(117 days)
When used without cement, the CD HORIZON™ Fenestrated Screws (with or without SEXTANT™ or LONGITUDE™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion 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, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement, the CD HORIZON™ Fenestrated Screws are intended 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. CD HORIZON™ Fenestrated Screws augmented with either Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
KYPHON™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions 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.
When used in conjunction with CD HORIZON™ Fenestrated Screws, KYPHON™ Xpede™ bone cement is intended 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. CD HORIZON™ Fenestrated Screws augmented with KYPHON™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Kyphon Xpede™ Bone Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Kyphon Xpede™ Bone Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.
Medtronic HV-RTM Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer. barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.
The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.
The provided text describes specific medical devices (KYPHON™ Xpede™ Bone Cement, CD HORIZON™ Fenestrated Screw Set) and their regulatory clearance (K171938). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than describing a study with acceptance criteria to prove device performance in a clinical setting in the way an AI/ML device would be evaluated for diagnostic accuracy.
Therefore, the requested information (acceptance criteria, study details for proving device meets criteria, sample sizes, expert involvement, MRMC study, standalone performance, ground truth types and establishment methods) is not applicable to this document.
This document refers to biocompatibility and mechanical testing for physical devices (bone cement and screws), which are evaluated against industry standards and by comparison to predicate devices, not through performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.
Here's how the requested points relate to the provided text:
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A table of acceptance criteria and the reported device performance: This document doesn't present acceptance criteria and device performance in the context of diagnostic accuracy or clinical outcomes for an AI/ML device. Instead, it describes:
- Biocompatibility: The materials of the CD HORIZON™ Fenestrated Screws (titanium alloy, titanium, cobalt-chromium-molybdenum alloy) have a long clinical history of safe and effective use, so no additional biocompatibility testing was required. The Xpede™ Bone Cement is identical to the predicate and uses equivalent implant materials, sterilization methods, and bacterial endotoxin testing (20 EU/ml pyrogen limit).
- Mechanical Testing:
- Axial Pull Out Testing (ASTM F543-07): CD HORIZON™ Fenestrated Screws augmented with the subject Kyphon Xepede™ Bone Cement were compared to those augmented with Medtronic HV-R™ Fenestrated Screw Cement. Result: Pull-out strength of the screws was equivalent.
- Flow Rate Analysis: Compared Kyphon Xpede™ Bone Cement to Medtronic HV-R™ Fenestrated Screw Cement regarding injection and flow characteristics using fluoroscopic imaging. Result: Flow rates of the subject and predicate cements were substantially equivalent.
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Sample sizes used for the test set and the data provenance: Not applicable. The testing described (biocompatibility, mechanical testing) refers to material and mechanical properties, not a clinical "test set" for diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic accuracy study requiring expert adjudication is described.
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Adjudication method: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Not applicable. The "ground truth" here relates to established material properties and mechanical performance standards, not clinical diagnoses.
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The sample size for the training set: Not applicable, as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”