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The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of:

• Symptoms that may be related to rhythm disturbances of the heart in adult patients.
• Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional.
• Efficacy of antiarrhythmic therapy
• Pacemaker function
• Symptoms that may be associated with myocardial ischemia

The Philips Holter Analysis System is not intended for use for pediatric patients.

The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters:

• Age: Between 33 to 82 years
• Height: Between 147 to 185 cm (58 to 73 inches)
• Weight: Between 53 to 118 kg (117 to 261 lbs)
• Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

The Philips Holter Analysis System (hereinafter known as Philips HAS) is offered as standalone software. It is intended to be installed into a user's PC (general purpose computing platform). The product evaluates the heart rhythms of ambulatory ECG data over an extended period and generates a preliminary analysis for physician's review. The ECG data is downloaded from compatible ambulatory ECG recorders. It is to be used by trained personnel.

The Philips Holter Analysis System accepts ECG recordings from DigiTrak XT recorders (K071733) and analyzes the patient's heart activity for the recorded period, typically from 24 hours up to 7 days. The analysis is not performed in real time. The DigiTrak XT recorder collects up to 168 hours (7 days) of ambulatory ECG. The software can analyze up to 168 hours (7 days) of contiguous ECG data.

The algorithm (Zymed Algorithm, also internally referred to as the CAlg-Holter Algorithm) used in Holter Analysis System was first developed and approved for use in the Holter Scanner Model 1210. It was continually updated and subsequently cleared for use in more Holter Models. It includes Heart Rate Variability (Time Domain) as a standard software report configuration in March 1996. The operating system converted from a DOS operating system to a Windows operating system in April 1999. Heart Rate Variability Frequency Domain was added in February 2001. The QT analysis was added in September 2001. The most recent 510(k) including above features and functions is under K010949.

The Zymed Algorithm in the HAS incorporates the following enhancements in the subject device:

• Upgraded AFIB detection by replacing the current algorithm with the Philips ST/AR AFIB algorithm's P wave detection feature. The feature was cleared in K101521 with Philips ST/AR ST and Arrhythmia Software.
• Enhanced HRV reporting by replacing current calculations with advanced data warehouse calculations from PhysioNet. Incorporated Nonlinear HRV to provide more characterization of heart rate variability that linear methods could miss.
• Incorporated bug fix, and code security
• Upgraded compiler

The EASI derived 12-lead display function was cleared in K020456. It remains unchanged in the subject device. Philips does not incorporate any additional usage in the subject device beyond these clearances. The EASI 12-lead is only for display purposes, allowing end users to visualize EASI lead ECG recordings in a traditional 12-lead format. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

No automatic functions or analyses utilize this data. The Zymed Algorithm performs its analysis on the raw ECG signal and does not use the EASI derived 12-lead in that analysis.

The Philips Holter Analysis System requires operator's intervention during and after the initial analysis. The Philips HAS allows the operator to view and print out an analysis report, individual heart rate strips, as well as a full disclosure report for physician's review, diagnoses, and observations. It is intended to assist the qualified medical professional in the interpretation of the recorded data; it is not intended to serve as a substitute for the review and overread of the recorded ECG data.

The Philips Holter Analysis System provides viewing, printing, and report capabilities as listed below:

• A view of the data and a summary of the heart events that have taken place
• Detection of anomalies such as ventricular ectopy and supraventricular ectopy
• Patency of the pacemaker and pacemaker anomalies
• Advanced scanning techniques, such as determining ST and QT anomalies
• Heart rate data and heart rate variability
• Full disclosure reports

The Philips Holter Analysis System can operate in a networked environment that includes the following devices and interfaces to transfer orders and Holter reports.

• Philips IntelliVue Information Center (PIIC) (K153702)
• A fleet of Holter Remote Links and one or more Holter Central Links
• IntelliSpace ECG Management System (ISECG) (K120855)
• An IntelliBridge Enterprise (IBE) data interface engine / brokering system
• DICOM-based enterprise systems

PIC , Holter Remote Links, and Holter Central Links provide alternate ECG input mechanisms for Holter analysis. ISECG Central Link, Report Viewer, and IBE can accept Holter reports. IBE can provide Orders and ADT information for HAS. DICOM-based systems support patient orders via DICOM Modality Worklist and accept exported DICOM Encapsulated PDF reports.

The Philips Holter Analysis System provides three models with different configurations for customers to select: Series 3000, Series 5000, and Series 7000.

The provided text does not contain detailed acceptance criteria or a comprehensive study plan that proves the device meets specific performance metrics in the format of a clinical or analytical validation study for an AI/ML medical device.

The document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the Philips Holter Analysis System to a predicate device (2010 Plus Holter for Windows, K010949). The information provided focuses on:

• Device Description and Intended Use: The Philips Holter Analysis System analyzes ambulatory ECG data for various cardiac parameters. It incorporates updated algorithms (e.g., ST/AR AFIB algorithm's P wave detection, enhanced HRV reporting) and supports interoperability. It is intended for adult patients and trained clinicians.
• Comparison to Predicate Device: Detailed tables compare the subject device's indications for use, target population, intended user, intended use environment, and various technological characteristics (e.g., Holter applications, EASI Hookup, supported channels, analysis configuration, arrhythmia and event detection, QT/ST analysis, Pacemaker analysis, Caliper, Important Events, Report Output, Supported ECG source) to the predicate.
• Performance Data Summaries: It states that the device "successfully passed all the testing conducted, and the results demonstrated the Philips Holter Analysis System meets the performance claims and supports a determination of substantial equivalence to the predicate device."
• Non-Clinical Tests - Standards: It lists compliance with several recognized standards (ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 60601-2-47, AAMI EC57). These standards cover risk management, software lifecycle, health software safety, usability engineering, and requirements for ambulatory electrocardiographic systems.
• Non-Clinical Bench Tests: It broadly states that the device was "evaluated against all applicable standards and internal procedures and successfully passed all verifications and validations. The results demonstrated that Philips Holter Analysis System meets all claims and supports a determination of substantial equivalence to the predicate."
• Clinical Studies: It explicitly states that "The Philips Holter Analysis System, like the predicate device, does not require clinical trials."

Missing Information:

The document does not provide the following specifics required to answer your prompt:

• A table of acceptance criteria and reported device performance: While it mentions "performance claims," the actual criteria (e.g., sensitivity, specificity, accuracy targets for specific arrhythmia detection) and the quantitative results are not in the document.
• Sample size used for the test set and data provenance: No details on the size or origin of any specific test datasets used for performance evaluation of the algorithmic changes.
• Number of experts used to establish ground truth and their qualifications: No information on how ground truth was established for any internal performance testing.
• Adjudication method for the test set: No mention of adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states no clinical trials were required. Thus, no MRMC study details are available.
• Standalone (algorithm only) performance: While the document describes software updates, it does not explicitly provide standalone performance metrics for the AI/ML components (like the upgraded AFIB detection or enhanced HRV). The entire device is presented as assisting clinicians, not replacing them.
• Type of ground truth used: No specific type of ground truth is detailed for performance evaluation, beyond stating it passed internal verification and validation against claims.
• Sample size for the training set: No information on training data is provided.
• How ground truth for the training set was established: No information on this.

Conclusion based on the provided text:

The Philips Holter Analysis System received 510(k) clearance based on substantial equivalence to a predicate device, supported by compliance with recognized standards and successful completion of non-clinical bench testing, software verification and validation, usability validation, and risk management activities. This regulatory pathway typically does not require extensive clinical trial data detailing specific algorithmic performance metrics or human-AI interaction studies as might be submitted for novel AI/ML devices with significantly different indications or technological characteristics. The document emphasizes adherence to engineering and quality standards, and broad performance claims rather than specific quantitative performance targets and studies.

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The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications:

• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
• Evaluation of patients for ST segment changes.
• Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
• Clinical and epidemiological research studies.
• Evaluation of patients with pacemakers.
• Indication of time and frequency domain heart rate variability.
• Evaluation of patient for QT interval.

The MH1 MicroHolter Recorder is a Holter recorder for ambulatory electrocardiogram (ECG) recording. The system consists of three components: a Recorder, a Base Station (computer interface) and the Base Software. The system operates like a conventional ECG monitoring system where data is recorded on Flash memory installed within the MH1 Recorder.

The MH1 MicroHolter Recorder is worn by the patient during ECG monitoring whereas the Base Station is connected to a computer.

After the recording is complete, the MH1 MicroHolter Recorder docks with the Base Station, connected to a personal computer via USB. The Flash memory is then automatically uploaded to the computer via the MH1 Base Software for basic analysis. Data can then be transferred to a Computer Analysis System for further analysis of the recorded ECG data. The MH1, MH1B Base Station and MH1 Base Software are compatible with Windows 98 or higher.

The MicroHolter Recorder system is primarily a 3 channel recorder designed to be as small and lightweight as possible, using a second hardware component, the Base Station, for data interface with a host computer and contact-less monitoring of the recorded signals for electrode placement purposes.

The recorder converts the three differential inputs into 10 bit digital values which are stored in an internal FLASH memory along with the condition of the annotate button and a parity check bit. Simultaneously, the data values are modulated onto a low frequency carrier signal which is applied to a magnetic loop antenna so that the signal may be picked up at a short distance and converted into a visible waveform on a host computer for verification of electrode lead function.

The provided document describes the Exelys MH1 MicroHolter Recorder, a device intended for ambulatory ECG recording, and details its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any statistical performance metrics typically associated with AI/algorithm-driven medical devices.

Instead, the document focuses on:

• Applicant Information: Contact details for Exelys LLC and their correspondent.
• Device Name and Classification: Proprietary and classification names, regulatory information, and product codes.
• Predicate Device: Identification of the Braemar, Inc. DL900 Series Holter Recorder (K071733) as the predicate device, emphasizing substantial equivalence in indications for use, performance, and technological characteristics.
• Device Description: Explanation of the MH1 MicroHolter Recorder's components (Recorder, Base Station, Base Software) and how it operates to record and transfer ECG data. It mentions the conversion of analog inputs to 10-bit digital values stored in internal FLASH memory and a low-frequency carrier signal for electrode placement verification.
• Intended Use/Indications for Use: A list of clinical scenarios where the device is intended to be used, such as evaluation of symptoms, therapeutic interventions, ST segment changes, patient response after activities, research studies, pacemaker evaluation, and heart rate variability/QT interval assessment.
• Summary of Technical Characteristics: Highlights the device's 3-channel recording capability, small size, lightweight design, and the use of the Base Station for data interface and contact-less signal monitoring.
• Testing: A general statement that "EXELYS LLC has conducted extensive validation testing... as a cardiovascular monitoring device that is capable of accurately recording and transmitting ECG data." It further states that all components "have been tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."
• Safety and Effectiveness Conclusions: Concludes substantial equivalence to the predicate device and states that the MH1 MicroHolter Recorder "raises no new safety or effectiveness issues."
• FDA Communication: An FDA letter granting 510(k) clearance based on substantial equivalence to the predicate device.

Therefore, based on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed. The document relies on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: No test set details are provided. The "extensive validation testing" is mentioned, but without specifics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment process is described beyond general validation.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is an ECG recorder, not an AI analysis tool for human interpretation.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device records ECG data; it does not perform automated analysis that would require a "standalone" performance study in the context of an AI algorithm. Its function is data acquisition for subsequent analysis by other systems or human readers.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document serves as a 510(k) premarket notification for a medical device (an ECG recorder) using the substantial equivalence pathway. It does not describe an AI/algorithm-based device and thus does not contain the types of performance study details requested in the prompt, which are typically associated with such technologies.

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