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The Surgeon Controlled Arm is indicated for use to hold and position a rigid laparoscope/endoscope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.

The Surgeon Controlled Arm for the Levita Magnetic Surgical System (MSS) comprises two collaborative surgeon-controlled arms, which along with their controllers, control software, and custom attachments, are intended to hold and control the Magnetic Controller of the commercially available MSS (most recently cleared under K191762) using an arm and to hold and control a commercially available endoscope with camera using the second arm. The design of the surgeon-controlled arms, referred to as the Scope Arm and the Magnet Arm, includes several redundant safety features that make them well suited for use with the MSS in the operating room environment, including hardware and software safety controls.

When mounted on the Scope Arm, an endoscope can be pivoted and translated as controlled by the user, while maintaining minimal motion at the point where the endoscope enters the patient's body via a standard trocar. Similarly, when mounted on the Magnet Arm, the Magnetic Controller can be moved to different positions on or away from the abdominal wall.

The Surgeon Controlled Arm includes the following components:

• (1) Two Carts, which are the Scope Cart and the Magnet Cart. Each Cart includes a surgeoncontrolled arm mounted on top of a moveable cart with custom attachments. One arm functions as a Scope Arm to hold a commercially available endoscope with endoscopic camera. The other arm functions as a Magnet Arm and includes a Magnet Holder to hold the Magnetic Controller of the MSS;
• (2) a Scope Holder for attachment and detachment of a compatible commercially-available endoscope to the end of the Scope Arm:
• (3) a Foot Controller for foot-actuated selection of the active arm and foot-actuated remote control for one of the arms at a time;
• (4) custom-programmed software, the Levita Custom Control Software Program.

The Surgeon Controlled Arm provides for computer control of a dual- arm device with motorized axes to hold and control the movements of a rigid endoscope and the Magnetic Controller of the Levita MSS during the minimally-invasive procedures cleared for the MSS (most recently cleared under K191762). The user selects the active arm and controls its movement using a Foot Controller. Only one arm is enabled for computer-controlled movement at any given time; while one arm is being moved, the other arm remains stationary. The user may also manually move the arms (i.e. hand guiding) at any time without the use of the Foot Controller.

For the Scope Arm, the reference point for scope movement is established as the Trocar Point and is set by the user, who positions the endoscope near the trocar inserted in the body opening (e.g. the abdominal fascial layer) and presses the Teach Trocar button on the Scope Adaptor. The Custom Control Software Program then calculates the required individual movements of the Scope Arm motorized axes relative to the Trocar Point in order to achieve the desired total movement of the endoscope with respect to the endoscope view. Once the Custom Control Software Program completes the Teach Trocar procedure, the Foot Controller is enabled, allowing the user in a standing position by the operating table to direct endoscope movement by using their foot to press on switches corresponding to the allowed movement directions.

For the Magnet Arm, the same arm hardware, software, and Foot Controller are employed to move the Magnetic Controller also in the same directions.

Based on the provided text, the device in question is the "Levita Magnetics Dual Robotic Arm Accessory" (also referred to as "Surgeon Controlled Arm"). The document is a 510(k) summary for FDA clearance. It describes the device, its intended use, comparison to a predicate device, and performance data submitted to demonstrate safety and effectiveness.

Here's an analysis of the acceptance criteria and study information, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific quantitative targets for each test. Instead, it describes various performance tests conducted and generally states that the device "meets functional requirements" or that tests were "performed successfully."

I will infer "acceptance criteria" as the general successful completion of the tests listed, and "reported device performance" as the documented successful outcome of these tests.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • For Simulated Use/Design Validation Testing: "three surgeons who perform laparoscopic surgery, representing the intended user." This implies a sample size of 3 for this specific validation.
  • For Human Factors Testing: "30 testers representing intended users." This specifies a sample size of 30 for human factors validation.
  • For other tests (Electrical Safety, Software V&V, Bench/Mechanical, Cybersecurity, Sterilization), the sample size would typically refer to the number of devices or software units tested, which is not specified but implicitly assumed to be sufficient for regulatory compliance.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's an FDA 510(k) submission, the studies would typically be prospective for validation purposes, conducted by the manufacturer or a contracted lab, likely in the US or a country with comparable regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For Simulated Use/Design Validation Testing: "three surgeons who perform laparoscopic surgery." Their qualification is that they "perform laparoscopic surgery." No specific experience (e.g., years) is mentioned.
• For Human Factors Testing: "30 testers representing intended users." The specific qualifications (e.g., medical professionals, years of experience) beyond "intended users" are not detailed.
• For other tests, ground truth is established via established engineering standards, software testing methodologies, or laboratory validations rather than expert medical consensus.

4. Adjudication Method for the Test Set

The document does not describe any formal "adjudication method" (like 2+1 or 3+1 consensus) for the "test set" in the context of expert review.

• For the Simulated Use/Design Validation Testing with three surgeons, it's implied that their collective assessment determined if the device specifications conformed to intended use and user needs. The document does not specify a disagreement resolution process or voting mechanism for these three surgeons.
• For Human Factors Testing, the assessment of "successful performance" and "no unexpected device-related events" would be based on the outcomes observed during the testing with the 30 participants, likely against predefined pass/fail criteria from a human factors study protocol. No expert adjudication is mentioned here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is more common for diagnostic AI devices where human performance (e.g., radiologists interpreting images) is directly compared with and without AI assistance on a set of cases. The Levita Magnetics Dual Robotic Arm Accessory is a surgical instrument system, not a diagnostic imaging AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone" performance, typically applied to AI algorithms, doesn't directly apply here in the same way. The software (Levita Custom Control Software Program) is an integral part of the robotic arm's control system. Its "performance" is evaluated as part of the overall system's functional and safety testing (e.g., software V&V, latency of arm motion, adherence to safety limits), rather than as a standalone diagnostic algorithm. The device, by its nature, is human-in-the-loop (surgeon-controlled).

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations is based on:

• Engineering Standards and Specifications: For electrical safety, EMC, and most bench/mechanical tests (e.g., strength, durability, velocities, accelerations, latency, range of motion, safety limits). The "ground truth" is compliance with these predefined technical and safety specifications.
• FDA Guidance Documents and Regulatory Standards: For software V&V, cybersecurity, sterilization, and human factors. The "ground truth" is adherence to these regulatory requirements and best practices.
• User Needs and Intended Use: For the simulated use/design validation and human factors testing, the ground truth is whether the device effectively meets user needs and functions as intended in a simulated clinical environment. This is established by observing and evaluating the performance of the device by representative users. There's no "pathology" or "outcomes data" ground truth as this is not a diagnostic device.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data." This is because the device is a hardware-based robotic surgical assist system with integrated control software, not a machine learning or AI algorithm that requires a distinct training phase. The software is custom-programmed, not "trained" in the machine learning sense from a dataset.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the machine learning context, this question is not applicable. The software's functionality is based on its design specifications, algorithms, and logical programming, verified through traditional software engineering V&V processes.

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