(52 days)
"Picasso-Master also known as ECT and Master3D" is a computed tomography 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. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray techniciana.
"Picasso-Master also known as ECT and Master3D" is equipped with state-of-the-art CMOS-CT sensor to capture 3D x-ray computerized tomography scanned image. It is capable of real time-image acquisition through an advanced digital imaging process which allows considerably efficient diagnosis, information management, and real-time sharing of image information on network.
Here's a breakdown of the acceptance criteria and the study information for the "Picasso-Master also known as ECT and Master3D" device, based on the provided 510(k) summary:
This device is an X-ray tomography system. As such, acceptance criteria generally focus on demonstrating that the new device functions similarly and produces comparable image quality to a legally marketed predicate device, especially considering the lack of an AI component explicitly described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner. Instead, the demonstration of substantial equivalence relies on showing that the new device has similar design, function, and intended use as the predicate devices, and that it has undergone appropriate testing according to internal company procedures. The "acceptance criteria" here are implicitly linked to demonstrating equivalency in technical specifications and image generation capabilities.
| Feature / Acceptance Criteria (Implicit: Equivalence to Predicate) | Predicate: EPX-Impla (K070658) Reported Performance | New Device: "Picasso-Master, ECT, Master3D" Reported Performance |
|---|---|---|
| Intended Use (Produce cross-sectional images for diagnostic details of oral & maxillofacial structures and ENT/dentomaxillofacial area via 360° rotational imaging) | Identified for "three Dimensional imaging for dental Purposes. Provides details of the anatomic structures for oral and maxillofacial surgical procedures." Acquires 360° rotational sequence of head and neck areas for diagnostic support. | Identified for "produce cross-sectional images... for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area." |
| X-ray Beam Type | Cone | Cone |
| Detector | Flat-Panel Detector (CsI + Photo Diode) | Flat-Panel Detector (CsI + Photo Diode) |
| Grayscale | 12 | 12 |
| Voxel size (mm) | 0.2 | 0.2 |
| Rotation angle | 360 degree | 360 degree |
| Scan time (sec) | 15 | 24 |
| Patient Position | Stand | Seated |
| Reconstruction time | Less than 2 min | 3min |
| KVp range | 40~90 (Normal 85kV) | 50~90 (Normal 85kV) |
| mA range | 2~10 (Normal 7) | 2~10 (Normal 7) |
| Focal spot (mm) | 0.4 | 0.4 |
| CT Slice Thickness | 0.1~1.0mm | 0.1~1.0mm |
| Overall Safety and Effectiveness | Satisfactory (as a legally marketed device) | Substantially equivalent to predicate device |
| Software Functionality and Performance | Not detailed, assumed satisfactory | "Software testing and validation were done according to written test protocols... Test results support the conclusion that actual device performance satisfies the design intent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for a clinical test set in terms of patient cases or images. The testing mentioned refers to "Software testing and validation" and "internal company procedures," which suggests laboratory or engineering testing rather than a clinical trial with a specific test set of patient data.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified, but given it's an X-ray imaging system, data would typically be derived from phantom studies, cadaver studies, or potentially a limited number of human scans (though not detailed here). The manufacturer is E-Woo Technology Co., Ltd. from Korea, so if any human data was used, it would likely be from Korea.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is a 510(k) for an X-ray medical device (hardware and reconstruction software), and not an AI/CADe/CADx system that interprets images, the concept of "ground truth" established by human experts for a "test set" in the context of diagnostic accuracy is not directly applicable in the same way as it would be for an AI algorithm. The device's performance is assessed on its ability to produce images with certain technical specifications and quality, not on its diagnostic interpretation.
- Number of Experts: Not specified, and likely not applicable in the context of establishing ground truth for diagnostic performance of the device itself. Technical professionals would have reviewed test results.
- Qualifications of Experts: "Designated technical professionals" reviewed test results. Specific qualifications not provided.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as would be used for assessing diagnostic interpretations of images by human readers or AI. The testing described is for the device's technical performance and software validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a medical imaging device, not an AI or CAD system that assists human readers. Therefore, there is no mention of human reader improvement with or without AI assistance, or an effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone X-ray CT system. Its performance refers to its ability to acquire and reconstruct images, not to an algorithm that provides diagnostic output independent of a human. There is no AI algorithm being described that would have a "standalone performance" in the context of diagnostic decision-making. The device is operated by physicians, dentists, and x-ray technicians.
7. The Type of Ground Truth Used
For a pure imaging device, "ground truth" typically refers to the accuracy of the physical measurements, image quality metrics (e.g., spatial resolution, contrast resolution, noise levels), and geometric accuracy of the reconstructed images against known phantoms or established imaging standards. The document states that "Test results support the conclusion that actual device performance satisfies the design intent," which implies that these types of technical ground truths were used for validation. There is no mention of pathology, outcomes data, or expert consensus on diagnostic findings as ground truth for evaluating the device itself.
8. The Sample Size for the Training Set
Not applicable. This document describes an X-ray CT device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm training set described.
§ 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.