Search Results

The Tumark Vision is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

This document is from a 510(k) premarket notification for a medical device called "Tumark Vision." It asserts substantial equivalence to a predicate device, "Tumark Professional." Because this is a 510(k) submission, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data outlining acceptance criteria and detailed device performance metrics in the way one might expect for a novel device or a Post-Market Approval (PMA).

Therefore, the requested information, particularly regarding acceptance criteria (beyond general safety and efficacy) and a rigorous standalone study proving device performance against those criteria, is not explicitly available in this type of submission. The document relies on similarity to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study. The "acceptance criteria" for a 510(k) are generally around demonstrating that the new device performs as intended and is as safe and effective as the predicate. The comparison table (page 5) highlights technological characteristics and shows that the "Tumark Vision" (new device) and "Tumark Professional" (predicate device) are functionally equivalent in most aspects, with the primary difference being the "Sphere-shaped design" of the marker in the new device compared to "U-shaped or X-shaped" in the predicate.

Specific "acceptance criteria" linked to a study are not provided. The document states: "All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met." However, it does not detail what those criteria were or the specific results.

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

This information is not provided in the document. A 510(k) summary primarily focuses on technical and performance characteristics comparison to a predicate device, rather than detailed clinical trial data. The document mentions "verification and validation activities" but doesn't elaborate on the type or scope of data used for these activities (e.g., patient data, in-vitro testing).

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 information is not provided. The submission does not describe a clinical study where expert ground truth was established for a test set.

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

This information is not provided. As no clinical study with a test set requiring adjudication is described, this detail is absent.

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 information is not provided. The "Tumark Vision" is a physical medical device (implantable marker system), not an AI/software device. Therefore, an MRMC study related to AI assistance for human readers would not be applicable or expected for this submission.

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

This information is not provided. This question is relevant for AI or software-as-a-medical-device (SaMD) products. The Tumark Vision is a physical implantable marker.

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

This information is not provided. Since there's no described clinical study involving a test set, the concept of "ground truth" for patient data in that context isn't detailed. For a device like this, the ground truth would typically relate to the physical properties of the marker (e.g., visibility in imaging modalities, biocompatibility, deployment success), which were likely evaluated through non-clinical (e.g., bench, animal) testing rather than patient-level ground truth established by experts.

8. The sample size for the training set

This information is not provided. "Training set" is a concept typically associated with machine learning or AI algorithms, which is not applicable to this physical device.

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

This information is not provided. As explained above, this concept is not applicable here.

Ask a specific question about this device