(342 days)
This device is indicated for use in monomorphic, stationary atrial and ventricular arrhythmias. This device collects, records, and displays cardiac depolarization events for patients under the care of a skilled health care practitioner.
The QMS 3000 "" is indicated for use in the storage, display, retrieval and measurement of ECG signals obtained from intracardiac catheters.
The OMS Mapping System™ , Model 2000 is a computerized Cardiographic QMS Mapping system designed for clinical applications to allow health care providers to collect, compute, map, record and display patient diagnostic data to provide a detailed electrophysiological map of the inside of the heart.
This device can be described as QMS software which receives signals from a proprietary QMS switchbox that connects to an ancillary "basket catheter" {not part of this system} and interfaces with a qualified electrophysiology amplifier {not part of this system}. This device receives signals from the "basket catheter" and uses a computer algorithm to derive the patient mapping information.
This device functions by receiving signals from the "basket catheter" and uses a computer algorithm to derive the patient mapping information.
The provided document is limited in detail regarding specific acceptance criteria and the study conducted to prove the device meets them. It appears to focus on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a detailed performance study against specific criteria.
Here's a breakdown of the available information based on your requested points:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values). Instead, it generically states that the device was tested to confirm safety and efficacy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The document emphasizes general safety and effectiveness and substantial equivalence to a predicate device. | "A series of non-clinical tests were conducted to verify the device is accurate and calibrated and can maintain calibration over its useful life." |
| "This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." |
Study Information
Due to the nature of the submitted document (a 510(k) summary for substantial equivalence), a full, detailed clinical study report as you might expect for a novel device is not present. The "study" mentioned primarily refers to non-clinical tests.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "a series of non-clinical tests." There is no indication of a patient-based test set size.
- Data Provenance: Not specified. The tests are described as "non-clinical," implying they were likely conducted in a lab setting rather than with patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. Given the non-clinical nature of the tests, there's no mention of experts establishing ground truth for a test set in a diagnostic context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not specified. No information about expert adjudication is provided.
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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:
- MRMC Study: No. The provided text describes a device for mapping electrophysiological data, not an AI-assisted diagnostic tool that would typically involve a multi-reader study comparing human performance with and without AI. The device uses algorithms to derive mapping information, but it's not positioned as an AI assistant for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The description of the device's function suggests it operates as a standalone system for deriving patient mapping information: "This device receives signals from the "basket catheter" and uses a computer algorithm to derive the patient mapping information." The "non-clinical tests" would likely evaluate this standalone performance in a controlled environment. However, specific metrics for this standalone performance (e.g., accuracy against a gold standard for electrical signal interpretation) are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified beyond general statements about accuracy and calibration maintenance for non-clinical tests. For electrophysiological mapping devices, ground truth for accuracy and calibration would typically involve controlled electrical signal inputs with known properties.
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The sample size for the training set:
- Sample Size: Not specified. The document is for a 510(k) submission, and detailed information about the development of the algorithms (including training data) is not typically included unless it's a novel AI/ML device requiring more extensive validation.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not specified. As with the training set size, this information is not provided in a 510(k) summary for this type of device.
Overall Conclusion:
The provided text serves as a 510(k) Summary of Safety & Effectiveness, primarily focused on establishing substantial equivalence to a predicate device (K-902716). It does not present a detailed scientific study with quantifiable acceptance criteria, specific test set sizes, or comprehensive data on algorithm performance. The "tests" mentioned are described as "non-clinical" and designed to verify accuracy, calibration, and maintenance of calibration, which are typical checks for medical devices but not in-depth performance studies against clinical ground truth.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).