(89 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 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:
- Software Verification and Validation: Ensuring the software changes function as intended and meet established requirements.
- 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.
§ 870.3640 Indirect pacemaker generator function analyzer.
(a)
Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.(b)
Classification. Class II (performance standards).