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Calculation and Historical Tracking of:

• . Actual Resistance
• Actual Reactance .
• Actual Impedance
• Actual Phase Angle (PA) .
• Estimated Body Fat Mass (FM) ●
• Estimated Fat Free Mass (FFM)
• Estimated Total Body Water (TBW) .
• Estimated Intra-Cellular Water (ICW) ●
• Estimated Extra-Cellular Water (ECW) ●
• Estimated Basal Metabolic Rate (BMR) .
• Estimated Daily Energy Expenditure (DEE) .
• Actual Body Mass Index (BMI) .

The device is not intended for use for diagnosis.

The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only.

The data are stored in PC in the Backup system of the E.S-BC software.

As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population .

As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use

The E.S- BC is a single frequency electrical bioimpedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), total body water (TWB) and fluid distribution: intracellular water, and extracellular water.

It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes. The E.S- BC has two operating modes: Direct and Algorithm.

Direct Mode measures and displays values for impedance (Z), phase (Ph), resistance (R) and reactance (Xc).

Algorithm Mode displays estimates of fat-free mass (FFM) ,fat mass (FM), total body Water (TBW), intracellular water (ICW), and extracellular water (ECW), plus their percentages. The device computes these values using accepted peer reviewed published algorithms tailored to the patient type: general population, obese patients, or children.

The provided text describes a 510(k) premarket notification for the E.S-BC Electro Sensor / Body Composition device. It details the device's summary and substantial equivalence to predicate devices but does not contain specific acceptance criteria, a detailed study protocol, or quantitative performance data beyond general statements of testing.

Therefore, I cannot fill in a table of acceptance criteria vs. device performance, or provide the detailed study information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies as requested. The document only mentions "Performance testing: 1. Testing and Calibration, 2. Software verification (SRS/STD/STR), 3. Clinical investigation (Miami University)" as evidence of performance.

Based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not specify quantitative acceptance criteria for the performance of the E.S-BC device's Body Composition estimations (FM, FFM, TBW, ICW, ECW) nor does it provide detailed performance results from the clinical investigation. It only generally states that testing and calibration and a clinical investigation were performed to show that specific differences (USB power, direct data transmission, different peer-reviewed algorithms) "do not affect the performances and the effectiveness of the E.S/BC system."

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

The document states a "Clinical investigation (Miami University)" was conducted, but it does not specify the sample size for this test set or whether the data was retrospective or prospective.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The device's primary function is direct measurement and algorithmic calculation, not human-in-the-loop diagnostic assistance for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

The document implies a standalone performance, as the device directly measures and computes body composition metrics. It has an "Algorithm Mode" that "displays estimates" using "accepted peer reviewed published algorithms." However, detailed results of such a standalone study (like accuracy metrics against a reference standard) are not provided beyond the general statement of a clinical investigation.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the clinical investigation. For body composition devices, common ground truth methods include DEXA scans, hydrostatic weighing, or isotope dilution, but the document does not specify which, if any, were used.

8. The Sample Size for the Training Set

The document mentions the use of "accepted peer reviewed published algorithms tailored to the patient type" for the Algorithm Mode. This implies that the algorithms were developed and likely "trained" (or validated) using pre-existing datasets. However, the document does not specify any training set sample sizes directly used by the applicant for algorithm development or refinement for the E.S-BC device itself.

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

Since the document refers to "accepted peer reviewed published algorithms," the ground truth for any underlying training data would have been established by the original researchers who developed and published these algorithms. The document does not provide details on how that ground truth was established, as it is leveraging existing algorithms rather than developing new ones from scratch.

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EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response. The device is not intended to be used for any diagnosis. The data are stored in the PC in the backup system of the EIS-GS software. The device is intended for use only in healthy adult subjects. The device is intended for use only in practitioner's office and clinical setting. Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician.

The EIS-GS system is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 6 disposable electrodes, reusable electrodes and reusable cables. Software installed on a computer. Protocol communication: USB port. Through the 6 tactile electrodes, a weak current with a very low frequency is sending alternatively between 2 electrodes with a sequence and the EIS-GS system is recording the electrical conductivity of 22 pathways of the human body. In accordance with the 21 CFR 882.1540, the EIS-GS system is a galvanic Skin response device that provides skin conductance measurements on the PC screen.

The provided document is a 510(k) Premarket Notification for the EIS-GS (Electro Interstitial Scan-Galvanic Skin) device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (SUDOSCAN).

However, the document does not contain typical acceptance criteria for device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy against a gold standard) or the results of a primary clinical study designed to prove such performance.

Instead, the submission focuses on technical specifications, verification, validation, and safety standards to demonstrate substantial equivalence to an existing legally marketed device.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available:

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

• Record intensity changes of 22 body parts/pathways following weak current/tension (1.28V, very low frequency).
• Skin conductance measurement range: 1 to 120 micro Siemens (Predicate: 10 to 100 micro Siemens).
• Data acquisition duration: 120s.
• Electrical output to the skin: 1.28 V (Predicate: 4 V maximum).
• Electrical output unit duration: 1s.
• Power density at electrode:

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• 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.
• 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 ESO software.
  The device is intended use only for adult subjects (> 20 years old)
  This Oximeter is intended to be used in spot-checking (5 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 practitioner.

• USB plug and play hardware device including an electronic box and reusable Adult SpO2 probe
• Software installed on a computer.
  Description of the features
• Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude.
• Mathematical analysis of the pulse waveform (photoelectrical Plethysmograph' feature).
• Mathematical analysis of the Heart Rate Variability (HRV 'feature).

The provided 510(k) submission for the Electro Sensor Oxi (E.S.O) does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria related to accuracy of SpO2, pulse rate, or the mathematical analyses for Photoelectrical Plethysmography (PP) and Heart Rate Variability (HRV).

Instead, the submission largely focuses on establishing substantial equivalence to a predicate device (Electro Sensor Teck Model PEMS, K083229) by demonstrating similar intended use, technological characteristics, and safety/effectiveness, with the main new characteristic being the derivation of heart rate from oximeter waveform analysis rather than an EKG device.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any performance evaluation.
• Data Provenance:
  • The document mentions "input data from the MIT-BIH database" for "Software algorithms tests." This suggests a retrospective dataset, likely from North America (MIT-BIH is a US-based database). However, it's not explicitly stated if this database was used for the "test set" in the context of device performance, but rather for software verification.
  • For the comparative testing of RR intervals and HRV, no details about where this data came from are provided.
  • The document references "published clinical investigations" for interpretation of PP and HRV results, stating these investigations "had been made with materials using the same technology (Pulse oximeter) and the same anatomical site (fingertip)." This implies reliance on existing literature rather than new clinical data from the E.S.O. itself. There is no information on the country of origin or whether these studies were retrospective or prospective, as they are external references not directly part of the E.S.O.'s submission data.

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

• Not Applicable / Not Specified. The document does not describe a process of establishing ground truth for a test set using experts for performance evaluation of the E.S.O. device.
• "Peer reviews" are mentioned for the mathematical analyses of PP and HRV, but the number or qualifications of these reviewers are not detailed, nor is it explicitly stated that they established a "ground truth" for a test set. Their role seems to be more about assessing the mathematical soundness of the algorithms.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. No formal adjudication method is mentioned as a test set for performance evaluation by human experts was not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This device is a pulse oximeter with mathematical analysis features, not an AI-assisted diagnostic tool that human readers would use to improve their performance with or without AI. Therefore, an MRMC study and effect size of human improvement with AI assistance are not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Partially Applicable, but with no detailed results. The "Software algorithms tests with input data from the MIT-BIH database" could be considered a form of standalone testing. The "comparative testing between EKG RR intervals (from predicate device) and SP02 RR intervals (from E.S.O)" and "comparative HRV analysis results from the predicate device and E.S.O." also suggest standalone comparison of the algorithm's output to a reference, but no specific performance metrics like accuracy, sensitivity, or specificity are provided. The document explicitly states that the PP and HRV analyses "are not intended use for diagnosis" and "no clinical validation is required for E.S.O" for these features.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For Software Algorithms Tests: The use of the "MIT-BIH database" implies that the ground truth for software verification would be derived from the annotations and established physiological parameters within that database (e.g., expert-annotated heartbeats, rhythm classifications from EKG).
• For RR Intervals and HRV Comparisons: The ground truth or reference standard used for the comparative testing between EKG RR intervals and SpO2 RR intervals would have been the EKG RR intervals from the predicate device. For HRV, the comparison was against HRV analysis results from the predicate device. This essentially uses an existing, cleared device as the reference standard.
• For SpO2/Pulse Rate: No explicit ground truth method is described for verifying the accuracy of the SpO2 and pulse rate measurements. Reliance seems to be on the OEM subcontractor's clearance and general safety standards rather than detailed clinical accuracy studies within this submission.

8. The Sample Size for the Training Set

• Not Specified. The document does not mention a training set or its sample size. The device relies on established algorithms for oximetry and mathematical analyses, rather than a machine learning model that would typically require a training set. The "Software algorithms tests with input data from the MIT-BIH database" is referred to for verification, not training.

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

• Not Applicable. As no specific training set for a machine learning model is mentioned, the method for establishing its ground truth is also not applicable.

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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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