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The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the SpaceLabs Medical Model 90492 ECG module. Diagnostic ECG analyzes detailed ECG waveforms in each cardiac cycle and the beat-to-beat variability in order to determine the cardiac rhythm. When used in conjunction with a SpaceLabs Medical Patient Care Management System (PCMS) monitor the SpaceLabs Medical Model 90492 ECG module provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events.

The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a softwareonly option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12lead ECG module. The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code. There is no additional hardware required for this option.

The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6. The 90492 ECG module is used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.

ECG data is displayed as an analog moving waveform or as various static waveforms. The analog ECG is passed through digital filters to eliminate unwanted signals. Standard ECG electrodes are used to interface the patient to the 90492 ECG module. Clinicians will position the electrodes in the customary locations. The electrodes are connected to shielded leadwires which are connected to a shielded cable. The cable is connected to the front of the 90492 module.

Unfortunately, the provided text does not contain the detailed information needed to fully answer your request. The document is a 510(k) summary for a medical device and primarily focuses on describing the device, its intended use, and its equivalence to a predicate device.

Here's what I can extract and what's missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds for ECG interpretation). The document generally states that "extensive safety and performance testing" was done and that the device "meets all of its functional requirements and performance specifications."
• Reported Device Performance: Not provided. The summary confirms that the diagnostic ECG algorithm is identical to those found in the Mortara Instrument ELI300 (K933143), ELI 100 (K920627), and ELI 200 (K920626A). To find performance, one would need to consult the 510(k) summaries or supporting documentation for those predicate devices, as this document asserts identical performance due to using the same algorithm.

Missing Information for a comprehensive table: Specific metrics (e.g., detection rates for specific arrhythmias, accuracy of QRS duration measurement, etc.) and quantitative results against those metrics.

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

• Sample Size: Not mentioned for any test set.
• Data Provenance: Not mentioned.
• Retrospective or Prospective: Not mentioned.

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):

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Not mentioned.

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:

• MRMC Study: Not mentioned. The device is described as a "Diagnostic ECG Analysis Option" which implies an algorithm that provides the analysis, but it doesn't describe a study comparing human readers with and without this algorithm's assistance.

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

• The document implies this is a standalone algorithm's performance inherited from the predicate devices. It states, "The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a software-only option... The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code." This suggests the algorithm's performance itself was assessed (or accepted based on predicate devices) without necessarily involving human-in-the-loop studies for this specific submission. However, the details of that standalone performance are not present here.

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

• Not mentioned. For ECG analysis, ground truth often involves expert cardiologist consensus readings.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned. Given that the algorithm is described as "identical to those found in the Mortara Instrument ELI300," the training and ground truth establishment would have occurred during the development and clearance of those earlier Mortara devices.

In summary: This 510(k) summary primarily focuses on regulatory equivalence to predicate devices, asserting that the device is "as safe and effective as the predicate device and raises no new issues" because it uses an identical, previously cleared algorithm. It does not provide the detailed performance study information typically requested for new algorithm submissions or when demonstrating specific performance against acceptance criteria. To obtain such details, one would need to review the K933143, K920627, or K920626A submissions for the Mortara Instrument devices.

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