Search Results

The SenoMark® Ultra Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

The SenoMark® Ultra Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains three PGA pads which are visible via ultrasound imaging for approximately 3 weeks and are essentially resorbed by the body after approximately 12 weeks. The center PGA pad contains a metallic wireform interwoven with a PVA polymer. The non-resorbable PVA polymer enhances viewing under ultrasound. The wireform is made of Titanium or BioDur™ 108 in a ribbon or coil shape respectively. The wireform is visible radiographically on a permanent basis. The SenoMark® Ultra Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.

The provided text is a 510(k) summary for a Special 510(k) device modification. It describes the SenoMark® Ultra Breast Tissue Marker and compares it to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets certain performance criteria beyond a general statement of "performance specifications" that are "identical to the specifications provided in the reference devices."

The document focuses on demonstrating substantial equivalence to a predicate device through technological comparison and nonclinical testing that assessed product characteristics and deployment mechanics. It explicitly states:

• "Performance specifications - With the change to the legally marketed UltraClip II US wireforms, the performance specifications for ultrasound imaging and MRI compatibility will now include permanent ultrasound visibility and scanning in up to a 3-Tesla MR system. These specifications are identical to the specifications provided in the reference devices."
• "To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, 'Design Control Guidance for Medical Device Manufacturers,' dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
  • Visual Inspection of Product for Pre-Deployment
  • Inversion Test
  • Deployment Force
  • Read and Understand the IFU"

Therefore, based solely on the provided text, I cannot fill in the requested table or detail a study proving specific acceptance criteria related to clinical performance (e.g., sensitivity, specificity, or reader improvement). The document focuses on physical and functional equivalence to a predicate device, not on diagnostic performance metrics.

Here's what I can extract based on the provided text, and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide quantitative acceptance criteria (e.g., minimum deployment force, specific visibility metrics) or detailed quantitative performance results for these tests. It only states that the performance is "comparable" and "performs as safely and as effectively as the legally marketed predicate device."

Study Details (Based on Provided Text):

The document describes "nonclinical tests" rather than a clinical study. The goal was to demonstrate "substantial equivalence" through evaluation of technological characteristics and performance criteria, referencing "FDA guidance document, 'Design Control Guidance for Medical Device Manufacturers,' dated March 11, 1997, and internal risk assessment procedures."

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: Not specified. The document only mentions "nonclinical tests."
• Data provenance: Not applicable, as this describes nonclinical tests, not data from patients.

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)

• Not applicable. This was a technical/engineering evaluation of the device itself, not a study requiring clinical ground truth from experts.

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

• Not applicable. No adjudication method described for nonclinical tests.

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

• No MRMC study was done, nor is this device an AI system.

6. 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.

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

• Not applicable in the clinical sense. For the nonclinical tests, the "ground truth" would be established engineering specifications or benchmarks for the predicate device, which are not detailed here.

8. The sample size for the training set

• Not applicable. No training set for an algorithm.

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

• Not applicable. No training set for an algorithm.

Ask a specific question about this device