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The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.

It can be used for the following indications:

• 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• 2. Evaluation of patients for ST segment changes.
• 3. Evaluation of drug response in patients taking anti-arrhythmic medications.
• 4. Evaluation of patients with pacemakers.

The Holter System, composed of a Holter recorder and Holter software, is designed to record and analyze continuous long-time (24-192 hours) ECG data. The Holter recorder contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated.

The provided text is a 510(k) Summary for the Edan Instruments, Inc. Holter System, models SE-2003 and SE-2012. It discusses the substantial equivalence to predicate devices and presents non-clinical performance data.

However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test and training sets for algorithmic performance, expert qualifications for ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria for an AI/algorithm-driven device.

The "Performance Data" section details non-clinical testing related to safety (biocompatibility, electrical safety, EMC) and software verification/validation, but not the clinical performance of the Holter system's analytical capabilities in terms of accuracy for rhythm or other ECG interpretations.

Therefore, many of the requested items cannot be extracted from the provided text.

Based on the available information, here's what can be provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of the device's analytical software. It only states that "all the results show pass" for bench testing and compliance with safety and EMC standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The document states "Clinical data: Not applicable."

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 provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

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 provided in the document. The document states "Clinical data: Not applicable." This suggests no such clinical study was conducted or submitted for this 510(k).

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

The document does not provide details on standalone algorithmic performance. It indicates that the "analysis results are offered to doctors on an advisory basis only," which implies a human-in-the-loop scenario, but does not quantify the algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided in the document.

8. The sample size for the training set

Not provided in the document.

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

Not provided in the document.

Summary of what is present in the document versus what is requested for AI/algorithmic device evaluation:

The provided document focuses on demonstrating substantial equivalence primarily through comparisons of technical specifications and non-clinical safety testing (biocompatibility, electrical safety, EMC, and general software verification/validation) against predicate devices. It does not contain the detailed performance data for the analytical software's diagnostic capabilities that would be expected for a comprehensive evaluation of an AI-driven or algorithm-driven medical device, especially regarding its accuracy in ECG interpretation. The statement "Clinical data: Not applicable" confirms the absence of a clinical study assessing the device's diagnostic performance in patients.

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The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.

The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):

• · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
• · Evaluation of patients for ST segment changes
• Evaluation of patients with pacemakers
• · Reporting of time domain heart rate variability
• · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.)
• · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• Clinical and epidemiological research studies

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used.

The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable.

The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems.

The connection between the Holter and computer is performed by using Bluetooth and USB dongle.

The Cardiospy analysis software provides ECG records of excellent quality.

The provided text describes the Cardiospy ECG Holter System, its intended use, and its equivalence to predicate devices, but it does NOT contain an explicit study section with detailed acceptance criteria, reported performance, or specifics about a study design (like sample size, ground truth establishment, expert qualifications, or MRMC studies).

However, it does reference compliance with specific standards which contain performance requirements. I will extract the relevant information from those standards and the document's general claims to construct a response as best as possible.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested and found to fulfill the standard requirements. The most relevant standard for performance claims for an ambulatory ECG system with an analysis algorithm is AAMI / ANSI EC57:2012, "Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms." While the document doesn't explicitly list specific performance metrics from this standard as acceptance criteria, its inclusion implies compliance with the performance objectives outlined in EC57.

Since specific numerical acceptance criteria and reported performance values are not provided in the document, I will infer general performance aspects based on the device description and the standards it claims to meet.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Non-clinical testing of the product and its accessory proves that the following standard requirements are met" and "The test results prove that the device fulfills the standard requirements." It does not provide details of any clinical or non-clinical performance study data directly.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set. The standards like EC57:2012 typically involve a "reference truth" or "expert-annotated" datasets, but the submission itself doesn't detail their use.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not provide information on any adjudication method used for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI/algorithm assistance. The device is described as an "ECG Holter System" with an "analysis algorithm" to "support the medical staff in analyzing and deciding the proper and adequate diagnosis," implying human-in-the-loop, but no comparative effectiveness study is presented.

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

The document implies a standalone analytical capability for the algorithm with features like "precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis." However, it explicitly states that the data and analysis "will be reviewed, confirmed, and used by trained medical personnel in the diagnosis." It does not provide specific standalone performance metrics or a study demonstrating algorithm-only performance. The compliance with EC57:2012 would typically require demonstrating algorithm performance, but the details are not in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for performance evaluation. For devices complying with AAMI/ANSI EC57, ground truth is typically established through expert consensus or a "reference truth" dataset, but details are absent here.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size.

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

The document does not provide any information about a training set or how its ground truth was established.

Summary based on the provided document:

The submission largely relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards for safety and performance (IEC 60601 series, AAMI EC57, ISO 14971, etc.). It claims that the device was tested and fulfills these standard requirements, leading to the conclusion that differences do not raise new questions of safety and effectiveness. However, it does not provide the specific details of performance studies such as sample sizes, data provenance, expert ground-truthing, or comparative effectiveness. These details would typically be found in a separate study report or a more extensive section of the 510(k) submission, which is not included in this excerpt.

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The M12 Matrix Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods up to 48-hours. The Matrix Holter System is intended for use under the supervision of a Physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

This procedure is commonly called a Holter procedure which captures ECG rhythm abnormalities which may be infrequent or provoked by activities outside of the physician office.

The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (M12R) and the Matrix Holter System Application (M12A).

The Matrix Holter Recorder component of the system will be worn by the patient and is used to record ambulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder.

The subject Devices will provide the following diagnostic functions:

• Acquiring, viewing, storing and printing ambulatory ECG waveforms from . patients using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
• Using optional Holter algorithms to generate measurements, data presentations . and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
• Using optional interpretive algorithms to generate measurements, data . presentations, graphical presentations, and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

The M12 Matrix Holter System is a Holter system consisting of the Matrix Holter recorder (M12R) and the PC-based Matrix Holter System Application (M12A). The complete system is referred to as the M12 Matrix Holter System.

The Matrix recorder is a Holter Recorder (ambulatory electrocardiograph) designed to be used with the PC-based Matrix Holter System Application. The Matrix recorder acquires ECG data, converts the data to digital format and stores the digital data. The data is not analyzed by the Matrix recorder. The Matrix recorder uses a 7 or 10 lead electrode hookup and placement to obtain data for use by the Matrix Holter System Application. The Matrix Holter System Application is a PC-based application which is used to analyze, view, print, and edit the data collected by the Matrix recorder. The ambulatory electrocardiograph data recorded by the Matrix recorder is transferred to the Holter System Application, where it is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Matrix Holter recorder acquires up to 12 leads of ECG data continuously for a period of up to 48 hours. The data is stored in digital format and is intended to be retrieved from the recorder by the Matrix Holter System Application for data review and analysis.

The Matrix Holter recorder contains a keypad to provide means to configure the recorder, check hookup lead quality, and start the recording. The patient can use the keypad to enter patient activated event marks into the recording.

The Matrix recorder has a display which provides operational status information to the hook-up technician and to the patient. This information includes hook-up lead quality and system status.

The Matrix recorder uses two AA batteries for power supply. Data is stored on a removable memory card. The data is transferred from the Matrix recorder to the Matrix Holter System Application by removing the memory card from the recorder and inserting the card into the memory card interface of the PC running the application. An optional wireless communication interface can also be used to transfer data from the recorder to the Matrix Holter System Application.

The Matrix Holter System Application is a PC-based application. This application runs on a conventional PC system with a processing/data storage module, a graphical color display, a user interface keyboard, a printer, memory card interface and communication interfaces.

The provided document does not contain a study explicitly detailing acceptance criteria and device performance in the format requested. The document is a 510(k) premarket notification summary for the Matrix Holter System, which generally focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria.

However, based on the information provided, I can infer some aspects that would typically be part of such a study for a cardiovascular device like a Holter system.

Here's an attempt to answer your request based on the available information, noting where specific details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state quantitative acceptance criteria or a reported device performance table. For a Holter system, acceptance criteria would typically revolve around the accuracy of arrhythmia detection and morphological classification compared to a gold standard. Since the submission is for substantial equivalence, the implicit "acceptance criteria" is that the device performs comparably to the predicate devices.

Inferred/Typical Performance Metrics for Holter Systems:

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

The document does not specify a sample size for a test set or the provenance of any data used for performance claims. 510(k) submissions often rely on substantial equivalence and verification testing (e.g., bench testing, limited clinical data) rather than large-scale clinical trials with defined test sets.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information on the number of experts, their qualifications, or their involvement in establishing ground truth for any test data. For Holter systems, ground truth for arrhythmia detection is typically established by expert cardiologists reviewing full-disclosure ECG recordings.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. MRMC studies are typically used to assess the impact of AI on human reader performance, which doesn't appear to be the primary focus of this 2005 510(k) submission for a traditional Holter system with "optional algorithms."

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly detail a standalone performance study for its "optional algorithms." It states these algorithms "generate measurements, data presentations, and graphical presentations on an advisory basis for patients," to be reviewed and interpreted by a clinician. This implies human-in-the-loop operation, rather than a standalone algorithm making definitive diagnoses. Although performance studies for algorithms are usually included in 510(k) for devices with "analysis algorithms," specific details are absent here.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. For Holter analysis algorithms, ground truth is typically derived from expert consensus review of the ECG waveforms.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is consistent with a 2005 submission for a device where advanced machine learning or deep learning (which require large training sets) might not have been the primary technology for the "optional algorithms." These algorithms could be rule-based or employ classical signal processing techniques.

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

The document does not provide information on how ground truth for any training set was established.

Summary of Missing Information:

The provided 510(k) summary focuses on the device description, intended use, and substantial equivalence to predicate devices. It lacks specific details regarding performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth methodologies that would typically be found in a detailed study report for an AI/ML-driven device or even a conventional device with specified performance claims beyond substantial equivalence. This is common for 510(k) submissions, where comparison to existing devices often suffices.

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The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races.

The BR-102 plus should not be used with neonates.

The BR-102 plus is a portable, compact, lightweight, microprocessor based ambulatory blood pressure monitor. Two versions are available:

• Using auscultatoric and oscillometric signals. During cuff delfation auscultatoric and . oscillometric signals are analysed by the microprocessor to determine the blood pressure, where the oscillometric measurement is used as a backup.
• Purely oscillometric method to use the device without a microphone. The oscillometric . signals are analysed by the microprocessor to determine the blood pressure.

The device is worn or carried by the patient. The cuff is borne on the upper arm. An electrical pump inside the device generates the pressure in the cuff. The BR-102 plus is powered from two AA size recharchable NiMH batteries. The BR-102 plus initialises blood pressure measurements depending on a predetermined shedule (normally predetermined by a physician), or on demand (by using the start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded, to be analysed by the PC software. The readings are displayed on the display for a short time.

The associated MT-300 PC software provides the setup of the system. A measurement shedule can be defined with the MT-300 program and up-loaded into the BR-102 plus. All the settings can also be made on the device. After the ambulatory blood pressure study has been completed (up to 48h) the stored readings in the BR-102 plus are downloaded to the PC using the MT-300 program. The MT-300 programm provides the data in tabular and graphic form, as well as a patient report and statistical values.

Here's an analysis of the provided text to extract the requested information about the BR-102 plus NIBP Holter System's acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the BR-102 plus has "satisfactory passed all tests" according to specific standards but does not provide a table of numerical acceptance criteria or the reported device performance against those criteria. It refers to:

• Standards Met: ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, EN 1060-3.
• Clinical Test Protocol: "International Test Protocol for validation of blood pressure measuring devices in adults" of the European Society of Hypertension.
• Performance Claim: "The BR-102 plus has satisfactory passed all tests."

Without a direct table of acceptance criteria and performance from the document, I cannot create one as specifically requested. The document primarily asserts compliance with established standards. ANSI/AAMI SP10 and the ESH protocol contain specific accuracy requirements for blood pressure devices (e.g., mean difference and standard deviation between device and reference measurements), but these values are not explicitly stated in the provided text as the device's acceptable performance or actual performance.

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

The document does not explicitly state the sample size used for the clinical test set. It mentions the "International Test Protocol for validation of blood pressure measuring devices in adults" by the European Society of Hypertension, which typically specifies sample sizes (e.g., usually 33 subjects) for validation studies, but this specific detail is not present in the provided text regarding the BR-102 plus study.

The country of origin for the data is not explicitly stated in relation to the clinical tests, but the submitter (SCHILLER AG) is located in Switzerland. The study type (retrospective or prospective) is also not explicitly stated.

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

The document mentions that the BR-102 plus measurements are compared with "manual auscultatory measurements as described in the SP10." The SP10 standard itself outlines requirements for expert observers (e.g., two trained observers) for auscultatory reference measurements. However, the exact number of experts used for this specific study and their qualifications (e.g., radiologist with 10 years of experience) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The document states that the comparison is made against "manual auscultatory measurements as described in the SP10." The SP10 standard generally prescribes comparison to two trained observers with specific disagreement criteria for valid measurements. However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the BR-102 plus study, beyond referencing the SP10 method, is not explicitly detailed in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this document. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone study was performed. The clinical tests involve comparing the device's measurements (algorithm only) to a reference standard (manual auscultation). The description of the device as a "microprocessor based ambulatory blood pressure monitor" that "determines the blood pressure" indicates its standalone function without human interpretation of raw signals for diagnosis.

7. The Type of Ground Truth Used

The ground truth used for comparison in the clinical tests was manual auscultatory measurements. This is explicitly stated: "To verify the overall system efficiency the measurments of BR-102 plus are compared with manual auscultatory measurements as discribed in the SP10."

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of device (a blood pressure monitor) based on established measurement principles (auscultation and oscillometry) typically would not have a "training set" in the sense of a machine learning algorithm that requires extensive labelled data for supervised learning. Its algorithms are usually pre-programmed based on physiological models and engineering principles, then validated against clinical standards.

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

As no training set is described or implied for this device in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided text. The device's functioning is based on physical measurement principles, not a data-driven training process in the AI sense.

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The SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. acquire annoulatory 2 of 5 chamic 20 C stient demographic information to on board flash memory.

The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.

The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data.

The SEER Light Extend Compact Digital Holter System ismot intended for use on patients weighing less than 10Kg.

The SEER Light Extend Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data in its on-board flash memory. The SEER Light Extend Controller downloads patient demographic information into the SEER Light Extend Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of the recording, the SEER Light Extend Controller is connected to the SEER Light Extend Compact Digital Holter Recorder by a cable and the stored ECG data is transferred from the recorder to the controller onto a standard compact flash memory card. Alternately, the SEER Light Connect, a USB interface, can download patient demographic information from a PC into the SEER Light Extend Compact Digital Holter Recorder and, via a PC, allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the SEER Light Extend Compact Digital Holter Recorder can be connected to the SEER Light Connect and the stored ECG data is transferred from the recorder directly to a PC.

Here's a breakdown of the acceptance criteria and study information for the SEER Light Extend Compact Digital Holter System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio). Instead, it relies on demonstrating equivalence to a predicate device and compliance with general quality measures.

Therefore, the "acceptance criteria" can be inferred from the overall claim of safety, effectiveness, and performance being "as well as the predicate device" and compliance with voluntary standards.

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

The provided text does not specify a sample size for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Test Summary" lists various testing stages (unit level, integration, final acceptance, performance, safety, environmental) but does not provide details about the data used for these tests.

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

The provided text does not mention the use of experts to establish ground truth or their qualifications. Given that the device is a data acquisition system that does not perform any analysis of ECG data, it is unlikely that clinical ground truth (e.g., disease diagnosis) would be directly established for the device's testing. The focus of the "ground truth" would likely be on the accuracy and integrity of ECG signal acquisition and storage.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method for a test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. The device is a "Digital Ambulatory Holter Recorder" for ECG signal acquisition. It "does not perform any analysis of the ECG data." Therefore, there is no AI component or analysis capability for human readers to interact with or be assisted by.

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

A standalone performance study for an algorithm was not applicable and therefore not done. As stated, the device "does not perform any analysis of the ECG data," implying no embedded algorithms for data interpretation or diagnosis. Its function is solely to acquire and store raw ECG data.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used. Given the nature of the device (ECG data acquisition and storage), the "ground truth" for its testing would primarily revolve around:

• Accuracy of ECG signal acquisition: Comparing the acquired digital signal to known input signals or reference recordings.
• Integrity of data storage: Verifying that the stored data is identical to the acquired data.
• Functionality of controls and data transfer: Ensuring all features operate as designed.

It would not involve clinical ground truth like "expert consensus," "pathology," or "outcomes data" directly related to disease diagnosis, as the device does not perform analysis.

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. This type of device, which acquires and stores raw data without performing analysis, typically does not utilize a "training set" in the machine learning sense. Its development and verification would involve engineering testing and validation against specifications, not algorithm training.

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

Since no training set is mentioned or applicable for this type of device, the method for establishing its ground truth is not discussed.

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The Norav Holter Analysis System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.)

5. Clinical and epidemiological Research Studies

6. Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.

7. Evaluation of patients with pacemakers.

Not Found

This FDA 510(k) clearance letter for the Norav Holter Analysis System, Model NH-300, V1.07, does not contain the detailed acceptance criteria or a study description as requested.

The document is a regulatory approval letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide specific performance metrics, study designs, or data provenance.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate clinical study report for the Norav Holter Analysis System.

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