(40 days)
The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.
The UC-5000 Mobile X-Ray consists of an X-ray generator, continuously adjustable light beam collimator, mounting arm, exposure cord with exposure switch, and AC power cord. This is a high-frequency generator of updated design. Light Weight (no batteries) No Special Power Requirements (115/220 VAC Power Input) High Frequency 5.0 kW Generator with Closed loop regulation Digital Displays: kVp, mA, mAs & exposure time. Optionally available with the system is an FDA cleared digital panel and software combination.
The provided text describes a 510(k) premarket notification for a mobile X-ray system (UC-5000 Mobile X-Ray) and seeks to prove its substantial equivalence to a predicate device (PowerMax 1260 Portable X-Ray System). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute performance or clinical efficacy against specific disease outcomes.
Therefore, the "acceptance criteria" and "study" described are focused on proving substantial equivalence to the predicate device, not on meeting specific performance metrics for an AI algorithm or clinical diagnosis. The information provided is primarily related to the device's technical specifications and compliance with safety standards.
Let's address each point based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly related to demonstrating that the UC-5000 is substantially equivalent to the predicate device (PowerMax 1260 Portable X-Ray System) in terms of safety and effectiveness, and that its technical specifications are comparable or improved within acceptable limits without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (UC-5000 Mobile X-Ray) | Comparison to Predicate (K090655 Model PowerMax 1260) |
|---|---|---|
| Intended Use (Same as predicate) | "The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammographic use." (Language added for CR/DR) | Similar, with added explicit mention of CR/DR compatibility ("Language added for CR/DR" on the UC-5000 side vs. "Not for mammographic use. Language later required by FDA" on the predicate). Both are for "General Purpose Radiographic applications." |
| Energy Source (Same as predicate) | "SAME" (120/220 V 50 – 60 Hz AC) | Identical |
| User Interface (Same as predicate) | "SAME" (Dedicated Touch Panel) | Identical |
| Control (Same as predicate) | "SAME" (Microprocessor) | Identical |
| HF Generator (Same as predicate) | "SAME" (30 kHz) | Identical |
| X-ray Tube (Same as predicate) | "SAME" (SXR-130-15-1.2; Stationary Anode, 130 kVp, Tungsten Target Material, 45,000 HU Storage Anode Capacity, 1.2 mm Focal Spot, 15° Target Angle) | Identical |
| Collimator (Same as predicate) | "SAME" (Collimare Model CPL-125-UC01-C) | Identical |
| Compliance with Performance Standards | "This device complies with all applicable performance standards under 21 CFR 1020.30 and 1020.31." | Identical claim for both predicate and new device regarding 21 CFR 1020.30 and 1020.31. |
| Compliance with Safety Standards | "IEC 60601-1: 2005 ANSI Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", "IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and test" | Both predicate and new device comply with the listed IEC 60601-1 and IEC 60601-1-2 standards (note: predicate listed 2005 version for 60601-1 and new device listed 2014 version for 60601-1-2, but the document states "SAME", implying continued compliance with the relevant versions). |
| Size / Weight (Comparable, but allows for differences) | 340 lb., 154.2 KG | Significantly different: Predicate is 110 lbs. / 50 kG. This is a clear difference, but likely addressed by the "Mobile X-ray system" classification and overall safety/effectiveness assessment. |
| Exposure Times (Comparable or acceptable range) | .01 - 5.00 sec | Slightly different: Predicate is 0.01 - 3.33 sec. New device has a longer maximum exposure time. |
| mA Range (Comparable or acceptable range) | 10 - 50 mA | Slightly different: Predicate is 12.5-60 mA. New device has a lower minimum and maximum mA. |
| kW (Comparable or acceptable range) | 5.0 kW | Improved: Predicate is 3 kW. New device has higher power. |
| kVp (Comparable or acceptable range) | 40 - 110kVp 41 steps | Slightly different: Predicate is 40 - 120kVp 80 steps. New device has a lower maximum kVp and fewer steps. |
| CR/DR Compatible | YES (with OPTIONAL computer, panel, and software: Flat Panel: ViZion DR Panel 14 x 17 Wireless, Viztek (K152279), Software: Opal Rad Imaging Software Viztek also cleared in K152279. Features: Window / Level; Image Preview; DICOM Print / Store; Fast Image Processing; (image displayed within 3 seconds); Computer: 20" All-In-One Tabletkiosk PC (TAIO20T) with Touch Screen) | Both are "YES". The new device explicitly details the optional digital components, which are themselves apparently FDA-cleared (K152279). This represents an enhancement rather than a fundamental change to the X-ray system itself. |
| Safety and Effectiveness Verification | "The results of bench testing, safety agency testing, risk analysis, and software validation indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation." | This is the overall conclusion of the substantial equivalence justification. The non-clinical testing results support this. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: This submission does not involve a "test set" in the context of an AI algorithm or a clinical study with patient samples. The testing conducted was non-clinical bench testing, safety agency testing, and software validation. There is no mention of a traditional "test set" size as one would describe for an algorithm performance study.
- Data Provenance: Not applicable. The testing described is performance testing of the device hardware and software, not data collected from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This is a 510(k) submission for an X-ray device, not an AI algorithm requiring expert ground truth for interpretation of medical images. The "ground truth" for this device's performance is its adherence to internal specifications and external safety/performance standards, verified through engineering tests.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set requiring adjudication in this context.
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
- No. This submission is for an X-ray device, not an AI-assisted reading tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is an X-ray device, not a standalone algorithm. While it mentions optional digital imaging components (panel and software), these are themselves FDA-cleared components (Viztek K152279) presumably validated separately. The focus here is on the X-ray generator and mobile system.
7. The Type of Ground Truth Used
- The "ground truth" for this device's substantial equivalence claim is multi-faceted:
- Compliance with recognized electrical safety and performance standards: IEC 60601-1, IEC 60601-1-2, and 21 CFR 1020.30/1020.31.
- Bench testing results: Measurements of kVp calibration, mA calibration, timer tests, mAs display, Half Value Layer, reproducibility, linearity, radiation leakage, collimator light illuminance and alignment, and X-ray field coverage.
- Software validation: Ensuring the software functions as intended and meets design specifications.
- Risk analysis: Identifying and mitigating potential hazards.
- Comparison to the predicate device's established performance and safety.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no training set for an AI algorithm in this context. The "ground truth" for the device's development and testing involved engineering specifications, design inputs, and regulatory standards.
§ 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.