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The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.

The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D.

As a result, a viscous injectable paste is obtained which can be introduced into a vertebral body using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing the bone cement is able to stabilize the vertebral lesions and vertebral compression fractures. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.

This document is a 510(k) Premarket Notification for the Vertecem II Mixing Kit, a PMMA bone cement. It is not an AI/ML device, therefore, the requested information regarding acceptance criteria, study data analysis, and expert involvement is not applicable. The device relies on physical, chemical, and mechanical comparative tests to establish substantial equivalence to predicate devices, not on AI/ML performance metrics.

Summary of Device and Regulatory Context:

The Vertecem II Mixing Kit is a radio-opaque, injectable acrylic bone cement designed for Vertebroplasty or Kyphoplasty procedures to treat pathological vertebral body fractures (e.g., from osteoporosis, hemangioma, metastatic cancers, myeloma). The 510(k) submission seeks to demonstrate substantial equivalence to two predicate devices: Vertecem (K090435) and BonOs Inject (K090460).

Acceptance Criteria and Device Performance (Not Applicable - Non-AI/ML Device):

This device is a medical material (PMMA bone cement) and its regulatory clearance is based on demonstrating substantial equivalence to existing predicate devices through physical, chemical, and mechanical comparative tests, not on an algorithm's performance in a diagnostic or predictive task. Therefore, the concept of "acceptance criteria" for AI/ML performance metrics, such as sensitivity, specificity, or AUC, and the associated study designs (e.g., MRMC studies, standalone studies) are not applicable.

The document states: "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data."

Table of Comparison (Based on the provided text, but note this is for material properties, not AI/ML performance):

(Note: The document states "Vertecem II bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices BonOs Inject and Vertecem," and "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data." Specific numerical values for these properties are not provided in the summary, but were part of the full submission.)

Regarding the specific questions about AI/ML device studies:

1. Sample size for the test set and data provenance: Not applicable. The study involved comparative physical, chemical, and mechanical testing of the bone cement, not a test set of data for an AI algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of material science refers to validated laboratory test results and established material standards, not expert consensus on medical images or patient outcomes.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance with AI assistance, which is irrelevant for a bone cement product.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
6. The type of ground truth used: For bone cements, the "ground truth" would be established physical, chemical, and mechanical properties determined through standardized testing methods, such as those outlined in ISO or ASTM standards, and their comparison to the predicate devices and regulatory requirements. It is a material science "ground truth," not a clinical "ground truth" established by experts.
7. The sample size for the training set: Not applicable. There is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

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The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertecem is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid privation in this type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

The provided text is for a 510(k) summary for the Vertecem Bone Cement, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It describes the device, its intended use, and states that non-clinical tests were performed to show compliance with bone cement standards. However, it does not contain information about a study that used a test set of data, human readers, or addressed acceptance criteria related to diagnostic performance or accuracy.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and device performance based on the input document for the following reasons:

• No Acceptance Criteria for Diagnostic Performance: The document describes the "Vertecem Bone Cement" and its physical properties and intended use for fixing vertebral fractures. It doesn't mention any diagnostic function where acceptance criteria related to accuracy, sensitivity, specificity, or similar metrics would apply.
• No Diagnostic Study: The summary discusses "non-clinical tests" indicating the device's properties are stable and comply with bone cement standards. This refers to material science and mechanical testing, not a study evaluating diagnostic performance on a test set of data. There is no mention of a test set, ground truth, expert readers, or AI in this context.
• No "Device Performance" in the Requested Context: The device performance mentioned in the document relates to the stability and compliance of the bone cement material, not to a diagnostic outcome that would be compared against acceptance criteria in the way you've outlined.

The prompt's questions (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set information) are all relevant to the evaluation of diagnostic algorithms (e.g., AI in radiology). Since this document is about a bone cement product, these questions are not applicable to the submitted content.

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