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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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