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This IDA-4 or IPT-MC is designed to be used by manufacturers, BioMedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analyzed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.

The "IDA-4 & IPT-MC" incorporate one to four self reading calibrated micro-burettes (transducers)which measure the volume of fluid flowing from one to four infusion devices into the device. Flow rates from 1 to 1000 mL per hour can be administered independently in each channel. This device is designed to be used by manufacturers, BioMedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline only. The device can be used to determine flow rates, flow volume, average flow rate (with from -100 mmHg to +300 mmHg), average bolus volume with total delivery, occlusion pressure.

The Bio-Tek IDA-4 & IPT-MC are infusion device analyzers. The provided text details their performance testing and specifications rather than a clinical study with human patients. As such, many of the requested categories for clinical study analysis are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• 0 to 9 psi (0-465 mmHg): ± 5% of Reading ± 0.1 psi or 6 mmHg
• 9 to 34 psi (465 to 1762 mmHg): ±5% of Reading ± 0.2 psi or 12 mmHg
  Maximum Reading: 2326 mmHg; or 45 psi; or 310 kPa |
  | Multi-channel Capability | One to four test channels each with independent operation. |
  | Display | Larger display (240 by 128 Supertwist LCD with backlight) capable of showing graphics or multiple lines of text. (Compared to predicate single display line). |
  | Flow Height Sensors | 18 flow height "sensors" in the transducer. (Compared to predicate 4 "sensors"). |
  | Cross Talk between channels | No cross talk between channels. |
  | Air-in-line detection | Monitor with error messages utilized to minimize believable but incorrect results. |
  | Blockage detection | If valve is blocked or partially blocked and value is outside of a range, an error message is displayed and printed. |

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

The document describes performance testing (verification and validation) for an infusion device analyzer, not a clinical study on human subjects or clinical data. Therefore, the concept of "test set" in the context of patient data, data provenance (country, retrospective/prospective), or sample size (in terms of patients/cases) is not applicable here. The testing was conducted internally by Bio-Tek Instruments, Inc. on the device itself and various infusion pumps.

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

Not applicable as this is performance testing of a medical device analyzer, not a study involving human experts establishing ground truth for diagnostic accuracy. The "ground truth" for the device's performance would be established by reference standards or calibrated equipment used to test the analyzer.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for human expert assessments in clinical studies, which is not the nature of this submission.

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 a submission for a medical device analyzer, not an AI or diagnostic imaging device involving human readers.

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

The device itself is a standalone analyzer. Its performance was verified and validated "using a controlled written plan." The testing established that the device "meets its marketing specifications." This indicates standalone performance testing of the device's metrological capabilities.

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

For this type of device (an analyzer), the ground truth is established by reference measurements from known, calibrated sources (e.g., precise flow rates and volumes from external calibrated pumps/systems) and adherence to engineering specifications. The document states accuracy specifications are with "water at 15 to 25° C," implying controlled laboratory conditions and standard fluid properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The device operates based on physical principles (sensors, micro-burettes) and established engineering parameters.

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

Not applicable, as no training set is relevant to this device's functioning.

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The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger".

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

The device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger".

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type.

The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

Index 2/CardioSat 100 simulates a human "finger" (toe/ear).utilize technology similar to that which the Pulse Oximeters utilize to measure SpO2 and pulse rate. This aspect of the technology used in Index 2/CardioSat 100 is protected by US Patent No. 5,348,005. Oximeters use the ratio of Red to InfraRed light to simulate readings related to the partial pressure and thus arterial oxygenation level of blood, which is expressed as SpO2 for this method of measurement. In Index 2/CardioSat 100 the pulsation of the signal serves to simulate the heart rate pulsation. This feature is identical to the predicate Index, K933519, SpO2 Simulator with the addition of a near simultaneous pulsing of the Red and InfraRed LEDs to test a wider range of Pulse Oximeter manufacturers models. Most Pulse Oximeters alternate the Red and InfraRed signals.

The simulators can also send this same types of signals electronically to the Oximeter under test simulating the Oximeter Probe's signal. Additionally, they can operate as intelligent volt/ohmmeters to analyze Oximeter Probes for continuity, shorts, opens, LED operation and Photodiode Operation.

This document describes the Bio-Tek Index 2 E, F, EF & CardioSat 100 E, F, EF, which are pulse oximeter simulators, testers, and analyzers. The information provided focuses on the device's performance testing and regulatory submission, rather than a clinical study evaluating the device's diagnostic accuracy or effectiveness in a patient setting.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific quantitative performance metrics. It generally states that the device is designed to "allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters" and "determine its performance qualities."

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

• Sample Size for Test Set: Not specified. The document refers to testing "over a wide range of Oximeter types" but does not give a number of oximeters or probes tested.
• Data Provenance: The testing is internal to Bio-Tek Instruments, Inc., and is described as "verification and validation" of the device itself rather than a study on clinical data. The text doesn't mention specific countries of origin for test data or whether it was retrospective or prospective. It's an internal product development and regulatory submission document.

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

Not applicable. The document describes the testing of a medical device simulator/tester, not a device that makes clinical diagnoses. The "ground truth" for this device would be its own electrical and simulated physiological outputs, verified against known engineering standards and the expected behavior of pulse oximeters, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of clinical findings. Verification and validation would involve engineering and quality assurance practices.

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

No. This document does not describe a MRMC comparative effectiveness study. The device is a simulator/tester for pulse oximeters, not a diagnostic tool for human readers.

6. Standalone Performance Study

Yes, in a sense. The described "Performance Testing: (Verification and Validation)" is essentially a standalone evaluation of the algorithm/device's functionality. The document states:

• "The predicate INDEX design was extensively verified and validated to be working per the design and published specifications."
• "The Index 2 and CardioSat 100 is being and will be fully verified and validated per a written plan prior to release. This plan includes verification/ validation that the device features work as intended over a wide range of Oximeter types and in some cases involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)."

This indicates testing of the device's ability to accurately simulate and analyze, without human interpretation as part of its primary function.

7. Type of Ground Truth Used

The ground truth for this device is based on:

• Engineering specifications and known electrical/physiological parameters: The device simulates pulse oximeter readings using ratios of Red to InfraRed light and pulsation for heart rate. Its ability to create these signals accurately is the ground truth.
• External confirmation: "...involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)." This implies calibration against known electrical standards and measurements.
• Reference to predicate devices: The device's technological characteristics are compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for what the new device should achieve.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm requiring a "training set" in the typical sense. Its functionality is based on direct simulation and measurement according to designed electronic and optical parameters.

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

Not applicable, as there is no "training set" for this type of device.

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The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.

The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.

Operational modes: The IDA-2 Plus will offer two modes of operation; stand alone and computer control. The computer control mode will allow the user to operate the device from an external program. All possible tests available in the stand alone mode will be available in the computer control mode. The computer control mode allows for a graphical display of data, found to be useful in troubleshooting a faulty drive mechanism in the infusion device under test.

Reading Speed: The device can operate in the Steady Flow Mode, which will give a time to first reading of 6 minutes at 1 mL/hr and 25 seconds at rates above 100ml/hr. In the Non-Steady & High Accuracy Flow Mode it will depend on the time to deliver 1 mL of fluid.

Occlusion Pressure Range: The IDA-2 Plus features a pressure transducer that is operational in the range of 0 to 34.8 psi. It has the ability to display the pressure value in psi or mm Hg. A print out is also available.

Volume Measurement: This feature displays the volume delivered into the IDA-2 Plus. Instantaneous/ Average Flow: This feature displays either the instantaneous or average flows through the device.

External communication links: The device uses a Centronics standard parallel interface that is Epson compatible. The printer can be set to print immediately after determining a rate or at intervals of 5 minutes or 1 hour. The serial RS232 port is used for computer control and is set at 2400 baud, using 8 databits, 1 stop bit and no parity.

Data reduction software: "Graphics Capture Program " This feature of the device allows the user to acquire and continuously graph the flow rate, volume and occlusion pressure from a separate computer. Numerical values for average flow rate, instantaneous flow rate and derived volume can be displayed for any instant along the time axis. The user has the option to erase, print or save the acquired data for future review and statistical evaluation.

The provided text describes a medical device called "IDA-2 Plus", an infusion pump analyzer. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a study proving device performance.

Here's an analysis of what is available and what is missing:

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

The document mentions that the IDA-2 Plus "was extensively verified and validated to be working per the design and published specifications" and "meets its marketing specifications". It briefly lists some operational ranges and features, which could be interpreted as performance specifications, but it does not provide a formal table of acceptance criteria with corresponding reported performance values from a specific study.

Available Performance-Related Information (interpreted as potential specifications/performance):

Missing: Specific, quantifiable acceptance criteria (e.g., "Accuracy of flow rate measurement shall be +/- X%") and the actual test results demonstrating compliance with these precise criteria.

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

Missing. The document states "extensively verified and validated" but provides no details on sample size for testing or data provenance.

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 is an analyzer for infusion pumps, not a diagnostic tool requiring expert interpretation of medical images or patient data. Its "ground truth" would likely be based on calibrated reference instruments and known fluid dynamics, not expert consensus.

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

Not applicable. As above, this doesn't involve subjective interpretation that would require 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 is not a diagnostic AI system for human readers.

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

The device can operate in "stand alone" mode, which implies it performs its analysis without continuous human intervention during the measurement process. The "computer control mode" would allow external programming, but the core measurement is likely standalone. However, the document does not describe a "standalone study" in the context of an algorithm's performance. It just describes modes of operation.

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

Implied: The "ground truth" for verifying this device's performance would be established through calibrated reference standards and known physical principles of fluid flow and pressure. For instance, a known, highly accurate flow generator would be used to supply fluid, and the IDA-2 Plus's measurements would be compared against that known input.

8. The sample size for the training set

Not applicable. This device is an analyzer, not an AI/ML model that requires a training set of data in the typical sense. It operates based on its internal sensing and measurement algorithms.

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

Not applicable. As above.

In summary, the provided text is a 510(k) summary for a medical device (an infusion pump analyzer). It focuses on the device's description, intended use, operational features, safety considerations, and similarity to predicate devices. It states that verification and validation were performed to meet design specifications, but it completely lacks the specific details of these studies that your questions are asking for, especially regarding acceptance criteria tables, sample sizes, and detailed ground truth establishment methods typical for AI/ML or diagnostic device studies.

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