Search Results

The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.

Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.

Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.

I will populate the table and address the questions as best as possible given the nature of the device and the provided document.

Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.

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

Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.

• Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
• Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
• Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.

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

This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests outlined here is established through:

• Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
• Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device

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.

Ask a specific question about this device