(32 days)
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it a 510(k) summary for the BiomarC Tissue Marker, which focuses on establishing substantial equivalence to a predicate device through technological characteristics and bench testing.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: Equivalent to predicate device (BiomarC K042296, Promex K023450) | "The technological characteristics are equivalent to the predicate device." |
| Safety: Tested to be safe | "Bench testing has demonstrated that the device is safe..." |
| Effectiveness: Tested to be effective | "Bench testing has demonstrated... effective..." |
| Performance: Substantially equivalent to predicate device | "...its performance is substantially equivalent to the predicate device." |
| Radiographic Visibility: Clearly visible on standard radiographs | "clearly visible on standard radiographs..." |
| MRI Compatibility: Clearly visible on MRI | "...as well as Magnetic Resonance Imaging (MRI)..." |
| Ultrasound Visibility: Clearly visible on ultrasound | "...and ultrasound." |
| Sterility: Device is sterile | "BiomarC is a sterile..." |
| Nonpyrogenicity: Device is nonpyrogenic | "...nonpyrogenic..." |
| Single Use: Device is for single use | "...single use tissue marker..." |
| Composition: Nonabsorbable pyrolytic carbon coated zirconium oxide marker | Description of material provided. |
Missing from the text: Specific quantitative or qualitative metrics for what constitutes "equivalent," "safe," "effective," or "substantially equivalent." For instance, there are no reported signal-to-noise ratios for visibility, specific biocompatibility test results, or detailed performance benchmarks. The statement relies on an overarching claim of equivalence to predicates.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "bench testing" but does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). Bench testing typically involves laboratory-based assessments of materials and functional properties, rather than human subject data sets that would have provenance details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable/Not mentioned. The document refers to "bench testing," which does not typically involve human expert ground truth establishment in the way clinical studies or image-based AI evaluations would. The assessment revolves around engineering and material properties, compared to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable/Not mentioned. Similar to point 3, bench testing does not involve adjudication methods like 2+1 or 3+1 typically used for clinical trial data or image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document focuses on bench testing and substantial equivalence to a predicate device based on technological characteristics. It does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
Not applicable. The BiomarC Tissue Marker is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's inherent function is what is being assessed.
7. The Type of Ground Truth Used:
For this device, the "ground truth" for the bench testing would likely be based on engineering specifications, material science standards, and established performance characteristics of the predicate devices. For example, "radiographic visibility" would be determined by whether the marker appears clearly on an X-ray image according to defined imaging parameters, or "sterility" confirmed by adherence to established sterilization validation protocols. It is not an "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set:
Not applicable. As the BiomarC Tissue Marker is a physical device and not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this device.
Summary of What the Document Provides:
The document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on:
- Comparison of technological characteristics to predicate devices.
- "Bench testing" to demonstrate safety, effectiveness, and performance equivalency.
- Basic functional descriptions (visibility on imaging modalities, sterility, nonpyrogenicity).
What is Lacking for an AI/Software Device Evaluation:
The provided text is entirely unsuitable for answering these questions in the context of an AI or software device. It illustrates a different type of medical device submission (a physical implantable marker) where the criteria for evaluation, "ground truth," and study types are fundamentally different from those applicable to AI/ML devices. Therefore, most of the requested fields are "Not applicable" or "Not mentioned" because they pertain to AI/ML specific evaluations.
§ 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.