(46 days)
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.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.