(332 days)
The HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.
The new MODEL HF 718BD X-RAY SYSTEM is a stationary x-ray system for imaging of peripheral extremities. The new MODEL HF 718BD X-RAY SYSTEM is based on the predicate Model 715BD Series X-Ray System. The modifications to the Model 715BD Series X-Ray System to create the new MODEL HF 718BD X-RAY SYSTEM are summarized as:
- The analog high voltage power supply in the predicate Model 715BD Series is replaced by a high-frequency high-voltage power supply in the new MODEL HF 718BD X-RAY SYSTEM.
- The line frequency counting technology of the exposure timer in the predicate Model 715BD Series is replaced by a crystal controlled digital exposure timing system in the new MODEL HF 718BD X-RAY SYSTEM.
- The current technique factors are moderately decreased from fixed 15 mA to fixed 10 mA in the new MODEL HF 718BD X-RAY SYSTEM.
- The voltage display on the predicate Model 715BD is an analog meter. With the new MODEL HF 718BD X-RAY SYSTEM, the user sets the kV and exposure time (can be stored as a user preset) and the pre-set values are presented to the user on a digital display.
The Source to Detector distance for the new MODEL HF 718BD X-RAY SYSTEM is 29 inches, which is identical to the predicate Model 715BD. In addition to the exposure control microcontroller in the predicate Model 715BD Series, an additional microcontroller is applied in the power supply to receive communication of kV by the xray control unit in the new MODEL HF 718BD X-RAY SYSTEM.
The provided document describes the acceptance criteria and study for the X-Cel X-Ray Corporation's HF 718BD X-Ray System. The submission is a 510(k) premarket notification, indicating the device is being deemed substantially equivalent to a legally marketed predicate device rather than undergoing a de novo approval process with extensive clinical trials. Therefore, the "acceptance criteria" here largely refer to demonstrating conformance to safety and performance standards relevant to X-ray systems, and "device performance" refers to its technical specifications and compliance with these standards, not clinical diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on predicate device equivalence and regulatory standards) | Reported Device Performance (HF 718BD X-Ray System technical characteristics) |
|---|---|
| Indications for Use: General purpose peripheral radiographic applications. | Indications for Use: Intended for use by qualified clinicians for the x-ray of hands and feet. (Equivalent to predicate, with added specificity for 'peripheral' as hands and feet). |
| Tube: Same as predicate. | Tube: Same. (Identical) |
| Tube Housing Assembly: Same as predicate. | Tube Housing Assembly: Same. (Identical) |
| Controller: Firmware exposure control. | Controller: Firmware exposure control. (Identical) |
| Display: Analog knob & numeric keypad. | Display: Touch Screen. (Similar, increased flexibility) |
| Exposure Timer: Firmware with AC line timing. | Exposure Timer: Firmware with crystal timing. (Similar, both methods set exposure time) |
| Orthoposer (Film Holder, Image Detector): Same as predicate. | Orthoposer (Film Holder, Image Detector): Same. (Identical) |
| High voltage Power Supply: Half wave rectified. | High voltage Power Supply: High frequency generator. (Similar, tested successfully to IEC 60601-1) |
| Beam Limiting Device: Same as predicate. | Beam Limiting Device: Same. (Identical) |
| High Voltage Setting: Pre-set by rotary control, 50kV to 70kV +/- 10%. | High Voltage Setting: Pre-set and by user entry, 50kV to 90kV +/- 10% adjustable in 2 kV steps. (Similar, both support preset kVp and time) |
| mA Setting: Fixed at 15mA. | mA Setting: Fixed at 10mA +/- 1%. (Similar, both support preset kVp and time) |
| Technique Factors Display: Analog display of Voltage and mA technique factors, Digital display of exposure time. | Technique Factors Display: Digital display of user-set Voltage and Exposure Time technique factors. (Similar, analog replaced by digital) |
| Exposure Timer Settings: User-defined exposure timer. | Exposure Timer Settings: Pre-set and user-defined exposure time settings. (Similar, additional feature of pre-sets) |
| Exposure Timer Display: Digital display of count of 60Hz line frequency of exposure. | Exposure Timer Display: Digital display of seconds of exposure. (Similar, modified display) |
| Power: 60Hz AC mains; 105 VAC to 130 VAC. | Power: 60Hz AC mains; 105 VAC to 130 VAC. (Identical) |
| Exposure Time: 0.10 to 3.0 seconds, +/- 10%, adjustable in steps. | Exposure Time: 0.050 to 0.500 seconds, +/- 10%, adjustable in steps. (Similar, high frequency generator allows shorter exposure time) |
| Source to Detector Distance: 29 inches. | Source to Detector Distance: 29 inches. (Identical) |
| Compliance with Regulatory Standards: Safety and effectiveness demonstrated through compliance with relevant standards. | Compliance with Regulatory Standards: Tested to and in compliance with standards including 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601-1 (3rd Ed), IEC 60601-1-2 (3rd Ed), IEC 60601-1-6, IEC 62304:2006, IEC 60601-2-54:2009, IEC 60601-3:2008, IEC TR 60878, EN ISO 14971, ISO 15223-1. |
| Software Validation: Ensure all design inputs and performance requirements are met. | Software Validation: Undergone software validation. |
| Performance Verification and Validation: Ensure all design inputs and performance requirements are met. | Performance Verification and Validation: Undergone performance verification and validation. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "This submission does not contain clinical data." Therefore, there is no clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for clinical performance evaluation. The "test set" in this context refers to non-clinical testing against engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical data was submitted, there was no ground truth establishment by experts for a clinical test set. The validation focused on engineering characteristics against standards.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring an adjudication method. Non-clinical testing involves comparing device output or characteristics against defined engineering specifications and standard requirements.
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. This device is an X-ray system, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray system, not an algorithm, and its performance (e.g., image generation) is inherently part of a human-operated system for image acquisition.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" was established by applicable regulations and standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601 series, ISO 14971) and engineering design inputs/performance requirements. The device was tested to ensure it met these established technical and safety benchmarks. There was no clinical ground truth (expert consensus, pathology, outcomes data, etc.) because no clinical data was presented.
8. The sample size for the training set
Not applicable. This is not an AI/ML device where a "training set" of data is used in the traditional sense. The device is a hardware X-ray system.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 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.