(238 days)
The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
KMD-Markl Tissue Marker is a sterile, single patient use, polymeric discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). KMD-Mark1 Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
The provided text describes a 510(k) premarket notification for the KMD-Mark1 Tissue Marker. It details the device's indications for use, description, and predicate devices. Here's an analysis of the acceptance criteria and the study as requested, based solely on the provided text:
No specific acceptance criteria or an explicit "study" proving the device meets those criteria are detailed in the provided input. The document primarily outlines the regulatory submission process and the general types of preclinical testing performed.
However, based on the information provided, we can infer the broad categories of "acceptance criteria" through the performance standards and the nature of the device.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets are not provided in the text, this table will be based on the general "Performance Standards" mentioned. The "reported device performance" is also generalized as specific results are not detailed.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary from text) |
|---|---|
| Sterilization Validation | Verified and validated per ISO 11135. |
| Biocompatibility | Tested per ISO 10993-1. |
| MRI Safety | Tested per F119, F2182, and F2034. |
| Radiographic Visualization | Verified and validated for visibility on standard radiographs (x-ray, mammography), ultrasound, and MRI. |
The following information (points 2-9) cannot be extracted from the provided text, as the document focuses on regulatory submission details and general testing categories, not the specifics of individual study designs or results.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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: Not mentioned. This device is a passive tissue marker, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and not applicable for this device type.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a tissue marker, "ground truth" would likely relate to its physical properties and visibility, rather than a diagnostic accuracy.
8. The sample size for the training set: Not mentioned. (Not applicable for this type of device as it's not a machine learning model).
9. How the ground truth for the training set was established: Not mentioned. (Not applicable for this type of device as it's not a machine learning model).
§ 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.