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Each module has specific feature and intended use

1. Pulse Oximeter:
   To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
   To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.
2. Heart rate variability (HRV) :
   To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability.
   The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis.
   The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
   The data are stored in PC in the Backup system of the ES Teck software.
   The device is intended use only for adult subjects (> 20 years old)
   This Oximeter is intended to be used in spot-checking (2 minutes)
   The device is intended use in licensed practitioner's office
   This device is no intended to be used at home, in hospital or out-of-hospital transport
   The device is not intended use in support life and not for continuously monitoring
   The system will be use by licensed practitioner.

The ES Teck System is a programmable electro medical system (PEMS) including:
. USB plug and play hardware device including an electronic box , 3 disposable clectrodes, reusable Adult SpO2 probe and reusable cables
Software installed on a computer. .
E.S Teck system is a combination of 2 devices (or modules) with specific features controlled by unique software:

Pulse Oximeter displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. The photoelectrical Plethysmograph' feature (PP) analyzes the pulse waveform provided by the oximeter.
A HRV (Heart Rate Variability) evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each ORS complex is detected and the so-called normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization.

Here's a breakdown of the acceptance criteria and study information for the Electro Sensor Teck (K083229), based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed, de-novo clinical trial data with explicit acceptance criteria and performance metrics in the way a modern clinical study report would. As such, the information below is extracted and inferred from the available text. Explicit acceptance criteria and device performance values are generally not stated in a 510(k) summary in the same granular detail as in a full study report.

Acceptance Criteria and Reported Device Performance

Important Context: For this 510(k), the primary "acceptance criterion" is demonstrably that the device is "substantially equivalent" to the identified predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. Direct numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are not presented in this summary, as the nature of the submission relies on the established performance of the predicate devices and verification through non-clinical means.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • HRV Module:
     • Test set: Input data from the MIT-BIH database. The exact number of records or patients from this database used is not specified.
     • Provenance: Retrospective (from the existing MIT-BIH database). Country of origin is not specified but the MIT-BIH database is a well-known international resource.
   • SpO2 Module:
     • Test set: "Clinical tests of the OEM subcontractor." The sample size and provenance (country of origin, retrospective/prospective) are not specified in this 510(k) summary; they refer to tests conducted by the OEM.
   • Photoelectrical Plethysmography (PP) Application:
     • Test set: "Published clinical investigations." The sample sizes and provenance are not specified for these external investigations.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • HRV Module (MIT-BIH database): The ground truth for the MIT-BIH database is established by expert cardiologists and technicians who annotate the ECG waveforms for heartbeats. The number and specific qualifications of those who originally annotated the MIT-BIH database are not provided in this document but are inherent to the database's creation.
   • SpO2 Module & PP Application: Given that no specific in-house clinical trials are detailed for these components (relying on OEM data and published literature), the number of experts and their qualifications for establishing ground truth are not provided in this submission.

3. Adjudication Method for the Test Set:

   • Not specified for any of the modules, as the primary method for the HRV module involved comparison against a pre-established database, and for SpO2/PP, it relied on OEM data and peer-reviewed literature.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned or performed, as this device primarily involves automated measurements and mathematical analyses, not interpretation by human readers.

5. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

   • Yes, the evaluation performed is effectively a standalone (algorithm only) performance assessment, as the device's function involves mathematical analysis of physiological signals. Human interpretation is not part of the core performance claim for the mathematical analyses.
   • The "mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis," explicitly stating they are for "reference only." This reinforces the standalone nature of the algorithmic output without requiring a human-in-the-loop for diagnostic purposes.

6. Type of Ground Truth Used:

   • HRV Module: Expert-annotated ECG data (from the MIT-BIH database) for heartbeat detection.
   • SpO2 Module: Likely established through highly accurate reference oximeters or CO-oximeters and potentially arterial blood gas measurements (implied by OEM clinical tests for SpO2, though not explicitly stated in this document).
   • Photoelectrical Plethysmography (PP) Application: Not directly mentioned, but inferred to be based on the established physiological principles and analyses validated in the "published clinical investigations" that used "the same technology."

7. Sample Size for the Training Set:

   • Not specified. The device relies on algorithms that are stated to be "exactly the same as in the predicate device." This suggests the training/development would have occurred during the predicate device's creation or by the OEM, and those details are not part of this 510(k) summary.

8. How the Ground Truth for the Training Set Was Established:

   • Not specified. Similar to the training set size, the ground truth establishment for the training data would be linked to the development of the predicate device's algorithms or the OEM's development process, which is not detailed in this submission.

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