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TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes.

TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.

The provided text describes a 510(k) summary for the TRACERS® Ta Bone Cement Opacifier, focusing on its substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not available in the given document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance acceptance criteria for a new clinical or technical study.

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

This information is not available. The document does not describe a performance study with a test set.

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

This information is not available. The document does not describe a performance study that involved expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not available. The document does not describe a performance study involving adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. The device's purpose is as an additive to provide radiopacity, not typically requiring this type of study for a 510(k) submission of this nature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the described device. The TRACERS® Ta Bone Cement Opacifier is a physical additive to a medical cement to enhance radiopacity for imaging purposes. It is not an algorithm or a software-based device that would have standalone performance (algorithm only) testing.

7. The Type of Ground Truth Used

This information is not available. The 510(k) submission is based on substantial equivalence, not on the performance against a defined ground truth from a study. The "ground truth" for this device would inherently be its physical properties and chemical composition, which are confirmed through validation of its manufacturing and material specifications, and its ability to become radiopaque as intended. The document states its intended use is "to provide radiopacity for imaging purposes," which implies that its performance would be assessed by its visibility under imaging. However, a specific study establishing "ground truth" in the context of clinical outcomes or expert consensus is not described.

8. The Sample Size for the Training Set

This information is not applicable and not available. The TRACERS® Ta Bone Cement Opacifier is a medical device (an additive), not a machine learning or artificial intelligence system that would require a training set.

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

This information is not applicable and not available, as there is no training set for this type of device.

Summary of the Document's Content:

The K033230 submission for TRACERS® Ta Bone Cement Opacifier is a 510(k) premarket notification. Its primary argument for market clearance is substantial equivalence to an already legally marketed predicate device, TRACERS® Bone Cement Opacifier (K023445).

• Intended Use: To be used as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.
• Product Description: Comprised of USP Barium Sulfate and unalloyed Tantalum disks, mixed with the Secour polymer (powder) before liquid monomer is added.
• The document explicitly states: "Based on the information provided in this notification, the subject device is substantially equivalent to the currently marketed predicate device with regard to intended use, technological characteristics, and design."

The FDA's response letter (DEC 12 2003) confirms a finding of substantial equivalence, allowing the device to be marketed. This type of submission does not typically involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human reader effectiveness studies as would be required for novel, higher-risk devices or AI/software-as-a-medical-device products. Instead, the focus is on demonstrating that the new device is as safe and effective as the predicate device based on its materials, design, and intended use.

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TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.

TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.

This 510(k) summary does not contain information regarding acceptance criteria or studies proving device performance in the typical sense of a diagnostic or AI-driven device.

The device, TRACERS Bone Cement Opacifier, is an additive to provide radiopacity to bone cements for imaging purposes. Its 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device (TRACERS Bone Cement Opacifier, K991893) based on its intended use, design, and technological characteristics, rather than detailed performance metrics from a clinical study for diagnostic accuracy.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document for the following reasons:

• Device Type: This is a material additive, not a diagnostic imaging device or an AI algorithm that generates predictions or diagnoses.
• Regulatory Pathway: The 510(k) process for this type of device typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing of material properties or direct comparison of formulation, rather than large-scale clinical trials measuring diagnostic performance.
• Lack of Performance Metrics: The document does not describe any quantifiable performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance. The radiopacity, which is its primary function, is likely assessed through physical or radiographic comparison to the predicate or standard materials, but no specific study details are shared here.

Summary of available and non-applicable information:

1. Table of acceptance criteria and the reported device performance:

   • Not applicable / Not provided. The document does not specify quantitative acceptance criteria or detailed performance results typically associated with diagnostic or AI devices (e.g., sensitivity, specificity thresholds). The performance implicitly refers to its ability to provide radiopacity when added to bone cement, making it visible in imaging for placement and visualization. This is assessed via substantial equivalence to a predicate.

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 / Not provided. No test set for evaluating diagnostic performance or AI algorithm output is mentioned.

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 / Not provided. No "ground truth" establishment by experts is described as this is not a diagnostic device requiring such validation for accuracy.

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

   • Not applicable / Not provided.

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 / Not provided. This device is an additive for bone cement, not an AI or diagnostic tool that assists human readers.

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

   • Not applicable / Not provided. This is not an algorithm.

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

   • Not applicable / Not provided.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set for an algorithm is mentioned.

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

   • Not applicable / Not provided.

In conclusion, this 510(k) submission focuses on demonstrating substantial equivalence for a material additive rather than providing detailed performance metrics from clinical studies that would require the information requested for AI or diagnostic devices.

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