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The 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 resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made: Change to the formulation of the bone cement liquid component.

The provided text is a 510(k) premarket notification for a medical device: Vertebroplastic™ Radiopaque Bone Cement. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for software or AI/ML-based devices.

Therefore, much of the requested information cannot be extracted directly from this document. The device is a physical bone cement, not a software or AI/ML device, so concepts like "test set," "training set," "ground truth experts," "adjudication method," and "MRMC study" are not applicable in the way they would be for digital health technologies.

However, I can extract information related to the device description and the basis of substantial equivalence.

Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or available:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on "technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" and "intended use and indications for use."

Therefore, a table of acceptance criteria and reported device performance as commonly understood for digital health devices cannot be created directly from this text. The "performance" assessment is qualitative, comparing the modified device to its 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. This is a physical bone cement, not a software or AI/ML device that would undergo testing with a "test set" of data. The "study" mentioned is a comparison of characteristics to a predicate device.

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. The concept of "ground truth for a test set" is not relevant to the substantial equivalence review of this physical device.

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

Not applicable. This is not a study involving human readers or a test set requiring adjudication in this context.

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, and no MRMC study is mentioned.

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

Not applicable. This is a physical bone cement, not an algorithm.

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

Not applicable. The review focuses on material properties and chemical composition compared to a predicate, not on clinical outcomes or diagnostic accuracy requiring "ground truth" as typically defined for AI/ML devices.

8. The sample size for the training set

Not applicable. This is a physical bone cement, not an AI/ML device that requires a "training set."

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

Not applicable.

Summary of what can be extracted from the document regarding the "study" for this device:

The "study" or justification for this device meeting its criteria is a demonstration of substantial equivalence to previously cleared predicate devices.

• Predicate Devices:

  • Vertebroplastic™ Radiopaque Bone Cement (K043406) - This is the original version of the same device, with the current submission being a modification.
  • SmartSet GMV Endurance Gentamicin Bone Cement (K033382)

• Basis of Substantial Equivalence:

  • Technological Characteristics: Chemical composition, material properties, performance characteristics, manufacture, packaging, and sterilization. (The document mentions a "Change to the formulation of the bone cement liquid component" as the modification being made.)
  • Intended Use and Indications for Use: The intended use and indications for use are stated to be similar (identical) to the predicate Vertebroplastic™ Radiopaque Bone Cement (K043406).

In essence, the "acceptance criteria" here implicitly are that the modified device's characteristics and intended use are sufficiently similar to the predicate devices such that it raises no new questions of safety or effectiveness. The "study" involves comparing the modified formulation against the established properties of the cleared predicate devices. Specific quantitative performance data from a clinical trial or bench test proving performance against strict numerical acceptance criteria are not presented in this summary, as is typical for 510(k)s seeking substantial equivalence for material modifications.

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Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.

Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made: A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.

This document is a 510(k) summary for a medical device (Aneuroplastic®) and an FDA clearance letter. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) submission process for this type of device (Methyl Methacrylate (MMA) for reinforcing and encapsulating cerebral aneurysms) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with acceptance criteria.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory classification, intended use, and the basis for substantial equivalence, which is typically through demonstrating similar technological characteristics to existing devices.

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DePuy CMW 1 Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

DePuy 1 Gentamicin Bone Cement is a self-curing cement. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:

• . DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation.
• . Changes are being made to the formulation of the bone cement liquid component.

The provided text is a 510(k) premarket notification for a medical device (DePuy CMW 1 Gentamicin Bone Cement). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

Instead, it focuses on:

• Device Description: General information about the bone cement and modifications being made (new 20g presentation and changes to liquid component formulation).
• Intended Use and Indications: Specifies its use in the second stage of a two-stage revision for total joint arthroplasty after infection clearance.
• Basis of Substantial Equivalence: States that the device is considered substantially equivalent to previously cleared/approved bone cements based on similarities in formulations, manufacturing methods, and intended use.
• FDA Correspondence: Letters confirming the 510(k) clearance and related regulatory information.

Therefore, I cannot provide the requested table and information as there is no data in the provided text to fulfill those requirements.

The document is a regulatory submission for a bone cement, not a study evaluating its diagnostic performance or clinical effectiveness with specific metrics. It states the intent to market based on substantial equivalence to existing devices, implying that the safety and effectiveness are inferred from those predicate devices, rather than demonstrated through a de novo clinical study with specific acceptance criteria.

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