(170 days)
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
- Tube head
- SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
- Touchscreen operator console.
- Modified brake mechanism for wheels
- Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices.
The provided text does not contain information about specific acceptance criteria or an internal study demonstrating that the device meets those criteria. Instead, it focuses on the device's substantial equivalence to predicate devices, compliance with regulatory standards, and summarizes non-clinical performance data.
Therefore, I cannot populate the table of acceptance criteria or provide details about a study proving the device meets acceptance criteria as described in your request. The document explicitly states that "clinical studies are not required" for this submission, further indicating the absence of a study focused on proving specific performance metrics against pre-defined acceptance criteria in a clinical setting.
However, I can extract information related to the device's performance, testing, and ground truth establishment in a general sense based on the provided text, especially concerning the evaluation of the flat panel detectors which are a key component.
Here's an analysis of what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, explicit acceptance criteria are not presented in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to various electrical, safety, and image quality standards (DQE, MTF).
| Acceptance Criteria (Not explicitly stated as such, but derived from performance evaluations) | Reported Device Performance (Subject Device) |
|---|---|
| Detective Quantum Efficiency (DQE) of Digital Panel | Paxscan 4336Wv4: 0.242 @ 1cycle/mm, 0.125 @ 2cycles/mm, 0.04 @ 3cycles/mm |
| CareView1500P: ~65% @ (0 lp/mm), ~20% @ (3 lp/mm) | |
| Modulation Transfer Function (MTF) of Digital Panel | Paxscan 4336Wv4: 0.521 @ 1cycle/mm, 0.206 @ 2cycles/mm, 0.08 @ 3cycles/mm |
| CareView1500P: ~70% @ (1 lp/mm), ~40% (@2 lp/mm), ~22% (@3 lp/mm) | |
| Image Quality (Readability by Radiologist/Radiographer) | "Images were of good quality which were easily read by the radiologist" |
| Electrical Safety | Complies with IEC-60601, IEC-60601-1-2, IEC-60601-1-3, IEC-60601-2-54, IEC-60601-2-28, IEC 60601-1-6 |
| Electromagnetic Compatibility (EMC) | Complies with IEC-60601-1-2 |
| Software Life Cycle Processes | Complies with IEC 62304:2006 |
| Risk Management | Complies with ISO 14971:2012 |
| Exposure Index of Digital X-ray systems | Complies with IEC 62494-1 |
| Determination of Detective Quantum Efficiency | Complies with IEC 62220-1-1 |
| Digital Imaging and Communications in Medicine (DICOM) | Complies with NEMA PS 3.1 - 3.20 (2016) and supports DICOM |
| Radiation Dose Documentation | Complies with IEC 61910-1 |
| Characteristics of Focal Spots | Complies with IEC 60336 |
| Determination of quality equivalent filtration and permanent filtration | Complies with IEC 60522:1999 |
| Biological evaluation of medical devices | Complies with ISO 10993-1:2009 |
| Information supplied by the manufacturer of medical devices | Complies with EN 1041:2008+A1:2013 |
| Medical devices - Symbols to be used with medical device labels | Complies with ISO 15223-1 |
| Performance Testing of Shipping Containers and Systems | Complies with ASTM D4169-16 |
| Performance Standard for Radiation Safety for Diagnostic X-Ray Systems | Complies with 21 CFR 1020.30 and 1020.31 |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of images/patients.
- Data Provenance: Not specified. It mentions testing was done "both in-house and by outsourcing to appropriate third-party vendors." The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that "The quality of the images obtained from the subject devices were analysed by a radiographer and a radiologist and it was found the images were of good quality which were easily read by the radiologist".
- Number of experts: At least one radiographer and at least one radiologist ("a radiographer and a radiologist").
- Qualifications: "radiographer" and "radiologist." No specific years of experience are mentioned.
4. Adjudication method for the test set:
- Not specified. The text simply says "analysed by a radiographer and a radiologist." It does not describe a formal adjudication process (e.g., 2+1, 3+1).
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. The device described is a mobile X-ray system, not an AI-assisted diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is an X-ray imaging system, not an algorithm for image interpretation. The "software/firmware" described primarily controls the operation of the device and integrates with image acquisition software.
7. The type of ground truth used:
- For image quality, the ground truth was "expert consensus" implicitly, as it was determined by the analysis of a radiographer and a radiologist who found the images to be of "good quality" and "easily read."
- For technical specifications (DQE, MTF, electrical safety, etc.), the "ground truth" or reference was compliance with various international standards (IEC, ISO, NEMA, ASTM, 21 CFR).
8. The sample size for the training set:
- Not applicable. The document discusses a physical X-ray device and its control software. There is no mention of a "training set" for an AI or machine learning algorithm. The software development "has been executed as per the requirements of ISO 62304" and undergone "software validation & verification," not machine learning training.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm mentioned.
§ 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.