Search Results

The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The provided documents (K093616) describe a medical device, the V.Mueller Camera Controller with Storage Cart, which is an endoscope holder. The submission focuses on substantial equivalence to a predicate device and does not involve the type of AI/ML performance evaluation typically associated with acceptance criteria tables, advanced statistical studies (like MRMC), or detailed ground truth establishment.

Therefore, many of the requested elements for describing acceptance criteria and study details are not applicable to this 510(k) submission. However, I will answer the applicable points based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was evaluated through "non-clinical tests under various conditions to assess the design performance and conformance to design specifications." It then concludes, "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate device with regard to functional characteristics." Specific, quantifiable acceptance criteria or detailed performance metrics are not provided in the given text. The primary acceptance criterion was likely substantial equivalence in functional characteristics to the predicate device (Statarius Endoscope Holder, K061292).

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical tests under various conditions" but does not detail the number of units tested or the duration/extent of testing.
• Data Provenance: The tests were "non-clinical" and likely conducted by the manufacturer, CareFusion, as part of their design verification and validation process. Country of origin of data is not explicitly stated but would typically be where the manufacturer is located or where the tests were performed (McGaw Park, IL, USA, based on the sponsor address). The study was prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.

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

This is not applicable. The device is a mechanical endoscope holder, not an AI/ML algorithm requiring expert-established ground truth for diagnostic accuracy. The testing would have focused on mechanical functionality, durability, and safety, likely against engineering specifications or comparative performance with the predicate device.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device, there is no "adjudication" of results in the sense of reconciling differing expert opinions. The testing would rely on objective measurements and observations of mechanical performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The V.Mueller Camera Controller is a mechanical surgical instrument.

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 endoscope holder, not an algorithm.

7. The type of ground truth used

This is not applicable in the context of diagnostic accuracy. For this mechanical device, the "ground truth" for testing would be objective engineering specifications, performance metrics (e.g., force required to move, stability, grip strength on endoscopes), and safety standards. The primary comparison point (not "ground truth" in the diagnostic sense) was the performance of the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or associated ground truth for this mechanical device.

Ask a specific question about this device