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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:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described (biocompatibility, software, hardware, safety, EMC, environmental) refers to engineering and quality assurance testing of the physical device and its software. Therefore, sample sizes for patient data or data provenance are not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The submission focuses on substantial equivalence through engineering and regulatory compliance testing, not clinical performance against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication in the clinical sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned as having been performed. The submission is for a handheld Doppler device and focuses on demonstrating substantial equivalence to predicate devices through technical and safety performance, not on AI-assisted interpretation or improvement for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The DMX/SRX Handheld Doppler is a medical device that provides direct physiological measurements (blood flow audio, waveforms, fetal heart rate, APPG pressures for DMX). While it has software and processing capabilities, it is not an "algorithm only" device in the sense of AI software for diagnostic interpretation. Its "performance" is inherently tied to human use (e.g., correctly positioning the probe, interpreting the audio/visual output).

7. Type of Ground Truth Used:

For the specified tests, the "ground truth" would be established by:

• Biocompatibility: Standardized test methods and controls as defined by ISO 10993-1.
• Software Performance: Requirements specifications and expected software behavior.
• Electronic Hardware/Mechanical Performance: Design specifications, engineering drawings, and functional requirements.
• Electrical Safety/EMC: Relevant IEC standards and their specified limits.
• Environmental Performance: Specified operating and storage conditions and their associated performance limits.

There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for these engineering verification tests.

8. Sample Size for the Training Set:

Not applicable. The DMX/SRX Handheld Doppler is not explicitly described as employing trainable machine learning algorithms. The testing relates to the device's inherent design and functionality, not a model trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set for machine learning is indicated.

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