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The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.

The Datrix E-Tac EX-1000 (here simply: EX-1000) Electrocardiographic [ECG] Event Recorder is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Lightweight and compact, the EX-1000 is designed to be as non-intrusive as possible to the patient, and can operate up for 30 days on two AAA alkaline batteries. The patient's ECG data are acquired via patient leadwires (two-lead, one-channel). At the onset of an event, the patient presses the [Record] button to store his or her ECG data in the recorder's flash memory. Events are recorded according to one of four user-selectable memory configurations. Up to two events may be recorded before transmission of the data to a compatible receiving station is required. The patient initiates data transmission via telephone by removing the patient leadwires and pressing the [Send] button, upon which the stored data are transmitted. A physician or other qualified medical professional reviews the transmitted data. Feedback on the EX-1000 recorder status is provided to the user (technician and/or patient) via a multi-colored LED and audible tones.

Here's an analysis of the Datrix E-Tac EX-1000 Electrocardiographic Event Recorder's acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Datrix E-Tac EX-1000 are implicitly defined by its compliance with recognized performance standards and its substantial equivalence to predicate devices, particularly regarding amplitude and timing (frequency) reproduction of ECG signals.

Additionally, a detailed comparison to predicate devices showed:EX-1000: Amplitude reproduction was not significantly different or better than all other devices in 20 of 24 cases, and not significantly different or better than at least one device in 3 of 24 cases.Only 1 of 24 cases showed significant difference for EX-1000: This occurred for a 2.0mV and 0.5 Hz input signal with measurements from EKG Speaks™ software. For the same signal with GEMS™ Lite, it was substantially equivalent to the King of Hearts Express.The overall conclusion was that the performance of the Datrix EX-1000 was substantially equivalent or better than the three predicate devices with regards to amplitude reproduction in nearly all combinations tested. |
| Compliance with Safety Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971 (General requirements for safety, electromagnetic compatibility, and risk management). | Met: The device has been tested and conforms to IEC 60601-1, IEC 60601-1-2, and ISO 14971. This indicates it meets safety, EMC, and risk management requirements. |
| Software firmware considered "minor level" of concern and in compliance with FDA guidance and design controls (21 CFR 820.30, FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", ISO 14971, "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management"). | Met: The firmware was designed, documented, and validated in accordance with required device Design Controls and considered "minor level" of concern. Risks were analyzed per FDA guidance. |
| Substantial Equivalence to Predicate Devices (Overall comparison of features, specifications, and performance). | Met: The study concluded that the Datrix E-Tac EX-1000 is substantially equivalent to other predicate ambulatory ECG event recorders currently in commercial distribution, based on direct comparisons of performance (amplitude and timing reproduction) and detailed specification breakdowns in the provided tables. The device demonstrated performance that was generally equivalent or superior to the predicate devices. |

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

• Sample Size: A total of 24 in-house simulated events were recorded. These 24 events were then transmitted twice each (2 x 24 = 48 transmissions) to two different receiving stations.
• Data Provenance: The data was in-house simulated, meaning it was generated under controlled laboratory conditions rather than collected from actual patients.

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state that human experts were used to establish ground truth for this performance testing.
• Instead, the ground truth was based on "known input signals." This implies that the amplitude and frequency characteristics of the signals fed into the devices were precisely defined and known beforehand due to their simulated nature.

4. Adjudication Method for the Test Set

• There was no explicit adjudication method described for the test set in the traditional sense (e.g., 2+1, 3+1).
• Since the study used "known input signals" as the ground truth, the comparison was directly between the device's output and these pre-defined, objective reference signals. Measurements were taken from printouts, implying direct quantitative comparison rather than a qualitative human assessment requiring adjudication.

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

• No MRMC comparative effectiveness study was done. This study focused on the technical performance of the device itself (measurement accuracy) rather than its impact on human reader performance or diagnosis. The ECG data transmission is for a physician or qualified medical professional to review, but the study did not evaluate human interpretation.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was evaluated. The study measured the ability of the EX-1000 (and predicate devices) to accurately reproduce amplitude and timing/frequency of known input signals without human interaction in the measurement process (beyond setting up the simulation and taking measurements from printouts). The device's firmware handles the acquisition, storage, and transmission of data autonomously. The comparison was device-to-predicate and device-to-ground truth (known input signals).

7. Type of Ground Truth Used

• The ground truth used was based on precisely controlled and "known input signals." This is a form of objective, engineered ground truth where the exact characteristics (amplitude and frequency) of the test signals are defined prior to testing.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device appears to be a hardware-based event recorder with firmware, not a learning algorithm. The "firmware" was designed, documented, and validated according to design controls, implying traditional software engineering development and testing, not a dataset-driven training process.

9. How Ground Truth for the Training Set Was Established

• As there was no stated training set for a machine learning model, this question is not applicable. The device's functionality is based on its direct electronic processing of ECG signals according to its engineering design and firmware instructions.

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