(275 days)
When used in conjunction with High V+ Bone Cement, the Nu Vasive Reline 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. NuVasive Reline Fenestrated Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with the Nu Vasive Reline Fenestrated Screws, High V+ 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. High V+ Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
The NuVasive Reline Fenestrated Screws are available in a variety sizes and are designed to connect to 5.0mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the NuVasive Reline System. The screws contain 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 screws are provided sterile or non-sterile.
The High V+ Bone Cement is a self-curing PMMA based (high viscosity, radiopaque) bone cement. High V+ Bone Cement is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder contains polymethylmethacrylate, barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The 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 purpose of this 510(k) is to expand the indications for use for the NuVasive Reline Fenestrated Screws to include its use with High V+ Bone Cement in the treatment of advanced stage tumors of the thoracic and lumbar spine.
The provided text is a 510(k) summary for NuVasive® Reline® Fenestrated Screws with High V+ Bone Cement. It outlines the regulatory submission for a medical device and does not describe an AI or software-as-a-medical-device (SaMD) study. Therefore, I cannot extract the information required to answer the prompt as the document focuses on the substantial equivalence of a physical medical device (screws and bone cement) based on technological characteristics and mechanical performance testing, not on an AI or SaMD's performance against clinical acceptance criteria.
The prompt specifically asks for details related to an AI/Software device, such as:
- Acceptance criteria and device performance table: This would typically involve metrics like sensitivity, specificity, AUC, or other quantifiable outputs for a diagnostic or prognostic AI.
- Sample size and data provenance for test set: For AI models, this refers to the dataset used for validation.
- Number and qualifications of experts for ground truth: Pertains to expert adjudication in studies for AI/SaMD.
- Adjudication method: How ground truth was established for AI/SaMD.
- Multi Reader Multi Case (MRMC) study: Relevant for evaluating AI-assisted human performance.
- Standalone performance: Performance of the AI algorithm without human intervention.
- Type of ground truth: How the true labels for the data were determined (e.g., pathology, outcomes).
- Training set sample size: For AI model development.
- Ground truth for training set: How truth was established for data used to train an AI model.
Since the document describes a physical device (bone cement and screws), these concepts are not applicable. The performance data mentioned (axial pull-out and removal torque testing, cement flow and bolus formation) are mechanical tests, not clinical performance metrics for an AI. The document explicitly states, "No clinical studies were conducted."
§ 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.”