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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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The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.

The Infutest 2000 Infusion Pump Analyzer is an instrument for measuring the volume of fluid delivered by an infusion pump. The instrument is based on an optically instrumented burette. Flow rates from 0.1 to 999.9 millilitres per hour can be derived from the incremental volume measurements in relation to the time of delivery. Infutest 2000 is a two channel system, which can be expanded to four channels by the addition of an accessory two channel sensor assembly called the Remote Sensor Module.

The Infutest 2000 is designed to accurately measure volumes and rates on a wide variety of infusion pump types, including syringe, linear and rotary peristaltic, cassette based, enteral and patient controlled analgesia.

In addition to volume and flow rate, Infutest can measure the pressure developed by an infusion pump that is pumping into an occluded line. This feature is designed to measure the occlusion pressure alarm limits of the infusion pump.

Results of all tests performed can be printed to paper and/or sent to an external device using the serial communications port.

Here's an analysis of the provided text regarding the Infutest 2000 Infusion Pump Analyzer, outlining its acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) summary from 1998 for an infusion pump analyzer, not a medical device designed for direct patient care with AI components. As such, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like those involving expert labels, MRMC studies, or training/test sets for AI models) will not be present or directly applicable. This device is a measurement tool, and its "performance" is about accuracy and precision in measuring infusion pumps.

Acceptance Criteria and Device Performance for Infutest 2000 Infusion Pump Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" with specific numerical targets for accuracy, precision, or other performance metrics. Instead, it describes the device's capabilities and implies that performance is achieved if these capabilities are met and the device is substantially equivalent to predicates. The "Verification and Validation" section confirms that the device was tested to work "per the input design and marketing specifications."

Based on the description of capabilities, here's a reconstructed table reflecting what the device claims to measure and how well it measures based on the context of its intended use as an analyzer, rather than specific acceptance criteria thresholds. The performance is implied by its design for accurate measurement of these parameters.

Notes on Acceptance Criteria: The document emphasizes "accurate measurement" in its description of the technological characteristics but does not quantify "accuracy" or "precision" with specific tolerances (e.g., ±X% of reading). The primary "acceptance" for this 510(k) is substantial equivalence to predicate devices (Bio-Tek IDA-2 Plus, DNI Nevada 404A). This implies that if the Infutest 2000 performs comparably to these legally marketed devices, it meets the regulatory acceptance.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "extensively tested, verified and validated" but does not provide details on the number of devices or types of infusion pumps used in the testing.
• Data Provenance: Not specified. It's internal validation by the manufacturer (Datrend Systems, Inc.). Given the nature of a 510(k) for a test device, this would likely involve new data generated by the manufacturer to demonstrate performance of their device against known reference standards or predicate devices. There's no mention of external data or specific countries of origin beyond the manufacturer's location in Burnaby, BC, Canada. The testing would be prospective in the sense that it was performed specifically for this submission.

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

This information is not applicable and not provided for this type of device. The Infutest 2000 is an analyzer that measures physical parameters (volume, flow rate, pressure) of infusion pumps. Ground truth for its measurements would be established through calibrated reference standards for flow, volume, and pressure, not expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1 consensus) are typically used for establishing ground truth in subjective assessments, such as medical image interpretation by human experts. For a device measuring physical quantities, comparison would be against known, calibrated standards.

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

This information is not applicable and not provided. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. The Infutest 2000 is a standalone measurement device with no human-in-the-loop AI assistance component in its intended function.

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

Yes, in a sense. The "Verification and Validation" section describes testing of the "Infutest 2000, the remote sensor module, the serial data transfer program and the graphics display program." This implies standalone testing of the device's functionality and its associated software components to ensure they meet design specifications. However, it's not "algorithm only" in the context of an AI/ML algorithm, but rather the integrated system's performance.

7. The Type of Ground Truth Used

The ground truth used for validating this device would be calibrated reference standards. This would involve:

• Known Volume Standards: Highly accurate measures of fluid volume (e.g., precise pipettes, gravimetric methods, or certified volumetric containers) to verify the Infutest's volume measurement accuracy.
• Known Flow Rate Standards: Systems capable of delivering fluid at precisely controlled and measured flow rates to verify the Infutest's flow rate accuracy.
• Calibrated Pressure Transducers/Gauges: To verify the accuracy of the Infutest's internal pressure transducers against known pressure inputs.

The document does not explicitly state how these ground truths were implemented, but this is the standard practice for calibrating and validating such an analyzer.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Infutest 2000 is not described as utilizing AI/ML algorithms that would require a "training set" in the conventional sense. Its operation is based on optical measurement and embedded logic, not learned patterns from data.

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

This information is not applicable for the same reasons as point 8. There is no mention of a training set for an AI/ML model for this device.

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