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The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.

The provided text describes a medical device, the RMI Dual Fluid Irrigating Syringe, and its testing for safety and effectiveness. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document focuses on the device itself and its manufacturing, biocompatibility, and basic functional performance, comparing it to predicate devices. It does not involve any AI components, image analysis, or diagnostic capabilities that would typically be evaluated with metrics like those commonly used for AI in healthcare (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Specifically, the following information is missing or not applicable based on the provided text:

• A table of acceptance criteria and the reported device performance: While there is a "Table of Tests and Results" for functional parameters (leak, flow, pull), these are for the physical device, not for an AI algorithm's performance against clinical acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI algorithm is mentioned. The sample sizes for functional tests (e.g., 13 units for leak/flow tests) refer to physical devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no AI algorithm requiring ground truth from experts.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the functional tests, the "ground truth" is simply the physical measurement or observation (e.g., "Passed" leak test).
• The sample size for the training set: Not applicable as there's no AI algorithm.
• How the ground truth for the training set was established: Not applicable.

The document primarily covers:

• Product Description: RMI Dual Fluid Irrigating Syringe.
• Component Materials: List of materials in contact with fluids.
• Predicate Device Identification: Micromedics, Inc. Surgical Sealant Dispenser (SSD) and Duoflo™ Dispenser.
• Summary of Biocompatibility: Various tests (skin irritation, sensitization, cytotoxicity, systemic toxicity, hemocompatibility, pyrogenicity, muscle implantation, Ames test) and their results, all indicating acceptable biocompatibility for medical device use.
• Functional/Performance Information:
  • Functional Testing: Leak tests, flow tests, and pull tests on stopcocks/tubing with reported results (e.g., "Passed," "all pulled to 17 lbs. or more").
  • Performance Testing: States the device is substantially equivalent in performance to two separate 10cc syringes or two taped-together syringes in delivering fluids simultaneously and in an equal 1:1 ratio.
• Comparison to Predicate Device (Micromedics SA-4310): Tabular comparison of characteristics like model, syringe volume, assembly, applicator tip configuration, and sterilization method.

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