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510(k) Data Aggregation
(145 days)
The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker.
The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.
The TUMARK® Flex is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable Nitinol clip-marker, a guide wire or tube and a handle with ejection mechanism. The guide wire is composed of a flexible tube, a distal ramp made of surgical high-grade steel with an opening for releasing the clip marker and a depth stopper with snap-in tip. The guide tube is composed of a tube section, a distal ramp made of surgical steel with an opening for releasing the clip marker, and a marking line, which shows the orientation of the ejection port for the clip marker. The handle is provided with a slider by means of which the clip can be released. The clip marker is situated in the distal ramp. TUMARK® Flex can be used together with, e.g. ultrasound and stereotactic X-ray imaging procedures.
The TUMARK® Flex is not indicated to be used in Magnetic Resonance Tomography (MRT). However, the clip marker placed in the patient can be exposed to a magnetic field of up to 3.0 Tesla, for instance in follow-up examinations.
The provided document is a 510(k) summary for the SOMATEX® TUMARK® Flex Tissue Site Marking System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study proving device performance against those criteria. The submission is not for a software or AI-driven device, but a physical medical device. Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI assistance studies, training set details) are not applicable to this type of submission.
Here's a summary of what can be extracted based on the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report device performance against such criteria. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, implying that the new device performs acceptably because it is "identical or similar in technology, design and material," with "minor technological differences" that "raise no new questions of safety and effectiveness."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a physical medical device. The document does not describe a "test set" in the context of data used for algorithm validation or a clinical study with a specified sample size for proving performance against acceptance criteria.
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)
Not applicable. This is a submission for a physical medical device, not a diagnostic or interpretive algorithm requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a submission for a physical medical device, not a diagnostic or interpretive algorithm requiring adjudicated ground truth.
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 tissue site marker, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as typically applied to diagnostic AI/software is not relevant to the approval of this physical medical device. Device performance is generally demonstrated through engineering testing, biocompatibility testing, material safety, and substantial equivalence to existing devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
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(140 days)
The Tumark® Professional and MRI Tumark® Professional are intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure.
The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.
The Tumark® Professional and MRI Tumark® Professional 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 Tumark® Professional is not indicated to be used in Magnetic Resonance Imaging (MRI) procedures. The MRI Tumark® Professional is MRI Safe and indicated to be used during MRI procedures. The introducer cannula which will be available in stainless steel (Tumark® Professional) or cobalt-chrome alloy (MRI Tumark® Professional) for use with magnetic resonance imaging techniques is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The cannulas will be available in different lengths. 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. The Tumark® Professional will be available with a U-shaped or X-shaped marker. The MRI Tumark® Professional will only be available with a U-shaped marker.
This document is a 510(k) Summary for the Tumark® Professional / MRI Tumark® Professional tissue site marking systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study proving performance against specific acceptance criteria.
Therefore, many of the requested fields related to a comparative effectiveness study, standalone algorithm performance, or ground truth establishment for a test set, cannot be found in this document.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for device performance in the way an AI/ML device study would. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, focusing on:
- Intended Use: Identical or similar
- Technology, Design, and Material: Identical or similar
- Biocompatibility, Sterility, and Packaging: Demonstrated safety and effectiveness through testing.
Since no specific performance metrics are provided, a "Reported Device Performance" column cannot be filled with quantitative data from this document.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Attach a marker to soft tissue at the surgical site during an open or percutaneous procedure, to radiographically and radiologically mark the surgical location in breasts. (MRI Tumark® Professional also for MRI procedures). | The Tumark® Professional and MRI Tumark® Professional's intended use is identical or similar to their predicate devices. |
| Technology, Design & Material: Similar primary components and component materials. | The proposed devices and predicate devices are identical or similar in technology, design, and material, with substantially equivalent component materials. Minor technological differences do not raise new questions of safety and effectiveness. |
| Biocompatibility: Safe for use in the human body. | Biocompatibility testing of the proposed devices demonstrates safety and effectiveness of the system. |
| Sterility: Sterilized for single-use. | Sterility testing of the proposed devices demonstrates safety and effectiveness of the system. |
| Packaging: Maintains sterility and protects the device. | Packaging testing of the proposed devices demonstrates safety and effectiveness of the system. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical performance study with a test set of data. The document mentions tests for biocompatibility, sterility, and packaging but does not detail sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth is described in this document.
4. Adjudication method for the test set
Not applicable. No test set is described.
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 physical medical device (tissue marker), not an AI/ML software. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an AI/ML study. For the device itself, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, and regulatory standards for medical devices (e.g., ISO standards for biocompatibility and sterility) and comparison to predicate devices that have already been considered safe and effective.
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.
In summary: This document is a 510(k) summary for a medical device (tissue marker) seeking clearance based on substantial equivalence to existing devices. It does not contain information related to software performance studies, AI/ML algorithms, or clinical trial data with acceptance criteria for such, but rather addresses the physical and functional characteristics of the device itself.
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