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Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease

Monitoring of patients in out-of-hospital convalescence settings

Monitoring of patients by physicians, clinics, or skilled care facilities

Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting

The device is not intended to sound real time alarms

This device does not replace physician's care

The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.

The Instromedix LifeSigns™ Cardiac Monitoring System is a device designed for diagnostic monitoring of stabilized patients in out-of-hospital environments. The FDA has cleared this device through the 510(k) pathway (K964408), signifying its substantial equivalence to predicate devices. The provided document focuses more on the regulatory submission and equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and corresponding results in a table format.

However, based on the information provided, we can infer the approach taken for demonstrating performance and regulatory acceptance.

Inferred Acceptance Criteria and Reported Device Performance

While explicit numerical acceptance criteria for accuracy, sensitivity, or specificity are not provided in the document, the core assertion for 510(k) clearance is substantial equivalence to legally marketed predicate devices. This implies that the LifeSigns System's performance for vital signs measurements (ECG, SpO2, heart rate, blood pressure) meets a level comparable to these established devices.

Study Details from the Provided Document:

Due to the nature of a 510(k) summary, specific details regarding sample size, data provenance, expert qualifications, and detailed study methodologies are not extensively provided as they would be in a clinical trial report. However, based on the text:

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "performance testing of vital signs measurements." It can be inferred that a test set of data was used to demonstrate equivalence, but the size and specifics (e.g., retrospective/prospective, country of origin) are absent. This would typically be detailed in a separate test report referenced in the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For vital signs monitoring devices, ground truth is typically established by comparing the device's readings against a recognized standard (e.g., another FDA-cleared device, a calibrated reference instrument, or manual measurements by trained professionals). The document does not specify the number or qualifications of experts involved in this ground truth establishment, if any were required beyond technical calibration.

3. Adjudication method for the test set: Not applicable based on the information provided. Adjudication methods like "2+1" are typically used in studies involving subjective interpretations (e.g., image reading), where multiple experts provide opinions that need to be reconciled for ground truth. For objective vital signs measurements, direct comparison to a reference standard is more common.

4. 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 LifeSigns System is a vital signs monitoring device, not an AI-powered diagnostic tool requiring human interpretation improvement studies. It collects and displays objective physiological data.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the system as collecting and displaying vital signs data. The "algorithm" here would pertain to the signal processing for ECG, SpO2, heart rate, and blood pressure calculation. The performance testing would inherently be standalone in terms of the device's ability to accurately measure these parameters before human interpretation of the trends or values.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The specific type of ground truth is not detailed. For vital signs, ground truth would typically come from:

   • Calibrated reference equipment: For blood pressure and SpO2, direct comparison to highly accurate and calibrated reference devices or invasive measurements.
   • Simultaneous recordings/manual verification: For ECG and heart rate, comparison to simultaneously acquired gold standard ECGs or manual heart rate calculation from rhythms.
     The document mentions performance testing, implying direct measurement and comparison, rather than subjective expert consensus, pathology, or outcomes data, which are more common for diagnostic imaging or disease progression studies.

7. The sample size for the training set: Not applicable and not provided. The LifeSigns System predates the common approach of using large training sets for deep learning or AI algorithms. Its functions for acquiring ECG, SpO2, heart rate, and blood pressure are based on well-established signal processing and measurement principles, not machine learning trained on large datasets.

8. How the ground truth for the training set was established: Not applicable, as no training set in the modern AI sense is described or implied for this device.

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Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention.

In-office acquisition and display of single and/or multi-lead ECG. Collection, storing, reporting, transfer, and management of patient(s) health information.

CardioMagic® 2000 Cardiac Monitoring System Software (CMS) is a productivity enhancing, office automation product. The intended users of CMS are physicians, clinics, and hospitals with cardiac patient follow-up and monitoring practices. CMS is a database software product, intended to involve competent intervention before any impact on health occurs. The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms. There are no known contraindications for use of this device.

CardioMagic software is installed on an IBM compatible personal computer, which may also be networked to other PC's. An Instromedix LifeSigns Receiving Center™ (LRC) may be attached to the PC, to acquire transmitted data and waveforms from transtelephonic pacemaker monitors and ECG event recorders.

CardioMagic provides remote control of the LRC, presents the received waveforms and data on the computer screen, assists in editing, viewing, and organizing the received data, and provides database support for patient and device information, and provide reports.

The CardioMagic® 2000 Software is not a device that performs any analysis or provides diagnostic output. It is described as a "productivity enhancing, office automation product" that assists in editing, viewing, and organizing received data, and provides database support. The document explicitly states: "The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms."

Therefore, the typical acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are not applicable to this software. The "study" described in the document is a substantial equivalence comparison to predicate devices rather than a performance study in the traditional sense for AI/ML devices.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that the device is a data management and display tool and not a diagnostic AI/ML algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC mentioned. The acceptance criteria relate to its functionality and equivalence to existing systems. The table below summarizes the comparison features, which serve as the "acceptance criteria" for functionality, and the device's reported capabilities.

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

This is not applicable as there was no "test set" in the context of proving diagnostic performance. The submission is a substantial equivalence claim based on comparing functionalities of the CardioMagic® 2000 Software to legally marketed predicate devices (previous CardioMagic products, PaceArt CPTS, and PaceBase). The data provenance would refer to the features of these predicate devices and the new device.

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

This is not applicable. There was no ground truth establishment for a diagnostic test set. The review focused on functional equivalence.

4. Adjudication Method for the Test Set

This is not applicable. No test set requiring adjudication was used.

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

No MRMC study was conducted or mentioned. The device does not involve human readers interpreting AI output to improve performance. It is a data management tool.

6. Standalone Performance Study

No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was conducted or mentioned. The software's purpose is to manage and display data, not to perform automated analysis or provide diagnostic outputs independently. The document explicitly states: "The software does not analyze the information."

7. Type of Ground Truth Used

This is not applicable as there was no ground truth for diagnostic or analytical performance. The basis for acceptance was the functional equivalence of the software's features to those of predicate devices.

8. Sample Size for the Training Set

This is not applicable. The CardioMagic® 2000 Software is not an AI/ML model that requires a training set. It's a software application with predefined functionalities.

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

This is not applicable.

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These devices are intended for use by patients who need to record their ECG during daily activites for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner.

These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.

The accelerated transmission protocol may be used by transtelephonic ECG transmitters. This protocol allows the stored ECG data to be sent more rapidly over the communications link to the receiver. Three devices that incorporate the Advanced Transmission Protocol (ATP) are presented in this summary statement. They are the King Of Hearts, Express ATP. the King Of Hearts, Prince ATP, and the HeartCard ATP.

These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.

Features and functions are identified to the identified predicate devices with the addition of the ATP feature. The Accelerated Transmission Protocol feature does not play any part in the recording of ECGs. It is only active in the transmit mode. The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. The transmitters convert the data to an FM signal, which is sent to a receiver (LRC 2000 Receiver) designed to receive the ATP protocol. The receiver demodulates the FM signal back to the analog ECG waveform, and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter.

Due to the limited information provided in the input, a comprehensive description of acceptance criteria and a study proving device performance, as typically required for contemporary medical device submissions, cannot be fully generated. The provided text is a "Summary Of Safety And Effectiveness" from 1996 for an "Accelerated Transmission Protocol (ATP)" for transtelephonic ECG transmitters, focusing primarily on the transmission aspect rather than diagnostic performance of the ECG recording itself.

The document implicitly defines the acceptance criterion for the ATP feature as its ability to transmit ECG data at an accelerated rate (3 times the acquisition rate) while maintaining the original scale and integrity of the ECG waveform upon reception.

Here's an attempt to structure the information based on the provided text, highlighting what is present and what is missing:

Description of Acceptance Criteria and Study to Prove Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document primarily focuses on the technical aspects of transmission, not diagnostic interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the ATP feature (data transmission), it's unlikely a traditional diagnostic adjudication method for ECG interpretation was used for this aspect. The "ground truth" would likely be the accurate reproduction of the original ECG waveform.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done based on the provided text. The device's primary function described here is accelerated transmission, not aiding human readers in diagnosis. Therefore, a study on human reader improvement with AI assistance is not relevant to this specific submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The description of the ATP feature and its functioning (encoding, transmission, decoding, and reproduction of the ECG waveform) inherently describes a standalone algorithmic performance. The device's ability to transmit and reproduce the ECG at the described speed and fidelity is its standalone performance. No human-in-the-loop is involved in the acceleration and reproduction process itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the transmission aspect would be the original ECG waveform as acquired by the device before transmission. The acceptance criteria imply that the received and expanded ECG waveform should accurately reflect this original.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not specified. The ATP is a protocol/feature for data transmission, not a learning algorithm that requires a training set in the typical machine learning sense. Its functionality is hard-coded based on signal processing principles.

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

• Ground Truth Establishment: Not applicable. As mentioned above, this is a protocol based on signal processing, not a machine learning model requiring a training set with established ground truth. The "ground truth" here is the mathematical and electrical integrity of the signal transmission and reproduction.

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