(403 days)
The implanted SmartClip® is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
The SmartClip® is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a delivery system. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.
Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm long and 1.25mm wide. The marker is placed into the barrel of the introducer and maintained prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and subsequently be detected by means of radiography (including mammographic imaging, ultrasound and MRI.
Delivery System:
The Delivery System consists of a stylet-lock to prevent accidental deployment and 17ga introducer needle with male luer lock nut. The stainless steel needle is approximately 2.2 cm. The marker is preloaded inside the needle and retained by a bone wax plug. The male luer lock nut provides secure attachment to the proximal end of a biopsy needle. When the stylet is completely depressed the marker and bone wax plug are deployed from the end of the proximal end of the biopsy needle.
The provided text is a K233639 510(k) Summary for the Elucent Medical, Inc. SmartClip Secure Soft Tissue Marker. It details the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study description with performance metrics for how the device meets those criteria.
Here's a breakdown of what is and is not available in the provided text regarding your request:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states that "Tested units met the acceptance criteria as defined in formal verification protocols," but it does not list these criteria or the specific performance results against them.
- Sample sizes used for the test set and the data provenance: Only general types of tests are listed (e.g., Simulated Use, Mechanical Integrity). The specific sample sizes for these tests are not provided, nor is the data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present, as clinical testing was deemed "not applicable" for this submission.
- Adjudication method for the test set: Not applicable, as no human reader studies are described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical tissue marker, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As clinical testing was not applicable, ground truth in the context of diagnostic accuracy is not discussed. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
- The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Information available in the provided text (related but not directly answering the core request about AI performance):
The document focuses on non-clinical testing to demonstrate the safety and effectiveness of the device. It lists the categories of tests performed:
- Simulated Use
- Mechanical Integrity
- Imaging Assessment
- MR Compatibility
- Biocompatibility (ISO 10993-1)
- Packaging (ISO 11607-1)
- Shelf Life
- Sterilization (ISO 11135)
The conclusion states: "SmartClip® Secure Soft Tissue Marker was verified to meet the all the product requirements and specifications. Tested units met the acceptance criteria as defined in formal verification protocols, meeting all requirements."
*In summary, the provided document is a 510(k) summary for a physical medical device (soft tissue marker) and does not contain the detailed information you requested regarding acceptance criteria and study data for AI performance or diagnostic accuracy studies. The submission is based on demonstrating substantial equivalence through non-clinical performance and safety testing against engineering standards.
§ 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.