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The implanted SmartClip® is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The SmartClip® is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a delivery system. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.

Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm long and 1.25mm wide. The marker is placed into the barrel of the introducer and maintained prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and subsequently be detected by means of radiography (including mammographic imaging, ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet-lock to prevent accidental deployment and 17ga introducer needle with male luer lock nut. The stainless steel needle is approximately 2.2 cm. The marker is preloaded inside the needle and retained by a bone wax plug. The male luer lock nut provides secure attachment to the proximal end of a biopsy needle. When the stylet is completely depressed the marker and bone wax plug are deployed from the end of the proximal end of the biopsy needle.

The provided text is a K233639 510(k) Summary for the Elucent Medical, Inc. SmartClip Secure Soft Tissue Marker. It details the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study description with performance metrics for how the device meets those criteria.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states that "Tested units met the acceptance criteria as defined in formal verification protocols," but it does not list these criteria or the specific performance results against them.
• Sample sizes used for the test set and the data provenance: Only general types of tests are listed (e.g., Simulated Use, Mechanical Integrity). The specific sample sizes for these tests are not provided, nor is the data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present, as clinical testing was deemed "not applicable" for this submission.
• Adjudication method for the test set: Not applicable, as no human reader studies are described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical tissue marker, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As clinical testing was not applicable, ground truth in the context of diagnostic accuracy is not discussed. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
• The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

Information available in the provided text (related but not directly answering the core request about AI performance):

The document focuses on non-clinical testing to demonstrate the safety and effectiveness of the device. It lists the categories of tests performed:

• Simulated Use
• Mechanical Integrity
• Imaging Assessment
• MR Compatibility
• Biocompatibility (ISO 10993-1)
• Packaging (ISO 11607-1)
• Shelf Life
• Sterilization (ISO 11135)

The conclusion states: "SmartClip® Secure Soft Tissue Marker was verified to meet the all the product requirements and specifications. Tested units met the acceptance criteria as defined in formal verification protocols, meeting all requirements."

*In summary, the provided document is a 510(k) summary for a physical medical device (soft tissue marker) and does not contain the detailed information you requested regarding acceptance criteria and study data for AI performance or diagnostic accuracy studies. The submission is based on demonstrating substantial equivalence through non-clinical performance and safety testing against engineering standards.

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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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The implanted SmartClip™ is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The SmartClip™ is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a Delivery System. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.

Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm wide. The marker is placed into the barrel of the introducer and maintained in place prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and breast) and subsequently be detected by means of radiography (including mammographic imaging), ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet, a stylet-lock to prevent and 15ga introducer needle. The stainless steel needle is approximately 10.8 cm long with 1cm depth reference marks. The marker is preloaded inside the needle and retained by a bone wax plug. When the stylet is completely depressed the marker and bone wax plug, are deployed from the end of the needle.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not include specific acceptance criteria with quantifiable metrics for the SmartClip™ Soft Tissue Marker alongside reported device performance data, nor does it detail a specific study with the characteristics you requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria. While it mentions "Performance Testing," it lists the types of tests conducted (e.g., Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization) but does not provide the concrete results, statistical analyses, or the detailed parameters of these tests.

Based on the provided text, I can extract the following information, but cannot fully populate the requested table or answer all questions due to the lack of specific performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for any of the performance tests (e.g., simulated use, mechanical integrity, imaging assessment). The data provenance is also not detailed (e.g., country of origin, retrospective/prospective). The emphasis is on types of tests performed rather than the experimental design or results.

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

This information is not provided in the document. The tests described (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are primarily bench-top or in vitro tests and physical characterizations, which generally do not require expert adjudication in the way clinical diagnostic studies might. For "Imaging Assessment," while expert interpretation would be involved, the text doesn't detail a specific study with expert readers.

4. Adjudication Method for the Test Set

As the document primarily discusses engineering and material tests, a formal "adjudication method" (like 2+1 or 3+1 for clinical image interpretation) is not applicable or mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not mentioned or indicated in this submission. This device is a passive tissue marker, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable as the SmartClip™ is a physical medical device (a tissue marker) and not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Mechanical Integrity/Simulated Use: Ground truth would be based on engineering specifications and acceptable performance parameters.
• Imaging Assessment: Ground truth would be the presence of the marker and its visibility under various imaging modalities, likely assessed visually by imaging professionals or engineers against expected image characteristics.
• MR Compatibility: Ground truth established through adherence to recognized MR safety standards and testing protocols (e.g., heating, artifact assessment).
• Biocompatibility: Ground truth established through in vitro and/or in vivo studies following ISO 10993 standards. The document states it "Passed."

8. The Sample Size for the Training Set

This is not applicable as the SmartClip™ is not a machine learning or AI device that requires a training set.

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

This is not applicable as the SmartClip™ is not a machine learning or AI device.

In summary: The provided 510(k) summary for the SmartClip™ Soft Tissue Marker focuses on demonstrating substantial equivalence through a comparison of "Indications for Use," "Technological and Performance Characteristics," and listing the types of performance tests conducted (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization). It explicitly states that "The SmartClip™ met all specified criteria and did not raise new safety or performance questions." However, it does not provide detailed quantitative acceptance criteria or the specific results and statistical data from these performance tests.

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