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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.

MOLLI 2 is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI 2 consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand 2), and a visualization tablet (MOLLI Tablet 2). The MOLLI Wand 2 and MOLLI Tablet 2 constitute the MOLLI 2 System. The MOLLI 2 System is intended for the nonimaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The provided text is a 510(k) Summary for the MOLLI 2 device. It details the device, its intended use, and a comparison to a predicate device (MOLLI, K210600). The primary purpose of this submission is to introduce minor changes to the previously cleared MOLLI device, specifically:

• Addition of a new needle length for the MOLLI Introducer.
• Hardware and software updates to the guidance system components (MOLLI Wand 2, MOLLI Tablet 2).

The document does not contain information related to acceptance criteria for an AI/algorithm-driven device's performance, nor does it describe a study to prove the device meets such criteria. The MOLLI 2 System is described as a "non-imaging detection" system for a marker, implying a physical detection mechanism rather than an algorithmic analysis of images.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical bench testing, sterilization validation, and electrical/software safety testing to address the minor hardware and software updates. It states: "These changes have undergone testing to ensure the device is as safe and effective as the predicate device," and "The results of these tests indicate that MOLLI 2 is substantially equivalent to the predicate device."

Specifically, the non-clinical testing performed includes:

• EO sterilization validation per ISO 14937 and ISO 10993-7
• Software testing per IEC 62304
• Electrical safety testing per IEC 60601-1 and IEC 60601-1-6
• EMC testing per IEC 60601-1-2
• Non-clinical performance bench testing

These are standard engineering and safety tests, not clinical performance studies for an AI/algorithm.

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