(16 days)
The UltraClip II US Wing and Coil are intended 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 UltraClip II US Wing and Coil are sterile, single use devices comprised of a disposable introducer needle and an implantable metal tissue marker with a polymer insert composed of polyvinyl alcohol (PVA). The device is designed to attach the marker to soft breast tissue at the surgical site during an open surgical breast at biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
The provided text is a 510(k) summary for the UltraClip II US Wing and Coil. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would be needed to fill out most of the requested table.
The submission is a declaration of substantial equivalence based on the technological characteristics being identical to the predicate device and the new device meeting "predetermined acceptance criteria of the design verification and validation testing performed under design controls." It does not provide the specifics of those criteria or the results of the performance testing.
Therefore, for aspects requiring specific study details, sample sizes, expert qualifications, and detailed performance metrics, the information is not available in the provided document.
Here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | "All predetermined acceptance criteria of the design verification and validation testing performed under design controls." | "The UltraClip II US Wing and Coil met all predetermined acceptance criteria..." |
| Technological Characteristics | Identical to the predicate device (UltraClip II Wing and Coil, K063238) in terms of intended use, indications for use, target population, fundamental scientific technology, operating principle, method of sterilization, packaging configuration, sterility assurance level, and performance characteristics. | "The technological characteristics of the subject device are identical to those of the predicate device..." |
| Specific Performance Metrics | Not detailed in document | Not detailed in document |
| Clinical Performance Metrics | Not detailed in document | Not detailed in document |
Study Details
| Information Point | Response |
|---|---|
| 1. Sample size for test set | Not specified. The document refers to "design verification and validation testing" but does not provide details on sample sizes for any specific test sets. |
| 1. Data provenance (e.g., country, retrospective/prospective) | Not specified. The document does not describe the nature, origin, or type of data collected for the design verification and validation. |
| 2. Number of experts for ground truth | Not applicable/Not specified. The document does not describe a study involving expert consensus for establishing ground truth, as it is a device for marking tissue, not for diagnosis that would require expert interpretation of images. |
| 2. Qualifications of experts | Not applicable/Not specified. |
| 3. Adjudication method | Not applicable/Not specified. |
| 4. MRMC comparative effectiveness study | No. The document does not describe a multi-reader multi-case comparative effectiveness study. The device is a tissue marker, not an AI diagnostic tool. |
| 4. Effect size of human readers with AI vs. without AI | Not applicable. |
| 5. Standalone performance (algorithm only) | Not applicable. This is a physical medical device (implantable clip), not a software algorithm. The "performance" refers to its physical and functional characteristics (e.g., ability to attach, visibility on imaging, sterility, etc.), not algorithmic accuracy. |
| 6. Type of ground truth used | Not applicable in the context of diagnostic AI. For a physical device, performance is typically validated against engineering specifications, material properties, biocompatibility standards, and functional tests (e.g., deployment, visibility under imaging). The document implies tests were performed against "predetermined acceptance criteria." |
| 7. Sample size for training set | Not applicable. This is a physical medical device, not a machine learning model. |
| 8. How ground truth for training set was established | Not applicable. |
§ 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.