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The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial.

After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication Cartridge.

The provided text describes the regulatory clearance of the RG 3ml Medication Cartridge and outlines studies conducted to demonstrate its substantial equivalence to a predicate device, primarily focusing on non-clinical performance testing.

Here's an analysis based on your request, highlighting what information is available and what is not:

1. Table of acceptance criteria and the reported device performance

Important Note: The document specifies that "differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness." This implies that the acceptance criteria for the new device were primarily demonstrated through equivalency testing against established standards and the performance of the predicate device.

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

The document describes non-clinical performance testing for a medical device (a medication cartridge). Such tests typically involve specific numbers of units (samples) of the device and may use standardized test fluids or conditions. However, the exact sample sizes used for each test (e.g., how many cartridges for flow rate testing, how many animals for biocompatibility) are NOT specified in this document.

The data provenance is from non-clinical laboratory testing and is not tied to human subjects, countries of origin, or retrospective/prospective studies in the way clinical trials would be.

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

This information is not applicable to the type of testing described. The "ground truth" for non-clinical performance testing is established by recognized international standards (e.g., ISO, ASTM) and the specifications of the compatible medical device (the CADD-MS®3 Ambulatory Infusion Pump). These are objective measurements against defined criteria, not subjective expert interpretations.

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

This is not applicable to the type of testing described, as there is no subjective interpretation or consensus among experts required for the results of the performance tests. The tests yield objective measurements against predefined acceptance criteria.

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

An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human interpretation is involved, often with AI assistance (e.g., radiology images). This information is not applicable as the device is a medication cartridge, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical medical component, not a software algorithm.

7. The type of ground truth used

The ground truth used for evaluating the RG 3ml Medication Cartridge performance includes:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 7886-2 for flow rate, ASTM standards for packaging.
• Predicate Device Specifications: The CADD-MS®3 Ambulatory Infusion Pump's specifications for compatible cartridges and its performance characteristics served as a benchmark for comparison.
• Defined Acceptance Criteria: Each test had specific pass/fail criteria derived from these standards and specifications.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set. The tests performed are engineering and biological validations, not algorithm training.

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

This is not applicable for the same reason as point 8.

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