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The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers in both the pre-hospital and hospital based environments.

The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide ECG simulation capabilities for applications in clinical training and product demonstration.

The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent performance problems. The SigmaPace 1000 is also intended to be used by training facilities to train medical personnel.

The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

The SigmaPace 1000 is a device used to verify the performance of various parameters of external cardiac pacemakers. This is done by connecting the external leads of the pacemaker to test inputs on the SigmaPace 1000 and selecting the pacemaker to test or by using the press buttons on the front panel display or via appropriate test cables by serial port (RS232). The SigmaPace 1000 can perform a variety of Transcutaneous and Transvenous (Atrial and Ventricular) Pacer tests.

Pulse current, rate, width, and energy
Qualitative demand and async mode tests
Amplitude sensitivity tests
Noise immunity tests
Paced and Sensed Refractory tests
Selectable model specific transcutaneous algorithms
Selectable test loads
DC leakage current (tranvenous)
Current drain test (transvenous)
Long term test for pacer output stability
ECG simulation for training activities

Acceptance criteria and device performance information for the DNI NEVADA INC. SigmaPace 1000 External Pacemaker Analyzer:

This submission document primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail specific quantitative acceptance criteria or a dedicated study report with performance metrics against those criteria. Instead, it describes a more general verification and validation process.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria and corresponding reported device performance values. It outlines the types of tests performed and attests that the device meets the requirements.

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample size used for the test set.
• The data provenance is not specified regarding country of origin or whether the testing was retrospective or prospective. It describes ongoing "verification and validation testing" which implies prospective testing of the device itself.

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. The ground truth for a pacemaker analyzer would typically be established by comparing its measurements to a known, highly accurate reference standard or a golden standard pacemaker. The document does not specify who conducted this comparison or their qualifications.

4. Adjudication method for the test set:

• An adjudication method is not mentioned. Given the nature of a test equipment device, performance would likely be validated against established electrical engineering standards and reference equipment, rather than expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The device is test equipment and is not directly involved in patient diagnosis or treatment by human readers. It analyzes external pacemakers, not medical images or patient data.

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

• Yes, performance testing described is for the standalone device. The SigmaPace 1000 is an automated external pacemaker analyzer. Its "algorithms testing" and other parameter verifications are inherently standalone performance assessments.

7. The type of ground truth used:

• The document implies the use of established engineering and functional specifications as the ground truth. The device "is tested to ensure it meets the requirements as defined in the product specification and advertising." This suggests the ground truth is derived from design specifications and established standards for pacemaker performance.

8. The sample size for the training set:

• This information is not applicable and not provided. The SigmaPace 1000 is a measurement device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its "algorithms" refer to specific testing protocols for different pacemaker models, not learned models.

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

• This information is not applicable and not provided for the reasons stated above (not an AI/ML algorithm requiring a training set). The "algorithms" are likely deterministic test sequences and calculation methods programmed into the device based on pacemaker manufacturer specifications and industry standards.

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