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BE micro/Trea intended use is collecting and recording physiological data to be used in neurology (EEG), polysomnography (PSG) and sleep disorder studies. The BE micro is intended for pediatric to adult population, and can be used either home or hospital environments. The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

The BE micro is manufactured by EBNeuro and intended for use in collecting and recording physiological data to be used in diagnosis in EEG (electroencephalography) and PSG (sleep disorder studies) clinical investigation. The BE micro is a portable multi-channel recording system that capture and digitally amplifies neurological (EEG) and/or Polysomnography (PSG) physiological activity and records the acquired data onto an internal NAND flash memory chip and/or sends those data directly to a PC via the USB port. The BE micro system is a small, lightweight recording system that is comfortable for the patient and simple for the clinician to set up. The Amplifier can be worn by the patient allowing in such way the patient to freely move or sleep while recordings are being made, allowing a more comfortable and efficient test.

The provided 510(k) summary for K093728 details the "BE micro/Trea" device, an electroencephalograph for collecting and recording physiological data in neurology and sleep studies. However, the document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance data.

The document does NOT provide information regarding specific acceptance criteria for clinical performance, nor does it describe a study proving the device meets such acceptance criteria through clinical performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "Summary of Non-Clinical Performance Data" section indicates:

• "Data to verify and validate the measurement algorithm and software functionality. RESULT: PASS"
• "Data to evaluate electrical safety and electromagnetic compatibility (per IEC 60601-1, IEC 60601-1-2, and other standards). RESULT: PASS"

This suggests that the performance requirements are related to the successful operation of the device's software and its compliance with electrical safety and EMC standards, rather than diagnostic accuracy or clinical effectiveness in identifying specific conditions.

Given the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit clinical performance acceptance criteria and corresponding reported performance are provided in the document, this table is based on the non-clinical performance data statements.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable from the provided document. The non-clinical performance data described relates to software functionality and electrical/EMC compliance, not a test set for clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable from the provided document, as no clinical test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Not applicable from the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or summarized in the provided document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study for an algorithm related to clinical diagnosis is described. The "measurement algorithm and software functionality" likely refers to the core processing of physiological signals rather than a diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable from the provided document for clinical performance. For the described non-clinical tests:

• For software functionality, the "ground truth" would be the expected output or behavior according to design specifications.
• For electrical safety and EMC, the "ground truth" is compliance with the specific parameters and limits defined in the referenced IEC and other standards.

8. Sample Size for the Training Set

Not applicable from the provided document, as no machine learning algorithm development (with training/test sets) for diagnostic purposes is described.

9. How the Ground Truth for the Training Set Was Established

Not applicable from the provided document.

Conclusion from document analysis:

The 510(k) summary for K093728 establishes substantial equivalence primarily through a comparison of technological characteristics with predicate devices and demonstration of compliance with engineering standards for software functionality, electrical safety, and electromagnetic compatibility. It does not contain information about clinical performance acceptance criteria or a clinical study proving that the device meets such criteria for diagnostic accuracy or effectiveness. This is typical for Class II devices like electroencephalographs, where substantial equivalence can often be demonstrated through technological and performance comparisons to existing legally marketed devices without requiring extensive de novo clinical performance studies for diagnostic accuracy.

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