truth" would be the subjective assessment of image quality by healthcare professionals, but no details are provided on how this evaluation was structured.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML product developed with a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.