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Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.

Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
The portable battery-powered device is intended for use by trained service technicians. Delta 3300 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and transcutaneous pacemaker.

It provides a basis for verifying the energy output of a defibrillator, including energy, peak current, and peak voltage. The device incorporates a simulation function of ECG and arrhythmia waveforms for verifying the performance of defibrillator monitors.

Delta 3300 also verifies transcutaneous pacemaker parameters such as pulse rate, width, amplitude, and energy as well as refractory and sensitivity measurement.

This document is a 510(k) premarket notification for the Delta 3300 Defibrillator/Pacemaker Analyzer. The information provided focuses on demonstrating substantial equivalence to a predicate device, the BC Group International, Inc. DA-2006.

Here's an analysis based on your requested criteria:

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

The document does not explicitly present a table of "acceptance criteria" for the Delta 3300's performance in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates performance by comparing its technical specifications and test results to those of the predicate device, aiming to show it is equivalent or better. The acceptance criteria are implicitly met by demonstrating that the Delta 3300's performance specifications are comparable to or improved over the predicate, and that it passed relevant safety and EMC standards.

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

This device is a defibrillator/pacemaker analyzer, a test and measurement instrument, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" with patient data or provenance does not apply. The performance evaluation was based on non-clinical bench tests. The document does not specify a "sample size" in terms of number of patient cases.

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. As a test and measurement device, ground truth is established by the known physical properties and outputs of the equipment being tested (e.g., a defibrillator's energy output), calibrated standards, and compliance with engineering standards. There is no mention of human expert consensus for establishing ground truth as there would be for an AI-powered diagnostic tool.

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

Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method.

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 standalone analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, in a sense. The "performance testing" described involved non-clinical bench tests of the device itself (electrical safety, EMC, embedded software verification). The device operates as a standalone instrument for measuring parameters of other medical devices (defibrillators and transcutaneous pacemakers) without human-in-the-loop interpretation of its internal functioning. Its performance is evaluated against engineering specifications and standards.

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

The ground truth for the performance testing of the Delta 3300 is based on:

• Engineering specifications and standards: e.g., the specified voltage/current/energy output of a defibrillator for measurement, the requirements of IEC 61010-1 for electrical safety, EN 61000 series for EMC, and IEC 61508 for software.
• Known, calibrated inputs/simulations: The device measures electrical signals; these signals would be generated by calibrated sources or actual medical devices with known performance characteristics to verify the analyzer's accuracy.

8. The sample size for the training set

Not applicable. This is a hardware device with embedded software, not a machine learning model that requires a training set in the AI sense. The embedded software was verified and validated according to IEC 61508, which involves testing against requirements, but not a "training set" of data.

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

Not applicable, as there is no "training set" in the context of this device. The phrase "ground truth" for embedded software might refer to the functional requirements and intended behavior established during the design and development phases, against which the software's performance is tested.

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The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients.

The Rigel Medical UniPulse 400 is a portable, rechargeable battery operated (with AC Adapter) defibrillator tester used to determine that a defibrillator and a defibrillator with a transcutaneous pacemaker function perform to their published performance specifications. The UniPulse 400 is connected to a defibrillator output and is used to measure the output energy delivered from the device into a standard resistive test load. It also provides waveform information on its integrated display. For pacemaker testing, a variable load from 50 to 1600 ohms is available in 50-ohm steps. Defibrillator paddles are connected directly to the UniPulse 400 for hands free operation, or to contact plates if using the paddles. When the defibrillator is discharged, the UniPulse 400 will display the energy delivered. Included in the UniPulse 400 is an ECG simulator with normal sinus rhythm and arrhythmia simulation to trigger automated defibrillation.

UniPulse 400 is used by biomedical and/or clinical engineers to verify performance of defibrillators used in their hospital. The UniPulse 400 provides statistical data measured from the device and can communicate to an external Bluetooth printer and a PC / Laptop via Bluetooth and USB.

The provided text describes the UniPulse 400 Defibrillator/Pacemaker Analyzer, a device used to verify the performance of defibrillators. However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in a format directly addressing typical AI/ML device study parameters.

The document discusses performance testing, but focuses on compliance with general safety and EMC standards rather than specific analytical performance metrics and their acceptance thresholds. It also states the device is not an AI/ML product, and thus many of the requested criteria (like ground truth, expert adjudication, MRMC studies) are not applicable.

Here's a breakdown based on the provided text, and where gaps exist because the device is not an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device was tested to comply with its specifications, but it does not explicitly list quantitative performance acceptance criteria for measuring energy output or pacemaker analysis, nor does it report specific numerical performance results against such criteria. The "Summary of Performance Testing" refers to compliance with safety (Electrical Safety, Electromagnetic Compatibility) and software development standards, not analytical performance accuracy or precision with defined thresholds relevant to a diagnostic AI/ML device.

2. Sample Size for Test Set and Data Provenance

This information is not applicable/provided in the context of an AI/ML test set. The UniPulse 400 is an analyzer for other medical devices, not a diagnostic tool that processes patient data. Performance testing appears to involve laboratory bench testing against standards, not a patient-based test set.

3. Number of Experts for Ground Truth and Qualifications

This is not applicable as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Its performance evaluation would involve comparing its measurements against known, calibrated inputs or reference devices, not expert consensus on medical images or signals.

4. Adjudication Method for Test Set

This is not applicable for the same reasons as (3).

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

This is not applicable. The UniPulse 400 is a measurement device for defibrillators, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical cases. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance Study

While the device's "performance testing" assesses its standalone function, it's not a standalone algorithm in the sense of an AI/ML diagnostic tool. The document states its performance was tested against its predetermined specifications, indicating standalone functionality, but does not provide details of this testing beyond compliance.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML diagnostic devices (e.g., pathology, outcomes data) is not applicable here. For the UniPulse 400, "ground truth" would likely involve highly accurate and calibrated reference measurements from specialized lab equipment or known, precise outputs from simulated defibrillator discharges. The document does not specify how the accuracy of these reference measurements was established.

8. Sample Size for Training Set

This is not applicable. The UniPulse 400 is a hardware and software device following traditional engineering principles, not an AI/ML algorithm that is 'trained' on a dataset.

9. How Ground Truth for Training Set was Established

This is not applicable for the same reasons as (8).

Conclusion from the document:

The K182905 510(k) summary for the UniPulse 400 primarily focuses on demonstrating substantial equivalence to a predicate device (Fluke Biomedical Impulse 7000dp Defibrillator Analyzer) by showing similar technological characteristics and compliance with general safety and electromagnetic compatibility (EMC) standards. The "Performance Testing - Bench" section states that the device was tested according to "predetermined specifications" and that the results show compliance, but it does not elaborate on what these specific performance specifications are (e.g., accuracy, precision of energy measurement), nor does it present the numerical results of these tests.

The document is a regulatory clearance for a physical measurement device, not an AI/ML diagnostic algorithm, hence the lack of information pertinent to AI/ML specific study requirements.

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The DA-2006-VL is used to determine that defibrillators are performing within their performance specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P.

The BC Group International DA-2006-VL Variable Load is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with international standards IEC 60601-2-4 and AAMI DF80.

The DA-2006-VL is a non-powered, selectable resistive load bank. Through various series and parallel resistor combinations. the DA-2006-VL allows a user to select 25, 50, 75, 100, 125, 150, 175, and 200 Ohm loads.

The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.

The provided text describes a medical device, the DA-2006-VL Defibrillator Analyzer Variable Load, and its equivalency to a predicate device, the Fluke Impulse 7010 Defibrillator Selectable Loads. However, the document does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, most of the requested information cannot be extracted from this document.

Here's the information that can be extracted and a note on what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The device was also tested to a standard:

• IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements. Result: Pass

2. Sample size used for the test set and the data provenance: Not applicable. This document describes a physical medical device (defibrillator analyzer), not a software or AI algorithm that would typically have a "test set" in the context of data. The testing performed was related to device function and electrical safety. The data provenance is also not applicable for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant for this device. The "ground truth" for this device's functionality would be established by engineering specifications and measurements using calibrated reference equipment.

4. Adjudication method 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: No. This document is not about an AI-powered device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.

7. The type of ground truth used: For the functional performance, the "ground truth" would be established by calibrated measurement standards and the device's design specifications. For the IEC standard, the ground truth is adherence to the standard's requirements.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.

The BC Group International DA-2006 Defibrillator Tester is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with specified requirements.

The DA-2006 is a microprocessor-based instrument that is used in the testing of defibrillators. It measures the energy output and provides information about the pulse. It is used on manual, semi-automatic and automatic defibrillators with monophasic or biphasic outputs.

The DA-2006P model additionally provides a Transcutaneous Pacemaker analysis function. It measures and displays pacer pulse information as well as performing Refractory Period, Sensitivity and Immunity testing,

All models have a built in 50 ohm human body simulation load as well as 12 lead ECG with arrhythmias and performance waveforms. Additionally, they have a centronics printer port, a serial port, oscilloscope output, high level ECG output, as well as provision for a batterv eliminator.

The DA-2006P makes viewing and selecting the desired waveforms and test data quick and intuitive, with all operational information being available on the 240 by 64 pixel graphic display, allowing for easy maneuvering through parameters and scrolling through available options.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DA-2006P Defibrillator Tester:

Device: DA-2006P Defibrillator Tester

Indications for Use: To determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily defined by compliance with specific international standards for electromagnetic compatibility and electrical safety, and the successful execution of internal validation and verification tests. The reported device performance is simply that the device "Pass"ed all these tests.

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

The document does not specify a sample size for any "test set" in the context of clinical or performance data from actual defibrillator/pacemaker measurements. The testing described is for the device itself (DA-2006P), not for the performance of defibrillators/pacemakers measured by the DA-2006P.

• Sample Size: Not applicable/Not specified for a "test set" related to clinical performance. The tests are on the device itself.
• Data Provenance: Not applicable in the sense of clinical data origin. The testing involves engineering and safety standards verification, likely performed in a controlled laboratory environment. There is no mention of country of origin for data or whether it was retrospective or prospective.

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

This information is not provided in the document. The "tests" described are against international engineering and safety standards (EN, IEC), and internal device validation/verification. These are typically assessed by qualified engineers and technicians, not clinical "experts" establishing a "ground truth" for medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of the described engineering and safety tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where human interpretation of medical data is involved and discrepancies need to be resolved. The "Pass" results indicate direct compliance with predefined technical specifications or standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers' performance with and without AI assistance is compared. The DA-2006P is a test instrument, not a diagnostic AI device intended for human interpretation of medical cases.

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

The concept of "standalone" performance without human-in-the-loop is typically applied to software algorithms that make independent assessments. The DA-2006P is a physical hardware device with embedded software. The described "Device Validation" and "Device Verification" could be considered "standalone" in the sense that they are testing the device's inherent functionality against its specifications, independent of a specific human operator's diagnostic interpretation. However, it's not "standalone" in the context of an AI algorithm making a clinical decision. The device is designed to be operated by a "trained service technician" to measure and display data.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the DA-2006P is based on:

• International Engineering and Safety Standards: The requirements and limits defined in EN61326, EN61000-3-2, EN61000-3-3, and IEC61010-1.
• Manufacturer's Internal Specifications: The defined hardware and software specifications and operational parameters of the DA-2006P itself, used for "Device Validation" and "Device Verification."

There is no mention of expert consensus, pathology, or outcomes data, as these are not relevant for the type of device and testing described.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The DA-2006P is not an AI/ML device that requires a "training set" in the conventional sense. It's a measurement instrument.

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

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

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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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Datrend Systems Inc. Phase 3 Defibrillator / Pacer Analyzer is a precision instrument for ensuring that defibrillators and defibrillators with transcutaneous pacemakers comply with performance specifications.

Phase 3 is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. It can also provide waveform information.

Phase 3's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohms, which roughly corresponds to the impedance of the human body. The defibrillator paddles are connected to Phase 3 contact plates, or directly connected to the energy input if using the hands-free defibrillator function. Thus, the defibrillator is connected through the load resistance of Phase 3. When the defibrillator is discharged, Phase 3 will calculate and display the energy delivered.

The intended end user is a trained / skilled biomedical equipment technician who is required to perform incoming inspections, scheduled periodic maintenance, and repair servicing of defibrillators, both stand alone and with pacing. Such end users may be associated with public, private, or commercial institutions, including: hospitals, clinics, third-party service companies that repair or calibrate medical equipment. In general, the end user is a technically trained individual, at a post-secondary school level, specializing in medical instrumentation technology.

Phase 3 is intended to be used in the laboratory environment, outside of the patient care vicinity, and is not intended to be used on patients or to test devices while connected to patients.

Phase 3 is not intended for over-the-counter use.

Phase 3 Defibrillator / Pacer Analyzer is a portable, line or rechargeable batterypowered defibrillator and transcutaneous pacemaker tester. Phase 3 is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. It can also provide waveform information. Phase 3 incorporates one fixed 50 ohm test load, which roughly corresponds to the impedance of the human body, for defibrillator testing. It also includes an option to vary the test load from 25 to 175 ohms in 25 ohm steps. For pacer testing, Phase 3 incorporates an integrated, variable internal test load, selectable from 50 ohms to 1,600 ohms in 50 ohm steps. The defibrillator paddles are connected to Phase 3 contact plates, or directly connected to the energy input if using the hands-free defibrillator function. Thus, the defibrillator is connected through the load resistance of Phase 3. When the defibrillator is discharged, Phase 3 will calculate and display the energy delivered.

Phase 3 implements connectivity through one USB Type "B" port (USB device), and through a bi-directional RS-232 port. The RS-232 port is intended for low-speed interface for data download and remote control operation, and provides the connection for an accessory Barcode Wand. The USB port is intended for highspeed interface with a PC and provides a full set of features for real-time data acquisition, remote control, and data download. Phase 3 also incorporates a nonvolatile memory or "data log" to save test results or "records" obtained from multiple tests.

Phase 3 optional accessories include a barcode reader and a PS/2 keyboard for rapid data entry of equipment control numbers, and a Serial Printer which may be . used to generate a hard copy of test results saved in the instrument's data logy The barcode reader and printer interface with Phase 3 by means of the RS-232 Port, and a separate 6-pin mini DIN is provided on Phase 3 for the PS/2 keyboard connection.

Phase 3 conducts the following tests and includes the features listed below:
a. Energy measurements
Optional variable loads for energy measurements (25 175 ohms)
Cardioversion tests
Peak Voltage and Current measurement
e. Storage and playback of output waveforms
f. 12 lead ECG simulation
ECG, Performance and Arrhythmia simulation g.
Transcutaneous Cardiac Pacemaker testing h.
Automatic External Defibrillator (AED) Test procedures i.
Large Graphical display 1.
Integrated Pacemaker Loads, selectable from 50 ohms to 1,600 ohms K.
RS-232, Centronics and USB (type B) communication interface

Principle of operation
i. Phase 3 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and/or transcutaneous pacemaker. These characteristics include: energy, peak current, peak voltage, pulse width, pulse rate, and refractory intervals.
ii. Measurements are accomplished by sampling a defibrillator signal from the defibrillator pads or from the pacer terminals at a high speed (~87ksps). Sampling is triggered by the rising or falling edge of the input. Triggering cran occur of enther edge to ensure that the waveform will be captured even if the operator places the defibrillator pads or connects the pacer leads in the reverse order.
iii. The defibrillator signal is digitized and stored into internal RAM. The test results are calculated based on standard numerical integration principles to deterroine the energy level. This process is applicable regardless of the value of the test load. These results are stored into a test record in RAM. Once all tests are completed, the user can save the test record by entering an equipment control number for identification and then transferring the record to non-volatile (NV) memory.

The provided text describes a medical device, the "Phase 3 Defibrillator / Pacer Analyzer," and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics typically used for AI/ML medical devices (e.g., accuracy, sensitivity, specificity, AUC).

The document is a 510(k) summary for a defibrillator tester, indicating substantial equivalence to a predicate device, not a clinical study report for an AI/ML diagnostic or prognostic device. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this document.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific performance acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) or reported device performance metrics are mentioned in the provided 510(k) summary. The summary focuses on the device's functional capabilities and its equivalence to a predicate device.

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

• Sample size: Not applicable/not mentioned. This device is a testing instrument for defibrillators, not a diagnostic device relying on a test set of patient data.
• Data provenance: Not applicable.

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

• Not applicable. The "ground truth" for this device would relate to the known characteristics of the electrical signals it measures, which are generated by defibrillators, not interpreted by experts.

4. Adjudication method 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:

• No MRMC study was done, as this is a defibrillator testing instrument, not an AI-based diagnostic device where human readers interact with AI.

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

• Not applicable. This device is a standalone instrument for measuring electrical signals from other medical devices; it does not involve algorithms for interpreting complex data for diagnosis or treatment decisions in the way AI devices do. Its "standalone" performance would be its measurement accuracy, which is not detailed here.

7. The type of ground truth used:

• For a device like this, the "ground truth" would be the actual, precisely known electrical characteristics (energy, peak current, peak voltage, pulse width, etc.) of defibrillator outputs. The document states that the device calculates these based on "standard numerical integration principles," implying that its accuracy would be compared against these known electrical standards, likely generated by precisely calibrated sources. However, the specific method of establishing this ground truth for a performance study is not detailed.

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.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device (a defibrillator tester) and primarily establishes its substantial equivalence to a predicate device. It does not contain the kind of performance data, study designs, or ground truth methodologies typically associated with the evaluation of AI/ML-driven diagnostic or prognostic tools that would warrant the detailed questions posed.

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This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.

The device has a built-in load resistance of 50 ohms with a test lamp which briefly illuminates if defibrillator energy of greater than 200 joules is detected. The device has a connector which is compatible with the PadPro System disposable defibrillator pads (K003548, K014209, K020288, K020203, and K020743).

The provided document is a 510(k) summary for the Defibrillator Cable Tester Model DT2200. It details the device's function, comparison to a predicate device, and the FDA's substantial equivalence determination. However, it does not contain a full study report with detailed acceptance criteria, device performance data, sample sizes, ground truth establishment, or multi-reader multi-case studies as typically expected for complex AI/ML medical devices.

The information primarily focuses on a comparison to a predicate device to demonstrate substantial equivalence, rather than a detailed performance study against defined acceptance criteria.

Here's an attempt to structure the information based on your request, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance Study for Defibrillator Cable Tester Model DT2200

The Defibrillator Cable Tester Model DT2200 is a device designed to serve as a 50-ohm cable test load for low-energy DC defibrillators. The 510(k) submission primarily establishes substantial equivalence to a legally marketed predicate device (Physio-control Defibrillator Test Load, K790394) rather than a formal performance study with pre-defined acceptance criteria against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance:
The document states that the Defibrillator Cable Tester Model DT2200 is "substantially equivalent to other test loads that are legally marketed for this purpose" in "all material respects." The device's primary function is to provide a 50-ohm test load and indicate if a defibrillator energy of greater than 200 joules is detected, which it is designed to do.

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

• Sample Size for Test Set: Not applicable. This submission does not describe a traditional "test set" in the context of clinical or AI/ML performance evaluation. The evaluation is based on technical specifications and comparison to a predicate device.
• Data Provenance: Not applicable. No patient data or clinical study data is presented. The evaluation is based on engineering specifications and direct comparison to a predicate device's design and function.

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

• Number of Experts: Not applicable. No clinical "ground truth" was established in this context. The determination of "substantial equivalence" was made by the FDA based on the provided technical comparison.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring 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

• No. This device is a hardware test device, not an AI/ML algorithm or imaging diagnostic tool. Therefore, an MRMC study is not applicable.

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

• Yes, in a way. The device itself operates in a standalone manner as a test load. Its performance is inherent to its design and functional specification (providing a 50-ohm load and illuminating an LED at 200+ joules). It does not involve an algorithm separate from its hardware function.

7. The Type of Ground Truth Used

• Ground Truth: For this type of device, the "ground truth" is intrinsically tied to established engineering standards for resistive loads and electrical safety/performance in medical devices. The predicate device's established safety and effectiveness implicitly serve as the benchmark for "substantial equivalence." The device's function is purely technical: to provide a specific electrical load and indicate a threshold energy.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model.

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The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.

The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.

The provided document is a 510(k) summary for a medical device (ZAP GUARD II, a defibrillator testing probe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a clinical study with acceptance criteria and device performance in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's an attempt to answer based only on the provided document:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document mentions "bench testing" and "functionally tested using a biphasic defibrillator" but does not quantify the number of tests or devices involved.
• Data Provenance: The testing was conducted by Guardian Angel Products, Inc. (the manufacturer). No information on country of origin of data or whether it was retrospective or prospective. It appears to be an internal, prospective validation of the device design.

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

• Not applicable/Not specified. The testing described for this device is physical and electrical performance rather than interpretation by human experts. The "ground truth" seems to be the expected electrical behavior and physical function.

4. Adjudication method for the test set:

• Not applicable/Not specified. No expert adjudication method is mentioned as the testing is non-clinical.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hardware testing probe, not an AI or imaging diagnostic tool that would typically involve human readers.

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

• Not applicable directly in the context of AI/algorithms. However, the performance described is that of the standalone device (ZAP GUARD II) functioning independently to test a defibrillator, without human interpretation of its internal workings to achieve the test result (i.e., the neon light illuminates or not).

7. The type of ground truth used:

• The ground truth for the performance testing appears to be based on:
  • Design Specifications: Conformance to pre-defined voltage and amperage requirements for the electrical circuit.
  • Expected Functional Behavior: The verifiable illumination of the neon lamp when connected to an operational biphasic defibrillator with intact wiring, indicating correct function.

8. The sample size for the training set:

• Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

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

• Not applicable. As noted above, there is no training set mentioned.

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