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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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The Tumark Vision 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 radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It 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 intended to be used with magnetic resonance imaging (MRI) techniques.

This document is from a 510(k) premarket notification for a medical device called "Tumark Vision." It asserts substantial equivalence to a predicate device, "Tumark Professional." Because this is a 510(k) submission, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data outlining acceptance criteria and detailed device performance metrics in the way one might expect for a novel device or a Post-Market Approval (PMA).

Therefore, the requested information, particularly regarding acceptance criteria (beyond general safety and efficacy) and a rigorous standalone study proving device performance against those criteria, is not explicitly available in this type of submission. The document relies on similarity to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study. The "acceptance criteria" for a 510(k) are generally around demonstrating that the new device performs as intended and is as safe and effective as the predicate. The comparison table (page 5) highlights technological characteristics and shows that the "Tumark Vision" (new device) and "Tumark Professional" (predicate device) are functionally equivalent in most aspects, with the primary difference being the "Sphere-shaped design" of the marker in the new device compared to "U-shaped or X-shaped" in the predicate.

Specific "acceptance criteria" linked to a study are not provided. The document states: "All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met." However, it does not detail what those criteria were or the specific results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. A 510(k) summary primarily focuses on technical and performance characteristics comparison to a predicate device, rather than detailed clinical trial data. The document mentions "verification and validation activities" but doesn't elaborate on the type or scope of data used for these activities (e.g., patient data, in-vitro testing).

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)

This information is not provided. The submission does not describe a clinical study where expert ground truth was established for a test set.

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

This information is not provided. As no clinical study with a test set requiring adjudication is described, this detail is absent.

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

This information is not provided. The "Tumark Vision" is a physical medical device (implantable marker system), not an AI/software device. Therefore, an MRMC study related to AI assistance for human readers would not be applicable or expected for this submission.

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

This information is not provided. This question is relevant for AI or software-as-a-medical-device (SaMD) products. The Tumark Vision is a physical implantable marker.

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

This information is not provided. Since there's no described clinical study involving a test set, the concept of "ground truth" for patient data in that context isn't detailed. For a device like this, the ground truth would typically relate to the physical properties of the marker (e.g., visibility in imaging modalities, biocompatibility, deployment success), which were likely evaluated through non-clinical (e.g., bench, animal) testing rather than patient-level ground truth established by experts.

8. The sample size for the training set

This information is not provided. "Training set" is a concept typically associated with machine learning or AI algorithms, which is not applicable to this physical device.

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

This information is not provided. As explained above, this concept is not applicable here.

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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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The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.

The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the proposed devices will be delivered with a protective tube.

This document pertains to the 510(k) summary for the Biopsy Handy / MRI Biopsy Handy devices, establishing their substantial equivalence to predicate devices. As such, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, the submission focuses on demonstrating safety and effectiveness through establishing substantial equivalence to previously cleared predicate devices. The "study" in this context refers to the comparison made between the new device and the predicate devices, rather than a clinical trial with specific performance metrics.

Therefore, many of the requested categories about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

• Not applicable for performance metrics. This document does not detail specific acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in a clinical context, nor does it report such performance metrics. The "acceptance criteria" for this submission would be related to meeting the FDA's requirements for demonstrating substantial equivalence, including biocompatibility, sterility, packaging, and MR-testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes a comparison to predicate devices, not a clinical study with a "test set" of patient data.

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 information is not relevant to a substantial equivalence submission comparing device characteristics.

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

• Not applicable. There is no "test set" or adjudication process described in this document in the context of clinical performance evaluation.

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 semi-automatic biopsy system, not an AI/ML-driven diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This device is a physical medical instrument, not a standalone algorithm.

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

• Not applicable. "Ground truth" in the context of clinical performance evaluation is not relevant to this submission. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML or data-driven model.

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

• Not applicable. There is no "training set" described.

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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.

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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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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