(49 days)
The MicroMark™ II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
The MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable introducer and applier. The introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier. The MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery MAMMOTOME® Probes which function as standard rigid coaxial introducer needles post biopsy. The Tissue Marker is used with imaging guidance (stereotactic and ultrasound). The stainless steel marker is Magnetic Resonance (MR) safe at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement / dislodgment, or heating.
The provided text describes the MicroMark™ II Tissue Marker, and the FDA's 510(k) clearance process. However, it does not include detailed study information, acceptance criteria, or performance data in the way requested. The document is a 510(k) summary that emphasizes substantial equivalence to a predicate device and mentions "bench testing" for MRI safety without providing specifics on the study design, sample sizes, or outcome metrics.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | MRI Safety: Device is "Magnetic Resonance (MR) safe at 3.0 Tesla field strength or less." "The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement / dislodgment, or heating." |
| General functionality for marking biopsy sites (implied by indications for use) | No specific performance metrics are provided (e.g., marker retention rate, visibility, migration rate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Bench testing."
- Data Provenance: Not specified, but generally, bench testing for device clearance would be conducted by the manufacturer (Ethicon Endo-Surgery, Inc.) in a controlled lab environment. This would be considered prospective for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "bench testing" described relates to MRI safety, not a clinical study requiring expert ground truth for interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing described is bench testing, not a clinical trial with independent review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No. The document describes "Bench testing" for MRI safety, not a clinical comparative effectiveness study involving human readers.
- Effect Size of AI vs. without AI assistance: Not applicable, as this is not an AI-driven device and no MRMC study was conducted.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Was a standalone study done? Not applicable in the context of an algorithm. The device itself (the marker) is the product being evaluated for its standalone physical properties (MRI safety). The bench testing performed for MRI safety could be considered a form of standalone performance evaluation for the device's physical attributes, but it's not "algorithm only" as the device has no algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: For the MRI safety testing, the "ground truth" would be established by scientific principles and validated measurement techniques for magnetic field interactions, movement, dislodgment, and heating in standardized phantom or test setups. This is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical tissue marker, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this type of 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.