(148 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 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.
§ 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.