(242 days)
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™) is indicated for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with CREO® or REVLOK® Fenestrated Screw Systems for posterior fixation, FORTRESS™ Radiopaque 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. FORTRESS™ Radiopaque Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
CREO® Fenestrated 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 in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the CREO® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the CREO® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System 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. CREO® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
REVLOK® Fenestrated 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 in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVLOK® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVLOK® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS-Plus™ bone cement, the REVLOK® Fenestrated Screw System 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. REVLOK® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
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FORTRESS™ Radiopaque Bone Cement: FORTRESS™ Radiopaque Bone Cements (FORTRESS™, FORTRESS-Plus™) are radiopaque, self-curing PMMA bone cements. FORTRESS™ is provided as two sterile components, a liquid component and a powder component, which are mixed together prior to use to form the cement. The bone cement is intended for single use only.
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CREO® Fenestrated Screw System: CREO® Fenestrated Screw System consists of fenestrated monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws are available in a variety of sizes to accommodate individual patient anatomy. CREO® Fenestrated Screws mate with 4.75mm, 5.5mm, and 6.35mm diameter rods and connecting components from the CREO® Stabilization System. In addition, CREO Threaded screws and locking caps mate with 6.0mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior use only. Staples are intended for anterior use only. Monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws to the rod. CREO® Fenestrated Screws are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel as specified in ASTM F136, F1537, F1295, F67 and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants. CREO® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
REVLOK® Fenestrated Screw System: The REVLOK® Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK® implants mate with 5.5mm diameter rods and REVLOK® 6.35 implants mate with 6.35mm diameter rods, and connecting components from the REVERE® Stabilization System. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod. The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK® implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138, and F67. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants. The REVLOK® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
I am sorry, but the provided text is a 510(k) summary from the FDA for a medical device (bone cement and screw systems) and does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/ML algorithm.
The document discusses:
- Indications for Use: What the device is intended for.
- Device Description: Details about the bone cement and screw systems.
- Performance Data: States that "Clinical literature data and cadaveric testing was provided to support the substantial equivalence of the subject device. Mechanical testing (axial pull-out and torque removal testing of augmented screws) was conducted in accordance with ASTM F543 and the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s,' May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."
- Technological Characteristics: Compares the subject device to predicate devices.
- Basis of Substantial Equivalence: Concludes substantial equivalence.
However, it does not include any of the AI/ML specific information requested in your bullet points, such as:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for an AI/ML test set or data provenance.
- Number of experts or their qualifications for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results (AI vs. human performance).
- Standalone AI performance details.
- Type of ground truth used for AI/ML.
- Sample size for the AI/ML training set.
- How ground truth for the AI/ML training set was established.
This document is for a physical medical device (bone cement and screw systems) and its substantial equivalence to other legally marketed devices, not for an AI/ML powered diagnostic or therapeutic device.
§ 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.”