(91 days)
The ClipLoc™ Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.
It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.
The ClipLoc Soft Tissue Marker is a sterile, single patient use device comprised of a small nickeltitanium marker (clip), a well as a disposable introducer and applier. The introducer is a coaxial cannula with a beveled tip and a molded hub. The ClipLoc is preloaded near the distal end of the cannula. The applier is a stylette with a cap. A plastic safety connector holds the applier and introducer needle in the appropriate position ("Ready") and helps prevent premature deployment of the marker. After removal of the safety connector, the ClipLoc is deployed by manually advancing the needle.
The ClipLoc may be used with either visual or imaging guidance (such as ultrasound, X-Ray, stereotaxy, or Magnetic Resonance). It may be used directly, or applied through another coaxial needle or guide associated with percutaneous biopsy. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating.
Here's a summary of the acceptance criteria and the study details for the ClipLoc Soft Tissue Marker, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radiographic Visualization | Device should be radiographically visible across various imaging modalities. | Satisfactory radiographic visualization of the deployed ClipLoc was achieved using X-Ray, Ultrasound, and Magnetic Resonance (up to and including 3.0 Tesla). |
| MR Safety and Compatibility (1.5 Tesla) | Device must perform as indicated and be safe and compatible in magnetic fields up to and including 1.5 Tesla. | The device performs as indicated in magnetic fields up to and including 1.5 Tesla. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength. |
| MR Safety and Compatibility (3.0 Tesla) | Device marker, when present, should not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating during an MR exam at 3.0 Tesla or less. | The ClipLoc Marker is MR safe and compatible up to and including 3.0 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating. |
| Material Compatibility & Functional Equivalence | Device should use implant-grade materials and have similar technological characteristics and components to predicate devices to perform its intended functions. | The ClipLoc Soft Tissue Marker is made of implant grade materials and has similar technological characteristics as the predicate devices. The proposed and predicate devices contain the same primary components to achieve these functions. The patient contact components and component materials for positioning the tissue marker in both the new and predicate devices are equivalent. The materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent. |
Study Details:
The provided document describes a premarket notification (510(k)) for the ClipLoc Soft Tissue Marker. The "study" referenced in the document is a preclinical testing phase to confirm the device performs as intended.
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Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of human subjects or a dataset. The performance data presented refers to preclinical testing. Therefore, information on sample size and data provenance in this context (e.g., country of origin, retrospective/prospective) is not applicable or provided. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the performance data is from preclinical testing, not a study involving human interpretation or ground truth establishment by experts in the typical clinical study sense. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as the performance data is from preclinical testing and does not involve a "test set" requiring adjudication. -
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. This device is a physical medical device (tissue marker), not an AI-powered diagnostic or assistive tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "satisfactory radiographic visualization," the "ground truth" would be the direct observation and assessment of the marker's visibility by the engineers/technicians performing the preclinical tests using the specified imaging modalities (X-Ray, Ultrasound, MR). For MR safety and compatibility, the "ground truth" would be the physical measurements and observations of the device's behavior in MR environments according to established standards. -
The sample size for the training set:
Not applicable. This is a physical medical device, and the "performance data" refers to preclinical testing and material characteristics, not machine learning model training. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.
§ 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.