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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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