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The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.

Here's an analysis of the provided information regarding the RDI Suction Safety Device, focusing on acceptance criteria and supporting studies, formatted as requested.

RDI SUCTION SAFETY DEVICE - K960937

This device is not an AI/ML powered device, therefore some of the requested information (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, etc.) is not applicable. The documentation primarily focuses on demonstrating substantial equivalence to a predicate device and basic functional and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the summary for the functional, material, or packaging tests. As this is not an AI/ML device, the concept of a "test set" in the context of clinical data or image analysis is not relevant. The testing described is laboratory-based functional and physical testing of the device itself.

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

This information is not applicable/not provided. The "ground truth" for this device's performance is established through direct physical and functional testing against defined standards and specifications, or by direct comparison to a predicate device's measured performance, rather than through expert review of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically associated with clinical studies or expert review processes, which are not described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. The RDI Suction Safety Device is a physical medical device, not a diagnostic tool utilizing AI.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation relies on:

• Standardized Test Methods: Adherence to established industry standards like ASTM F1140-88, NSTA Project 1A, AAMI/ISO for sterilization, and Tripartite Biocompatibility Guidance.
• Predicate Device Performance: Direct comparison of observed performance (pressure relief, one-way flow, vacuum relief) to the measured functional characteristics of the Delta Vacuum Relief Valve (K760894). The predicate device's performance serves as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set" in that context.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.

The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8" thick, closed cell polyethylene foam material. Attached to the foam is a 1/2" wide, 20" long, 4 mil thick, polyvinyl chloride strip referred to as a "tail".

The provided text describes a medical device, the "RDI Cardiac Insulation Pad," and its submission for pre-market notification (K960312). However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in AI/ML device studies.

The document focuses on:

• General Information: Device name, applicant.
• Indications for Use: To insulate the myocardium during open heart surgery.
• Device Description: Materials and construction.
• Classification: Class II.
• Safety and Effectiveness: Stating substantial equivalence to another device (Sorin/Shiley Inc. Cardiac Insulation Pad).
• Other Safety and Effectiveness Data: This section lists various tests primarily related to material biocompatibility, sterilization, pyrogenicity, and basic functional characteristics like thermal conductivity, tail pull strength, water absorption, and package integrity. Crucially, these are engineering and material property tests to ensure the device is safe and performs its basic physical functions, not a study evaluating its clinical effectiveness or diagnostic performance against acceptance criteria.

Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study proving device performance as it's typically understood in the context of AI/ML or diagnostic devices. The document does not describe such a study.

Here's how I would answer based on the provided text, highlighting what is present and what is missing:

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

The provided document describes engineering and material-related tests, not performance metrics related to clinical efficacy or diagnostic accuracy. Therefore, a table of acceptance criteria and reported device performance in the context of clinical outcomes or AI performance (e.g., sensitivity, specificity) cannot be generated from this text.

The document mentions "Functional Testing" and states the RDI Cardiac Insulation Pad was "Found to be similar to Sorin/Shiley" for:

• Thermal Conductivity
• Tail Pull Test
• Water Absorption

It also states:

• Fluid contact materials comply with Tripartite Biocompatibility Guidance.
• Sterilization is "Validated AAMI/ISO Method I validation for Gamma radiation sterilization."
• Pyrogenicity: "Non-Pyrogenic."
• Package Integrity: "Passed in accordance with ASTM F1140-88."
• Shipping & Distribution: "Passed in accordance with NSTA Project 1 A vibration/drop tests."
• Shelf life: "Successful two year shelf life Accelerated Aging."

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

Not applicable. The document describes material and functional tests, not a clinical or AI performance study with a test set. Therefore, there is no information on sample size for a test set 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. There is no mention of a test set requiring expert-established ground truth.

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

Not applicable. There is no mention of a test set or 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 document does not describe an AI device, let alone an MRMC study related to human reader performance with or without AI assistance.

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

Not applicable. This document describes a physical medical device, not an algorithm, and therefore no standalone algorithm performance was assessed.

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

Not applicable. The document describes tests of physical properties and safety characteristics, not a diagnostic or clinical performance study that would require a "ground truth" in the sense of a clinical outcome or expert diagnosis.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set is mentioned.

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

Not applicable. As above, this is not an AI/ML device and no training set or ground truth for it is mentioned.

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