(110 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 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:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study details or effect size.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- 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.
§ 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.