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The DMX is a radiographic system used in hospitals, clinics, and medical practices. The DMX enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The DMX is not meant for mammography. The DMX can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The DMX is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes

The DMX System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy.

The DMX System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography.

The DMX System typically includes a tube support, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide autotracking of the tube crane based on the position of the radiographic table or wall stand.

The provided text describes a medical device, the DMX radiographic system, and outlines its substantial equivalence to a predicate device, the OTC12D Auto. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm's performance. The document is a 510(k) summary for an X-ray system, focusing on its safety, effectiveness, and substantial equivalence to an existing device for general radiographic imaging.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving an AI device meets them. The document primarily discusses the physical components and regulatory compliance of a conventional X-ray system.

To answer your request, here's what could be inferred if this were an AI device undergoing a performance study:

1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not contain any acceptance criteria or reported device performance for an AI/ML algorithm. The tables in the document compare components and general functionality of the DMX system to its predicate, not performance metrics like sensitivity or specificity for diagnosis.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a test set or data provenance for an AI/ML algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document does not describe the establishment of a ground truth for an AI/ML algorithm.

4. Adjudication Method for the Test Set:
Not applicable. The document does not describe a test set or adjudication method for an AI/ML algorithm.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The document does not mention an MRMC study or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. The document does not mention a standalone performance study for an AI/ML algorithm.

7. Type of Ground Truth Used:
Not applicable. The document does not describe the type of ground truth for an AI/ML algorithm.

8. Sample Size for the Training Set:
Not applicable. The document does not describe a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. The document does not describe how ground truth was established for a training set for an AI/ML algorithm.

In summary, the provided FDA 510(k) summary for the DMX X-ray system focuses on the substantial equivalence of its hardware and general functionality to a predicate device. It does not contain any information related to the performance evaluation or clinical studies of an AI/ML device.

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The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.

This document describes the Huntleigh Healthcare Ltd DMX/SRX Handheld Doppler and Probes, and its substantial equivalence to predicate devices. It focuses on engineering and performance verification, rather than clinical studies with acceptance criteria in the context of device performance metrics like sensitivity or specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the DMX/SRX Handheld Doppler, especially in comparison to clinical outcomes. Instead, it details various engineering and regulatory compliance testing.

The document states that "The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use." This implies that the acceptance criteria are met if the new device demonstrates similar performance and safety characteristics as the legally marketed predicate devices through the conducted verification and validation tests.

Below is a table summarizing the types of testing performed, which serve as the basis for demonstrating equivalence and meeting "acceptance criteria" in a broad sense for a 510(k) submission:

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