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The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient detects symptoms indicated to him by his physician. It is indicated when such recordings are required for diagnosis, prognosis, and management of transient symptoms such as dizziness, syncope, palpitations, and arrhythmias.

The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event."

The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.

The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).

The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.

The provided text does not contain specific acceptance criteria or a study demonstrating that the TX3 Cardiac Event Recorder meets such criteria.

Instead, it's a 510(k) Summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against predefined acceptance criteria.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria. However, I can infer some points based on the provided text:

Based on the provided document, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance
   The document does not specify quantifiable acceptance criteria for device performance. It states that the device and/or its predicate "met the requirements of AAMI standard EC38" and that "software has had extensive validation testing." However, no specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection, or accuracy of pacemaker pulse duration measurement) or corresponding target values are provided.

*Note 1: While AAMI EC38 is a standard for ambulatory electrocardiographs, the document does not break down which specific requirements were met or provide quantitative results from meeting those requirements.*

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* Sample Size: Not specified.
* Data Provenance: Not specified. The document explicitly states "Clinical tests: Not required." This implies that the validation relied on non-clinical testing and equivalence arguments, not on clinical data collected from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
   Not applicable, as no clinical tests or human expert ground truth establishment for a test set are mentioned. The testing focused on engineering standards and software validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   Not applicable, as no clinical tests were performed requiring adjudication of results against a ground truth.

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
   No MRMC study was mentioned or implied. The device is an event recorder, not an AI-assisted diagnostic tool that aids human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   The document describes the TX3 as a "Cardiac Event recorder" that records ECGs and transmits them to a central station (Paceart WINCPTS 86-12 system). The "unit can also determine the pulse duration of implanted pacemakers in Post-Event mode." This suggests standalone algorithmic functions for pacemaker pulse duration, but no specific performance study for this standalone algorithm is detailed beyond the general statement about meeting AAMI EC38 and extensive software validation. The overall device is a recorder; its performance is related to its ability to accurately capture and store ECGs, not to interpret them in an AI context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   For the non-clinical tests mentioned (AAMI standard EC38 and software validation), the ground truth would likely be established by:

   • AAMI EC38: Reference standards for electrical performance, accuracy of recording, signal integrity, and safety parameters as defined by the standard.
   • Software Validation: Requirements specifications, expected outputs for given inputs, and absence of bugs, verified through testing. No biological or clinical ground truth is implied for these tests.

8. The sample size for the training set
   Not applicable. The device is a hardware cardiac event recorder with associated software, not a machine learning or AI model that requires a distinct "training set."

9. How the ground truth for the training set was established
   Not applicable (no training set for an AI model).

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The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center, with the ability to record three electrocardiographic leads or to derive 12 electrocardiographic leads from the three transmitted.

The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted. When the five electrodes are attached to the patient in the special configuration shown in the manual and the PaceArt WINCPTS central-station software with 12-lead option is used, the physician can either record a twelve-lead electrocardiogram or a three-lead electrocardiogram at the analysis center. The system for derivation of the 12-lead electrocardiogram from the five-electrode recording is called the "EASI" system. There are two elements to the Home Trak Plus system: a "looping" cardiac event recorder, and a special central-station program.

Here's an analysis of the provided text regarding the HomeTrak Plus EASI Event Recorder System's acceptance criteria and studies:

Summary of Device Performance Study Information for HomeTrak Plus EASI Event Recorder System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "A series of patients" in Clinical Test 1. No specific number for the test set is provided.
• Data Provenance: Not explicitly stated, but clinical tests imply prospective data collection from patients. The country of origin is not mentioned.

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

• The document does not provide details on the number of experts or their qualifications involved in establishing the ground truth. The comparison is made to a "predicate device" and a "Burdick 12-lead electrocardiograph," implying these established devices served as the de-facto gold standard for comparison, rather than a separate expert panel establishing a new ground truth.

4. Adjudication Method for the Test Set

• No specific adjudication method is mentioned. The comparison is stated as "equivalent," implying a direct comparison of the ECG recordings without a formal multi-reader adjudication process.

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

• No, a MRMC comparative effectiveness study is not mentioned. The studies described are focused on demonstrating equivalence of the device's output to existing technologies, not on improving human reader performance with AI assistance.

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

• Yes, the clinical tests essentially demonstrate standalone performance in the sense that the device's output (ECG recordings) is directly compared to other devices. The "equivalent" determination is based on the device's ability to produce similar ECGs, independent of human interpretation during the testing phase.

7. The Type of Ground Truth Used

• The ground truth was established by comparison to legally marketed predicate devices and established medical equipment. Specifically:
  • An "EASI predicate device" (Clinical Test 1)
  • A "Burdick 12-lead electrocardiograph" (Clinical Test 2)
  • The "CPTS central station equipment" previously cleared by FDA (K915632) for 12-lead ECG systems.
  • This indicates a "comparison to a gold standard device" approach.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This type of device (an event recorder) primarily records and derives signals based on known physiological principles and algorithms (like the EASI system), rather than using a machine learning model that would require a distinct training set. The "software has had extensive validity testing," but this refers to traditional software engineering validation, not machine learning model training.

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

• Not applicable, as no training set for an AI/machine learning model is described. The "EASI coefficients" are likely pre-determined constants based on physiological modeling, not learned from a training set.

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The event recorder, called the "Heart Access Plus," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms indicated to him by his physician. The unit is intended to be used in the patient's home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be interpreted by a physician.

The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart Access Plus operates in the so-called "Looping" mode, in which it is always active, and in which it records an interval of one channel of cardiac activity before and an interval after the depression of the button; durations of the intervals are programmable. The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

The Paceart "Heart Access Plus"™ combines a "looping" cardiac event recorder and a voice diary. The feature permits the device to record a sample of the electrocardiogram both before and after the patient senses a symptom of a cardiac event and presses the "activator" button, unlike many other recorders which only record the ECG for a period after the sensing of the symptom. The voice diary permits a patient to record the circumstances which led to his making a recording.

The number and duration of events are programmable by the physician. The device can record up to 270 seconds of electrocardiogram. Each event can be programmed for 5 to 50 seconds of "pre-history" ECG (ECG before the activator button is pressed) and 5 to 95 seconds of "post-history" ECG (after the activator button is pressed). There can be one or two channels (two electrodes per channel, placed as desired) and up to six events: the total duration of all of the events for all of the channels is limited by the total record time of 270 seconds. The device will not permit programming more events than can be stored, and once the memory is full no more electrocardiograms can be recorded. The voice diary permits recording up to 90 seconds of notes.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the Paceart Heart Access Plus Event Recorder:

Based on the provided documentation, the Paceart Heart Access Plus received 510(k) clearance based on substantial equivalence to predicate devices and compliance with a relevant standard. The acceptance criteria are primarily defined by this equivalence and standard adherence, rather than specific performance metrics explicitly listed as "acceptance criteria."

Acceptance Criteria and Reported Device Performance

Study Information

The provided text describes the type of testing performed rather than a detailed standalone study report with specific statistical results.

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

   • Sample Size: Not explicitly stated. The documentation mentions "tests" were conducted, but does not specify the number of devices tested, the number of events recorded, or the number of patients involved in any comparative or standard compliance testing.
   • Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission, the testing would typically be conducted by the manufacturer or a contracted lab. It's not specified if patient data (e.g., ECGs) from a specific country was used or if it was retrospective or prospective.

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

   • Not applicable/Not mentioned. The testing primarily revolved around technical equivalence to a predicate device and adherence to a recognized standard (AAMI EC38). Expert consensus for specific diagnostic ground truth (e.g., classifying arrhythmias) is not described in this context. The interpretation of recordings is stated to be by "a physician" at a central receiver, but this is describing the intended use, not the ground truth establishment for the device validation.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used when comparing observer interpretations of data. Here, the "test set" appears to be the device itself being compared to a predicate or a standard, rather than a clinical dataset adjudicated by multiple readers.

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

   • No. An MRMC study comparing human readers with and without AI assistance was not done. This device is a cardiac event recorder, a hardware device for capturing ECG data, and does not involve AI or human interpretation assistance in the sense of a diagnostic algorithm.

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

   • Yes, in spirit. The "testing" against the predicate device and the AAMI EC38 standard is essentially a standalone performance evaluation of the device's ability to accurately record and function according to its design and industry benchmarks. It’s not an "algorithm" in the modern AI sense, but rather the device's inherent functional performance. The device's performance in recording ECG data is evaluated independently of human interpretation during the testing phase.

6. Type of Ground Truth Used:

   • The ground truth for the equivalence testing would be the performance of the predicate device (Ralin Heart-Aide or Braemar ER700) and the specifications outlined in the AAMI EC38 standard. For example, if AAMI EC38 specifies frequency response or common mode rejection ratios, the device's measured performance in these areas would be compared against those specifications.

7. Sample Size for the Training Set:

   • Not applicable. This device is a hardware event recorder, not an AI/machine learning algorithm that requires a "training set."

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

   • Not applicable, as there is no training set for this type of device.

Summary of Key Findings from the Document:

The 510(k) clearance for the Paceart Heart Access Plus was primarily based on a demonstration of substantial equivalence to existing predicate devices (Ralin Heart-Aide Event recorder and Braemar ER700 Event Recorder) and compliance with the AAMI EC38 standard for ambulatory electrocardiographs. The document confirms that "the two devices are equivalent" and that the Heart Access Plus "meets the applicable requirements" of AAMI EC38, leading to the conclusion of safety and effectiveness. The testing described is focused on the hardware device's functional performance against established benchmarks and predicate device performance, rather than complex clinical studies involving human interpretation or AI algorithms.

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Paceart Wrist Electrodes are intended to be used for home monitoring of pacemaker patients via telephone monitoring systems.

Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring. Physically the device consists of a flat metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable, attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable connector to a jack on the monitor. The plug is of sufficiently large diameter so that it will not fit into a power outlet. The wrist electrode is used for home telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is not intended for use as a general-purpose electrocardiographic electrode or for long-term monitoring.

Here's a breakdown of the acceptance criteria and study information for the Paceart Wrist Electrodes, based on the provided text:

Paceart Wrist Electrodes: Acceptance Criteria and Study Details

The provided submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for novel performance. The "acceptance criteria" are implied by showing the Paceart device performs equivalently or better than the predicate device and meets relevant AAMI standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "human subject" (singular) for the clinical comparison, suggesting a very small sample, possibly a single individual or a small, unspecified number.
• Data Provenance: The study was a "Clinical Comparison" with human subjects. The country of origin is not specified but implicitly in the context of a US 510(k) submission, it would often be the US. The study was prospective in nature, as it involved actively conducting tests with human subjects.

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

Not applicable. The "ground truth" here is the recorded ECG signal and the physical characteristics/measurements. There were no human expert interpretations requiring consensus to establish ground truth for this device's performance. The comparison was directly between the output of the device and a predicate, and against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of physical and electrical properties, not an interpretative task requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the physical and electrical performance of the device itself, not on the improvement of human readers with or without AI assistance. This device is not an AI-powered diagnostic tool.

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

Yes, the bench tests for noise and offset voltage, as well as the biocompatibility assessment, represent standalone performance evaluations of the device's physical and electrical characteristics. The "Clinical Comparison" also evaluated the device's ability to record an ECG signal on its own, for direct comparison to a predicate, which also functions as a standalone assessment.

7. The Type of Ground Truth Used

• Bench Tests (Noise & Offset Voltage): The ground truth was established by direct physical measurement according to AAMI standard EC12-1991, Paragraph 4.2.2.3 and 4.2.2.2.
• Biocompatibility: The ground truth was established by material specification (Type 304 Stainless Steel is "biologically inert") and its historical use.
• Clinical Comparison (ECG Signal Quality): The ground truth was the ECG signal generated simultaneously by the predicate device, against which the Paceart device was compared for "virtually identical" results.

8. The Sample Size for the Training Set

Not applicable. This device is a passive medical component (electrodes), not an algorithm or AI model that requires a training set.

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

Not applicable, as there is no training set for this device.

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