(88 days)
The OneMark Breast Localization Marker is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or soft tissue intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or detection imaging (OneMark Detection Imaging System), the OneMark Breast Localization Marker is located and may be surgically removed with the target tissue. The OneMark Detection Imaging System is intended only for the detection of the OneMark Breast Localization Marker.
OneMark is an integrated localization system consisting of the OneMark Detection Imaging System and the OneMark Breast Localization Marker preloaded in an injector device. The OneMark Detection Imaging System is an ultrasound-based intraoperative inspection tool used by clinicians to localize the OneMark Breast Localization Marker, a hydrogel pellet implanted in tissue to mark the site of a lesion. The primary goal of the system is to aid a surgeon in resection of a marked cancer lesion. The system may be used to inspect the marked tissue in all typical workflow situations from initial implant post-biopsy through resection and ex-vivo specimen review.
This FDA 510(k) summary for the OneMark Breast Localization Marker and OneMark Detection Imaging System does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding test sets, ground truth establishment, or clinical studies (MRMC or standalone algorithm performance).
The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. It lists various non-clinical tests performed but does not provide specific performance metrics, acceptance criteria, or results from these tests beyond stating that they indicate substantial equivalence.
Therefore, the requested information cannot be extracted from the provided text. The document does not describe:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are mentioned for the device's function (e.g., accuracy of localization, sensitivity/specificity).
- Sample size used for the test set and the data provenance: No information about a test set, its size, or origin (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications: No details on expert involvement or ground truth establishment.
- Adjudication method for the test set: Not applicable as no test set data is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance: No MRMC or clinical effectiveness study is described. The device is a localization marker and detection system, not an AI diagnostic tool that assists human readers in interpreting medical images.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as the "OneMark Detection Imaging System" is an ultrasound-based intraoperative inspection tool designed for clinical use, implying human operation and interpretation. The "algorithm" mentioned (processing phase shift into a vibrant color image) is part of a system used by clinicians, not a standalone diagnostic AI.
- The type of ground truth used: No ground truth for an efficacy study is described.
- The sample size for the training set: No information on a training set.
- How the ground truth for the training set was established: Not applicable.
The "Non-clinical performance bench testing" is listed, but no details about its methodology, specific acceptance criteria, or results are provided. The "GLP animal testing" is also mentioned, but again, without specific performance data relevant to the device's localization accuracy or effectiveness.
§ 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.