Search Results
Found 1 results
510(k) Data Aggregation
(392 days)
The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.
The RXS1000 is intended to acquire real-time, clinical digital intraoral X-ray images using a solidstate imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC(software).
This document describes the FDA's clearance of the RXS 1000, an intraoral digital X-ray sensor, based on its substantial equivalence to a predicate device (K163282). As such, the document primarily focuses on establishing "substantial equivalence" rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical performance study.
Therefore, many of the requested elements for a detailed scientific study are not applicable or not explicitly provided within this FDA 510(k) summary document.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" as pass/fail thresholds for clinical performance but instead focuses on demonstrating equivalence to a predicate device. The performance characteristics are compared between the subject device (RXS 1000) and the predicate device (Apex Dental Sensors Size #1).
| Parameter | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (RXS 1000) | Equivalence/Difference |
|---|---|---|---|
| Technological Characteristics | |||
| Sensor type | CMOS | CMOS | Equivalent |
| Scintillator Material | CsI | CsI | Equivalent |
| Sensor dimension | 39 x 25 x 5.3 mm (Predicate) | 42 x 26.2 x 6.7 mm | RXS 1000 is larger than predicate device, but patient isn't feel uncomfortable when use. |
| Image area | 30 x 20 mm | 30 x 20 mm | Equivalent |
| Pixel size | 20 x 20 µm | 20 x 20 µm | Equivalent |
| Resolution | 1500 x 1000 pixels | 1500 x 1000 pixels | Equivalent |
| DQE | More than 20% at 3.5 ln/mm | More than 20% at 3.5 ln/mm | Equivalent |
| MTF | More than 40% at 5 lp/mm | More than 40% at 5 lp/mm | Equivalent |
| Cable length | 2 m (Predicate) | 3 m | For our research, user prefer 3m length cable. |
| USB interface | USB 2.0 (Predicate) | USB 3.0 | USB 3.0 is not only higher transfer data speed, but also can backwards compatibility USB 2.0 interface. |
| Sensor Input Voltage | DC 5V | DC 5V | Equivalent |
| Clinical Performance | (Not explicitly defined in terms of specific metrics like sensitivity/specificity) | (Not explicitly defined as a separate study with metrics like sensitivity/specificity) | The document states "RXS 1000's specification is equivalent to predicate device" in conclusion, implying similar clinical performance based on technological equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document is a 510(k) summary demonstrating substantial equivalence based on technological characteristics and adherence to standards, not a clinical trial report with a test set of patient data.
- Data Provenance: Not applicable for a clinical test set. The technical specifications listed implicitly refer to characteristics measured on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. There is no clinical test set requiring ground truth establishment by experts mentioned in this document.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement
- No. An MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. This type of study would typically be performed for AI-enabled diagnostic devices to assess human reader performance with and without AI assistance, which is outside the scope of this particular submission for a digital X-ray sensor itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The RXS 1000 is an intraoral digital X-ray sensor, which is a hardware device that acquires images, not an algorithm operating in standalone mode for diagnostic interpretation. Its "performance" relates to image quality and technical specifications of the sensor hardware.
7. The Type of Ground Truth Used
- Not applicable for clinical efficacy. The "ground truth" here is implied by the technical specifications of the device itself and its equivalence to a legally marketed predicate. For example, "pixel size 20x20 µm" is a measurable characteristic of the sensor, not a clinical ground truth established by experts or pathology.
8. The Sample Size for the Training Set
- Not applicable. The RXS 1000 is a hardware sensor, not a machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is involved for this type of device.
In summary, the provided document, a 510(k) summary for an intraoral digital X-ray sensor, focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and compliance with relevant standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). It does not contain information about a clinical performance study with acceptance criteria, test sets, ground truth establishment by experts, or AI algorithm performance typically found for software-as-a-medical-device (SaMD) or AI-enabled diagnostic tools.
Ask a specific question about this device
Page 1 of 1