(491 days)
- The DRS system of the "Uniscan" model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position.
- The DRS system of the "Pulmoscan" model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor examination with the purpose of early diagnostics of the thorax organs.
- The DRS system of the "Pulmoscan-T" model is a mobile specialized-purpose diagnostic system, particularly, for mass examination (screening) of wide groups of population directly at the places of their maximum concentration (in educational institutions and at enterprises), in remote areas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purpose of early diagnostics of the thorax organs.
The principal of functioning of the DRS system is based on:
- generation of highly stable low-energy X-ray radiation (from 40 up to 150 keV) with controllable parameters (voltage, current, time, exposure duration) by means of an X-ray source connected to the X-ray power supply unit;
- formation of a flat narrow with the width D fan-shaped X-ray beam with the possibility of masking according to the radiation angle a by means of the adjustable diaphragm;
- adjustment of the area of the patient's body to be examined (input dimensions A B) by scanning with a flat X-ray beam in the field of the scanning angle b with the possibility of specifying and visual control of the scanning (exposure) field;
- magnification of the planar X-ray image of the patient with the specified enlargement by projecting it to the scanning X-ray detector located at a considerable distance from the patient;
- obtaining the digital X-ray image of the area to be examined by means of the scanning X-ray detector (on the basis of a linear matrix multiclement semiconductor detector), converting the absorbed X-ray radiation into digital form;
- formation of the two-dimensional digital projection image on the computer monitor with the possibility of manipulation and archiving by means of the special software
The acceptance criteria for the "Pulmoscan," "Uniscan," and "Pulmoscan-T" Digital Radiographic Systems are not explicitly detailed in the provided text as specific performance metrics and their corresponding thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, performance standards, and electrical safety.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the acceptance criteria are met by demonstrating similarity to the predicate device, the Siemens Multix FD and Thorax FD Stationary X-Ray System (K983732).
| Characteristic | Acceptance Criteria (Predicate Device K983732) | Reported Device Performance ("Pulmoscan," "Uniscan," and "Pulmoscan-T") |
|---|---|---|
| Intended Use: | 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. | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical safety | Electrical Safety per Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment, CE Marking Requirements | SAME |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench and user testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document states "user testing" but does not specify the number or qualifications of experts involved in establishing ground truth for the test set. Given the nature of the submission for substantial equivalence based on technical specifications and safety rather than a clinical performance study with diagnostic endpoints, a formal "ground truth" establishment by experts in the typical sense of AI/diagnostic device validation studies is not described.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1) for establishing ground truth is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with and without AI assistance or evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in this context. The device's performance is inherently tied to its function as a diagnostic imaging system operated by trained personnel.
7. The Type of Ground Truth Used:
Given that this is a 510(k) submission for an X-ray system relying on substantial equivalence, the "ground truth" typically refers to the established safe and effective performance of the predicate device. The new device is deemed acceptable because it performs equivalently on safety and technical characteristics. There is no mention of ground truth established through expert consensus, pathology, or outcomes data in the context of a new diagnostic claim.
8. The Sample Size for the Training Set:
This question is not applicable. The device is a radiographic system, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for this type of device.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is summarized as "bench and user testing." The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices."
The conclusion further reiterates: "After analyzing both bench and user testing data, it is the conclusion of Medlink Imaging that the 'Pulmoscan,' 'Uniscan,' and 'Pulmoscan-T' Radiographic Systems are as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."
While the details of these tests are not provided in the summary, they would have focused on verifying that the "Pulmoscan," "Uniscan," and "Pulmoscan-T" systems met the same technical specifications, safety standards (21 CFR 1020.30, UL standards, IEC standards), and produced images comparable in quality and diagnostic utility to the Siemens Multix FD and Thorax FD systems.
§ 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.