Search Results

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:

1. 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).
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or origin (country, retrospective/prospective).
3. 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.
4. Adjudication method for the test set: Not applicable as no test set data is presented.
5. 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.
6. 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.
7. The type of ground truth used: No ground truth for an efficacy study is described.
8. The sample size for the training set: No information on a training set.
9. 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.

Ask a specific question about this device

The SignalMark Breast Marker is intended to provide accuracy in marking a surgical site and/or a biopsy location for visualization during surgical resection.

The SignalMark Breast Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in breast tissue to "mark" the location of the biopsy or surgical site. It is intended to be used on adults undergoing open surgical breast biopsy or percutaneous breast biopsy, in a surgical setting, such as a hospital or medical clinic with operating suites. The SignalMark Breast Marker consists of two components:

• . Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue.
• Marker Pad: Component made of USP-grade porcine gelatin-based hydrogel with methylene blue-colored silicon dioxide microspheres. The marker aids in the visualization of tissue allowing surgeons to readily locate the biopsy site for subsequent tissue or tumor resection.

The provided document, a 510(k) summary for the SignalMark Breast Marker, describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study designed to prove the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Therefore, a table of acceptance criteria and reported device performance in those terms is not available from this document.

However, the document does detail other aspects of the testing performed, which can be extracted and summarized.

No clinical studies involving human patients, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance studies are described in this 510(k) summary, as it focuses on non-clinical (bench and animal) testing. The device is a physical marker and not an AI/algorithm-based diagnostic tool, so certain sections of your request (e.g., effect size of human readers improving with AI, standalone performance, training set details) are not applicable.

1. A table of acceptance criteria and the reported device performance

As mentioned, this document does not provide a table of acceptance criteria for diagnostic performance or clinical effectiveness, nor does it report device performance against such criteria. The testing focused on demonstrating equivalence to predicate devices through physical and biological testing.

The document lists the following non-clinical tests performed:

Note: The document states, "No FDA performance standards have been established for the SignalMark Breast Marker." This indicates that the equivalence was demonstrated against the predicate's known performance for these non-clinical aspects, rather than against specific regulatory performance metrics for this type of device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes for each of the bench and animal tests. It only lists the types of tests conducted. For example, for "Biodistribution in rodents" and "Safety and efficacy in porcine," the specific number of animals used is not provided.
• Data Provenance: The document does not mention the country of origin of the data. The studies were non-clinical (bench and animal), so the terms "retrospective" or "prospective" as they apply to human clinical studies are not directly relevant. These were experimental studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical (bench and animal) testing, not a diagnostic accuracy study requiring expert establishment of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the document describes non-clinical (bench and animal) testing, not a diagnostic accuracy study requiring adjudication.

5. 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

This section is not applicable. The SignalMark Breast Marker is a physical implantable marker, not an AI or imaging diagnostic device. No MRMC study or AI assistance is mentioned or relevant to this device's 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The SignalMark Breast Marker is a physical implantable marker, not an algorithm, and therefore does not have "standalone performance" in the context of AI or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described:

• For Biocompatibility, the ground truth is adherence to the ISO 10993-1 standard.
• For Bench Performance tests (e.g., dimensional inspection, deployment, hydration, ultrasound visibility), the ground truth would be the pre-defined engineering specifications, material properties, and expected physical behaviors of the device, often compared to the predicate device's characteristics.
• For Animal Performance tests (biodistribution, safety, efficacy, biologic response), the ground truth is derived from the observed biological reactions, histology, and functional outcomes in the animal models, compared to established norms or the predicate device's effects.

8. The sample size for the training set

This section is not applicable. The SignalMark Breast Marker is a physical medical device, not a machine learning or AI model, and therefore does not have a "training set" in that context. The device's design and manufacturing processes are developed through traditional engineering and material science principles.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Ask a specific question about this device