(118 days)
The Cianna Medical Permanent Tissue Marker is intended to mark tissue during a percutaneous breast biopsy procedure and be permanently visible by radiography and visible for up to thirty days by ultrasound.
The Cianna Medical Permanent Tissue Marker and Delivery System consists of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) within the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging. The Cianna Medical Permanent Tissue Marker and Delivery System is provided sterile, and is for single use only.
The provided text describes the non-clinical performance evaluation of the Cianna Medical Permanent Tissue Marker and Delivery System, focusing on biocompatibility. It explicitly states that no clinical data was used to determine substantial equivalence. Therefore, there is no information about acceptance criteria for device performance in a clinical setting, nor any study proving the device meets such criteria.
However, I can provide the acceptance criteria and results for the non-clinical performance data as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test Performed | Acceptance Criteria (Standard) | Reported Device Performance (Test Result/Conclusion) |
|---|---|---|
| ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells | ISO 10993-5 | Passed. Non-cytotoxic |
| ISO Intracutaneous Reactivity Test | ISO 10993-10 | Passed. The test requirements were met |
| Sensitization: Guinea Pig Maximization | ISO 10993-10 | Passed. Negative for evidence of sensitization |
| ISO Acute Systemic Injection Test | ISO 10993-11 | Passed. The test requirements were met |
| Material Mediated Rabbit Pyrogen Test | ISO 10993-10 | Passed. Non-Pyrogenic |
| Bacterial Mutagenicity Test-Ames Assay | ISO 10993-3 | Passed. Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | ISO 10993-3 | Passed. Non-Mutagenic (non-genotoxic and non-clastogenic) |
| In Vivo Mouse Micronucleus Assay | ISO10993-3 | Passed. Non-Mutagenic |
| 30 Day Rabbit Implantation with Subchronic Toxicity | ISO 10993-6, ISO10993-11 | Passed. No local or systemic signs of toxicity |
| 13 Week Rabbit Implantation with Subchronic Toxicity | ISO 10993-6, ISO10993-11 | Passed. No local or systemic signs of toxicity |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes non-clinical, in-vitro, and in-vivo animal (mouse, guinea pig, rabbit) tests for biocompatibility, not human clinical test sets. The sample sizes for each specific biocompatibility test are not detailed in this summary.
- Data Provenance: Not specified, but given the nature of the tests (ISO standards), these are laboratory-based studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth typically refers to clinical or pathological assessment in human studies. For these non-clinical tests, the "ground truth" is established by adherence to the specified ISO standards and validated laboratory methodologies, performed by qualified laboratory personnel.
4. Adjudication method for the test set:
- Not applicable. These are not studies requiring adjudication by multiple experts in the sense of clinical image review. The results are based on standardized laboratory protocols and interpretations.
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. The document explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices." This is not an AI-assisted device, nor does it involve human readers interpreting images in a clinical setting.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (tissue marker), not an algorithm or AI system.
7. The type of ground truth used:
- Non-Clinical Biocompatibility Standards: The "ground truth" for the non-clinical tests is based on the established safety thresholds and methodologies defined by the specific ISO 10993 series standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation and sensitization, ISO 10993-11 for systemic toxicity, ISO 10993-3 for genotoxicity, and ISO 10993-6 for local effects after implantation). These standards provide the basis for evaluating material safety.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
§ 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.