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The device is for use during diagnostic examinations or surgical procedures to support and position a patient.

The operating table has been designed to fulfil the special requirements for patient positioning during surgical treatment. The side rails are provided for fitting additional parts. Before positioning the patient the device has to be covered with sheets. It is an electrohydraulical operated system which can be controlled by means of a hand control box, IR-transmitter, foot switch or with the override. Power is supplied by batteries, which can be recharged by a built-in battery charger. The operating table has the following functions: Trendelenburg / reverse Trendelenburg positioning, Lateral tilt movement (right / left), Leg plate movement (up/down), Back plate movement (up / down), Head plate movement (up / down), Hight adjustment. The table top is subdivided as follows: Head plate, removable back plate section, back plate, seat plate, leg plates. Each foam upholstered patient section is radiotranslucent and electrically conductive.

This document describes a medical device, a Mobile Operating Table (Model 1132.01). It is a 510(k) submission, indicating a regulatory filing in the US for medical device approval. The submission focuses on demonstrating substantial equivalence to a predicate device (Betastar 1131.02 Mobile Operating Table).

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria expressed as performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall, F1 score).
• Any studies involving sample sizes for test sets, training sets, or data provenance in the context of diagnostic or analytical performance.
• The use of expert radiologists or other medical professionals to establish ground truth for a diagnostic device.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Any type of ground truth beyond compliance with engineering and safety standards.

Instead, the document details compliance with engineering, electrical safety, and quality management standards, which serve as the "acceptance criteria" for this type of medical device (an operating table). The "study" proving these criteria are met is the design, manufacturing, and quality control processes conforming to these standards.

Therefore, I cannot fulfill the request for a table of acceptance criteria with reported device performance in the manner typically expected for a diagnostic AI or image analysis device, nor can I provide information about sample sizes, expert ground truth, or MRMC studies, as these concepts are not applicable to the content of this specific document.

Below is an attempt to structure the available information as closely as possible to your request, but please note the significant limitations based on the provided text.

This document describes the validation of a Mobile Operating Table (Model 1132.01), not a diagnostic or AI-driven device. Therefore, the acceptance criteria and supporting "study" are focused on engineering compliance, safety, and quality management standards rather than diagnostic performance metrics like sensitivity, specificity, or reader studies.

1. Table of Acceptance Criteria and the Reported Device Performance

For this device, "acceptance criteria" refers to compliance with recognized safety, electrical, and quality management standards. The "reported device performance" in this context is the statement of compliance with these standards.

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

Not applicable in the context of diagnostic device testing. This document pertains to the safety and functional compliance of an operating table as a medical device, not a diagnostic algorithm. Therefore, there is no "test set" of clinical data, nor is there "data provenance" in the sense of patient data. The "testing" involves engineering verification and validation against specified standards.

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

Not applicable. "Ground truth" in this context is defined by the technical specifications and requirements of the referenced international and national standards for medical electrical equipment and quality management. Experts involved would be engineers, quality assurance personnel, and regulatory specialists ensuring adherence to these standards, rather than medical experts establishing diagnostic ground truth from patient cases.

4. Adjudication method for the test set

Not applicable. There is no "test set" requiring adjudication by clinical experts as this is not a diagnostic 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

Not applicable. This device is an operating table, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an operating table and does not involve any algorithms for standalone diagnostic performance.

7. The type of ground truth used

The "ground truth" for this device's "performance" is based on engineering specifications, international and national safety standards (e.g., IEC 601-1, DIN EN ISO), and quality management system requirements (e.g., ISO 29001, ISO 46001). Compliance with these established standards is the basis for proving safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device and therefore does not have a "training set" of data.

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

Not applicable. As there is no training set, this question is not relevant.

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Ask a specific question about this device