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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.

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 nonimaging 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 and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

This FDA 510(k) summary focuses on design modifications to an existing device, the MOLLI 2 System, specifically introducing new MOLLI Wand configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite) and corresponding software/hardware updates. As such, the submission primarily relies on non-clinical testing to demonstrate substantial equivalence, rather than a full de novo clinical study with detailed performance outcomes like sensitivity and specificity.

Therefore, many of the requested detailed points regarding acceptance criteria, study design for performance metrics like sensitivity/specificity, expert consensus, and effects on human reader performance are not explicitly available or described in this type of submission. The provided text outlines what non-clinical tests were conducted to support the changes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Performance Testing including Multi Marker Localization System Accuracy, Wand Essential Performance (Accuracy and Feedback) and Multi Tissue Accuracy Testing" was performed. However, it does not provide specific acceptance criteria values (e.g., "accuracy must be > 95%") nor the reported numerical performance values. It only concludes that "The results of these reports indicate that the subject device is substantially equivalent to the predicate device."

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

Not specified in the provided text. The testing was non-clinical (laboratory/benchtop) rather than human subject testing, so "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense of clinical trials.

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

Not applicable/specified. For non-clinical performance testing, the ground truth would typically be established by calibrated instruments or predefined scenarios, not human experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human readers interpret data, not for non-clinical device performance testing.

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

No, a MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing for design changes.

6. Standalone (Algorithm Only) Performance

The "MOLLI 2 System" is a device that includes hardware (wands, tablet) and software. The performance testing described (Multi Marker Localization System Accuracy, Wand Essential Performance, Multi Tissue Accuracy) would be considered standalone performance of the device's ability to detect and localize markers, without a human "interpretation" component in the clinical sense. However, the exact metrics and results are not provided.

7. Type of Ground Truth Used

For the non-clinical performance testing, the ground truth would typically be established through:

• Engineering specifications / Known values: For accuracy tests, the true position or characteristics of the marker would be precisely known or set.
• Calibrated measurement tools: Instruments used to measure the output of the device would be calibrated to provide true values.
• Controlled experimental setups: Scenarios designed to simulate real-world use with known parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) for device modifications, not an AI/ML algorithm development submission requiring a "training set" in the machine learning sense. The software modifications are to support communication and compatibility with new hardware, implying changes to control logic rather than a learning algorithm.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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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 be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

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

The MOLLI 2 System's acceptance criteria and the study proving it meets these criteria are described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes non-clinical testing, specifically "Biocompatibility testing." It does not provide details about a "test set" in the context of human data or clinical study for device performance evaluation. Hence, there's no information on sample size for a test set or data provenance (e.g., country of origin, retrospective or prospective) for such a study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study mentioned is non-clinical biocompatibility testing, not a study requiring expert readers to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is described.

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

No, an MRMC comparative effectiveness study was not reported. The information provided focuses on non-clinical testing related to extending the implant duration of the MOLLI Marker.

6. If a Standalone Performance Study Was Done:

The document describes "Biocompatibility testing" as part of non-clinical testing to demonstrate safety. This can be considered a standalone assessment of certain aspects of the device (specifically, the MOLLI Marker's biocompatibility for extended use). It's not a standalone performance study in the sense of evaluating the accuracy or effectiveness of the MOLLI Systems for detection and localization of the marker, but rather the safety of the marker itself.

7. The Type of Ground Truth Used:

For the biocompatibility testing, the "ground truth" would be established by standardized scientific methods and tests for assessing biological response to materials, as defined in international standards (e.g., ISO 10993 series). This would involve laboratory analyses and observations according to established protocols, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.

8. The Sample Size for the Training Set:

Not applicable. The document describes non-clinical biocompatibility testing and does not mention a training set, which is typically associated with machine learning or AI model development.

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

Not applicable, as no training set is mentioned in the context of the described testing.

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