Search Results

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.

Ask a specific question about this device

This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.

The Bone Cement Radio-Opacifier is an additive to be used with Codman Cranioplastic (K873689) to provide radiopacity to the resin and assist in placement and visualization of material.

The provided text describes a 510(k) summary for a Bone Cement Radio-Opacifier. This submission is for a medical device that acts as an additive to provide radiopacity for imaging purposes.

Based on the available information, the device is not an AI/ML-enabled medical device. It's a physical additive (Barium Sulfate, USP) to bone cement to make it visible on X-rays. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for algorithms, sample sizes for AI training/testing, expert adjudication, MRMC studies, and standalone performance, are not applicable.

The document focuses on establishing substantial equivalence to a predicate device (Parallax Tracer Radiopaque Particles) based on identical intended use and performance attributes. The "performance testing" mentioned is likely physical/chemical testing for the radio-opacifier's ability to provide radiopacity and its impact on the functional characteristics of the bone cement.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance testing.
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing performed by Cardinal Health in the US. This is a non-clinical evaluation of a physical product.

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

Not applicable for this type of device. The "ground truth" would be objective measurements of radiopacity or material properties, not expert interpretations of images.

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

Not applicable. Testing would involve objective measurements against specifications, not subjective adjudication of results.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" in this context would be objective measurements of physical and chemical properties (e.g., radiopacity, set time, mechanical strength after mixing) to demonstrate equivalence to the predicate and ensure the additive doesn't compromise the bone cement's function. No specific type of "ground truth" (like pathology or outcomes data) is mentioned as it's not relevant to this device's function.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Study Type:

This appears to be a non-clinical performance study focused on demonstrating substantial equivalence of a physical medical device (a radio-opacifying additive) to a legally marketed predicate device. The study would involve laboratory testing to compare the physical and functional characteristics of bone cement mixed with the new radio-opacifier against bone cement mixed with the predicate radio-opacifier. The specific tests (e.g., related to radiopacity, setting time, strength) are not detailed but are implied by the claim of "substantially equivalent... with regard to functional characteristics."

Ask a specific question about this device

Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.

Vista Scientific Barium Sulfate is a dry powder supplied sterile and non-pyrogenic for use as a radiopacifying additive to Codman Cranioplastic™ (Type 1-Slow set) bone cement. The Barium Sulfate is supplied in a quantity of 6 grams, packaged in a closed 120 mL polymer container, and sealed within a double sterile peel pouch package configuration.

The provided document (K024359 for Vista Scientific Barium Sulfate) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use, and states that it is substantially equivalent to a predicate device. This type of document typically does not contain the detailed performance study results you are asking for (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

The purpose of a 510(k) submission for a device like this (an additive to a bone cement to provide radiopacity) is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through performance, biocompatibility, and microbiological testing. It focuses on showing the new device performs as designed and is suitable for its intended use, similar to its predicate.

Therefore, many of the specific details you requested are not available within the provided text.

However, I can extract the information that is present:

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

The document does not provide a specific table of acceptance criteria nor detailed quantitative performance metrics for the device itself (e.g., specific radiopacity values or thresholds). It broadly states:

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. The document mentions "Performance, biocompatibility and microbiological testing," but does not detail the sample sizes, study design (retrospective/prospective), 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 (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Given the nature of a radiopacifying additive, "ground truth" would likely relate to objective measurements of radiopacity rather than expert interpretation of images.

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

This information is not provided in the document.

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

An MRMC study is not applicable and was not done for this device. This device is an additive to bone cement, not an AI or imaging diagnostic tool. The concept of "human readers improve with AI" does not apply here.

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

A standalone algorithm performance study is not applicable and was not done for this device. This device is an additive to bone cement, not an algorithm.

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

The "ground truth" for a radiopacifying agent would likely be objective physical or chemical measurements of its ability to absorb X-rays and provide contrast, compared to a standard. The document does not explicitly state the specific type of ground truth, but it would not be expert consensus, pathology, or outcomes data in the traditional sense for an imaging diagnosis. The evaluation would focus on the material properties.

8. The sample size for the training set

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.

Parallax™ Tracer Radiopaque Particles

Here's a breakdown of the acceptance criteria and study 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 provided text does not include information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The non-clinical test results section broadly states "Performance testing demonstrated...", without specific details on the test set.

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

The provided text does not include information regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information is typically related to studies involving human interpretation or performance, which is not detailed here.

4. Adjudication method for the test set

The provided text does not include any information about an adjudication method for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The device is "Parallax™ Tracer Radiopaque Particles," an additive to a cranioplasty material, not an AI or diagnostic imaging device that would typically involve human reader performance studies in this context.

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

This question is not applicable. The device is a physical additive (radiopaque particles) to a cranioplastic material, not a standalone algorithm.

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

The concept of "ground truth" as typically applied to performance studies of diagnostic algorithms is not directly applicable to this device. The "ground truth" in this context would likely refer to objective measurements of the functional characteristics of the combined material (Cranioplastic and Tracer Particles) compared to Cranioplastic alone. The text implies a comparison of "functional characteristics" to establish substantial equivalence.

8. The sample size for the training set

The provided text does not include information about a training set since this is not an AI or machine learning device.

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

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device