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The contrast delivery system REMPRESS is an intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures.

The main components of the REMPRESS are the Console, Powerhead and Main Control Unit. The configurations of the REMPRESS are a pedestal or table mount configuration. The three main components are possible in the angiographic suite and normally in close proximity to the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that integrated in a laptop computer). The Console communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection via the contribution of the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe.

The provided text describes the Nemoto Kyorindo Co., Ltd. REMPRESS Contrast Delivery System and details its technical characteristics in comparison to predicate devices, along with some information about performance testing. However, it does not contain a detailed study proving device acceptance criteria in the format requested. Specifically, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical or performance study with detailed acceptance criteria and validation results as a standalone study might.

Here's a breakdown of the available information and what is missing from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines "acceptance criteria" by stating that performance testing was completed to verify the new device's ability to perform within its "specificated" parameters, aligning with the substantial equivalence chart. It claims the system "successfully delivered the volumes within the allowable specifications" and that measured pressures and speeds "were within the allowable specifications." However, the specific numerical limits or ranges for these "allowable specifications" are not explicitly stated as acceptance criteria.

The following table summarizes what can be inferred for "acceptance criteria" from the provided text and the general performance statements:

What's Missing:

• Specific quantitative acceptance criteria (e.g., "Volume must be within ±X% of programmed volume," "Flow rate must be within Y ml/s," "Pressure must be within Z PSI"). The text only refers to "allowable specifications" without defining them.

2. Sample Size for the Test Set and Data Provenance

Missing. The document mentions "During testing" for volume, flow rate, pressure, and manual control speeds, but it does not specify the sample size for any of these tests (e.g., number of injections, number of devices tested). It also does not state the data provenance (e.g., country of origin, retrospective or prospective).

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

Not Applicable (or Missing). This information is typically relevant for studies involving qualitative assessments or diagnoses (e.g., medical imaging interpretation). For a device like a contrast injector, "ground truth" is established through direct physical measurements of objective technical parameters (volume, flow rate, pressure, speed) using calibrated equipment. It does not involve human expert interpretation in the same way.

4. Adjudication Method for the Test Set

Not Applicable. As "ground truth" is established by direct measurement of physical parameters, there is no expert adjudication process in this context.

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

No. The provided text describes performance testing for a medical device (contrast injector), which focuses on engineering specifications and physical performance. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This document does not describe such a study.

6. Standalone Performance Study

Yes, implied. The "SUMMARY OF PERFORMANCE TESTING" section describes tests conducted on the REMPRESS device itself to verify its performance against "specificated parameters." This constitutes standalone testing of the algorithm (or, in this case, the device's operational capabilities) as it evaluates the device's output independently, not in conjunction with human performance.

7. Type of Ground Truth Used

The ground truth for the performance testing of the REMPRESS device was established through objective physical measurements using instruments to assess parameters like:

• Fluid volume delivered (compared to programmed volume).
• Flow rate (calculated from recorded volume and injection time).
• Pressure (monitored during injections).
• Manual (ram) control speeds.

8. Sample Size for the Training Set

Not applicable (or Missing). The REMPRESS is a mechanical/electronic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Performance testing validates the device's operational parameters rather than training a model.

9. How Ground Truth for the Training Set Was Established

Not applicable. As a non-AI device, there is no "training set" for which ground truth would be established.

In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence through technical comparisons and a high-level summary of performance testing. It lacks the granular detail of a full study report that would typically include specific acceptance criteria, comprehensive methodology (including sample sizes and data provenance), and detailed results. The device's "performance is deemed acceptable and substantially equivalent to the predicate devices" based on the unspecified "allowable specifications."

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