(185 days)
PortView is indicated for use in acquiring images of patient teeth. It is intended for intra oral x-ray examinations and produces instant, digital, intra-oral x-ray images of a patient's teeth for diagnosis of diseases of the teeth and oral structures.
The digital x-ray sensor system, Port View produces instant, digital, intra-oral x-ray images of a patient's mouth for diagnosis of the tecth and oral structures. It consists of digital intraoral sensors and image processing software as followings.
Digital Intraoral sensor: is an indirect light converting digital X-ray detector. Incident X-rays are converted to visible light by a scintillating device. (material) such as Csl(Cesium lodide), the light is coupled optically to a light detection imager which is based on CMOS technology. The sensor supports USB 2.0 Direct connectivity to personal computers and or laptops.
Image processing software; provides various functions such as Image acquisition. Image scarch, Image Processing including Enhancement. 21) analysis (Zoom. Rotate, and Measurement) and Image Printing & Saving and DICOM 3.0 application.
Here's a breakdown of the acceptance criteria and study information for the PortView Digital X-ray sensor system, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit, quantifiable acceptance criteria with a performance table for a new, unique claim. Instead, the "acceptance criteria" are implied by meeting established safety standards and performing comparably to the predicate devices.
| Metric/Standard | Acceptance Criteria (Implied/Predicate Performance) | Reported Device Performance (PortView) |
|---|---|---|
| Safety | Compliance with IEC 60601-1 | Performed to IEC 60601-1 standards; satisfactory results |
| EMC | Compliance with IEC 60601-1-2 | Performed to IEC 60601-1-2 standards; satisfactory results |
| Effectiveness (Implied by Substantial Equivalence) | As safe and effective as predicate devices (Schick CDR, Gemini DUSB) for acquiring intraoral x-ray images for diagnosis of dental diseases and oral structures. | Bench and clinical evaluation indicates the new device is as safe and effective as the predicate devices. |
| Technological Characteristics Comparison to Predicates | Matching or superior technical specifications (e.g., sensor size, active area, technology, interface, dynamic range, cable length, CPU, memory, HDD, OS, DICOM compliance, monitor settings) | See Comparison Table below for detailed matching. |
Comparison Table (from the document, showing how PortView meets technological characteristics of predicates):
| Manufacturer | GENORAY Co., Ltd. (PortView) | Schick Technologies. Inc. (CDR) | Edlen Imaging LLC (Gemini DUSB) |
|---|---|---|---|
| Implementation | Software and Sensor | Software and Sensor | Sensor Only |
| Sensor size (mm) | Size1: 36.73 X 24.35 | ||
| Size2: 42.8 X 30.49 | Size 1: 31 X 22 | ||
| Size 2: 37 X 24 | |||
| Size 2: 43 X 30 | Size1: 36.73 X 24.35 | ||
| Size2: 42.8 X 30.49 | |||
| Sensor Active Area (mm²) | Size1: 600 | ||
| Size2: 900 | Size1: 432 | ||
| Size2: 600 | |||
| Size3: 921 | Size 1: 600 | ||
| Size2: 900 | |||
| Technology | CMOS | CMOS | CMOS |
| Interface to PC | USB 2.0 | USB 2.0 | USB 2.0 |
| Dynamic Range | 4096:1 | 4096:1 | 4096:1 |
| Cable length(m) | 3 | 2 | 3 |
| CPU | Intel Pentium Dual-Core 2.5GHz(E5200) or higher | Intel Pentium IV or AMD 3GHz or higher | 2.0 GHz Pentium 4 |
| Memory | 1GB or higher | 1 GB | 1GB |
| HDD | 10GB or higher (Client), 100GB or higher (Server) | 80 GB HD | 80GB |
| OS | Windows XP service pack 2 or higher | Windows XP Professional or Windows Vista Home Premium | Windows XP Pro / 7 |
| DICOM Compliance | DICOM 3.0 | DICOM 4.5 | DICOM 3.0 |
| Monitor Settings (Min.) | 1024 X 768 | 1024 X 768 | 1024 X 768 |
2. Sample size used for the test set and the data provenance
The document states "the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, it does not specify the sample size for a distinct "test set" (such as a specific number of patients or images).
Regarding data provenance:
- The manufacturer is GENORAY Co., Ltd. from Korea.
- The study is described as "clinical evaluation" which implies prospective data collection, but no further details are given to confirm this. The document does not specify the country of origin of the clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication method for the test set
The document does not specify any adjudication method.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss AI assistance improving human readers. The device is a digital X-ray sensor system and image processing software, not an AI-driven interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable in the context of this 510(k) for a digital X-ray sensor system. The device's primary function is image acquisition and basic processing, not autonomous algorithm-based diagnosis. The performance is inherently tied to human interpretation of the images produced.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used. Given the "clinical evaluation," it would likely involve clinical assessment or radiographic interpretation, but the method for establishing a definitive "ground truth" for comparison is not detailed.
8. The sample size for the training set
The document does not specify any training set size. This is consistent with the device being an imaging system, not typically a machine learning algorithm requiring a separate training set for its core functionality.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of an algorithm or AI model, there is no information on how ground truth for a training set would have been established.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.