(88 days)
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists.
Indication:
The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts.
The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device must be used for stand mounted imaging of the chest.
Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Contraindication:
The use of X-radiation for diagnostic purposes in the following subjects is contraindicated.
- Pregnancy, especially first trimester
The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.
The provided text describes a 510(k) premarket notification for a mobile X-ray system named "AirRay" (K222896). The submission focuses on demonstrating substantial equivalence to a predicate device (TR90BH, K182207) primarily through comparisons of technical characteristics and compliance with recognized standards.
Based on the provided document, here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance with corresponding "reported device performance." Instead, it focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with electrical safety, EMC, and software validation standards.
The most relevant "performance" aspects discussed are technical specifications compared to a predicate device. If we were to infer "acceptance criteria" from the comparative table (Table 1. Comparison of Proposed Device to Predicate Devices on page 11) and the summary of non-clinical tests, it would revolve around meeting safety and essential performance standards.
| Acceptance Criteria (Inferred from non-clinical tests & predicate comparison) | Reported Device Performance (as stated) |
|---|---|
| Electrical Safety Compliance | "The AirRay complies with the electrical safety and electromagnetic compatibility requirements established by the standards." |
| (Specifically: IEC 60601-1:2005/AM1:2012, IEC 60601-1-3:2008+AMD:2013, IEC 60601-2-54:2009/AM2:2018, IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+AMD:2013, IEC 60601-1-6:2010+AMD1:2013) | |
| Electromagnetic Compatibility (EMC) Compliance | "The AirRay complies with voluntary standards for electromagnetic compatibility." |
| (Specifically: IEC 60601-1-2:2014) | |
| Software Validation | "The software was designed and developed according to a software development process and was verified and validated." |
| (Specifically: IEC 62304:2006, FDA guidance "The content of premarket submissions for software contained in medical devices, on May 11, 2005") | |
| Battery Performance | "Rechargeable Li-ion polymer battery pack has been tested and is in conformity with the standard IEC 62133." |
| "And we performed the battery performance test about battery charging time. discharge time and usage count, Battery rated load, overcurrent protection and recovery." | |
| Radiation Safety | Conforms to "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use," 21 CFR 1020 Subchapter J, 21 CFR 1020.30, 21 CFR 1020.31. |
| Intended Use | Similar to predicate device, not introducing a new intended use. (Pages 10-11) |
| Technical Characteristics | "Similar" or "Same" as predicate device for key parameters like Tube Voltage Range, HF Generator, Memory settings. "Similar" for Output Power, Size, Weight, Energy Source, Exposure Times. "Different" for X-ray Tube and Collimator, but not deemed to adversely affect safety or effectiveness. (Pages 10-11) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" of patient data for evaluating the diagnostic performance of the X-ray unit. The submission appears to rely on non-clinical (engineering and safety) testing and comparison to a predicate device to establish substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set with ground truth established by experts is described in this document.
4. Adjudication method for the test set
Not applicable. No clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this document. The submission focuses on the safety and technical characteristics of the X-ray generation device itself, not on the interpretation of images produced by it, or the comparative diagnostic accuracy of human readers with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device, "AirRay," is a portable X-ray unit, which generates X-rays for diagnostic imaging. It is a hardware device, not an AI algorithm for image analysis. Therefore, a standalone performance assessment of an algorithm is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this submission focuses on the X-ray generating device and not on a diagnostic algorithm, there's no mention of ground truth related to image interpretation. The "ground truth" here would be that the device meets its technical specifications and safety standards as verified through engineering tests.
8. The sample size for the training set
Not applicable. The AirRay device is hardware (an X-ray unit), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As clarified in point 8, this is a hardware device and does not involve AI algorithms requiring a training set.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.