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Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.

The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power.

The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf).

column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.

The provided text is a summary of safety and effectiveness for the Drager Gemina Wall-Mounted Workplace System, a non-powered device intended to provide physical support for medical equipment, storage, and dispensing of medical gases and electrical power. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device that generates diagnostic or prognostic outputs, or measures a physiological parameter.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a clinical study. Substantial equivalence is a regulatory pathway for class II devices in the US, where a new device is shown to be as safe and effective as a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to what constitutes "performance" and "safety" in the context of this device's intended use and the provided comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission as a substantial equivalence claim for a physical support system, the "acceptance criteria" are implicitly met by demonstrating equivalence to predicate devices in design, materials, function, and safety features. Performance is described in terms of its features and comparability to other marketed devices.

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

Not applicable. This is not a study involving a test set with patient data or performance metrics that would require a sample size. The "test" here is a comparison against predicate devices' specifications and functional descriptions. The data provenance is a regulatory filing for a device manufactured in the Federal Republic of Germany, distributed in the United States.

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. "Ground truth" in the context of evaluating a physical support apparatus's equivalence to existing products does not involve clinical experts establishing a diagnosis or outcome. The "truth" is established by comparing the device's design, materials, and functional specifications to those of legally marketed predicate devices, which is part of the regulatory review process.

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

Not applicable. There is no test set in the conventional sense of a clinical or performance study that would require an adjudication method.

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 device is a physical support system and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not have an "algorithm" or standalone performance in the context of diagnostic or therapeutic functions. Its "performance" is its ability to physically support equipment, deliver gases/electricity, and its safety features.

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

The "ground truth" for this regulatory submission is the specifications, features, and safety profiles of legally marketed predicate devices (DVE 4000 and Horizon Headwall System). The Gemina System's "truth" is established by demonstrating that its characteristics are substantially equivalent to these predicates.

8. The sample size for the training set

Not applicable. This is not a machine learning or data-driven device that requires a training set.

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

Not applicable. There is no training set for this type of device submission.

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