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The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.

The Plug System S Plus (Modified) is a vaporizer mounting adapter that will allow Dräger Vapor 19.n vaporizers to be mounted to Selectatec Manifolds. The Plug System S Plus (Modified) is a modification to the currently distributed Plug System S Plus (K973051).

The provided text describes a traditional medical device (vaporizer mounting adapter) rather than an AI/ML-based device. Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," “sample sized used for the test set,” “number of experts,” “adjudication method,” and “sample size for the training set,” are not applicable.

Here's the information extracted from the provided text, adapted for a traditional device context:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify a distinct "test set" in the context of data for an algorithm. Instead, it refers to "representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds" for the compatibility testing. The exact number of machines or specific test cases is not provided.

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

N/A - This concept does not apply to the testing of this traditional device. Testing involved physical and functional verification against standards and compatibility with other hardware.

4. Adjudication method for the test set

N/A - This concept does not apply to the testing of this traditional device.

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

N/A - This is not an AI/ML device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

N/A - This is not an AI/ML device. The device's performance is inherently "standalone" in that it performs its function without AI or human intervention in its direct operation, but it requires human users for its application.

7. The type of ground truth used

The "ground truth" for this device's performance was based on:

• Compliance with an established industry standard (ASTM Standard 1161-88, Sections 8 and 12).
• Functional compatibility with specified existing medical equipment (Dräger Vapor 19.n vaporizers and Selectatec Series Mounted Manifolds, and Ohmeda Tec 5 interlock mechanism).

8. The sample size for the training set

N/A - This is not an AI/ML device, so there is no training set.

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

N/A - This is not an AI/ML device.

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The Plug System S Plus is intended for mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.

The Plug System S Plus is a vaporizer mounting adapter that will allow Dräger Vapor 19.1 vaporizers to be mounted on Selectatec Series Mounted Manifolds.

The provided text describes a medical device called the "Plug System S Plus," which is a vaporizer mounting adapter. The document focuses on demonstrating that this device is substantially equivalent to existing devices, primarily the Ohmeda Tec 5 Continuous Flow Vaporizer (Tec 5), to obtain FDA clearance.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format as one might expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is described through comparison and adherence to standards.

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

The document does not specify a "test set" in the context of a dataset for an AI model. The "testing" referred to is for hardware qualification.

• Sample Size for Testing: Not explicitly stated numerically (e.g., number of units tested). It mentions "testing to demonstrate compliance" and "testing for the effects of mounting the device on representative Ohmeda anesthesia machines." The term "representative" implies a selection, but no specific count is given.
• Data Provenance: The testing appears to have been conducted by the manufacturer, Drägerwerk AG (Germany) or North American Dräger (USA), as part of their qualification process. It is an internal prospective testing related to device development and regulatory submission.

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

This is not applicable to this document. The device is a mechanical adapter, not a diagnostic tool requiring expert interpretation of results. "Ground truth" in this context would be engineering specifications and functional performance. The "experts" involved would be the engineers and technicians performing the qualification tests. Their specific number and detailed qualifications are not provided, but it's assumed they are qualified personnel for device testing.

4. Adjudication Method for the Test Set

This is not applicable. There's no interpretive task that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and compliance with engineering specifications and standards.

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

This is not applicable. This device is a mechanical adapter. It is not an AI-based system, nor does its function involve human interpretation of cases or data. Therefore, an MRMC study and effect size in human reader improvement with AI are not relevant.

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

This is not applicable. The device is a mechanical component. There is no algorithm or AI component involved, standalone or otherwise.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is based on:

• Engineering Specifications: The design parameters and functional requirements of the Plug System S Plus.
• Predicate Device Performance: The known and accepted performance characteristics of the Dräger-Vapor® 19.1 and the Ohmeda Tec 5 Continuous Flow Vaporizer. This includes their interlock mechanisms and vaporizer bypass functions.
• Industry Standards: Compliance with ASTM Standard F 1161-88.
• Functional Testing: Demonstrating that the device performs its intended function (mounting, interlock, bypass) correctly on representative machines.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and established medical device standards.

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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