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Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.

A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy, internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.

Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.

The provided text describes a 510(k) submission for the "Freehand Endoscopic Camera Controller" and states that clinical tests were not necessary because the device uses the same technology as a predicate device. Therefore, there is no study provided that proves the device meets specific acceptance criteria based on clinical performance.

The acceptance criteria and device performance information would typically be derived from such clinical studies. Since no clinical study was performed or presented for K090340, the following points address the questions based on the available non-clinical data and the reasoning for not requiring clinical data.

1. A table of acceptance criteria and the reported device performance

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

• Sample size: Not applicable for clinical testing.
• Data provenance: Not applicable for clinical testing. The device was deemed substantially equivalent to a predicate based on technical specifications and intended use, not new clinical data.

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

• Not applicable as no clinical test set was used to establish ground truth.

4. Adjudication method for the test set

• Not applicable as no clinical test set was used.

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 MRMC or comparative effectiveness study was performed as no clinical tests were deemed necessary. This device is an endoscopic camera controller, not an AI-assisted diagnostic tool for "human readers."

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

• Not applicable. This device is a robotic camera controller, not an algorithm with standalone performance in a diagnostic context.

7. The type of ground truth used

• Not applicable for clinical validation. For non-clinical validation, ground truth would be defined by the standards of IEC 60601-1 and IEC 60601-1-2, which are engineering and safety standards.

8. The sample size for the training set

• Not applicable. There is no mention of a training set for an algorithm based on clinical data.

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

• Not applicable.

Summary of the study/non-clinical assessment:

The submission for K090340 (Freehand Endoscopic Camera Controller) did not include a clinical study to prove the device meets acceptance criteria. Instead, the manufacturer argued that clinical tests were unnecessary because the Freehand is a modification of a previously cleared device (Prosurgics EndoAssist, K043284) and uses the same core technology. The changes made were stated to be for "simpler control mechanisms that should result in greater reliability, as well as several convenience features." The safety and efficacy were demonstrated through non-clinical tests showing compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards. The substantial equivalence argument implied that the predicate device's established safety and efficacy extended to the Freehand due to the nature of the modifications.

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