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The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. KYPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.

This document is a marketing clearance (510(k)) for a medical device, KYPHON™ VuE™ Bone Cement, and as such, it primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and performance data in the format typically seen for an AI/ML medical device.

Key takeaway: This document describes a PMMA bone cement, not an AI/ML device. Therefore, the specific types of acceptance criteria and study designs (e.g., MRMC studies, ground truth establishment with experts, data provenance for test/training sets) that are applicable to AI/ML devices are not relevant to this 510(k) submission and are not present in the provided text.

The document discusses acceptance criteria and performance data related to the physical and chemical properties of the bone cement, its biocompatibility, sterility, and shelf life, comparing it to existing predicate devices.

However, to answer your request using the information available and adapting it to the framework you provided (even though it's designed for AI/ML), I will interpret "acceptance criteria" and "device performance" in the context of this traditional medical device.

Acceptance Criteria and Device Performance for KYPHON™ VuE™ Bone Cement

The acceptance criteria for KYPHON™ VuE™ Bone Cement, as described in this 510(k) submission, are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, particularly KYPHON® Xpede™ Bone Cement and Spineplex™ Bone Cement. This equivalence is established through various performance tests that ensure the new device meets established standards for bone cements.

1. Table of Acceptance Criteria and the Reported Device Performance (Adapted for a Non-AI/ML Device):

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify exact sample sizes for each performance test (e.g., number of cement samples tested for mechanical properties, or biological replicates for biocompatibility). It generally states that "Performance testing was performed to characterize the bone cement." The data provenance is laboratory testing conducted by the manufacturer, Tecres S.p.A., with no specific mention of the country of origin for the test data for the performance studies described, although the manufacturer is based in Italy. These were likely prospective lab tests performed specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as this is not an AI/ML device that requires human expert ground truth for imaging interpretation. The "ground truth" for this device's performance is established by its physical, chemical, and biological properties, measured against established engineering and biological standards (ASTM, ISO, Pharmacopoeia).

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of data, typically for AI/ML devices; they are not relevant for the objective physical, chemical, and biological tests performed on bone cement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, usually in diagnostics. This device is a bone cement, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

No, this is not applicable. This is not an algorithm. The "standalone performance" of the bone cement refers to its physical and chemical properties as measured in a lab, which are summarized under "Performance Testing" in section 8 of the 510(k) summary.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., ASTM F451-16, ISO 5833:2002, ISO 10993 series for biocompatibility).
• Objective laboratory measurements of its physical (e.g., mechanical strength, setting time), chemical (e.g., composition, residuals), and biological (e.g., cytotoxicity, endotoxin levels) properties.
• Comparison to predicate device performance, demonstrating "comparable performances."

8. The Sample Size for the Training Set:

This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this device would be its formulation and manufacturing process, optimized through R&D.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" in the development of the bone cement would relate to established material science principles, biocompatibility requirements, and clinical needs for bone cements, which guide its formulation and testing.

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