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The SEER 1000 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The SEER 1000 Holter recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of patients for up to 7 days. The device stores the acquired ECG data in its on-board flash memory. Patient demographic information can be downloaded from a PC application or from a mobile application (IPhone, IPod, IPad) into the SEER 1000 recorder via Bluetooth during hookup time. With the PC application or mobile application you can start or stop a recording and you can check signal quality of the ECG data during hookup time or recording. At the end of the recording, the SEER 1000 can be directly connected to a PC via an USB cable to download the recorded data for later evaluation. It is not possible to connect an USB cable and an ECG patient cable to the recorder at the same time.

The provided text describes the SEER 1000 Holter recorder and its 510(k) summary. However, it explicitly states that no clinical testing was performed and that the device's substantial equivalence was determined based on non-clinical tests (electromagnetic compatibility, electrical safety, and ECG performance according to AAMI ANSI EC 38).

Therefore, the following information, which typically relies on clinical studies with human participants, cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: No performance metrics for diagnosing conditions in a clinical setting are provided. The "device performance" mentioned in the non-clinical tests refers to compliance with electrical and ECG standards, not diagnostic accuracy.
2. Sample size used for the test set and the data provenance: No test set of patient data was used as there were no clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable due to the absence of clinical studies.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. The SEER 1000 is a Holter recorder without analysis capabilities; it does not incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a recorder, not an analytical algorithm.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" was compliance with established engineering and performance standards (IEC 60601-1-2, IEC 60601-1, AAMI ANSI EC 38).
8. The sample size for the training set: Not applicable as there is no algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and Testing:

The SEER 1000 Holter recorder achieved 510(k) clearance based on substantial equivalence to predicate devices (SEER Light Extend Compact Digital Holter System and CardioMem® CM 3000-12BT). The key argument for substantial equivalence was that the SEER 1000, like its predicates, continuously records ECG data and does not perform cardiac analysis itself. It is intended to be used with an ECG analysis software package by a trained physician or healthcare professional.

Acceptance Criteria and Study for the SEER 1000:

The acceptance criteria for the SEER 1000 were primarily related to safety, electrical performance, and electromagnetic compatibility, aligning it with recognized industry standards.

• Sample size for the test set and data provenance: Not applicable. No patient data or clinical test sets were used.
• Number of experts used to establish ground truth for test set: Not applicable. For non-clinical tests, "ground truth" is defined by compliance with the referenced standards.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. The device performs no analysis and does not involve AI or human reader improvement studies.
• Standalone (algorithm-only) performance: Not applicable. The device is a recorder, not an algorithm.
• Type of ground truth used: For the non-clinical tests, the ground truth was the requirements and methodologies defined within the specified international and national standards (IEC 60601-1-2, IEC 60601-1, AAMI ANSI EC 38).
• Sample size for the training set: Not applicable. No algorithms were involved that required a training set.
• How the ground truth for the training set was established: Not applicable.

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