(133 days)
The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
These implanted markers are used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The markers are fabricated of biocompatible materials. Specifically, gold (99.99%), medical grade titanium or PEEK Optima (polymer) with a medical grade stainless steel core.
They are available in varying lengths and have a diameter of 1.0 MM (+/- 0.2 MM)
They are intended for single use and are permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
This document is a 510(k) summary for the Mixed Media Marker (MMM) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as one might find for a novel device. Therefore, much of the requested information regarding a formal study with acceptance criteria is not present in this document.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative acceptance criteria for image-based performance, nor does it present a tabular comparison of such criteria against measured performance. Instead, it relies on a qualitative statement of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visibility in typical medical imaging devices (X-ray, CT, MRI, etc.) | "These markers have been imaged using the typical medical imaging devices and they are visible in all of the modalities required." |
| No adverse effect on safety or effectiveness due to material change. | "Sufficient testing has been performed to show that the change in materials did not adversely affect the safety or effectiveness of the new device." |
| Imaging characteristics similar to predicate devices. | "The new markers image in the same fashion as the predicate devices thus met the rules governing substantial equivalence." |
| Not intended for use with ultrasonography. | "MMM's not intended for use with ultrasonography." (This is a limitation, not a performance criterion, but is mentioned in relation to imaging.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No details on the sample size of markers tested, the type of data (e.g., in vivo, ex vivo, phantom studies), or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. No ground truth establishment process by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned.
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
There is no MRMC study mentioned, nor is there any AI component to this device. This document describes an implanted physical marker, not an AI-driven medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical marker; there is no algorithm or software component described that would have a standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The document mainly focuses on demonstrating substantial equivalence through material changes and qualitative statements about visibility. There's no mention of a formal "ground truth" used for performance evaluation beyond general imaging visibility.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical implanted marker and does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
§ 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.