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The Tumark® Professional 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 indicated to be used with magnetic resonance imaging (MRI) techniques.

The Tumark® is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The introducer cannula which consists of stainless steel is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker.

This 510(k) summary does not contain information on acceptance criteria, device performance, or any studies conducted to prove the device meets specific acceptance criteria. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text. The document states that the Tumark Professional is "substantially equivalent" to predicate devices based on similar intended use, technology, design, and materials, suggesting that its performance is implicitly acceptable if the predicate devices' performance was.

Here's what I can extract from the provided text, related to your questions, but it's not the full scope of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Tumark Professional. It relies on the substantial equivalence argument.

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

• Not provided. No test set or data provenance is mentioned.

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

• Not provided. No information on expert involvement for a test set.

4. Adjudication Method for the Test Set:

• Not provided. No information on any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not provided. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance (which is not applicable here as this is a physical medical device, not an AI diagnostic tool).

6. Standalone Performance Study (Algorithm Only):

• Not provided. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Not provided. No studies with ground truth establishment are mentioned.

8. Sample Size for the Training Set:

• Not provided. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not provided. Not applicable as no training set is mentioned.

What is available in the document that might be related conceptually, though not directly answering your questions:

• The 510(k) summary focuses on establishing Substantial Equivalence to legally marketed predicate devices:
  • ClipLoc Soft Tissue marker (K033447)
  • UltraClip Tissue Marker (manufactured by Inrad Inc. - K number not provided but mentioned as a predicate)
• The basis for substantial equivalence is "same intended Use and the similarities in technology, design and materials."
• "Both the Tumark Professional and the predicate devices consist of the same primary components and the component materials of the proposed device and the predicate devices are substantially equivalent."
• "The minor technological differences between the proposed device and the predicate devices do not raise new questions of safety and effectiveness."

In essence, the device's "acceptance" is based on its similarity to already approved devices, implying that if the predicates are safe and effective, so too is the Tumark Professional. This type of submission (510(k)) often relies on comparisons to existing devices rather than new, extensive performance studies for novel acceptance criteria.

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