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The ZOLL E Series External Defibrillator is indicated for the defibrillation, noninvasive transcutaneous pacing, CPR monitoring, and multi-parameter monitoring of patient vital signs including: ECG monitoring, Pulse Oximetry (SpO2), End Tidal CO2, 12 lead ECG monitoring, and Non Invasive Blood Pressure for resting patients in critical care and transport conditions. It also supports data printing, data recording, and 12 lead data transmission via cellular fax modem, RS232, and Bluetooth.

The ZOLL E Series with Bluetooth Dial Up Networking 12 Lead Transmission provides a means of transmitting the 12 lead patient record wirelessly, via Bluetooth, directly to a cellular device. The cellular device then makes an internet connection to a transfer station which redirects the record to a recipient via email or fax.

Based on the provided text, the device is the ZOLL E Series® with Bluetooth Dial Up Networking 12 Lead Transmission, and the submission is a 510(k) for a modification to an existing device (K042007). This submission primarily focuses on establishing substantial equivalence for a change in how the 12-lead ECG data is transmitted wirelessly, rather than introducing a new medical function that requires extensive clinical studies with specific performance criteria.

Therefore, the typical structure for "acceptance criteria" and "device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, or AUC) for a diagnostic AI device is not applicable here. Instead, the "acceptance criteria" would relate to the functional requirements of the new transmission method and its equivalence to the predicate device. The "study" described is verification and validation testing to ensure the modified product maintains its intended functions and does not degrade existing performance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "extensive performance testing" and "functional testing" but does not quantify the number of devices tested, the number of transmission events, or any patient data records used for testing the transmission function.
• Data Provenance: Not specified. Given that this is largely functional and software testing for a connectivity feature, the "data" would likely be test data generated specifically for verifying the Bluetooth transmission, rather than de-identified clinical data with specific provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This submission is not for a diagnostic device that requires expert consensus for ground truth on clinical data. The testing is for the functional performance of a data transmission feature.

4. Adjudication method for the test set

• Not Applicable. No ground truth adjudication is mentioned as this is a functional/connectivity modification, not a diagnostic accuracy study.

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

• No. An MRMC study was not done. This device is not an AI-assisted diagnostic tool for human readers; it's a medical device with a modified data transmission feature.

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

• No. This refers to the performance of a connectivity feature of a medical device, not a standalone algorithm's diagnostic performance. The 12-lead ECG analysis function that generates the data is part of the E Series device itself, and its performance would have been established during the original 510(k) (K042007) or previous submissions. This K081081 is about the transmission of that data.

7. The type of ground truth used

• Not Applicable (or implicitly, system specifications/expected output): For functional testing of a transmission feature, the "ground truth" would be the successful and accurate transmission of the 12-lead ECG data, matching the source data at the destination, within specified timing and reliability parameters. This is verified against the device's design specifications. No clinical "ground truth" like pathology or expert consensus is relevant for this specific modification.

8. The sample size for the training set

• Not Applicable. This modification is for a software/connectivity feature, not a machine learning algorithm that requires a training set.

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

• Not Applicable. As there is no training set mentioned or implied, this question is not relevant.

Summary of the K081081 Submission Context:

This 510(k) is for a relatively minor modification to an already cleared medical device. The "device" being discussed in the context of this submission is specifically the mechanism of 12-lead ECG data transmission (from indirect through an intermediate device to direct via Bluetooth Dial Up Networking). The performance testing described is focused on ensuring that this change in transmission protocol works correctly and does not negatively impact the device's overall safety, effectiveness, or other existing functions as a defibrillator, pacer, and multi-parameter monitor. It is not an AI or diagnostic algorithm submission.

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