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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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Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).

The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:

• . 10cc VacLok syringe
• Luer cap .
• 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .

The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.

This is a 510(k) summary for a medical device (Clearview Plus Bone and Vertebral Body Biopsy Needles), not a study demonstrating algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.

The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Clearview Bone and Vertebral Body Biopsy Needles, K011206). Substantial equivalence means the device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" here refers to the regulatory criteria for demonstrating substantial equivalence, not performance metrics of an algorithm.

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

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

The provided document does not contain quantitative acceptance criteria or performance data in the way one would expect for an AI/ML device. For a 510(k) submission like this, "acceptance criteria" would primarily relate to demonstrating that the new device shares the same intended use, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device. The "reported device performance" is essentially the finding of "substantial equivalence."

Acceptance Criteria for 510(k) (Inferred for this type of submission):

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 is a 510(k) for a physical medical device, not an AI/ML algorithm that would undergo a test set evaluation. The decision of substantial equivalence is based on comparing the device and its documentation to a predicate, not on clinical performance data from a test set in the context of an algorithm.

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. No "ground truth" establishment in the context of an algorithm's performance on a test set is discussed. The "experts" involved would be the FDA reviewers and the manufacturer's regulatory team.

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

Not applicable. No test set for algorithm performance.

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-assisted device.

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

Not applicable. This is a physical biopsy needle.

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

Not applicable. No ground truth in the context of an algorithm's performance. The "ground truth" for this submission is that the predicate device is already legally marketed and considered safe and effective.

8. The sample size for the training set

Not applicable. No training set for an algorithm.

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

Not applicable. No training set for an algorithm.

In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device. It is not an AI/ML device and therefore the questions pertaining to acceptance criteria and study designs relevant to AI/ML algorithms are not applicable to this text. The "study" here is essentially the comparison and justification provided by the manufacturer (Parallax Medical, Inc.) to the FDA for demonstrating substantial equivalence to a predicate device.

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Parallax Cranioset is a resinous material for repair of cranial defects.

Parallax Cranioset is a resinous material for repair of cranial defects.

The provided 510(k) summary for the Parallax Cranioset, a methyl methacrylate for cranioplasty, does not contain detailed information about specific acceptance criteria or an analytical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information based on your requested categories:

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

The document does not explicitly list quantitative acceptance criteria with reported performance values. It states: "Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." This implies that the device met the functional characteristics of the predicate, but specific quantitative metrics are not provided.

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

The document does not specify a sample size for any "test set" in the context of clinical or analytical performance. It describes "performance testing" but does not detail the methodology. There is no information on data provenance (e.g., country of origin, retrospective or prospective).

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. The study focuses on material properties and functional equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth for a test set.

4. Adjudication method for the test set

This information is 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

No such study was conducted or described. The device is a material for cranioplasty, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a medical material, not an algorithm.

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

Given the nature of the device (methyl methacrylate for cranioplasty), the "ground truth" for demonstrating substantial equivalence would likely involve established material standards and the performance characteristics of the predicate device. This would typically not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. It would likely involve:

• Material composition analysis: Verifying that the composition is the same as the predicate.
• Physical and mechanical property testing: Comparing properties like tensile strength, compressive strength, setting time, biocompatibility, etc., against the predicate device and relevant standards.

8. The sample size for the training set

This information is not provided and is not applicable for this type of device. There is no "training set" as it is not a machine learning or AI device.

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

Not applicable, as there is no training set for this device.

Summary of the Study and Equivalence:

The study proving the device meets the acceptance criteria is described as "Non-clinical Test Results: Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." The basis for this equivalence is that "The materials contained within Parallax Cranioset are all materials that appear in the predicate device." This suggests a comparative study against the predicate device (Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689)) for material composition and functional characteristics (e.g., mechanical properties, setting properties). The specific details of this testing (e.g., number of units tested, specific tests performed, quantitative results) are not included in this summary. The key "acceptance criterion" was achieving substantial equivalence to the legally marketed predicate device.

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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.

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