(264 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 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:
| Acceptance Criteria (Related to the change) | Reported Device Performance |
|---|---|
| Safety and effectiveness with increased MOLLI Marker implant duration (greater than 30 days). | Biocompatibility testing demonstrated the safety of the MOLLI Marker for extended implant duration. The device does not raise new issues of safety or effectiveness compared to the predicate device. |
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.
§ 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.