(14 days)
Models SP-HF-2.8 and SP-HF-4.0 are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held.
The provided document describes the safety and effectiveness summary for two portable X-ray units, Models SP-HF-2.8 and SP-HF-4.0. The study's acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device, the MinXray HF100H.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally understood to be that the new devices (Models SP-HF-2.8 and SP-HF-4.0) perform as safely and effectively as the predicate device (MinXray HF100H) and present no new indications for use or significant technological differences that would raise new questions of safety or effectiveness. The document achieves this by comparing technical specifications and intended use.
| Characteristic | Acceptance Criteria (Predicate Device: MinXray HF100H) | Reported Device Performance (Models SP-HF-2.8 & SP-HF-4.0) | Meets Acceptance Criteria? |
|---|---|---|---|
| Intended Use | Portable general purpose diagnostic X-ray unit | SAME (Models SP-HF-2.8 and SP-HF-4.0 are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.) | Yes |
| Physical Characteristics: | |||
| Size | 8.75"H x 9.5" W x 15.35" D. | 8.7"H x 10.4" W x 16.5" D | Yes* |
| Weight | 40.9 lbs | 33 lb | Yes* |
| Energy Source | 120 V 50-60~ AC | 90 to 285 VAC (50-60 Hz) | Yes* |
| User Interface | Up-Down pushbuttons for three kVp selections and exposure time selections with LED indicators | Up-Down pushbuttons for kVp and mAs. kVp adjustable in 1 kVp steps | Yes* |
| Exposure times | 0.08-2.00 Sec. In 192 steps | SP-HF-2.8: 0.002-10 sec 38 steps | |
| SP-HF-4.0: 0.001-10 sec 41 steps | Yes* | ||
| Ma. | 20 mA | SP-HF-2.8: 5, 6.4, 8, 10, 12.5, 16, 20, 25, 32, 40, 50 | |
| SP-HF-4.0: 5, 6.4, 8, 10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100 | Yes* | ||
| KvP | 100 KvP | SP-HF-2.8: 110 KvP | |
| SP-HF-4.0: 115 KvP | Yes* | ||
| Standards & Safety Characteristics: | |||
| Performance Standard | 21 CFR 1020.30 | SAME | Yes |
| Electrical safety | UL 2601, IEC 60601-1 | SAME | Yes |
| Overall Safety and Effectiveness | "as safe and effective as the predicate device" | "the Models SP-HF-2.8 and SP-HF-4.0 are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." | Yes |
Note: For the physical and operational characteristics (Size, Weight, Energy Source, User Interface, Exposure times, Ma., KvP), the acceptance criteria are not explicitly stated as strict numerical equivalence. Instead, "substantial equivalence" is being claimed, meaning the differences are not considered to raise new questions of safety or effectiveness. The new devices often show improvements (e.g., wider range of mAs/kVp, lower weight) or minor variations that are deemed acceptable and within the scope of the predicate device's intended use.
2. Sample size used for the test set and the data provenance
The document states that "bench and user testing" was performed. However, there is no specific sample size provided for the test set. The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "user testing" but does not specify the number or qualifications of experts used to establish ground truth. Given the nature of the device (portable X-ray unit) and the era of the submission, "user testing" likely refers to evaluations by technicians or qualified medical personnel regarding the device's operational aspects and image acquisition capabilities rather than diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth from the "user testing."
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 MRMC comparative effectiveness study was done or reported. This device is a portable X-ray unit, not an AI-powered diagnostic tool. The comparison is between the new X-ray unit and a predicate X-ray unit, focusing on technical specifications and overall safety/effectiveness in producing images, not on human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone algorithm performance study was done or reported. This is a hardware device for image acquisition, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of a "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, expert consensus on disease presence) is not applicable or described in this 510(k) summary. The "ground truth" for this submission revolves around the technical performance metrics of the X-ray unit (e.g., kVp, mA, exposure times, safety standards) and whether it can produce diagnostic-quality images, implicitly judged during "user testing." The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device based on its technical specifications and intended use.
8. The sample size for the training set
Not applicable. This submission is for a medical device (X-ray unit) that does not involve machine learning or AI algorithms requiring a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not utilize 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.