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The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

The Tumark® Vision, Tumark® Professional, Tumark® Q, and Tumark® Professional Q-Shape are sterile products for single use only. Each consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. The clip marker is contained within the cannula when new and unopened. The cannula tip is bevelled, has markings 1 cm apart for measuring depth, and a textured surface behind the tip. The handle has a slide button for one-handed marker placement and a safety catch system to prevent premature deployment. The clip markers have different shapes: spherical (Tumark Vision), U-shape (Tumark Professional), Q-shape (Tumark Q), and Q-shaped (Tumark Professional Q Shape). The symbol of the clip marker shape is depicted on the handle.

Based on the provided text, the device in question is a tissue site marking system, specifically the Tumark Vision, Tumark Professional, Tumark Q, and Tumark Professional Q-Shape. These devices are intended to attach a marker to soft breast tissue and axillary lymph nodes to radiographically mark the location of a surgical site.

It's important to note that this document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving safety and effectiveness through extensive new clinical trials like a PMA (Premarket Approval) application would. Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical and limited clinical data submitted for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of number of patients or cases for the in vitro (bench) testing. The "test set" for the non-clinical evaluations appears to be the devices themselves.

• Sample Size for Bench Testing: Not explicitly stated as a numerical count of devices tested. The text says "Bench testing was performed to validate the device design" and lists aspects like "Device Function," "Device Performance," and "Device Stability during transport."
• Data Provenance: The studies are described as "in vitro testing" and "bench testing." There is also a "Clinical Analysis" which involved a "literature review" and "physician statements."
  • Country of Origin: Not explicitly stated, but the applicant (SOMATEX Medical Technologies GmbH) is based in Berlin, Germany.
  • Retrospective or Prospective: The bench testing is presumably prospective (planned tests). The literature review is retrospective. The physician statements are likely prospective or current.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "Clinical Analysis" mentions "physician statements," implying medical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified for the presented bench testing. The evaluation is based on meeting pre-defined acceptance criteria for the physical and functional characteristics of the device. For the clinical analysis, "physician statements" were obtained, but no multi-reader adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No MRMC comparative effectiveness study was done or reported. This device is a physical marker, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device (implantable clip), not an algorithm or software.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" is based on engineered specifications and the physical performance of the device against those specifications (e.g., successful deployment, visibility under imaging modalities, structural integrity). This is a technical and objective validation against design requirements.
• For Clinical Analysis (Supporting Indications): The "ground truth" for the expanded indication (axillary lymph nodes) relies on a literature review and physician statements, suggesting a consensus of existing medical knowledge and expert opinion. It is not based on direct patient outcomes data from a new clinical study.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set." The development of the device would involve engineering design and iterative testing, not AI model training.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set Establishment: Not applicable as there is no "training set" in the context of an AI/ML model for this device. The design and validation of this device follow traditional medical device engineering and testing methodologies.

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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.

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