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The ESA615 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA615 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 provides following function categories: ECG Functions, ECG-Performance Testing.

Fluke Biomedical's ESA615 Electrical Safety Analyzer (hereafter referred to as the ESA615) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 can be controlled by a suitably equipped computer to carry out tests, via either a cable or wirelessly. The ESA615 consists of the following components: 1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors. 2) Plastic injection molded case parts. 3) Liquid Crystal Display for user interface. 4) Power cord for powering the unit at 120V and 60Hz.

Here's a summary of the acceptance criteria and study information for the ESA615 Electrical Safety Analyzer, based on the provided text:

Device: ESA615 Electrical Safety Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to the predicate device (MPS450) based on similar technological characteristics and performance, not against specific, quantifiable acceptance criteria. The "differences" column below highlights how ESA615 performance differs from the predicate.

2. Sample size used for the test set and the data provenance

The document mentions "Laboratory studies have been conducted with a representative patient monitor..." but does not specify the sample size (number of "representative patient monitors" or tests performed) or the data provenance (country of origin, retrospective/prospective).

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

Not applicable. The device is an analyzer, not a diagnostic tool requiring expert interpretation. The "ground truth" for its performance is its physical and electronic output measurements compared against its published specifications.

4. Adjudication method for the test set

Not applicable, as this is a device performance verification, not a clinical study requiring human interpretation and multi-expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrical safety analyzer and ECG simulator, not an AI-assisted diagnostic tool.

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

Yes, the testing described appears to be standalone performance verification of the ESA615 itself, against its published specifications. The description "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA615 will perform within its' published specifications" indicates this.

7. The type of ground truth used

The ground truth for the test set appears to be its own published specifications, as verified by "Laboratory studies... to verify and validate the ESA615 will perform within its' published specifications."

8. The sample size for the training set

Not applicable. This is a hardware device with firmware, not a machine learning model that requires a training set.

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

Not applicable.

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The ESA620 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA620 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 provides following function categories:

• ECG Functions .
• ECG-Performance Testing ●

Fluke Biomedical's ESA620 Electrical Safety Analyzer (hereafter referred to as the ESA620) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic injection molded case parts.
3. Liquid Crystal Display for user interface.
4. Power cord for powering the unit at 120V and 60Hz.

This document describes the regulatory submission for the Fluke Biomedical ESA620 Electrical Safety Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (MPS450), rather than proving that a device meets and acceptance criteria via a study. As such, many of the requested details about a study to prove acceptance criteria are not present in the provided text.

Here is an analysis based on the provided document:

Study Type and Purpose:
The document describes non-clinical testing performed to verify and validate the ESA620. The primary purpose of this testing was to demonstrate substantial equivalence to the predicate device (MPS450), not to meet predefined acceptance criteria in a robust clinical or standalone AI study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the traditional sense of a performance study with specific target metrics for accuracy, sensitivity, specificity, etc. Instead, it compares the technological characteristics and intended use of the ESA620 against its predicate device, the MPS450, to establish substantial equivalence.

The "differences" column in the provided table implicitly represents areas where the ESA620's performance or features might be considered against the predicate. However, these are presented as factual differences rather than "acceptance criteria" where a specific pass/fail threshold is defined for each.

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

• Sample Size: The document states "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA620 will perform within its' published specifications -Document: NPI-05012012-00002". This indicates a very limited "sample size" of only one representative patient monitor for the non-clinical tests. This is typical for a device meant for testing other equipment, where the focus is on the device's output accuracy and stability, rather than diverse patient data.
• Data Provenance: The studies were conducted in a laboratory setting ("Non-Clinical Test Data"). The country of origin for the data is not specified, but given the submitter (Fluke Biomedical) is US-based and the submission is to the FDA, it is highly likely to be U.S.-based. The data is prospective in the sense that it was generated specifically for this submission to validate the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided in the document. For a technical device like an electrical safety analyzer, "ground truth" would typically refer to the accuracy of its measurements and simulations compared to established standards and calibrated reference equipment, rather than expert human interpretation. The "validation" likely refers to engineering design verification and validation by qualified engineers rather than clinical experts.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided as the validation described is non-clinical performance testing of measurement parameters against specifications, not an assessment requiring multiple human readers and adjudication.

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

• No, an MRMC study was not done. This type of study is specifically designed for assessing the impact of AI assistance on human reader performance, typically in diagnostic imaging. The ESA620 is a test and measurement device, not a diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only) Performance Study:

• The document implies a standalone performance assessment of the device, but not in the context of an "algorithm" as would be found in AI/ML devices. The "Non-Clinical Test Data" section states "The ESA620 software has been successfully validated to confirm the performance of the device." This confirms that the device's technical performance (measurements, simulations) was evaluated independently against its specifications.

7. Type of Ground Truth Used:

• The "ground truth" for this device would be established engineering specifications, calibrated reference standards, and potentially a "golden standard" or master device that has been proven accurate. The statement "to verify and validate the ESA620 will perform within its' published specifications" indicates that the ground truth was the published specifications themselves, which are derived from metrology standards.

8. Sample Size for the Training Set:

• This information is not applicable/not provided. The ESA620 is a hardware device with embedded firmware; it is not an AI/ML device that requires a "training set" in the context of machine learning. The validation described is traditional software and hardware verification.

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

• This information is not applicable. As it's not an AI/ML device, there's no "training set" or corresponding ground truth establishment process in that sense. The "ground truth" for the device's function (e.g., whether it accurately outputs a 1mV ECG signal) would be based on fundamental electrical engineering principles, national/international standards (e.g., IEC 60601 for medical electrical equipment safety), and calibration to a higher-level physical standard.

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The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.

The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:

• ECG adult or neonatal
• Invasive and non-invasive blood pressure
• Respiration

The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.

The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:

• ECG adult or pediatric
• Invasive and non-invasive blood pressure
• Respiration
• Temperature
• Cardiac Output
• Fetal Simulation includes fetal, maternal ECG, & uterine contractions (ProSim 8 only)
  Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional

Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic iniection molded case parts.
3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4. Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.

• 2) Plastic injection molded case parts.
• 3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
• 4. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
• 5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 devices:

Executive Summary:

The Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 are vital signs simulators designed to test and verify the basic operation of patient monitoring devices. The devices function by providing electronic and pneumatic simulations of various physiological parameters. Extensive non-clinical bench testing was conducted to demonstrate that the ProSim devices perform within their published specifications and are substantially equivalent to their predicate devices (MedSim300B, Cufflink, and Index 2MF SPO2 for ProSim 6/8). Clinical testing was not performed, as the devices are intended for laboratory use for preventative maintenance and not for direct patient use or medical equipment calibration. The ground truth for the testing was the published specifications of the device itself, verified through laboratory measurements.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a detailed comparison table between the ProSim devices and their predicate devices, indicating various performance characteristics. Since the acceptance criteria are essentially the published specifications and the study aims to show the device performs within those specifications, the "reported device performance" is implicitly that the device met these specifications, thus demonstrating substantial equivalence.

Below is a summarized table consolidating key features and their performance (or range of performance), with the acceptance criteria being that the ProSim meets or improves upon the predicate device's comparable specification or meets its own stated specifications if it's a new feature or different range.

ProSim 4 (compared to MedSim 300B and Cufflink)

ProSim 6 & 8 (compared to MedSim 300B, Index 2, and Cufflink)

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The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications. The MPS450 provides the following function categories: ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)

Fluke Biomedical's MPS450 Multiparameter Simulator (hereafter referred to as the MPS450) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG, blood pressure, respiration, temperature, artifact, and arrhythmia conditions. The MPS450 is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

The provided document describes the Fluke Biomedical MPS450 Multiparameter Simulator, a device intended to test the operation of patient monitors by simulating various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device, the MedSim300B.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MPS450 are implicitly defined by comparing its performance specifications to those of the predicate device, the MedSim300B. The differences highlight where the MPS450 either meets or exceeds the predicate's capabilities or where features were deemed "not needed by customers."

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The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.

The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.

The provided text is a 510(k) summary for the Impulse 7010 Defibrillator Selectable Loads, which is an accessory to a defibrillator tester. The document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a study with acceptance criteria and device performance evaluation in the manner typically found for AI/ML medical devices or diagnostic tools.

Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this regulatory submission for a simple accessory device. The device is a physical component (resistance box) for testing other medical devices, not a diagnostic or AI-powered system that would undergo extensive performance validation against a clinical ground truth.

However, I can extract the relevant information where available and explain why other sections are not applicable.

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

This information is not explicitly provided in the 510(k) summary. For a device like the Impulse 7010, acceptance criteria would typically relate to the accuracy of the selectable resistance values it provides. The summary states that the device "simulates 25 to 200 Ohm thoracic impedance" and consists of "Four 50 Ohm resistors switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms." The implication is that the accuracy of these resistance values is critical for its function as a defibrillator tester accessory, but specific numeric tolerances or performance data are not reported 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)

Not applicable. This device is an accessory that provides fixed resistance loads for testing other equipment. Its performance validation would involve electrical engineering tests (e.g., measuring the actual resistance output) rather than a clinical "test set" of data or patients. No clinical data or patient data is mentioned or relevant for this device.

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)

Not applicable. This device does not generate diagnostic outputs or interpretations that require a "ground truth" established by medical experts. Its "ground truth" is based on fundamental electrical engineering principles.

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

Not applicable. No "test set" or clinical adjudication is described or relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, nor is it a diagnostic tool that involves human readers interpreting cases.

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

Not applicable. This is a hardware accessory, not an algorithm.

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

Not applicable in the clinical sense. The "ground truth" for this device would be established by fundamental electrical measurement standards (e.g., a high-precision ohmmeter to verify the resistance values provided).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable for the same reason as above.

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The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.

The Impulse 600013/7000DP is a portable, rechargeable, battery-operated defibrillator tester. The Impulse 7000DP also functions as a transcutaneous pacemaker tester. The device's defibrillator input is connected to the output of a defibrillator under test which provides a 50-Ohm test load, approximately the impedance of the human body. The Impulse 6000D/7000DP simulates patient electrocardiogram signals to trigger automated defibrillation when a ventricular fibrillation waveform is presented, and the device tests that the automated defibrillator does not advise shock when a normal sinus rhythm electrocardiogram is presented. The energy output delivered by the defibrillator under test is measured. The Impulse 7000DP also tests transcutaneous pacemaker outputs by presenting a low level electrocardiogram at various pulse rates and measures the response of the pacemaker under testing rate and amplitude. For pacemaker testing, the device incorporates inputs of 50 to 1500 Ohm impedance test loads. The Impulse 6000D is a defibrillator tester only without the pacemaker test option. Both models have 10 electrocardiogram outputs to simulate patient milli-volt level electrocardiogram signals to test combination patient monitors/defibrillators/pacemakers.

The Impulse 7000DP has a USB type "B" interface to a PC to allow data download to a PC. It is electrically isolated from the measurement circuitry and allows remote control of the test from a PC. A BNC type connector on the rear panel also allows an oscilloscope to record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel.

The accessories for the Impulse 6000D/7000DP include an external power supply to operate and re-charge the internal battery. Optional adapters to connect defibrillators marketed by different manufacturers to the standard 4 mm banana style input jacks are available.

Waveform analysis determines the characteristics of a defibrillator discharge pulse. Peak voltage amplitude, current, timing, overall energy and the refractory period of a pacemaker are recorded. Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources with mathematical calibration constants for any offset and gain errors.

The provided text describes a medical device, the Impulse 6000D/7000DP Defibrillator Tester, and its FDA 510(k) clearance (K072114). However, it does not contain the specific details required to fully address your request.

The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.

Therefore, I cannot provide a complete answer to your request. Here's specifically what is missing or cannot be inferred from the provided text:

• Acceptance Criteria Table: No explicit acceptance criteria are mentioned for the device's performance. The document only states the device "is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications." These "performance specifications" are not detailed.
• Study That Proves the Device Meets Acceptance Criteria: While a 510(k) submission requires performance data, the provided summary does not include the actual study design, results, or comparison to specific acceptance criteria. It mentions "waveform analysis determines the characteristics of a defibrillator discharge pulse," and "digital signal processor calculates the measurements and corrects hardware error sources," but doesn't elaborate on the studies or their outcomes.

Here's what can be extracted/inferred from the provided text, acknowledging the significant gaps:

Analysis of Acceptance Criteria and Performance Study:

The provided document (a 510(k) summary and FDA clearance letter) does not detail specific acceptance criteria or a comprehensive study that proves the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The device's purpose is to determine if defibrillators and pacemakers are performing "within their performance specifications." These specifications themselves are not provided.
• Reported Device Performance: The document describes the device's functions (e.g., measuring energy output, simulating ECG signals, testing pacemaker outputs), but it does not provide quantitative performance metrics or results against any defined criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified.

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

• Not applicable as no such expert-based ground truth establishment is described for a performance study in this document.

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

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a defibrillator and pacemaker tester, not an AI-assisted diagnostic tool.

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

• The device itself is a standalone tester. The document describes its functional capabilities (e.g., "Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources..."). This implies the device provides objective measurements independently. However, no specific details on standalone performance studies (e.g., accuracy, precision tests) are provided in this summary.

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

• For a device like this, the "ground truth" would likely be established through reference standards (e.g., highly accurate and calibrated physical measurement equipment, or known electrical signals) to which the device's measurements are compared. However, the document does not specify the ground truth methodology used for its internal validation or for its 510(k) submission package.

8. The sample size for the training set:

• Not applicable. This device is a measurement instrument, not a machine learning algorithm that requires a training set.

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

• Not applicable (as above).

In summary, the provided 510(k) documents focus on device description, intended use, and substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria, sample sizes, or ground truth methodologies. To obtain such information, one would typically need to review the full 510(k) submission package, which is not provided here.

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