(284 days)
The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.
The Atlas is provided high resolution radiographic images in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
Here's an analysis of the provided text regarding the ATLAS Digital X-Ray Detector, focusing on acceptance criteria and supporting studies:
It is important to note that the provided document is a 510(k) summary for premarket notification, not a full study report. As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing independent clinical or performance studies with specific acceptance criteria and detailed patient-level data. The document does not contain information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details. The "Performance Characteristics" section lists applied standards rather than reporting actual performance against specific acceptance criteria.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, explicit "acceptance criteria" for performance metrics in the context of a prospective study are not detailed. Instead, the document demonstrates substantial equivalence by comparing the device's technical specifications and intended use to legally marketed predicate devices. The implicit "acceptance criterion" is that the ATLAS device's specifications should be comparable to or better than the predicate devices without raising new safety or effectiveness concerns.
| Feature | ATLAS (Reported Performance) | Comparison to Predicate Devices (Implicit Acceptance) |
|---|---|---|
| Intended Use | Matches predicate devices. | Met: The intended use of ATLAS is identical to the main predicate (Xaminer) and broadly aligned with the second predicate (QXR-9), covering head-to-toe diagnostic radiographic exposures for adult and pediatric patients, excluding mammography. |
| Classification | Class II / MQB | Met: Matches predicate devices. |
| Feature (General) | High-resolution digital imaging, 98% fill factor, lower dose, single CCD detector. | Met: Similar general features and benefits (high resolution, digital format, fill factor, lower dose) as described for Xaminer. QXR-9 also emphasizes high-resolution digital imaging. The ATLAS shares the 98% fill factor, while Xaminer claims 100%. This difference is not presented as raising new safety/effectiveness concerns, implying it's either negligible or offset by other factors. |
| Sensor | CCD + scintillator | Met: While the phrasing is slightly different ("CCD+ scintillator" vs. "CCD- scintillator" for predicates), this is understood to be the same underlying technology for indirect digital radiography, utilizing a scintillator to convert X-rays to light, which is then captured by a CCD. |
| Imaging Pixels | 3,103 x 3,085 (9 Megapixel) | Met: Comparable to predicate devices (3,072 x 3,072, 9 Megapixel). |
| Active Image Size | 17" x 17" | Met: Matches predicate devices (43 cm x 43 cm or 17" x 17"). |
| Pixel Size | 144 microns | Met: Matches predicate devices. |
| Nyquist Resolution | 3.5 lp/mm | Met (or exceeded): This is higher than Xaminer (3.2 lp/mm) and matches QXR-9 (3.5 lp/mm). This improvement is considered a positive technological characteristic. |
| Bit Depth | 16Bit capture | Met (or exceeded): This is higher than both predicate devices (14 bit capture). This improvement is considered a positive technological characteristic, allowing for more grayscale information. |
| Fill Factor | 98% | Comparable: Xaminer reports 100%, but 98% is still a very high fill factor, indicated as contributing to maximum efficiency and lower dose. The submission implies this difference does not raise new concerns. |
| Preview Image | Less than 5 seconds | Met: Comparable to Xaminer (Less than 5 seconds), and slightly longer than QXR-9 (Less than 3.5 seconds). This difference is implicitly deemed acceptable and not a new safety/effectiveness concern for the intended use. |
| Imaging Detector Weight | 45kg-50kg | Improved: Significantly lighter than Xaminer (75 kg). This is an improvement in handling and logistics, not raising new safety/effectiveness concerns. |
| Safety Standards | Conforms to EN ISO 14971, EN 60601-1, EN 60601-1-4, EN 60601-1-2. | Met: Conforms to the same or equivalent international and European safety standards as the predicate devices, indicating adherence to established safety requirements. |
The conclusion states that ATLAS "has substantial equivalent intended use... and has substantial equivalent technological and performance characteristics," with "few technological differences" that "do not raise new types of safety or effectiveness issues." This is the core "proof" presented for a 510(k).
Study Details (Based on the Provided Text):
1. Sample sized used for the test set and the data provenance:
* Sample Size (Test Set): Not specified. The document does not describe a specific clinical or technical test set with patient data for the ATLAS device in the way a full performance study would. The comparisons are based on technical specifications and potentially bench testing rather than a separate device performance evaluation on a patient dataset.
* Data Provenance: Not specified. No mention of country of origin or whether data was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not specified. The document does not detail a study involving expert-established ground truth for a test set. This type of information would be relevant for studies assessing diagnostic accuracy, which is not the primary focus of this 510(k) summary for a digital X-ray detector seeking substantial equivalence.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. No adjudication method is mentioned as there is no described test set with human interpretation.
4. 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:
* No. An MRMC study was not done. The ATLAS is a digital X-ray detector, which is a component of an X-ray system, not an AI-powered diagnostic tool. Its function is to capture and digitize images.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* No. The ATLAS is a hardware device (digital detector), not an algorithm or AI. Standalone performance as typically understood for AI or image processing algorithms is not applicable here. Its performance is inherent in its image acquisition capabilities.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable/Not specified. The assessment appears to be based on engineering specifications and adherence to standards, rather than direct comparison to a clinical ground truth for diagnostic accuracy. For a digital X-ray detector, ground truth often involves phantoms and objective image quality metrics (e.g., Modulation Transfer Function, Detective Quantum Efficiency) rather than clinical diagnostic outcomes. However, such detailed performance data is not provided here. The implicit "ground truth" for showing equivalence is the established performance of the predicate devices.
7. The sample size for the training set:
* Not applicable/Not specified. This device is not an AI or machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established:
* Not applicable/Not specified. As above, there is no training set for this type of device.
Summary of "Proof" in the 510(k):
The "proof" in this 510(k) summary for the ATLAS Digital X-Ray Detector is primarily based on:
- Comparison to Predicate Devices: Demonstrating that its intended use, technological characteristics, and performance specifications are substantially equivalent to those of two already-cleared predicate devices (Xaminer and QXR-9). Where differences exist (e.g., higher Nyquist resolution, greater bit depth, lighter weight, slightly different fill factor), they are presented as either improvements or not raising new safety or effectiveness concerns.
- Adherence to Standards: Compliance with relevant international safety and quality management standards (e.g., EN ISO 14971, EN/IEC 60601 series, ISO 13485).
- Bench and Laboratory Testing: The conclusion mentions "analyzing both bench as well as laboratory testing to applicable standards." While details of these tests are not provided in the summary, this indicates that the device underwent engineering and performance verification against technical benchmarks to ensure it met its specifications and safety requirements.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.