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The IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.

The IntriCon Sirona is a device for use as either an Event Recorder (ER), with or without Arrhythmia Detection, or Holter Monitor (HM). The device can operate in one of three modes depending on clinician selected options.

The provided text is a 510(k) summary for the IntriCon Datrix Sirona Event/Holter Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, particularly for performance metrics like sensitivity, specificity, or accuracy for arrhythmia detection.

The "Non-Clinical And Performance Testing" section broadly states: "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." It references compliance with several electrical safety and performance standards (IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998) but does not provide specific performance data or a statistical analysis of diagnostic accuracy.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because this information is not present in the provided document.

The document indicates that the device is an "Electrocardiograph, ambulatory (without analysis)" and states that "IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data... for review by a licensed physician." This strongly suggests that the device's primary function is data acquisition and transmission, with the diagnostic analysis being performed by a human physician, not the device itself. The phrase "without analysis" in the classification name further supports this.

Based on the provided text, the following information is either not applicable or not available:

1. Table of acceptance criteria and reported device performance: Not available. The document primarily focuses on electrical safety and functional standards, not diagnostic performance metrics.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not available, as diagnostic analysis is stated to be performed by a "licensed physician" reviewing the transmitted data.
4. Adjudication method for the test set: Not available.
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: Not applicable. The device is classified as "without analysis" and there's no mention of AI assistance. The physician performs the analysis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's classification "without analysis" and intended use imply it does not perform standalone algorithmic analysis for diagnosis.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable. There's no mention of an algorithm requiring training.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is available:

• Intended Use: Diagnostic evaluation of patients experiencing transient symptoms suggesting cardiac arrhythmia.
• Device Function: Records ECG data, which is then transmitted for review by a licensed physician. It can operate as an Event Recorder (with or without Arrhythmia Detection functionality, though the classification name says "without analysis") or Holter Monitor.
• Compliance: Tested to IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998. These are generally electrical safety and basic functional standards for medical devices, not diagnostic performance standards for arrhythmia detection algorithms.
• Predicate Device Comparison: Claims "nearly identical technical data, same indications for use, same safety standards tested to" as Braemar Er900 (K071011/K072008) and Datrix VX3 (K031074). This is the basis for substantial equivalence, implying that if the predicates met certain performance, this device is expected to as well, but the specific performance data is not provided.

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The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

The IntriCon Datrix Centauri MT APETS is a device used for recording patient ECG data for as long as 30 days. Selected data are sent for review from the recorder, through a phone service to a receiving station where they are available for review by a physician or other qualified medical professional. The Centauri MT APETS is capable of 1, 2, and 3-channel recording, depending on the type of cable being used. The recorder can run for up to 30 days. Battery life depends on the mode and battery option chosen by the user. The patient's ECG signal is acquired via commercially available silver-chloride electrodes appropriate for long-term recording.

The provided 510(k) summary for the IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) does not include explicit acceptance criteria nor a detailed study proving the device meets said criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Braemar, Inc. Fusion Wireless Recorder (K081444) and Datrix E-Tac EX-1000 Electrocardiographic Event Recorder (K042022)). The conclusion states: "Comparison to the predicate devices listed shows nearly identical technical data, same indications for use, same safety standards tested to, and raises no new questions of safety or efficacy."

The submission focuses on compliance with general safety and performance standards rather than specific diagnostic accuracy metrics.

Here's an breakdown of the information that can be extracted, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical targets for performance (e.g., sensitivity, specificity, positive predictive value, negative predictive value for arrhythmia detection).
• Data demonstrating the device's ability to accurately detect and transmit various types of arrhythmias.

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

Missing Information:

• Sample Size for Test Set: The document does not describe any specific clinical or performance test set used to evaluate the device's diagnostic accuracy. It mentions "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system," but details of these tests, including sample size for diagnostic performance, are absent.
• Data Provenance: Without a description of a test set, there is no information on country of origin of data or whether it was retrospective or prospective.

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

Missing Information:

• As no specific test set for diagnostic performance is described, there is no mention of experts or how ground truth was established for such a set.

4. Adjudication Method for the Test Set:

Missing Information:

• No test set for diagnostic performance is described, therefore no adjudication method is mentioned.

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

Missing Information:

• No MRMC comparative effectiveness study is mentioned. The submission is focused on the device's standalone functionality and equivalence to predicates, not its impact on human reader performance.

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

• Standalone Performance: The device's intended use explicitly states it "automatically generates an event triggered by an arrhythmia detection algorithm." This implies a standalone algorithm component. However, no performance metrics (e.g., sensitivity, specificity for various arrhythmias) for this algorithm are provided in the document. The submission relies on "substantial equivalence" to predicate devices, which presumably have a similar algorithmic function.

7. Type of Ground Truth Used:

Missing Information:

• Given the lack of a detailed diagnostic performance study, the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for any such evaluation is not stated.

8. Sample Size for the Training Set:

Missing Information:

• No information about a training set or its sample size is provided. This is typical for submissions focused on established technologies demonstrating substantial equivalence, where detailed de novo algorithm development data might not be required.

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

Missing Information:

• As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of Acceptance Criteria and Study Limitations:

The provided 510(k) summary is for a device seeking clearance based on "substantial equivalence" to existing predicate devices. This type of submission generally does not require a detailed clinical performance study with explicit acceptance criteria for diagnostic accuracy, nor does it typically detail the development and validation of AI algorithms with associated training and test sets in the same manner as a de novo submission or a device with novel technology.

The "Performance Testing" section primarily lists compliance with general electrical safety and EMC standards (IEC60601-1:1998, IEC 60601-1-2: 2001, AAMI EC 38-1998) and states that "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." This indicates engineering and functional testing, not necessarily a clinical study for diagnostic performance.

Therefore, this document does not contain the detailed information requested regarding specific acceptance criteria, diagnostic performance study design, sample sizes, ground truth establishment, or expert involvement for evaluating the arrhythmia detection algorithm's accuracy. The approval is based on the claim that the device is "substantially equivalent" to already-cleared devices, implying its performance characteristics are comparable to those predicates.

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The Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.

The Cardio WiFi electrocardiograph continuously records data to a flashcard and displays it at high resolution. It features a large, liquid crystal display ("LCD") that allows a medical professional to periodically check the test subject's full, 12-lead ECG, either at intervals or in the event of a patient symptom. The device is portable and is battery-powered. Data is stored for later review at an ECG review station. Data transfer is accomplished via WLAN 802.11 b or g.

This device, the Datrix Cardio WiFi Electrocardiograph, is a portable electrocardiograph without analysis capabilities. As such, the submission primarily focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This submission did not involve a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a human-in-the-loop performance. Instead, the evaluation was based on non-clinical testing to established international and national standards for electrocardiographs. Therefore, there is no sample size of patient data or provenance information to report.

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

Not applicable. The ground truth for this type of device (a data acquisition device without analysis) is adherence to established engineering and performance standards, not diagnostic accuracy. Therefore, no experts were used to establish ground truth from patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication of patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a basic electrocardiograph without analysis, meaning it does not incorporate Artificial Intelligence (AI) for interpretation or diagnostic assistance. Therefore, no MRMC study was conducted to evaluate human reader improvement with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device does not have an "algorithm" for diagnostic interpretation in the sense of AI. It acquires and stores ECG data. The performance evaluation was based on the device's ability to accurately and safely perform its intended function of acquiring ECG data, not on the performance of a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used:

The ground truth used for this submission was based on established engineering and performance standards for electrocardiographs, specifically:

• AAMI EC11
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-25
• Internal quality system test procedures for performance, functionality, and reliability.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set" of data.

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

Not applicable as there is no training set.

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The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs.

The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to: review and edit specific patient ECG data including intervals such as QT measurements and algorithm generated preliminary interpretative statements. ECG records are all associated by patient ID and other demographic data. Secure access to the database is provided.

CardioServer ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG data transferred from a Datrix Cardio WiFi electrocardiograph device. All ECG records are associated by patient ID, and a final record including physician interpretation can be created.

The software system analyzes data using an ECG analysis algorithm developed under direction of Dr. Peter MacFarlane, University of Glasgow (note: the same algorithm is contained in the predicate device to which equivalency is being claimed). The ECG display is able to show 1, 3, or 12 leads at once, full disclosure, user-selected strips, and interpretations editable bv physician. Hardware requirements: are Windows 2000 or 2003 Server operating system; Pentium IV, 2GHz (minimum); 512 MB RAM (minimum); 10/100 Ethernet (minimum); RAID 5 storage; 1024x768 monitor; and standard back-up technology.

The provided text describes a 510(k) summary for the Datrix CardioServer ECG Management System. However, it does not contain specific acceptance criteria, a detailed study proving the device meets criteria, or the types of quantitative performance metrics typically associated with AI/ML device evaluations.

Instead, the submission focuses on:

• Establishing substantial equivalence to a predicate device (Quinton Pyramis ECG Management System K032038).
• Describing the software's functionality, intended use, and hardware requirements.
• Stating compliance with the FDA Guidance Document: "General Principles of Software Validation."
• Highlighting that the device utilizes the same ECG analysis algorithm (University of Glasgow ECG Algorithm) as the predicate device.

Given this, I cannot provide the requested information in the format specified because the document does not contain it. The provided text primarily addresses regulatory compliance through substantial equivalence, general software validation, and technological comparison to a predicate device. It lacks the details of a performance study with specific acceptance criteria and outcome metrics for algorithmic performance.

Here's what I can extract based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified. The document mentions the University of Glasgow ECG Algorithm, implying its origin, but does not detail a specific dataset used for this device's testing or validation of the algorithm's performance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not specified. The document does not describe a performance study involving expert-established ground truth. Interpreted statements are "editable by physician," but this pertains to clinical use, not the validation process.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC study was not described. The document does not mention any studies involving human readers or comparative effectiveness with AI assistance.

6. If a standalone (algorithm only without human-in-the-loop performance) was done:

• A standalone performance study of the algorithm's diagnostic accuracy, as typically reported today, is not detailed. The document states: "The software system analyzes data using an ECG analysis algorithm developed under direction of Dr. Peter MacFarlane, University of Glasgow (note: the same algorithm is contained in the predicate device to which equivalency is being claimed)." This indicates the algorithm itself has a history, but a specific standalone validation study for this device is not provided in terms of performance metrics. The testing focused on software validation and functionality.

7. The type of ground truth used:

• Not specified. For the algorithm (University of Glasgow ECG Algorithm), it is generally understood that such algorithms are developed and validated against expert consensus or clinically confirmed diagnoses, but the details for this submission are absent.

8. The sample size for the training set:

• Not specified. This refers to the training of the University of Glasgow ECG Algorithm, which is an external component, and its training details are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:

• Not specified. (Refer to point 8).

Summary of Missing Information:

The provided 510(k) summary is primarily concerned with establishing substantial equivalence to a predicate device and demonstrating software validation according to FDA guidance. It leverages the fact that it uses the same ECG analysis algorithm as the predicate device. It does not contain the detailed performance study data (acceptance criteria, test set characteristics, ground truth establishment, expert involvement, specific performance metrics for diagnostic accuracy) that would be expected for a more modern AI/ML device submission demonstrating algorithmic performance.

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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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The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data as well as pacemaker pulses during the events of the patient's daily activity.

The VX3 is a lightweight, compact, digital Holter recorder designed for the recording of ECG data collected from ambulatory patients. A derivative of the Datrix DR512 digital Holter recorder, the VX3 has enhanced features, including an LCD to verify leadwire hookup and display recorder status and error messages, optional keypad for selection of various options, and optional pacemaker pulse detection. Various channel and lead configurations are accommodated by using the appropriate leadwire set without additional recorder reconfiguration. Data are recorded on industry standard compact flashcards for subsequent download and to a Holter playback system. Sampling rates are factory programmable to accommodate compatibility with various OEM Holter playback systems.

The provided document is a 510(k) Premarket Notification Summary for the Datrix VX3 Series Digital Holter Recorder. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new performance study with detailed acceptance criteria and expert reviews of an AI/algorithm-based device.

Therefore, the document does not contain the information requested in the prompt, such as detailed acceptance criteria for an AI device, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or details about the training set for an algorithm.

The document primarily focuses on:

• Device Description: The VX3 is a digital Holter recorder for ECG data collection from ambulatory patients, with features like an LCD, optional keypad, and optional pacemaker pulse detection.
• Intended Use: Recording ECG data and pacemaker pulses for physician review after processing by a Holter playback system.
• Predicate Device Comparison: A table comparing the Datrix VX3 to the Datrix DR512 and Braemar DXP1000 across functional, physical, environmental, and electrical specifications. This comparison is used to establish substantial equivalence, meaning the safety and effectiveness of the new device are similar to legally marketed devices.

Conclusion: The provided text describes a medical device's technical specifications and its comparison to predicate devices for regulatory clearance, but it does not detail acceptance criteria or a study proving device performance in the context of an AI/algorithm-based system as requested.

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The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient's daily activity.

The DR512 is a lightweight, compact, digital Holter recorder designed for ambulatory ECG applications. Three channels of ECG data are collected via a 5 or 7 lead wire set and silver-chloride electrodes. The recorder is battery powered to ensure electrical isolation of enclosure coated with an electromagnetic interference spray. The DR512 has internal calibration, and a patient activated event marker button. ECG data are collected for 24 hours.

Here's a breakdown of the acceptance criteria and the study information for the DATRIX DR512 Digital ECG Holter Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for the device, but rather describes a series of comprehensive tests performed to ensure the device met its "design specifications." Therefore, the "acceptance criteria" below are inferred from the tests conducted, and the "reported device performance" is a summary of the general findings.

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

• Sample Size for Test Set: The document does not explicitly state the number of subjects or the specific sample size used for the "subject testing" mentioned. It only refers generally to "subject testing."
• Data Provenance: The document does not specify the country of origin of the data. It mentions "subject testing," which is generally prospective, but no further details are provided.

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

• This information is not provided in the document. The study focuses on the technical performance and accuracy of the device itself rather than its diagnostic interpretation by humans.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. The study tested the recorder's technical performance and data recording capabilities, not direct diagnostic output requiring adjudication of human-interpreted results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The submission describes testing the technical specifications and functionality of the recorder, not evaluating the diagnostic performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• Yes, in effect, a standalone study was performed in terms of the device's technical functionality. The testing detailed (analog and digital hardware verification, firmware testing, compression algorithms, environmental tests) assessed the device's performance purely as a recording instrument, independent of human interpretation or a "human-in-the-loop" for its operation. The device's primary function is to record and store data, which is then processed by a separate "Holter playback system" and reviewed by a physician. The study confirmed the accuracy of this recording and storage.

7. The Type of Ground Truth Used

• The "ground truth" for the various tests was primarily based on:
  • "Design specifications": The device's performance was measured against its intended technical specifications.
  • Known input signals: For example, compression algorithms were tested with "line segment data, calibration signals, and simulated ECG waveforms," where the expected output would be known.
  • Expected functional responses: For tests like event button circuits, battery polarity, RAM write-read, and environmental tests, the "ground truth" was whether the device performed as designed and expected under specific conditions.
  • Compatibility with existing systems: For playback systems, the ground truth was successful data transfer and processing.

8. The Sample Size for the Training Set

• This information is not provided and is likely not applicable in the context of this device. The DR512 is a hardware recorder with firmware, not a machine learning or AI algorithm that requires a "training set" in the typical sense for diagnostic purposes. The firmware and algorithms (e.g., compression) would have been developed and tested against engineering specifications and simulated data during design, rather than "trained" on a dataset.

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

• As a "training set" in the machine learning context is not applicable, the ground truth for any internal development or testing of firmware/algorithms was established based on engineering specifications, mathematical models, and known characteristics of ECG signals and data compression techniques.

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