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510(k) Data Aggregation
(97 days)
The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions.
This document is a 510(k) summary for a Combined High Frequency X-ray Source (Model: PSM-PD series). It describes the device, its intended use, and a comparison to a predicate device (Sedecal SPL-HF-4.0 and SPL-HF-2.0, K103522) to demonstrate substantial equivalence.
The content focuses on the technical specifications and safety performance of the X-ray source itself, rather than the diagnostic accuracy of an AI-powered medical image analysis device. Therefore, a study demonstrating device performance against specific clinical acceptance criteria, as one would expect for an AI algorithm, is not present in this document.
The "device" in this context is an X-ray generator, a component of an X-ray system. The performance data presented (electrical safety, EMC, software V&V, mechanical/acoustic testing) are engineering validation tests to ensure the hardware and its embedded software function correctly and safely, and meet relevant industry standards. They are not clinical studies for diagnostic accuracy.
Therefore, for aspects relevant to AI-powered medical image analysis (like sample size, ground truth establishment by experts, MRMC studies, standalone performance), the document states "Clinical images are not necessary to demonstrate substantial equivalence, based on the nature of the device (an x-ray generator) and on close similarities to the predicate system. Successful Bench Testing results should be sufficient to show device safety and effectiveness."
Here's a breakdown based on your request, highlighting what is (and isn't) available in this document given the nature of the device:
Acceptance Criteria and Device Performance (as an X-ray Source)
The acceptance criteria are not explicitly listed in a single table but are implied by the performance requirements and standard compliance mentioned. The "reported device performance" is essentially the statement of compliance with these standards and the verification that the device meets its design specifications.
Table of Acceptance Criteria (Implied from Performance Requirements) and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-54. | The device complies with IEC 60601-1, IEC 60601-1-3, and IEC 60601-2-54 standards. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | The device complies with IEC 60601-1-2 standard for EMC. |
| X-ray Tube Voltage | Regulation Range: 40kV~125kV, 1kV step size, tube voltage can be set according to power. | PSM-PD5.6CPL/CPLG, PSM-PD5.6CPE/CPEG, PSM-PD4CPL/CPLG, PSM-PD4CPE/CPEG, PSM-PD3.5CPL/CPLG, PSM-PD3.5CPE/CPEG all have a tube voltage regulation range of 40kV~125kV. |
| Deviation: ±(3%+1kV) | Verified by third-party registration testing to meet requirements. (Implicitly within this deviation). | |
| X-ray Tube Current | Regulation Range: (Model-dependent) PSM-PD3.5CPL/CPLG: 5-63mA; PSM-PD4CPL/CPLG: 5-80mA; PSM-PD5.6CPL/CPLG: 5-100mA. Increasing according to R'20 number system (specific data listed). | The stated ranges are the device's performance. The R'20 number system is used. |
| Deviation: ±(4%+1mA) | Verified by third-party registration testing to meet requirements. (Implicitly within this deviation). | |
| Loading Time | Regulation Range: 1ms~10000ms, increasing according to R'20 number system (specific data listed). | The stated ranges are the device's performance. The R'20 number system is used. |
| Deviation: not greater than ±(2%+0.2ms) @ >5ms; ±(5%+1ms) @ $\le$5ms. "controlled within the scope of the international standard requirements." | Verified by third-party registration testing to meet international standard requirements. | |
| Current Time Product (mAs) | Regulation Range: 0.1-320mAs, increasing according to R'20 number system (specific data listed). | The stated ranges are the device's performance. The R'20 number system is used. |
| Deviation: ±(5%+0.1mAs) | Verified by third-party registration testing to meet requirements. (Implicitly within this deviation). | |
| Operating Frequency | Maximum operating frequency: 300kHz ±20kHz. | The device performance is 300kHz ±20kHz. |
| Functional Requirements | Exposure technology modes (mA/ms, mAs, mAs/ms), Fault diagnosis and prompt (active handbrake release error, oil tank temperature exceed limit error). | Device has mA/ms, mAs, mAs/ms modes. System prompts for handbrake release during exposure and oil tank over-temperature. |
| Software V&V | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern "Moderate" (failure could indirectly result in minor injury). Software functions: basic data configuration, exposure parameter setting (mode, filament, tube voltage, current, loading time, mAs), information indication and fault prompt. | Software verification and validation testing were conducted, and documentation was provided. Verified by internal tests and third-party registration tests to meet requirements of clinical application. |
| Cybersecurity | Data interface: RS-232 output for communication. Evaluation for cybersecurity. | Device has an RS-232 interface. "The subject device have been tested and evaluated for cybersecurity." |
| Mechanical/Acoustic Testing | Acoustic Testing, Elongation of bending cable, Crimp assembly, cable tensile strength, cable flexibility, minimum bending radius, simulated use testing. | These tests were conducted. (Implicitly, the device passed, though specific results are not detailed). |
| Other Operational Conditions | Temperature: 0 | The device is designed to operate within these ranges. |
Regarding the other specific points of your request for AI-powered device studies:
- Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of images.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not established for this device as it is an X-ray generator.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device does not involve AI assistance for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic accuracy. The "ground truth" for this device refers to physical and electrical specifications verified by bench testing and compliance with engineering standards.
- The sample size for the training set: Not applicable. This device is a hardware component with embedded control software, not a machine learning model that undergoes "training."
- How the ground truth for the training set was established: Not applicable.
In summary: This 510(k) submission for an X-ray source focuses on demonstrating substantial equivalence to a predicate device through detailed comparison of technical characteristics, safety standards compliance, and engineering validation (bench testing, software V&V, electrical and mechanical performance). It is not a clinical study assessing the diagnostic performance of an AI-enabled medical image analysis device. Therefore, many of the requested details regarding AI study design are not present in this document.
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