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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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Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.

Tumark for Eviva and Tumark for Brevera are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism.

The introducer cannula has a blunt tip and can only be used together with an introducer. The handle is equipped with a slide-button which allows for a one handed placement of the marker by pressing it forward. A safety catch system prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the marker.

The provided text is a 510(k) Summary for the "Tumark for Eviva" and "Tumark for Brevera" devices. This document summarizes the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, rather than a standalone study proving its performance against specific acceptance criteria for regulatory approval of a novel device. The primary goal of a 510(k) is to show substantial equivalence, not necessarily to prove efficacy/safety as an entirely new product.

Therefore, many of the requested details about a standalone study, multi-reader multi-case studies, expert adjudication methods, and explicit training set details are not present in this type of submission. The focus is on bench and in vitro testing relative to the predicate device.

Here's an analysis of the provided information, addressing what is available and noting what is not:

1. Table of Acceptance Criteria and the Reported Device Performance

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 explicitly stated for each test (e.g., number of devices tested for sterility, shelf life, or blunt tip evaluation). The "Device Performance" test mentions "X-, Q-, and Vision markers" and deployment into a "breast phantom," implying a physical test, but the number of deployments or phantoms is not given.
• Data Provenance: The document does not specify the country of origin of the data. The applicant is based in Germany.
• Retrospective or Prospective: Not applicable as the studies described are bench and in vitro tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as the "studies" are bench and in vitro tests assessing physical and material properties, not diagnostic performance requiring expert interpretation.

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

• This information is not provided as the "studies" are bench and in vitro tests, not diagnostic performance studies with a need for 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable. The device is an implantable marker, not an AI-powered diagnostic tool for interpretation by human readers.

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

• A standalone performance study in the context of an algorithm was not done and is not applicable. The device is a physical medical device (implantable marker). The performance studies listed are bench tests of its physical and material properties.

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

• For the bench and in vitro tests, the "ground truth" would be established physical measurements, material science standards (e.g., ISO for biocompatibility and sterility), and successful mechanical deployment into a phantom. There is no expert consensus, pathology, or outcomes data used for these types of tests.

8. The sample size for the training set

• This information is not applicable/not provided. The device is an implantable marker, not an AI or algorithm-based system that requires a "training set." The tests conducted are to confirm the physical and biological properties of the device.

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

• This information is not applicable/not provided as there is no "training set" for this type of device.

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