Search Results

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):

Ask a specific question about this device

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scolosis, and/or lordosis), tumor, pseudarthrosis, and/ or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intented to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

The NEO Pedicle Screw System™ consists of screws, rods and connectors which are available in different sizes. The system includes the relevant instruments which are mainly single use, disposable and delivered sterile, just few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome allov and delivered sterile. Connectors are made out of titanium allov and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The provided text describes a 510(k) premarket notification for the BonOs Inject Bone Cement and NEO Pedicle Screw System. It does not contain information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.

Therefore, I cannot provide the requested information based on the given text. The document refers to:

• Non-clinical performance testing: Static compression bending, dynamic compression bending, static torsion (per ASTM F1717), and axial gripping capacity (per ASTM 1798).
• Biocompatibility testing.
• MRI safety and compatibility evaluation.
• Sterilization cycle validation: In accordance with ISO 11137-2.
• Bacterial endotoxin testing: Per ANSI/AAMI ST72:2011 using the LAL pyrogen testing.
• Usability testing.

However, it explicitly states: "No clinical studies were conducted." This means there is no clinical data from patients or human readers to determine performance metrics against acceptance criteria like sensitivity, specificity, or accuracy in a diagnostic context. This document pertains to a medical device where performance is assessed through mechanical and material properties, not through AI or diagnostic imaging.

Ask a specific question about this device