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The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum.

Mediastinoscopy is carried out

• In order to evaluate the operability of patients suffering from bronchial carcinoma which have . already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies.
• For diagnostic clarification of primary and secondary diseases of the mediastinum, when other . examination methods have been unable to provide the nature, and in particular the histological character of the disturbance.
• For the removal of nodes and tumors. .
• For the diagnosis and removal of lymphatic nodes.

Various auxiliary instruments are used in mediastinoscopy:

• The smoke evacuation tube is used to evacuate smoke during HF or laser applications.
• The telescope rinsing tube (optic irriyation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid.
• The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/histological purposes.
• The tumor grasping forceps are used for grasping and manipulating tissue. .
• The micro grasping forceps with HF are used for coagulating small vessels and grasping. .
• The HF coagulation suction devices are used for suction and for coagulation while holding tissue 'out of the way' during endoscopic operations of the larynx in connection with CO, lasers or in mediastinoscopy.
• The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for . coagulation of small lesions.

The Optical Mediastinoscope is a tubular, conical shaped endoscope with a handle and a build-in telescope with fiber illumination which is bent at a 90° angle. The endoscope tube consists of two spreadable spatulas which allow distention of the operative field, and therefore, optimizes vision. The spatulas may be dismounted for easier cleaning.

For efficiency during diagnostic and therapeutic procedures, a variety of accessory instruments are needed, e.g. biopsy and grasping forceps, puncture, suction and coagulation tubes or telescope rinsing tubes

The provided text describes the 510(k) summary for the "Optical Mediastinoscope and Accessories" (K971166). This document is for a medical device that requires premarket notification but does not describe the use of any AI/ML technologies. Therefore, many of the requested fields related to AI/ML performance and studies are not applicable.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission is for a physical medical device (mediastinoscope) and accessories, not an AI/ML algorithm. Performance data described includes mechanical tests and sterilization tests, not a "test set" in the context of an AI/ML model.

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

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/ML model for this device. The performance data relates to physical properties and sterilization effectiveness, assessed through laboratory tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of an AI/ML model that would require an adjudication method. The performance data is based on physical and sterilization testing.

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 submission is for a physical medical device and does not involve AI/ML or human "readers" or "interpreters" in the context of diagnostic imaging.

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

Not applicable. This submission is for a physical medical device and does not involve an AI/ML algorithm.

7. The type of ground truth used

Not applicable. As this is not an AI/ML device, the concept of "ground truth" in this context is not relevant. The performance data stems from mechanical and sterilization testing to demonstrate the device's physical integrity and functionality.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

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

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set" with established ground truth.

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