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The SmartClip™ Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio™ Navigation System) the SmartClip™ is located and surgically removed with the target tissue. The EnVisio™ Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip™ that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The EnVisio™ Navigation System is a medical device that detects the presence of the SmartClip™ Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClips™ within the surgeon's field of view during the procedure. The EnVisio™ Navigation System will be utilized in an operating room where surgical excision of soft tissue is performed. The EnVisio™ system can detect and provide real-time three-dimensional navigation for up to three separate SmartClips™ each programmed to emit a unique electromagnetic signature. The EnVisio™ Navigation System equipment components are the Console, Heads Up Display, Patient Pad and Foot Pedal. The EnVisio™ Navigation System Navigator and Calibration Disk are sterile, non-patient contacting single use devices which are available separately.

The document provided does not contain a detailed study that proves the device meets specific acceptance criteria with quantifiable metrics such as accuracy, sensitivity, or specificity. Instead, it states that "Performance testing was conducted to evaluate and characterize the performance of the EnVisio Navigation System" and that "The EnVisio Navigation System met all specified criteria and did not raise new safety or performance questions."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance.

Based on the information available in the document:

1. A table of acceptance criteria and the reported device performance
Not explicitly provided with quantifiable metrics in the document. The document states that the system "met all specified criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not provided in the document.

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, as this device (EnVisio Navigation System) is described as an "aid" for non-imaging detection and localization. It is not an AI-assisted diagnostic tool for "human readers." Therefore, no MRMC study comparing human readers with and without AI assistance is mentioned or relevant in the provided text.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a "Navigation System" intended to aid in detection and localization. The description "non-imaging detection and localization (by navigation)" implies human-in-the-loop operation, as it guides a surgeon. There is no mention of a standalone algorithm-only performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.

8. The sample size for the training set
Not provided in the document.

9. How the ground truth for the training set was established
Not provided in the document.

The document focuses on establishing substantial equivalence to a predicate device (Cianna Medical SAVI Scout Reflector and SAVI Scout System K181007) based on indications for use, intended use, technological characteristics, and principles of operation, rather than detailing a specific clinical performance study with statistical endpoints and acceptance criteria for a novel AI or diagnostic system. The performance testing mentioned ("System Design Verification," "Navigation Performance Verification," "Navigation Performance Validation," "EMC/Safety Testing," "Packaging/Shelf Life," "Sterilization Validation") are engineering and regulatory compliance tests, not typically clinical efficacy studies that would report accuracy metrics against a ground truth.

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