(52 days)
The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.
The XR5 diagnostic X-ray system is used for image capture by using X-rays on a patient's body. The XR5 is a conventional X-ray machine, with an intuitive operation console to provide the user an easy way to manage optimal conditions for quality images. The high frequency generator is capable of delivering the exposition dose appropriate for general X-ray and diagnostic images of a patient. This system is made to use other detector options including: conventional films, CR, or Digital Flat Panel Detectors. Please note that the quality of the image in any detector depends on the manufacture of the receptor device. The XR5 diagnostic X-ray system doesn't provide an AEC feature.
The provided text describes the OSKO, INC. XR5 Diagnostic X-ray System, which is a conventional X-ray machine. However, the document (a 510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion by Siemens Medical Solutions USA, Inc.) rather than outlining specific acceptance criteria or a dedicated study proving the device meets those specific acceptance criteria in terms of clinical performance metrics.
Instead, the document emphasizes:
- Technical equivalence: Comparing specifications like generator type, image acquisition methods, and the use of FDA-cleared digital detectors.
- Compliance with safety and electrical standards: Referencing IEC 60601-1, IEC 60601-2-54, and EN60601-1-2.
- Performance of individual components: The digital detectors are evaluated based on DQE, MTF, and line resolution, with these parameters serving as indicators of their performance.
Therefore, many of the requested items (e.g., specific acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) are not detailed in this type of regulatory submission, as it's not a clinical performance study report for diagnostic accuracy of the overall system.
Here's an attempt to answer the questions based only on the provided text, with many fields explicitly stated as "Not Applicable" or "Not Provided" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define specific "acceptance criteria" for diagnostic performance of the overall XR5 system as a diagnostic device (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technical specifications and performance of key components (digital detectors). The "reported device performance" primarily refers to the technical specifications and the performance metrics of the digital detectors used with the system.
| Acceptance Criteria Category (Implied by document) | Specific Criteria (from document) | Reported Device Performance (XR5 / Digital Detectors) |
|---|---|---|
| System Functionality | General X-ray and diagnostic imaging of all body parts for adult and pediatric patients. | The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts. Operated by a qualified/trained doctor or technician. Designed to be used with conventional film/screen, CR cassettes, or digital detectors. |
| Safety Standards Compliance | Compliance with IEC 60601-1; 2005 + A1 (2012) and IEC 60601-2-54; Edition 1.0.2009. Applicable EMC requirements (EN60601-1-2:2007 / AC : 2010). | "The XR5 diagnostic X-ray system has been tested in accordance with Safety standard of IEC 60601-1; 2005 + A1 (2012) and IEC 60601-2-54; Edition 1.0.2009. The test reports have shown good performance, substantially equivalent to the predicate device. The XR5 has also met applicable Electro Magnetic Compatibility (EMC) requirements; EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007)." |
| Digital Detector Performance (Component Level) | Evaluation according to IEC 62220-1:2003 Standard (for DQE, MTF, line resolution). | MTF @ 3.5 lp/mm: 1717SCC (K122173): 13%, 1417WCC (K141566): 12.1%, FLAATZ600 (K132842): 50.02%. |
| DQE @ 0 spatial frequency: 1717SCC: 54%, 1417WCC: 76.7%, FLAATZ600: 50%. | ||
| Line resolution: Similar between 3.0~3.5 lp/mm for all listed detectors. | ||
| Software Validation | Firmware validation testing to verify risk analysis and individual performance results within predetermined acceptance criteria. | "The complete system configuration including the firmware function has been assessed and tested by the manufacturer and passed all in-house testing criteria. The firmware validation test was designed to evaluate for the X-ray system including X-ray exposure control and exposure switch performed by XR5. ... individual performance results were within the predetermined acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided. The document states that "Bench performance parameters for the digital detectors are sufficient to demonstrate substantial equivalence to a predicate device" and that "Clinical images are not necessary to establish substantial equivalence based on the previously FDA cleared detectors." This implies that a formal clinical test set with a specific sample size for diagnostic performance was either not conducted or not deemed necessary for this 510(k) submission.
- Data Provenance: Not provided for any clinical data. Non-clinical performance data for the detectors references the IEC 62220-1:2003 Standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. No clinical test set to establish ground truth for diagnostic accuracy is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set for diagnostic accuracy is described.
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
Not applicable/Not provided. This device is a conventional X-ray system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a conventional X-ray system, not an algorithm, and no standalone performance study in this context is mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable/Not provided for diagnostic accuracy of the overall system. The document does not describe the establishment of clinical ground truth for diagnostic accuracy for the XR5 system itself. For the digital detectors, their performance metrics (DQE, MTF, line resolution) are physics-based measurements rather than clinical ground truth on patient outcomes.
8. The sample size for the training set
Not applicable/Not provided. This device is a hardware X-ray system, not an AI algorithm requiring a training set. The firmware is "programmed with ANSI C language," suggesting traditional software development and testing rather than machine learning training.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, this device is a hardware X-ray system; no training set for an AI algorithm is mentioned.
§ 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.