(304 days)
The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
The EasyMark Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker.
The provided text describes the 510(k) premarket notification for the EasyMark Tissue Marker. It details the device, its indications for use, and a comparison to predicate and reference devices. However, it does not contain specific acceptance criteria or the study results proving the device meets those criteria, nor does it include information about a standalone study, MRMC study, sample sizes, ground truth establishment, or expert details for such studies.
Based on the information provided, here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists the types of non-clinical tests performed but does not state the specific acceptance criteria for each test or the quantitative results from those tests.
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 as the document only states "non-clinical testing and evaluation was conducted." It doesn't detail specific sample sizes for any of the performance tests.
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 as the document does not describe any studies involving human experts or ground truth establishment in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no studies involving human interpretation or adjudication are described.
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
This information is not provided. The EasyMark Tissue Marker is a physical implantable device, not an AI software. Therefore, an MRMC study with human readers improving with AI assistance would not be relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical tissue marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document describes performance testing, but not the specific methods used to establish ground truth for metrics like "Accuracy of Marker Deployment." It likely refers to objective measurements against predefined specifications.
8. The sample size for the training set
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.
Summary of Provided Information (within the scope of the document):
Device Name: EasyMark Tissue Marker
Intended Use: To attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
Non-clinical Testing and Evaluation Performed to demonstrate substantial equivalence to the predicate device:
- Performance Testing Bench:
- Accuracy of Marker Deployment
- Marker Deployment Force
- Usability of the Device
- Imaging Assessment (X-ray and MRI)
- Safety and Compatibility in Magnetic Resonance (MR) Environment
- Tissue Marker Migration Potential
- Delivery Device Cannula Tensile Test
- Delivery Device Push Rod Tensile Test
- Biocompatibility
- Sterilization
- Packaging
- Shelf Life
Predicate Device: UltraClip® Tissue Marker, K993785
Reference Device (for biocompatibility of delivery device): SelectCore, K093256
Conclusion: The non-clinical testing and evaluation demonstrated that the EasyMark Tissue Marker "does not raise new concerns of safety or effectiveness and is substantially equivalent to the predicate device."
Disclaimer: The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not typically include detailed acceptance criteria or study results in the format requested, especially since the device is a physical marker and not an AI or diagnostic software tool.
§ 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.