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Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.

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Resinous Material for repairing cranial defects.

Bone Cement for Cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.

The provided document, K040152, is a premarket notification for a medical device (Bone Cement for Cranioplasty) and does not describe acceptance criteria, performance studies, or AI algorithm validation in the way requested. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a performance study report for an AI or software as a medical device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

Here's what can be gathered, with caveats:

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

The document states: "Performance testing demonstrated that the proposed Bone Cement is substantially equivalent to currently marketed Cranioplastic with regard to functional characteristics."

However, it does not provide specific acceptance criteria (e.g., tensile strength range, curing time limits) or quantitative reported device performance values. It only states substantial equivalence.

Remaining questions (2-9) are not applicable or cannot be answered from the provided document because:

• This document is for a traditional medical device (bone cement), not an AI/software medical device. Therefore, concepts like test sets, training sets, ground truth establishment by experts, AI adjudication methods, or MRMC studies do not apply to this submission.
• The summary indicates "Non-clinical Test Results," implying physical and chemical property testing of the bone cement, not performance of a diagnostic algorithm.

Summary of non-applicable/unanswerable points:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to a physical product, not a data-driven algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for bone cement.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 for an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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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."

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Concert™ Cranioplast is a resinous material for repair of cranial defects.

Concert™ Cranioplast is a resinous material for repair of cranial defects.

The provided text is a 510(k) summary for a medical device called "Concert™ Cranioplast," which is a methyl methacrylate material for cranioplasty. The document states that the device is substantially equivalent to a predicate device, Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).

However, the provided text does not contain any information regarding acceptance criteria, specific device performance metrics, clinical study details, sample sizes, expert involvement, ground truth establishment, or any of the other specific items you requested in your prompt.

The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance testing. It simply states:

"Performance testing demonstrated that Concert™ Cranioplast is substantially equivalent to Cranioplastic with regard to functional characteristics."

Without further documentation, it is impossible to fulfill your request for detailed information about acceptance criteria, study design, and results. This summary is at a very high level and indicates that detailed performance data was submitted, but it is not publicly available in this document.

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