Search Results

Kyphon® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. 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. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

KYPHON® HV-R® Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided document is a 510(k) premarket notification for a medical device: KYPHON® HV-R® Bone Cement. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance.

Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in this document.

This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as another legally marketed device (the predicate). It usually relies on comparisons of technological characteristics, materials, and intended use, rather than new clinical trials or performance studies against specific acceptance criteria for a novel technology or AI algorithm.

Summary of why the requested information is not in the document:

• Acceptance Criteria & Device Performance: The document doesn't define new acceptance criteria for the KYPHON® HV-R® Bone Cement's performance. Instead, it asserts that its performance characteristics (design features, device materials, chemical composition, device performance, packaging, manufacturing, sterilization) are "substantially equivalent" to predicate devices.
• Sample Sizes (Test/Training) & Data Provenance: Not applicable, as no new performance study data is presented. The document is about comparing to existing predicates.
• Expert Ground Truth & Adjudication: Not applicable, as there's no diagnostic or analytical performance study requiring expert review.
• MRMC Study / Standalone Performance: Not applicable, as this is not a diagnostic device or AI algorithm with human-in-the-loop interaction.
• Ground Truth Type: Not applicable.
• Training Set Details: Not applicable.

The document states: "The subject KYPHON® HV-R® Bone Cement has the same fundamental scientific technology as the predicates KYPHON® HV-R® Bone Cement (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone Cement (K151227 S.E. 11/16/2015). The subject device utilizes equivalent implant materials, sterilization methods and bacterial endotoxin testing applying the same 20 EU/mL pyrogen limit specifications utilizing the gel clot test method as the predicates..." This highlights the comparative nature of the submission.

Ask a specific question about this device