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The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

The Mendaera Guidance System is a software-controlled, electromechanical system designed to provide guidance for precise placement of common interventional devices during ultrasound-guided percutaneous procedures. The Mendaera Guidance System is intended to be used in percutaneous procedures with live 2D ultrasound imaging.

The primary components of the Mendaera system are the electromechanical arm ("Robot"), Cart, Drape Kit, and Universal Instrument Guide Kit.

The Robot is a handheld component that attaches to a compatible ultrasound probe and is responsible for establishing and maintaining a deterministic trajectory for the interventional device or needle. The Robot has features that allow for rigid, deterministic coupling between the robot and the probe, and the two are secured together via a locking mechanism.

The Cart includes a touchscreen, a graphical user interface ("GUI") for visualizing the live 2D ultrasound image and overlays, and a computer which runs the Mendaera software.

The Drape Kit contains a sterile drape to act as a barrier between the operator or patient and re-usable components of the system.

The Universal Instrument Guide Kit contains the instrument guide, Universal instrument adapter, and gauge inserts. The Universal instrument adapter enables coupling to interventional instruments ranging from 14G to 25G. The adapter and gauge insert both attach to the instrument guide, which connects to the robot. Movement of the interventional instrument is translated to the robot, and allows for the display of an estimate of the instrument position on the live 2D ultrasound image. Rotational motion of the gauge insert and separation of the instrument adapter enables the instrument guide, robot, and ultrasound probe to be removed while leaving the interventional instrument in place.

The Drape Kit and Universal Instrument Guide Kit are provided in two configurations each:

• Universal Instrument Guide Kits: for compatible instruments in long and short lengths
• Drape Kits: for covering all aspects of the handheld or robot only

The robot and cart are provided non-sterile and are reusable. The contents of the Drape Kit and Universal Instrument Guide Kit are provided sterile and are intended for single-use.

The system is used interoperably with compatible, commercially available ultrasound systems. The system is designed to work in both in-plane (longitudinal) and out-of-plane (transverse) configurations. The list of compatible ultrasound systems and associated probes is:

• EchoNous Kosmos (K212100): Lexsa, Torso-One

The provided FDA 510(k) clearance letter and 510(k) Summary for the Mendaera Guidance System primarily focus on establishing substantial equivalence through non-clinical testing. It does not contain details about acceptance criteria for device performance (e.g., accuracy, precision) in a quantifiable manner, nor does it describe a study specifically designed to prove the device meets such criteria through a comparative clinical effectiveness study or standalone performance study in humans.

The document highlights various non-clinical tests conducted to support substantial equivalence, but it lacks the specific metrics and study designs typically associated with proving quantitative performance against defined acceptance criteria.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will extract the information that is present and indicate where information is missing.

Overview of Device Performance and Supporting Studies

The Mendaera Guidance System underwent a range of non-clinical tests to demonstrate substantial equivalence to its predicate device (Verza Guidance System, K160806). The studies focused on various aspects including biocompatibility, reprocessing/sterilization, EMC and electrical safety, software verification and validation, bench testing, animal testing, and human factors validation. While these studies confirm the device's adherence to safety and fundamental functionality standards, the provided text does not define specific quantitative acceptance criteria for core performance metrics (e.g., accuracy, precision, latency) and associated clinical study results proving the device meets these criteria in a human population.

Missing Information:

• Specific quantifiable acceptance criteria for device performance (e.g., accuracy in mm, latency in ms).
• Reported device performance against these quantifiable criteria.
• Details of a study proving the device meets these specific performance criteria in humans.
• MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
• Standalone (algorithm-only) performance study details.
• Type of ground truth used for performance evaluation (beyond "technical feasibility and safety" in animal models).

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not provide specific quantifiable acceptance criteria or reported performance metrics for the device's guidance capabilities (e.g., accuracy of instrument placement, latency). It generally states that "bench testing verified that the design specifications and customer requirements have been met" and "a live animal study demonstrated that the system can be used safely and effectively."

The document outlines types of testing performed, which imply functional acceptance criteria were used internally, but these are not disclosed as specific quantifiable values in the provided text. For example, "accuracy" is mentioned as a design input requirement for bench testing, but no specific accuracy value is given as an acceptance criterion or reported performance.

2. Sample Size and Data Provenance for Test Set

The document mentions several types of testing but does not clearly delineate "test sets" in the context of human clinical data or imaging datasets used for performance evaluation in the way requested.

• Human Factors Validation Study: Conducted to evaluate usability and critical tasks. No specific sample size (number of users) is provided, nor is the provenance of the "data" (e.g., simulated environment, specific patient population).
• Animal Testing: Performed on a "live model." No specific sample size (number of animals or procedures) is provided.
• Bench Testing: Performed to verify design input requirements (workflow, latency, accuracy, etc.). This typically involves engineering test data rather than patient data.

Sample Size for Test Set: Not specified for any human-relevant performance evaluation.
Data Provenance:
* Human Factors: Implied simulated-use environment, but no geographic or retrospective/prospective details.
* Animal Testing: "live model," but no specific details on animal type, origin, or retrospective/prospective nature.
* Bench Testing: Laboratory environment, engineering data.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the establishment of ground truth by experts for a performance test set, especially in a clinical context.

• Experts Used: Not specified.
• Qualifications of Experts: Not specified.

The closest mention relates to human factors testing, where users (medical professionals) evaluated usability, but this is distinct from establishing ground truth for device performance metrics.

4. Adjudication Method for Test Set

Since there is no clearly described "test set" with expert interpretations requiring adjudication for ground truth, no adjudication method is detailed.

• Adjudication Method: Not applicable/Not specified in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that an MRMC comparative effectiveness study was done to assess how human readers/operators improve with AI vs. without AI assistance. The focus is on the device's capability to provide guidance, not in improving human diagnostic or interventional accuracy through AI assistance compared to unassisted performance.

• MRMC Study Done: No.
• Effect Size of Human Improvement (with AI vs. without AI): Not applicable, as no MRMC study performed per the document.

6. Standalone (Algorithm Only) Performance Study

The Mendaera Guidance System is described as a "software-controlled, electromechanical system" providing physical guidance for instrument placement visualized on ultrasound. It's an active guidance system, not a passive AI algorithm for image analysis or diagnosis. Therefore, a "standalone algorithm only" performance study, as typically understood for AI diagnostic algorithms, is not directly applicable to this type of device in the same way. The software's function is integrated into the electromechanical system to provide the guidance; its "performance" is implicitly tied to the overall system's function.

• Standalone Performance Study Done: Not applicable in the context of an algorithm-only diagnostic output; the software's performance is integral to the entire system's guidance function, which was evaluated via bench and animal testing.

7. Type of Ground Truth Used

The document primarily relies on engineering specifications and "technical feasibility and safety" demonstrated in animal models rather than clinical ground truth obtained from pathology, outcomes data, or expert consensus on patient cases for performance evaluation.

• Type of Ground Truth:
  • Bench Testing: Design input requirements (e.g., workflow, latency, accuracy, ultrasound image display, robot controls, functional safety features) served as the "ground truth" or target for verification. These are engineering specifications.
  • Animal Testing: Demonstrated "technical feasibility and safety" in a live model, implying successful instrument placement and lack of adverse events in animals as the "ground truth" for basic function and safety.

8. Sample Size for Training Set

The document describes the device as a "guidance system" which implies a hardware and software system, not necessarily an AI/ML model that requires a "training set" in the traditional sense of large datasets for model learning (e.g., image recognition). While the software likely was developed using internal data and iterative testing, no "training set" sample size is mentioned.

• Sample Size for Training Set: Not applicable/Not specified as the document does not describe an AI/ML model trained on a data set in the traditional sense for diagnostic or predictive purposes.

9. How Ground Truth for Training Set was Established

Given that a "training set" for an AI/ML model is not described, the method for establishing its ground truth is also not applicable. The software verification and validation would have been against defined design specifications and requirements, as stated.

• How Ground Truth for Training Set was Established: Not applicable/Not specified.

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