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BP-BT Kiosk is designed to measure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication: Prescription use in medical or clinic environment only.Rx only.

BP-BT Kiosk has the same design as the predicated device with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is first adapted to the arm size and then, inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. BP-BT Kiosk will not inflate the cuff higher than 300 mmHg. BP-BT Kiosk will turn on an irregular heartbeat if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and transmitted via Bluetooth wireless module. The cuff is also deflated automatically to 0 mmHg at the same time.

The provided text describes the BP-BT Kiosk, a non-invasive blood pressure measurement system, and its clinical validation for substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BP-BT Kiosk are based on the standard IEC 80601-2-30, which pertains to automated non-invasive sphygmomanometers. The reported device performance demonstrates compliance with these standards for blood pressure and pulse rate measurement accuracy.

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

• Sample Size: 267 sets of data were measured for the clinical test.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions a "Clinical Test" was performed.

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

The document does not explicitly state the "number of experts" or their specific qualifications for establishing the ground truth. However, it indicates that the comparison was made against a "Mercury Blood pressure monitor," which is generally considered a gold standard (ground truth) for non-invasive blood pressure measurement in clinical settings, typically operated by trained medical professionals.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method like "2+1" or "3+1." The evaluation appears to be a direct comparison between the BP-BT Kiosk and a Mercury Blood Pressure Monitor.

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

No, an MRMC comparative effectiveness study was not done. The BP-BT Kiosk is a standalone medical device for measuring blood pressure and pulse rate, not an AI-assisted diagnostic tool that would involve human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.

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

Yes, a standalone performance evaluation was done. The "Clinical Test" directly assessed the accuracy of the BP-BT Kiosk's measurements (algorithm only) against a Mercury Blood Pressure Monitor. The reported performance metrics (average and standard deviations for systolic and diastolic pressure, and pulse rate error) reflect the device's standalone accuracy without human intervention in the measurement process.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical test was comparison with a Mercury Blood Pressure Monitor. This is considered a gold standard method for accurate non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This suggests that the device's capabilities were likely developed and validated using existing methodologies for non-invasive blood pressure measurement, and the clinical test served as the primary validation of its performance against a known standard.

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

Since a dedicated "training set" is not mentioned in the context of machine learning or AI, the concept of establishing ground truth for a training set as typically understood in AI/ML development does not apply here. The device's underlying technology and algorithms for oscillometric blood pressure measurement would have been developed based on established physiological principles and engineering practices, with validation against reference methods during its design and development phases. The "Clinical Test" served as the final-stage validation for regulatory submission.

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Oxi-W system is intended for use:

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.

To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.

To analyze the basic rhythms of the NN or RR intert rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate to the autonomic nervous system function.

The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for 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 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 for 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 for use in support life and not for continuously monitoring

The system will be used by practitioner.

The Oxi-W System is a programmable electro medical system (PEMS) including:

• Pulse oximeter with data transmission via Bluetooth. -
• -Software installed on a computer

Hardware :

• collects SpO2%, pulse rate value and vertical bar graph pulse amplitude -
  (photoplethysmography) and sends the encrypted numbers to the Software.

Software:

• Display SP02%, and photoplethysmography. -
• Mathematical analysis of the pulse waveform (Photoplethysmography) using the first and second derivative of the wave to provide values related to the microvascular condition.
• Mathematical analysis of the pulse waveform (Photoplethysmography) to detect the heart rate and provides values of the heart rate variability related to the autonomic nervous system function.

The Oxi-W System, a programmable electromedical system consisting of a pulse oximeter with Bluetooth data transmission and computer software, was evaluated for performance and effectiveness.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria Met:

The Oxi-W system addresses differences from its predicate device (LD-Oxi system K160956) through a series of performance tests and analyses, rather than a clinical trial. The justification for not requiring clinical tests is that the Oxi-W algorithms and hardware share the same intended use and results as the predicate device, which itself did not require clinical tests.

Specifically, the following tests were conducted:

• Laboratory tests: These included compliance with international standards such as IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-61, addressing general safety, electromagnetic compatibility, and particular requirements for pulse oximeter equipment.
• CRC (Cyclic redundancy check) Coding: This was performed to demonstrate the software's ability to accurately capture, store, and analyze data measured by the hardware.
• Calibration tests: These were conducted using a simulator oximeter.
• Software verification and validation (SRS/SDS/STD/STR): This comprehensive process confirmed the software's functionality and reliability, particularly for the new protocol communication required by the Bluetooth data transmission.
• Bluetooth testing and cybersecurity risk analysis: These were conducted in accordance with FDA Wireless Guidance (2014), Cybersecurity Guidance (2013), and relevant Bluetooth white papers and FDA safety communications. This addressed the increased risk associated with Bluetooth data transmission and a different microcontroller.

Absence of Specific Information:

The provided text does not include the following information:

• Sample size used for the test set and data provenance: No specific sample sizes for testing are mentioned beyond references to "laboratory tests" and "calibration tests." The origin of any test data (e.g., country of origin, retrospective/prospective) is also not provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information is given about experts or their qualifications for establishing ground truth.
• Adjudication method for the test set: No adjudication method is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no indication that an MRMC study was performed. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
• Standalone (i.e., algorithm only without human-in-the-loop performance) study: While the device provides mathematical analysis, the evaluation is not explicitly described as a standalone study of the algorithm's performance without human interaction. The device is intended to provide values for practitioner judgment.
• Type of ground truth used: The type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the tests is not specified. Given the nature of the device (pulse oximetry and physiological signal analysis), it can be inferred that the ground truth for calibration and accuracy would likely come from established measurement standards and potentially comparison against clinical reference devices, but this is not explicitly stated.
• Sample size for the training set: There is no mention of a training set or its sample size, as the document focuses on regulatory submission and performance testing rather than algorithm development specifics.
• How the ground truth for the training set was established: As no training set is mentioned, this information is not provided.

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The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography in adults.

It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.

TBL-ABI can be used on patients with unilateral lower limb amputation.

The TBL-ABI System is intended to be used to spot-check patients. The TBL-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TBL-ABI System comprises:

• 3 Bluetooth blood pressure devices with attached cuffs.
• Software installed on a computer

It is intended to measure a patient's Ankle Brachial Index (ABI) and provide Pulse Volume Recording (PVR) / volume plethysmography.

This is done through an automated process.

The operator places the three devices with different color-coded electronic boxes on the right or left arm, and on each leg as described in the instructions for use, and the devices connect to the computer via Bluetooth.

Once the devices are connected, the operator clicks start on the software to start the measurement. The devices will then automatically control the inflation of the cuffs and monitor the variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.

TBL-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from the patient's limbs.

Measurements are conducted as a single occurrence on the three limbs, thus eliminating any requirement to rest the patient between measurements.

The test period takes approximately 3 minutes.

ABI values, as well as the Pulse Volume recording (PVR), are displayed on the software installed in a computer. The results are saved in a backup file and can also be printed.

The TBL-ABI System, a device for measuring Ankle-Brachial Index (ABI) and Pulse Volume Recording (PVR), was reviewed for substantial equivalence to a legally marketed predicate device (TM-ABI, K143152). The provided document is a 510(k) summary, which typically presents a summary of verification and validation testing, rather than detailed study protocols and results for clinical performance. Therefore, information regarding human reader studies, ground truth establishment for clinical data, and specific sample sizes for clinical accuracy testing (if any were performed on human subjects) is not extensively detailed.

However, based on the provided text, the device primarily relies on non-clinical performance and engineering validation to demonstrate substantial equivalence, particularly concerning the accuracy of its physiological measurements and the safety of its technological changes (e.g., Bluetooth communication).

Here's an analysis of the acceptance criteria and the non-clinical study that proves the device meets these criteria, as described in the document:

1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance (as claimed by the manufacturer and deemed sufficient by FDA):

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

• Sample Size: The document does not specify a "test set" in terms of human subjects or patient data for clinical performance evaluation. The study primarily relies on non-clinical testing (bench testing, engineering validation, software verification). The performance claims related to pressure accuracy and ABI accuracy (± 3mmHg and ± 0.1 respectively) are presented as specifications that are met, likely through calibration and validation against established standards or measurement principles rather than a patient-based test set.
• Data Provenance: Not applicable as the "study" described is verification and validation, predominantly on the device itself and its components. The document implies comparison to the predicate device's established performance, rather than new clinical data generation.

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

• Not applicable. As the evaluation focused on non-clinical performance and substantial equivalence to a predicate device with established performance specifications, "ground truth" was likely established through engineering standards, calibration references, and predicate device specifications. No mention of expert radiologists or similar clinical experts is found for establishing ground truth from patient data.

4. Adjudication Method for the Test Set:

• Not applicable, as the evaluation focused on non-clinical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study was not done. The device is a diagnostic tool that provides objective measurements (ABI, PVR) and does not involve human interpretation of images or signals that would typically necessitate an MRMC study to show human reader improvement with AI assistance.

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

• The device inherently operates as a "standalone" algorithm in that it performs automated measurements and calculations (Ankle-Brachial Index and Pulse Volume Recordings). The performance specifications for pressure and ABI accuracy (± 3mmHg, ± 0.1 ABI respectively) represent the algorithm's performance. The "study" (non-clinical testing) demonstrated that the device (including its algorithm for measurement calculation) meets these specified accuracy limits.

7. The Type of Ground Truth Used:

• For the core physiological measurements (pressure, ABI), the ground truth is implicitly based on metrological standards and established physiological measurement accuracy limits (e.g., ± 3mmHg for blood pressure, which is a widely accepted standard for non-invasive blood pressure devices). The device's performance is claimed to meet these standard accuracy limits, similar to its predicate device.
• For software and hardware functionality, the ground truth is derived from engineering specifications, test protocols (SRS/SDS/STD/STR), and standard compliance (e.g., IEC 60601 series).
• For biocompatibility, the ground truth is established by ISO 10993 standards.

8. The Sample Size for the Training Set:

• Not applicable. The document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a combination of non-clinical testing and comparison of technological characteristics. It does not typically involve training a machine learning model, which would require a training set. The device performs calculations based on established physical principles (pneumo-plethysmography), not learned patterns from data.

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

• Not applicable, as there was no training set for a machine learning model.

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LD-Oxi system is intended for use:

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 analysis 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 LD-Oxi 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.

The LD-Oxi System is a programmable electro medical system (PEMS) including:

2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe

2 Software installed on a computer

Description of the features

Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude (photoplethysmography).
Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature).
Mathematical analysis of the Heart Rate Variability (HRV feature).

The provided document does not contain full details of a specific study proving the device meets acceptance criteria, specifically not in the format of a typical clinical validation study with detailed performance metrics, sample sizes, and expert ground truth establishment.

However, based on the information provided in the 510(k) Summary for the LD-Oxi System (K160956), here's what can be inferred and pieced together regarding acceptance criteria and performance, as well as the types of studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to a predicate device (Electro Sensor Oxi K102442) rather than defining explicit acceptance criteria with numerical targets. For performance, it largely relies on the general equivalence to the predicate and standard compliance. The specifications table (page 4) compares the LD-Oxi with the predicate (ESO) for various parameters.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly mention "test sets" or provide details on sample sizes for clinical performance evaluation. The "Performances and Effectiveness" section (page 7) lists general tests, but no specific human subject data or sample sizes for these tests are provided.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "Peer reviews for the photoelectrical plethysmography mathematical analysis" and "Peer review reference for the heart rate variability mathematical analysis." However, it does not specify the number or qualifications of these experts.

4. Adjudication Method

No adjudication method is mentioned for any "test set" or peer review process.

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

No MRMC study comparing human readers with and without AI assistance is mentioned. The device's primary function is as a monitor and analyzer, not as an AI-assisted diagnostic tool for human readers. The mathematical analyses (PP and HRV) are explicitly stated "ARE NOT intended use for diagnosis."

6. Standalone Performance Study

The document refers to the following for performance and effectiveness:

• Calibration tests (simulator oximeter): This implies standalone testing of the oximeter's core functionality against known standards.
• Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database): This indicates standalone testing of the software algorithms (including PP and HRV analysis) using a recognized physiological database. This could be considered a form of standalone performance evaluation for the algorithmic components.
• Peer reviews: As mentioned above, these are qualitative assessments of the mathematical analysis.

7. Type of Ground Truth Used

• For the core oximeter function (SpO2% and pulse rate), the ground truth for calibration would likely come from simulator oximeter standards.
• For the software algorithms (PP and HRV), the mention of the MIT-BIH database suggests that the ground truth for these analyses would be derived from the expert-annotated physiological data contained within that database. (The MIT-BIH Arrhythmia Database, for example, is known for its expert annotations of ECG signals, which can be related to HR and HRV).

8. Sample Size for Training Set

The document does not specify a separate "training set" or its sample size. The description of the device and its validation focuses on direct measurement, software verification against existing databases, and established principles of oximetry and physiological analysis, rather than a machine learning model that requires a distinct training phase.

9. How Ground Truth for Training Set was Established

Since a "training set" as commonly understood in machine learning is not explicitly detailed, the method for establishing its ground truth is also not described. If the device uses algorithms developed using physiological databases like MIT-BIH, then the ground truth for those underlying algorithms would have been established by the experts who curated and annotated those databases.

In summary:

The LD-Oxi System's acceptance criteria and proven performance rely heavily on demonstrating substantial equivalence to a predicate device (ESO) and compliance with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-61). Performance claims are supported by calibration tests using simulators and software verification using data from established databases like MIT-BIH, implying a form of standalone algorithmic testing. Detailed clinical trial data with specific sample sizes, expert qualifications, or adjudication methods for new data collection are not provided in this 510(k) summary, as the nature of the modifications and the intended use (monitoring and analysis, not diagnosis from AI) did not necessitate such extensive studies for this particular submission.

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SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.

The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population.

Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

The SudoC is a programmable electro medical system including:

• USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot.
• Software installed on a computer. ●

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The provided text is a 510(k) Premarket Notification for a device named SudoC. This document primarily focuses on demonstrating that the SudoC device is substantially equivalent to a previously cleared predicate device (SudoPath K131568) and does not contain detailed information about specific acceptance criteria, study designs, or reported device performance for the SudoC as an independent, de novo submission would.

Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide the information that is present and explain why other information is not available.

Here's a breakdown based on the provided text:

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

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported performance values for the SudoC. The core of this submission is to demonstrate substantial equivalence to a predicate device, meaning it asserts that the modifications to SudoC do not change its performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document states that the modifications to the proposed device "do not change the performance of the device" as shown with:

• New risk management
• Software verification (SRS/SDS/STD/STR)
• Summary of Design Control Activities and Declaration of Design control conformity.
• Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
• The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement.

The crucial point is the "Comparison of the conductance values" which suggests some testing was done, but details like sample size, provenance, or whether it was a "test set" in the context of a clinical study are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The SudoC is a galvanic skin response measurement device, which measures physiological responses. "Ground truth" in this context would likely refer to the accuracy of the measurements themselves or their correlation with a specific physiological state, which is not detailed in this type of submission for substantial equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

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

This information is not provided. The device (SudoC) is described as a measurement device that provides values, and "It is the physician's responsibility to make proper judgments based on these numbers." This indicates it's a diagnostic aid, not an AI-assisted detection or interpretation system that would typically involve human reader performance studies.

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

The SudoC is a measurement device. It provides raw "values." The "algorithm" here would be the processing of the galvanic skin response to produce those values. The document asserts that the fundamental scientific technology and the range of conductance measurements (1 to 120 micro Siemens) are the same as the predicate. While software verification was done, a standalone performance study with specific metrics is not detailed as per the typical requirements for a new, complex algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated. For a galvanic skin response device, the ground truth would likely be the accurate measurement of skin conductance. The document states "Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode," suggesting that the accuracy of the conductance measurement itself with the new electrodes was assessed against the prior electrode type.

8. The sample size for the training set

This information is not provided. Since this is a 510(k) for a measurement device and not an AI/ML algorithm requiring extensive training data, such details are typically not included unless the specific modifications involved significant new algorithmic development or a new intended use. The software changes primarily relate to "New design and change in time and sequence of measurement."

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

This information is not provided, for the same reasons as point 8.

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The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.

TM-ABI system can be used on patients with unilateral lower limb amputation.

The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TM-ABI System is a programmable electro medical system (PEMS). The system comprises:

• Σ USB plug and play hardware.
• Software installed on a computer

It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography.

This is done through an automated process.

The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device.

When connected, the operator clicks start on the software to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.

TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows:

Left ABI = Left ankle pressure / Arm pressure

Right ABI = Right ankle pressure / Arm pressure

ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.

Here's an analysis of the acceptance criteria and study information for the TM-ABI System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions a "Clinical Study comparing the device results and standard Doppler method results to assess the Ankle Brachial Index." However, it does not explicitly state the sample size for this clinical study.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be a prospective study comparing the device to the standard Doppler method.

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

The document does not provide details on the number of experts or their qualifications for establishing the ground truth. It refers to "the standard Doppler probe method" as the comparative reference.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The clinical study is described as comparing the device results directly to the standard Doppler method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or described in the provided text. The study focused on the device's performance against a reference method (Doppler probe) rather than measuring improvements in human reader performance with or without AI assistance.

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

Yes, a standalone study was performed. The clinical study evaluated the device's ability to measure ABI/ABPI against the standard Doppler probe method. The device automates the process of inflation, pressure monitoring, and ABI calculation. The reported "r=0.88" is a measure of the algorithm's performance in correlation with the reference.

7. Type of Ground Truth Used

The ground truth used for the clinical study was the standard Doppler probe method for measuring Ankle Brachial Index (ABI). This is a well-established clinical gold standard for ABI measurement.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. The device utilizes an "oscillometric method" and pre-defined algorithms for calculating ABI. While such systems are developed using data, the 510(k) summary focuses on the validation of the final device, not the specifics of its internal model training.

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

Since a training set sample size or a distinct "training set" study is not detailed, the method for establishing its ground truth is also not described. The device's underlying technology (oscillometry) and algorithms are likely based on established physiological principles and prior data, but the specifics of a training data ground truth are not provided in this document.

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ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer)

When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS 1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management.

The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results.

The device provides values. It is the physician responsibility to make proper judgment based on these numbers.

The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.

Prescription Use X

ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).

When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management.

The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results.

The device provides values. It is the physician responsibility to make proper judgment based on these numbers.

The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_and_performance_table": [
      {
        "Criterion": "Data management",
        "Acceptance Criteria Met?": "YES",
        "Reported Device Performance": "YES"
      },
      {
        "Criterion": "Historical test results",
        "Acceptance Criteria Met?": "YES",
        "Reported Device Performance": "YES"
      },
      {
        "Criterion": "Operating system",
        "Acceptance Criteria Met?": "Windows",
        "Reported Device Performance": "Windows"
      },
      {
        "Criterion": "Results screen",
        "Acceptance Criteria Met?": "PC",
        "Reported Device Performance": "PC"
      },
      {
        "Criterion": "Displayed data",
        "Acceptance Criteria Met?": "SpO2%, HRV analysis, photoelectrical Plethysmography analysis, conductance values, body composition and Blood pressure.",
        "Reported Device Performance": "SpO2%, HRV analysis, photoelectrical Plethysmography analysis, conductance values, body composition and Blood pressure."
      },
      {
        "Criterion": "Data acquisition",
        "Acceptance Criteria Met?": "Direct acquisition and/or upload from the device",
        "Reported Device Performance": "Direct acquisition and/or upload from the device"
      },
      {
        "Criterion": "Data analysis",
        "Acceptance Criteria Met?": "Memory",
        "Reported Device Performance": "Memory"
      },
      {
        "Criterion": "Data analysis (other entry)",
        "Acceptance Criteria Met?": "YES",
        "Reported Device Performance": "YES"
      },
      {
        "Criterion": "Indication for use",
        "Acceptance Criteria Met?": "clinical settings",
        "Reported Device Performance": "clinical settings"
      }
    ],
    "2_sample_size_and_data_provenance_test_set": "The provided document is a 510(k) summary for a software device (ANS1 Software). It describes the software's intended use and compares it to a legally marketed predicate device (ES Complex Software). The focus of this submission is to demonstrate substantial equivalence based on the software's data management capabilities and functionalities, rather than a clinical performance study with a 'test set' in the traditional sense of diagnostic accuracy. Therefore, information on sample sizes for a test set and data provenance (country of origin, retrospective/prospective) for a clinical performance study are not applicable or provided in this regulatory document. The submission relies on software verification and risk management.",
    "3_number_and_qualifications_of_experts_ground_truth": "The document describes a Special 510(k) submission for software, focusing on safety and effectiveness through comparison to a predicate device and software verification. It does not mention the establishment of ground truth by human experts for a performance study. Clinical judgment remains with the physician, who is intended to review, analyze, and evaluate the historical test results provided by the software. Therefore, the concept of experts establishing ground truth for a test set is not applicable here.",
    "4_adjudication_method_test_set": "The nature of this 510(k) submission (software for data management, not a diagnostic algorithm) does not involve a clinical performance study requiring adjudication of a test set. The document focuses on demonstrating substantial equivalence to a predicate device and fulfilling software verification requirements. Thus, no adjudication method is described or relevant.",
    "5_mrmc_comparative_effectiveness_study": "No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned or appears relevant to this 510(k) summary. The device is a data management software, not a diagnostic aid that directly impacts human reader performance in interpreting images or clinical signals where an 'AI vs without AI assistance' effect size would be measured.",
    "6_standalone_performance_study": "This 510(k) is for a data management software. While 'software verification' is mentioned, a standalone performance study in the context of diagnostic accuracy (i.e., algorithm-only performance without human-in-the-loop) is not described. The software's function is to upload, analyze, and display data from other cleared devices for healthcare professionals to review. Its 'performance' is assessed through data management capabilities and software specifications, not typically through standalone diagnostic accuracy metrics.",
    "7_type_of_ground_truth_used": "Given that the device is data management software and not a diagnostic algorithm, the concept of 'ground truth' in the context of clinical pathology or outcomes data is not directly applicable. The 'ground truth' for this type of submission lies in the accurate processing and display of data generated by associated cleared medical devices (TM-Oxi, SudoPath, ES-BC). The 'truth' of the data itself originates from these input devices, and the software's role is to manage and present it reliably.",
    "8_sample_size_training_set": "As this is a 510(k) for data management software rather than a machine learning or AI algorithm involving a 'training set' in the typical sense, information on a sample size for a training set is not provided or applicable. The software's functionality is based on established data processing and display, not on learning from a dataset.",
    "9_how_ground_truth_for_training_set_was_established": "Since the device is data management software and not an AI/ML algorithm that undergoes a training phase, there is no 'training set' or 'ground truth for a training set' to establish. The document focuses on software verification and comparison to a predicate device's functionalities."
  }
}

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SudoPath is a Galvanic skin response measurement device. The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

SudoPath is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 2 reusable cables to connect the box to electrodes and 4 tactile electrodes placed on the sole of the feet and on the palm of the hands. Software installed on a computer. As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The provided document is a 510(k) Premarket Notification for the SudoPath device, a Galvanic Skin Response (GSR) measurement device. It details the device's characteristics and compares it to a previously cleared predicate device (EIS-GS).

However, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of AI/ML or comparative diagnostic performance.

Here's why and what information is missing:

• Type of Device: The SudoPath is described as a hardware device (with an electronic box, cables, and electrodes) and accompanying software for measuring galvanic skin response. This is a measurement device, not a diagnostic AI/ML system that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or reader improvement.
• Focus of the 510(k) Summary: The summary focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved by showing that the SudoPath has the same intended use, similar hardware, and the same fundamental scientific technology as the predicate device. The "modifications" listed (change of trade name, removal of two frontal electrodes, and changes in software for number and sequence of measurements) are presented as minor and not affecting safety or effectiveness.
• "Performances and Effectiveness" Section: This section only lists:
  1. New risk management (generic for medical devices).
  2. Software verification (SRS/SDS/STD/STR - standard software development lifecycle documentation).
  3. Summary of Design Control Activities and Declaration of Design control conformity (again, standard quality system requirements).
     None of these refer to clinical performance studies, AI/ML model performance metrics, or human reader studies.
• Substantial Equivalence Justification: The conclusion explicitly states: "The SudoPath device is equivalent in performances, technology, safety and efficacy to the legally marketed (unmodified) predicate device." This equivalence is established through the technical comparisons provided, not through a comparative clinical study.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study data, ground truth, expert involvement, or MRMC studies because this information is not present in the provided 510(k) summary.

Specifically, the document DOES NOT provide:

1. A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy, sensitivity, specificity, etc.) relevant to AI/ML or a diagnostic claim. The "performance" mentioned refers to the device's functionality and equivalence, not its diagnostic output accuracy.
2. Sample size used for the test set or data provenance because no clinical performance test set, in the sense of a diagnostic evaluation study, is described.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size of human readers improving with AI assistance. This device is a measurement device, not an AI assistance tool for image interpretation.
6. Information on standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating that the changes made to the predicate device (EIS-GS) to create SudoPath are minor enough that new clinical performance data is not required, as it is fundamentally the same type of measurement device.

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The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients. The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. TheTM-Oxi device is intended for spot-checking of patients. The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

The TM-Oxi is a programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP). The system comprises: a. Hardware: Non- invasive blood pressure, pump and valve boards and connections, tube, bladder and cuff 510k cleared (K093013) not modified. USB HUB DC converter with 3 features. Power supply of NIBP board via USB hub connected to USB port of the PC and microchip converter 5V to 6 V. microchip converter 510k cleared (K090671) not modified via USB hub > connected to USB port of the PC. connected to USB port of the connected to USB port of the PC. > b. Software: The used software are ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management. software 310k humber K 115204 for addinations of the data from oximeter (ESO) and blood pressure device (Contec 08A K110774). pressure device (Contect 687 ATT 10777). Therefore the TM-Oxi system will be a combination of the 2 separate devices.

The provided text describes the TM-Oxi device, its intended use, and its equivalence to legally marketed predicate devices, but it does not contain a detailed study report that specifically outlines acceptance criteria and subsequently proves the device meets them with specific performance metrics from a study.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices by comparing their technical specifications and by stating that the TM-Oxi uses cleared components and software from previously cleared devices.

Here's an analysis of the information provided, addressing your points where possible, and highlighting what is not available in the text:

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

The document provides a comparative table (page 4) between the TM-Oxi hardware and a predicate device (MD2000B Vital sign monitor K100740), which lists technical specifications. These can be inferred as performance criteria that the TM-Oxi is designed to meet or be equivalent to.

Note regarding "Reported Device Performance": The document states that "The TM-Oxi hardware has same intended use and same performances and effectiveness" as the predicate. It then uses the technical specifications of the predicate and OEM components as a proxy for the TM-Oxi's performance. The detailed study proving these specific metrics for the TM-Oxi as a system is not presented in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document primarily relies on the fact that existing 510(k) cleared components were used. It refers to ISO 9919 reports from the OEM oximeter and ANSI/AAMI SP10:2002/A1:2003/A2: 2006 reports from the OEM blood pressure device. These reports would contain the sample size and data provenance for the original component clearance, but these details are not included in this K130056 summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document states that the TM-Oxi system "does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers." The clinical assessment and ground truth establishment would likely have been part of the original OEM component clearances, but no details are given for the TM-Oxi system specifically.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This information is not provided. The TM-Oxi is a physiological patient monitor providing objective measurements (SpO2, PR, NIBP) and data management, and not an AI-assisted diagnostic tool that would typically involve human readers interpreting results for improved diagnostic effectiveness.

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

The document mentions "Integration tests for oximeter and blood pressure device" and "Software structural testing using CRC (Cyclic redundancy check) Coding was performing to accurately capture, store, and analyze the data measured by the hardware." (Page 5).
It also states: "The TM-Oxi software uploads the data of the device and displays in clinical settings as an enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, and evaluate the historical tests results." (Page 2).
This suggests the software performs data processing and display independently. However, a formal "standalone performance study" with specific metrics (e.g., accuracy against a gold standard) for the integrated system's measurements is not detailed. The reliance is heavily on the pre-cleared status of the hardware components which have their own performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided for the TM-Oxi system specifically. For the original oximeter and NIBP components, the ground truth would typically be established against highly accurate reference devices (e.g., co-oximetry for SpO2, invasive blood pressure for NIBP) during their respective ISO 9919 and ANSI/AAMI SP10 validations.

8. The sample size for the training set

This information is not provided. The software "ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management" are pre-cleared components. Details on their training data (if any machine learning was involved, which is unlikely for basic data analysis/management software) are not included.

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

This information is not provided.

Summary of the "Study" (or rather, justfication for substantial equivalence):

The document argues for substantial equivalence by stating that the TM-Oxi device is a combination of previously 510(k) cleared hardware components and software.

• Hardware: It utilizes an oximeter and a non-invasive blood pressure device (NIBP) where the PCB boards, pump, valve, tube, bladder, cuff, and oximeter are from OEM subcontractors and were "cleared for use together" or are themselves 510(k) cleared devices (e.g., MD 200A K093013, CMS50E K090671).
• Software: It uses pre-cleared software components: ESO Software (K102442) for data analysis and ES Complex Software (K113264) for data management, which are described as using the "same source codes" as the TM-Oxi software for data of the oximeter and blood pressure device.
• Testing:
  • Integration tests for the oximeter and blood pressure device were performed.
  • Software structural testing (CRC) was done to ensure accurate data capture, storage, and analysis.
  • Laboratory testing for electrical safety (IEC 60601-1-1) and EMC (IEC 60601-1-2) was conducted for the components.
  • Software verification (SRS/SDS/STD/STR) was performed.
• A Clinical Test was deemed NOT required: The document explicitly states: "Since the TM-Oxi is using 510K cleared devices clinically tested (ISO 9919 and SP10) and with regard of the testing describe above, the TM-Oxi do not required additional clinical test." This means that the clinical performance data for the individual components (oximeter and NIBP) from their original clearance processes (which included adherence to ISO 9919 and ANSI/AAMI SP10 standards) were sufficient, and no new clinical study was performed for the integrated TM-Oxi system to prove its performance against the listed acceptance criteria.

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ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management. The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.

ES Complex Software is an optional software accessory for use with the following models with management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use combination Contec 08A and ESO, and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the 4 devices and displays the data into a computer for enhanced data management.

This submission K113264 is for the Electro Sensors Complex Software (ES Complex Software). The documentation indicates that performance was evaluated through Software Verification & Validation and Risk Management, rather than a clinical study comparing device performance against specific acceptance criteria. This means the typical metrics for diagnostic accuracy (sensitivity, specificity, etc.) and associated study design elements (sample size, expert ground truth, etc.) are not applicable here.

The device's performance is described in terms of its functionality and its ability to manage data from connected medical devices. The "Table of comparison" highlights its equivalence to the predicate device in terms of data management, historical test results, operating system, and results screen.

Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available 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:

• The submission does not mention a traditional "test set" or sample size in the context of diagnostic performance evaluation with patient data.
• The performance evaluation focused on Software Verification & Validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34) and Risk Management (D-28). These types of tests typically involve controlled functional testing, integration testing, and simulated scenarios rather than a dataset of patient cases.
• Data Provenance: Not applicable as there wasn't a test set of patient data from a specific country or collected retrospectively/prospectively for diagnostic performance. The input data for the software is stated to come from other 510(k) cleared medical devices.

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

• Not applicable. There was no "test set" of patient cases requiring expert interpretation to establish ground truth. Software verification and validation utilize established software engineering practices and possibly simulated data or test cases based on expected device outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There was no test set of patient cases requiring adjudication of ground truth.

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. This type of MRMC study was not performed or referenced. The device is a data management software, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with and without AI.

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

• The "standalone" performance, in this context, refers to the software's ability to fulfill its stated functions independently. The submission indicates that Software Verification & Validation was performed. This would confirm the algorithm's functional correctness in uploading, displaying, and managing data as intended, without human intervention in the data processing itself, but human professionals are the intended users for reviewing the managed data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable as there was no diagnostic "test set" requiring ground truth for clinical accuracy. For software verification, the "ground truth" would be the expected functional behavior and output of the software according to its design specifications (e.g., data is uploaded correctly, displayed accurately, historical tracking functions as intended).

8. The sample size for the training set:

• Not applicable. The Electro Sensors Complex Software is a data management software, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. Its functionality is based on programmed logic and integration with other medical devices.

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

• Not applicable, as no training set was used for this software.

Summary of Device Performance Evaluation:

The K113264 submission demonstrates substantial equivalence for the Electro Sensors Complex Software primarily through comparison to a predicate device (Health care system software K110948) and by declaring adherence to an established software development lifecycle (Software Verification & Validation) and risk management processes. The focus is on the software's functional performance in data management from connected medical devices, rather than a diagnostic accuracy claim that would necessitate patient-level performance studies. The key performance evaluations cited are:

• Software Verification & Validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34): This confirms that the software's components and system meet specified requirements and perform their intended functions correctly.
• Risk Management (D-28) according to ISO 14971: This ensures that potential risks associated with the software have been identified, evaluated, and mitigated.
• Adherence to ISO 62304: This standard governs medical device software life cycle processes, ensuring a structured approach to software development, maintenance, and risk management.

The comparison table highlights that the ES Complex Software shares the same core functions (data management, historical data tracking, operating system, PC display) as the predicate device, although it handles different types of physiological data and is indicated for clinical settings only (whereas the predicate included home use). The conclusion is that the device is "equivalent in performances, technology, safety and efficacy to the legally marketed predicate devices."

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