(28 days)
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
The SecurMark Biopsy Site Marking System is intended for use with the manual method of deployment. It can be visualized under various imaging modalities such as ultrasound, x-ray, magnetic resonance, direct visualization, and others. This system is intended for single patient use only.
The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and deployment device.
The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the deployment device.
The provided text is a 510(k) summary for the SecurMark Biopsy Site Marking System. It details the device, its indications for use, and a comparison to predicate devices. However, explicit acceptance criteria and a description of a study proving the device meets these criteria are not detailed in the provided text.
The section titled "Non-Clinical Evaluation" generally states that tests were performed and that "The devices met or exceeded the acceptance criteria for all evaluations." but it does not specify what those acceptance criteria were, what the reported device performance was against those criteria, or the methodology of the study.
Therefore, I cannot populate most of the requested table and information as it is not present in the provided text.
Here is what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met or exceeded criteria for all evaluations (simulation, shelf life, tensile testing, functionality at specified temperatures, MRI compatibility and artifacts, X-ray distinctive visualization, calcification distinguishability, sterilization, biocompatibility, tolerance analyses, and viscosity and moisture). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (likely from the manufacturer's internal testing, no country of origin is mentioned, retrospectivity/prospectivity not 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)
- Not specified. The evaluation appears to be non-clinical (device performance tests) rather than reader studies involving human observers and ground truth from experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the evaluations are non-clinical device performance tests.
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 MRMC or comparative effectiveness study is described. The device is a physical marker system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as the device is a physical marker system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the human sense. For the non-clinical tests, the "ground truth" would be engineering and material science standards/specifications.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
§ 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.