(157 days)
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 System is a personal computer based pacemakertesting 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 system is comprised of the following components:
- . Personal Computer
- . Paceart System software
- LaserJet Printer .
- Parallel (TTM, Clinical, and Full) .
- USB module (TTM and Full) ●
- Isolation transformer .
- Cables .
The provided text describes the Paceart System, a personal computer-based pacemaker testing system, 12-lead electrocardiograph, and transtelephonic receiving station.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on regulatory compliance rather than specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy. The testing performed was against recognized standards for medical devices.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Compliance) |
|---|---|
| Compliance with AAMI/ANSI EC 11: 1991 (Diagnostic Electrocardiographic Devices) | Device was tested in accordance with applicable sections. |
| Compliance with AAMI/ANSI EC 38: 1998 (Ambulatory Electrocardiographs) | Device was tested in accordance with applicable sections. |
| Compliance with FCC CFR 47, Part 68 (Connection of Terminal Equipment to the Telephone Network) | Telephone circuitry was tested to FCC CFR 47, Part 68. |
| Compliance with FDA Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions | Requirements were applied. |
| Compliance with FDA guidance document "Off-The-Shelf Software Use in Medical Devices" (for OTS software) | Information provided in Section 9.0 Off-The-Shelf Software was prepared in accordance with this document. |
| Substantial Equivalence to Predicate Devices | Medtronic Paceart considers the system to be substantially equivalent based on data, information, and similarities to predicate devices. |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a "test set" in the context of diagnostic performance (e.g., number of ECGs or patients). The testing described is against engineering and regulatory standards, not a clinical diagnostic performance study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission focuses on engineering and regulatory compliance rather than a diagnostic performance study requiring expert ground truth.
4. Adjudication method for the test set:
This information is not provided as it's not relevant to the type of testing described.
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 was not conducted or reported. The device predates the widespread use of "AI" in medical devices as understood today, and the submission is focused on device functionality and regulatory compliance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The submission focuses on the functionality of the system as a tool for analysis and data management, and its compliance with standards. It does not present data on an "algorithm only" performance in the context of diagnostic accuracy. The device, by its nature (pacemaker artifact analyzer, ECG, transtelephonic station), is intended for use by medical professionals.
7. The type of ground truth used:
The concept of "ground truth" as typically understood in diagnostic performance studies (e.g., pathology, outcomes data, expert consensus) is not applicable to the type of testing described in this submission. The "ground truth" for the tests performed was compliance with technical specifications and regulatory standards.
8. The sample size for the training set:
A "training set" in the context of machine learning or AI is not mentioned or relevant to this 510(k) submission.
9. How the ground truth for the training set was established:
This information is not applicable as there is no mention of a training set or AI/machine learning development.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).