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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.

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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 consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.

The provided text describes a 510(k) premarket notification for the UltraCor Twirl Breast Tissue Marker. However, it explicitly states that no performance data (bench testing or clinical analysis) was warranted due to the nature of the change.

The key information regarding acceptance criteria and study details is as follows:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable.

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:

• MRMC Study: No. This device is not an AI-assisted diagnostic tool, but rather an implanted marker.

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

• Standalone Performance: No. This device is an implanted marker, not a diagnostic algorithm.

7. The type of ground truth used:

• Ground Truth Type: Not applicable. The submission is based on an update to the Indications for Use, supported by a literature review and physician statements on existing clinical practice, rather than a direct performance study to establish a ground truth.

8. The sample size for the training set:

• Sample Size: Not applicable. No training set was used.

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

• Ground Truth Establishment: Not applicable.

Explanation from the document:

The 510(k) submission (K180061) for the UltraCor Twirl Breast Tissue Marker focused on an update to its Indications for Use to include axillary lymph nodes. The manufacturer explicitly states:

• "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted." (Page 5, Section 8. Performance Data)
• "The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements." (Page 5, Section 9. Clinical Analysis)

Therefore, this submission did not involve a study to prove performance against specific acceptance criteria in the traditional sense of a diagnostic or therapeutic device. Instead, it leveraged existing knowledge and clinical practice to justify the expanded indication of an already cleared device.

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The UltraCor Twirl Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.

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

The provided document describes the UltraCor® Twirl™ Breast Tissue Marker and its substantial equivalence to a predicate device, UltraClip® II US Wing and Coil. It outlines performance testing that was conducted, but it does not present acceptance criteria in a table format nor does it describe a study proving the device met specific performance metrics in a way that allows for a direct comparison table as requested.

The document focuses on design verification and validation testing, confirming that modifications from the predicate device do not impact safety or effectiveness. The conclusion states that the subject device "met all predetermined acceptance criteria of design verification and validation," but it does not list these criteria or the specific results against them.

Therefore, based on the provided text, I cannot complete parts 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your request as these specific details are not present. The document summarizes the types of tests performed, rather than the quantitative results or the methodology for establishing ground truth, sample sizes, or expert involvement in those tests.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the document:

• Device Name: UltraCor® Twirl™ Breast Tissue Marker
• Predicate Device: UltraClip® II US Wing and Coil (K090547)
• Types of Testing Performed (as listed in "Performance Testing Summary"):
  • Marker shape distinguishability
  • Ultrasound visibility
  • Marker deployment accuracy
  • Marker deployment force
  • Marker deployment
  • Marker retention
  • Marker dimensional testing
  • Applicator dimensional testing
  • Applicator tensile testing
  • Visual inspection of the product
  • Visual integrity of the packaging
  • Pouch seal strength of the packaging
  • MRI testing (magnetic field interactions, MRI-related heating, artifact testing)
  • Biocompatibility testing on the applicator and the marker implant
• Ground Truth for performance testing: The document implies that the ground truth for these tests was based on "applicable standards, guidance, test protocols and/or customer inputs," but the specifics of how this ground truth was established are not detailed.

Information that is NOT available in the document and therefore cannot be provided in response to your request:

1. A table of acceptance criteria and the reported device performance: The document states that the device "met all predetermined acceptance criteria," but does not list these criteria or report the specific performance metrics achieved against them.
2. Sample size used for the test set and the data provenance: Not specified for any of the performance tests. The nature of these tests (e.g., bench testing) suggests lab-based experiments, but details are missing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method for the test set: Not applicable and not mentioned, as this device's testing relates to physical properties, not diagnostic interpretation.
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: Not applicable. This device is a breast tissue marker, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the document mentions "applicable standards, guidance, test protocols and/or customer inputs," the specific type of ground truth (e.g., whether "ultrasound visibility" was assessed by expert consensus on images, or by quantitative metrics) is not detailed.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document confirms that various design verification tests were conducted, and the device met its acceptance criteria, contributing to its substantial equivalence determination. However, it does not provide the granular detail requested concerning the specific acceptance criteria, test results, sample sizes, or expert involvement.

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