(475 days)
The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
The BelSensor GOLD is an indirect converting x-ray detector that converts incident xrays by a scintilator into visable light, which is coupled optically to a light detection imager based on CMOS technology. Incident x-rays are automatically detected to generate digital images for dental intra-oral applications.
The BelSensor GOLD supports USB 2.0 connectivity to personal computer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BelSensor GOLD:
The provided document describes a 510(k) summary for the BelSensor GOLD, a digital X-ray sensor for dental intra-oral applications. It is crucial to note that this document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical study with detailed performance metrics against specific acceptance criteria.
Therefore, much of the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly present in this type of regulatory submission summary. The demonstration of safety and effectiveness relies on comparison to a predicate device and adherence to relevant standards.
Let's break down what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, spatial resolution targets) and their corresponding measured performance values are NOT explicitly stated in this 510(k) summary.
The primary "performance" discussed is in comparison to the predicate device in terms of technological characteristics.
| Characteristic | Acceptance Criterion (Implicitly, to be equivalent/similar to predicate) | Reported Device Performance (BelSensor GOLD) |
|---|---|---|
| Intended Use | Acquire dental intra-oral radiology images, operated by healthcare professionals, can use positioning devices or be handheld. | Same as predicate |
| Technology | CMOS | CMOS |
| Interface with PC | USB | USB |
| Dynamic Range | Similar or better than predicate (16,384:1) | 15,000:1 (Slightly lower than predicate, but within typical ranges for such devices and likely considered acceptable for substantial equivalence) |
| Sensor Cable Length | Similar or better than predicate (2.8m) | 3m (Slightly longer, which is generally a practical improvement) |
| Sensor Size | No direct criterion, but various sizes offered by predicate | 30 x 20 mm, 36 x 26 mm (Predicate has 30 x 39 mm, implying multiple sizes are acceptable) |
| Number of Sensors | Not applicable as a direct performance metric; design choice | 2 (Predicate has 1) |
| Safety | Adherence to IEC 60601-1 (2005) | Performed and compliant |
| EMC | Adherence to IEC 60601-1: 1988 + A1: 1991 + A2:1995, IEC 60601-1:2005, EN 60601-1: 2006, EN 60601-1-2: 2007 | Performed and compliant |
| Biocompatibility | Adherence to USP testing guidelines | Performed and compliant |
Missing: Specific quantitative performance metrics like spatial resolution (lp/mm), signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), DQE (Detective Quantum Efficiency), exposure latitude, etc., that would typically be associated with acceptance criteria for image quality.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated for a clinical performance test set. The document primarily relies on non-clinical testing (electrical, mechanical, environmental safety, EMC, biocompatibility) and comparison to a predicate device. If human imaging tests were performed, the details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not stated. This summary does not describe a clinical study where expert ground truth establishment would be required. The evaluation focuses on technical equivalence and compliance with standards.
4. Adjudication Method for the Test Set
Not applicable/Not stated. No clinical adjudication process is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic AI devices and involves evaluating how human performance changes with or without AI assistance. This device is an imaging sensor, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The BelSensor GOLD is an imaging sensor (hardware), not an algorithm or software-only device. Therefore, a "standalone" algorithm performance study is not relevant in this context. The standalone performance would be its physical performance characteristics, which are implicitly covered by the technical comparisons and standards compliance.
7. Type of Ground Truth Used
Not explicitly stated in terms of a clinical ground truth. For non-clinical testing, the "ground truth" would be the specifications of the tests and standards (e.g., a specific electrical property should measure within a certain range, or a material should not cause a toxic reaction).
8. Sample Size for the Training Set
Not applicable. The BelSensor GOLD is a hardware imaging sensor. It does not utilize machine learning or AI algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" for this device.
Summary of Device Evaluation in the 510(k) Filing:
The safety and effectiveness of the BelSensor GOLD are primarily established through:
- Substantial Equivalence: Direct comparison of its intended use and technological characteristics to a legally marketed predicate device (Dexis Sensor K090458).
- Adherence to Standards: Compliance with recognized international standards for electrical, mechanical, environmental safety (IEC 60601-1 series), EMC (IEC 60601-1-2), and biocompatibility (USP testing guidelines).
The 510(k) process is less about presenting de novo clinical study data with specific acceptance criteria and more about demonstrating that a new device is as safe and effective as a previously cleared device.
§ 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.