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The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or Implantable Cardioverter Defibrillators.

The Medtronic Paceart Optima System Software, Model POS12D, is intended for use with the Medtronic Paceart System, previously cleared per K024278. The Paceart System is a 12-lead electrocardiograph, transtelephonic receiving station, and a clinic management tool that organizes patient, device and programmer information. The Paceart System is designed to integrate data from implanted cardiac device programmers, pacemaker transmitters, cardiac event recorders, and remote data networks, such as the Medtronic CareLink® Network, into a single patient record, enabling clinicians to conduct their daily work through commonly formatted data and clinic workflow tools. Note: The Paceart System will also be marketed and referred to as the Paceart Optima System when using the Paceart Optima System Software. The Paceart System consists of hardware and software. There are no design or process changes to the hardware components of the Paceart System as part of this submission. Therefore, the subject of this 510(k) submission is for the Paceart Optima System Software only and contains only information on the software changes.

The provided 510(k) summary for the Medtronic Paceart Optima™ System Software (K110693) does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-driven medical devices.

Instead, this submission is for a software update to an existing system (Paceart System, K024278). The "Summary of Testing" section explicitly states: "Software verification testing and validation testing is performed to demonstrate the Paceart Optima System Software meets established performance criteria and to support equivalency to the referenced predicate device."

This indicates a focus on software functionality and equivalence to a predicate, rather than an independent clinical performance study with defined acceptance metrics for a specific algorithm's output.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The submission focuses on:

1. Software Verification and Validation: Ensuring the software changes function as intended and meet established requirements.
2. Substantial Equivalence: Demonstrating that the updated software is equivalent in intended use, design, materials, and performance to the predicate device.

Conclusion:

The provided document describes a software update for a clinic management system, not a device with AI/ML components requiring specific performance metrics against a clinical ground truth. The "testing" mentioned refers to standard software verification and validation, aimed at ensuring the new software features work correctly and the overall system remains equivalent to its predicate. No details regarding clinical studies, ground truth establishment, or specific performance metrics are present because they are not typically required for this type of software update submission.

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• The device is for prescription use only.
• The device is intended to be used in a clinic or hospital.
• The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG.
• The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
• In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.

Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port.
Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module:

• An analog front end.
• Digital Signal Processing USB Interface Unit.
• TTM Interface for analog phone lines.
• TTM Interface for digital phones.
  The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).

The provided document is a 510(k) summary for the Cygnus 12 Lead/TTM ECG Module. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain explicit acceptance criteria or a detailed study report that would typically prove a device meets specific performance metrics.

Instead, the summary states:

"The device was tested in accordance with applicable sections of AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices and AAMI/ANSI EC 38: 1998, Ambulatory Electrocardiographs."

This indicates that the device's performance was evaluated against the standards outlined in these AAMI/ANSI documents, which would inherently contain performance requirements and testing methodologies for ECG devices. The "Summary of testing" section broadly states this, and the "Conclusion" relies on functional similarities with the predicate device (K915632) to establish substantial equivalence.

Without access to the actual test reports or the specific sections of the AAMI/ANSI standards that Cygnus LLC applied and measured against, a detailed table of acceptance criteria and reported device performance cannot be generated from this document alone.

Therefore, many of your requested points cannot be extracted directly from this 510(k) summary. I will answer what is available and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit acceptance criteria and corresponding reported performance are not detailed in this 510(k) summary. The document states compliance with AAMI/ANSI EC 11: 1991 and AAMI/ANSI EC 38: 1998. These standards would contain the acceptance criteria for diagnostic and ambulatory ECG devices, respectively. Without access to these standards and Cygnus's specific test reports, a detailed table cannot be created.

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

This information is not provided in the 510(k) summary. The document only mentions that the device was "tested in accordance with applicable sections" of the AAMI/ANSI standards, but provides no specifics about the test set, sample size, or data provenance.

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)

This information is not provided in the 510(k) summary, as it does not detail the specific testing methodology for establishing ground truth or the involvement of experts in that process.

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

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not described or referenced in this 510(k) summary. This device is a measurement and monitoring system, not an AI-assisted diagnostic tool in the typical sense that would necessitate such a study (i.e., it's not performing diagnostic interpretation that would then be compared to human readers).

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

The 510(k) summary describes a "fully functional ECG and Pacemaker monitoring system." The testing mentioned (AAMI/ANSI EC 11 and EC 38) would evaluate the standalone performance of the device's measurement capabilities (e.g., accuracy of ECG waveform acquisition, heart rate measurement, pacemaker pulse detection). While not explicitly stated as "standalone algorithm performance," the nature of these standards implies testing the device's technical specifications and measurements without a human interpreting the device's output to influence the device's function or measurement.

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

The document does not explicitly state the "type of ground truth used." For a device measuring ECG signals and detecting pacemaker activity, the ground truth would typically be established through:

• Reference standard equipment: Comparison to known, calibrated, and highly accurate ECG and pacemaker simulators or other established reference devices.
• Physiological recordings: In some cases, recordings from human subjects or animal models where true physiological events are simultaneously measured by gold-standard methods, although the AAMI/ANSI standards primarily focus on technical performance.

Given the nature of the device and the standards cited, the ground truth would likely involve a combination of precise electrical signals, simulated ECGs, pacemaker pulses, and potentially recordings validated against professional interpretation or other highly accurate monitoring equipment.

8. The sample size for the training set

This device is not presented as an AI/machine learning model requiring a "training set" in the conventional sense. Therefore, this information is not applicable and not provided. The device's performance would be based on its engineering design, hardware, and algorithms for signal acquisition and processing, evaluated against technical standards.

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

As the device is not an AI/machine learning model with a "training set," this question is not applicable.

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The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

The Medtronic Paceart® System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.

The provided text is a 510(k) summary for the Medtronic Paceart System. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, this document does not contain specific acceptance criteria or the details of a study demonstrating that the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample sizes, expert qualifications, adjudication methods, and details of standalone or MRMC studies, are not present in this regulatory submission summary. These types of details would typically be found in a separate study report or a more detailed technical file for the device.

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