(30 days)
The BioZorb LP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
The information provided is a 510(k) premarket notification for the BioZorb LP Marker. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for device performance. Medical devices cleared via 510(k) often rely on non-clinical data (e.g., bench testing) to demonstrate equivalence if their technology and intended use are similar to existing devices.
Based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
The document states that "The modified BioZorb Marker met all specified criteria and did not raise new safety or performance questions" for the listed tests. However, the specific acceptance criteria (e.g., quantitative thresholds for mechanical integrity) are not detailed in this summary. The performance is generally stated as meeting criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Simulated Use | Met all specified criteria |
| Mechanical Integrity | Met all specified criteria |
| Imaging Assessment | Met all specified criteria |
| MR Compatibility | Met all specified criteria |
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. The tests listed (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are typically non-clinical bench or lab tests, not clinical studies involving human patients. Therefore, terms like "test set" in the context of patient data, data provenance, or retrospective/prospective would not apply here.
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 or applicable to the type of testing described. The tests are non-clinical, and thus do not involve expert interpretation of images or other data for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided or applicable. Adjudication methods are typically used in clinical trials involving expert review of patient data, which is not described here.
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 mention of an MRMC study or AI assistance. This device is a physical implantable marker, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility), the "ground truth" would be established by engineering specifications, material properties, and objective measurements during the testing process, not by expert consensus, pathology, or outcomes data in the clinical sense. The specific details of how ground truth was established for each test are not provided.
8. The sample size for the training set
This is not applicable as the device is a physical marker and there is no mention of a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as above.
§ 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.