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510(k) Data Aggregation
(21 days)
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
This device is a tissue marker, not an AI/ML device, so many of the requested elements pertaining to AI/ML device studies (e.g., test set, training set, ground truth experts, MRMC study, standalone performance) are not applicable or detailed in the provided documents. The provided text outlines a 510(k) summary for a medical device called the "[Trade Name] Preloaded Tissue Marker Device" and its associated FDA clearance letter.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics Equivalence to Predicate Devices | Confirmed equivalent to predicate devices (BiomarC Preloaded Tissue Marker Device K042296 and BiomarC Tissue Marker K063193). |
| Risk Assessment (FMEA) | Performed to assess risks associated with modifications introduced. |
| Biocompatibility | Testing performed and results confirmed substantial equivalence to predicate devices. |
| Sterility | Validation performed and results confirmed substantial equivalence to predicate devices. |
| Distribution Simulation | Testing performed and results confirmed substantial equivalence to predicate devices. |
| Shelf Life | Testing performed and results confirmed substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML device. For this physical medical device, specific sample sizes for each type of testing (biocompatibility, sterility, etc.) are not provided in the summary. Data provenance is implied to be from laboratory and engineering testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device study.
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, an MRMC comparative effectiveness study was not done, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, as this is not an AI/ML device. Performance was evaluated for the device itself through various engineering and scientific tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of medical device, "ground truth" refers to established scientific and engineering standards and tests. The "ground truth" for the acceptance criteria was based on:
- Predicate Device Equivalence: The performance and characteristics of the already cleared predicate devices.
- Standardized Testing: Biocompatibility standards, sterility validation protocols, distribution simulation standards, and shelf life testing protocols.
- Risk Analysis: Failure Modes and Effects Analysis (FMEA).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.
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