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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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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 2 Wand and MOLLI 2 Tablet constitute the MOLLI 2 system. The MOLLI 2 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 provided text is a 510(k) summary for the MOLLI 2 device. It describes modifications to an already cleared device and the testing performed to demonstrate substantial equivalence. However, it does not contain the specific detailed information for acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you requested.

The document states that updates to the MOLLI Introducer and the user guide were made, and non-clinical testing was performed to address these changes. This testing included "Biocompatibility testing to demonstrate safety of MOLLI Introducer" and "Bench testing to demonstrate effectiveness of MOLLI Introducer." It also mentions "Justification for updating cardiac device contraindication to a warning."

Here's what can be extracted based on the lack of information about a clinical study demonstrating performance against acceptance criteria for the entire system for specific clinical outcomes:

1. Table of acceptance criteria and reported device performance:
* Not explicitly provided. The document focuses on demonstrating safety and effectiveness for minor modifications (siliconized needle, updated contraindication to warning) through non-clinical testing. It does not present a table of measurable acceptance criteria for the overall device performance in a clinical context (e.g., accuracy of lesion localization) and corresponding performance metrics from a study.

2. Sample size used for the test set and data provenance:
* Not applicable / Not provided for an effectiveness study. The document refers to "Biocompatibility testing" and "Bench testing" for the MOLLI Introducer and a "Justification for updating cardiac device contraindication to a warning." These are not typically described with "test sets" in the context of clinical performance data provenance. There is no mention of a human subject test set or data provenance (country of origin, retrospective/prospective) for clinical performance.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable / Not provided. Since there's no mention of a clinical test set or a study involving human subjects to establish clinical performance, there's no information on experts establishing ground truth for such a study.

4. Adjudication method for the test set:
* Not applicable / Not provided. As no clinical test set for overall device performance is discussed, an adjudication method is irrelevant in this context.

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:
* No, it was not. This document describes a surgical marking and guidance system. It does not appear to involve AI or a multi-reader multi-case comparative effectiveness study in the context of diagnostic interpretation or AI assistance. The "MOLLI 2 System" is described as for "non-imaging detection of the MOLLI Marker."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. The MOLLI 2 System is a medical device for surgical guidance, not an AI algorithm performing a diagnostic task in a standalone manner. Its function is to assist in localizing a marker.

7. The type of ground truth used:
* Not applicable / Not provided for clinical performance. For the non-clinical tests mentioned, the "ground truth" would be established by the testing standards and specifications (e.g., for biocompatibility, the reference standards for cytotoxicity, irritation, sensitization; for bench testing, engineering specifications for force, stiffness, etc.). There is no mention of clinical ground truth (e.g., pathology, outcomes data) as part of this submission for evaluating clinical device performance.

8. The sample size for the training set:
* Not applicable. The device described is a physical medical device (marker, introducer, wand, tablet) for surgical guidance, not a machine learning or AI model that requires a training set of data.

9. How the ground truth for the training set was established:
* Not applicable. As above, this is not an AI/ML device requiring a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating that minor modifications to an already cleared device do not raise new safety or effectiveness concerns, primarily through non-clinical (bench and biocompatibility) testing and justification. It does not present data from a clinical study evaluating the device's performance against specific clinical acceptance criteria, nor does it involve AI or large datasets for training and testing as one might find in an AI/ML medical device submission.

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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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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 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 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.

MOLLI is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand), and a visualization tablet (MOLLI Tablet). The MOLLI Marker is preloaded in the MOLLI Introducer. The MOLLI Wand and the MOLLI Tablet constitute the MOLLI 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.

This document is a 510(k) premarket notification from the FDA, and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about a clinical study involving human subjects to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical context (e.g., sample size, expert ground truth, MRMC study, effect size of human reader improvement with AI, standalone performance, training set details).

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information NOT available in the document (and why):

• Acceptance Criteria Table with Reported Performance: This document describes non-clinical bench testing and safety standards, not clinical performance metrics with pre-defined acceptance criteria.
• Sample size used for the test set and data provenance: No clinical test set involving device performance on human subjects is described. The "test set" mentioned in this context refers to non-clinical bench testing.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: There is no clinical data from human subjects requiring expert ground truth for performance evaluation.
• Adjudication method for the test set: Not applicable as there's no clinical test set requiring adjudication.
• 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: This is a non-AI device (an implantable marker and detection system), and no clinical MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this device type.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance as no clinical study is described. Ground truth for non-clinical tests would be established by physical measurements and engineering specifications.
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

What the document does describe (relevant to your prompt but not directly answering all parts):

The document focuses on non-clinical testing to demonstrate the device's safety and effectiveness compared to predicate devices. This includes:

• Summary of Non-Clinical Testing:
  • Biocompatibility testing per ISO 10993-1
  • Packaging validation testing per ISO 11607-1 and ASTM D4169-19
  • EO sterilization validation per ISO 14937 and ISO 10993-7
  • Software testing per IEC 62304
  • Electrical safety testing per IEC 60601-1
  • EMC testing per IEC 60601-1-2:2014
  • MRI compatibility testing per ASTM standards F2052-15, F2119-07, F2182-11, and F2213-17.
  • Non-clinical performance bench testing including V&V testing, MOLLI Marker displacement testing, tissue performance testing, and needle penetration testing (per ISO 7864)
  • Human factor validation testing

The document concludes that "Based on the testing performed... it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device." This is the core of a 510(k) submission: demonstrating substantial equivalence, often without the need for large-scale clinical trials if non-clinical data is sufficient to address safety and effectiveness concerns.

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