(199 days)
When used in conjunction with the CarboClear Fenestrated Pedicle 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.
When used in conjunction with High V+ Bone Cement, the CarboClear Fenestrated Pedicle 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. CarboClear Fenestrated Pedicle Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The CarboClear Fenestrated Pedicle Screws are cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+ Bone Cement) into the vertebral body. The CarboClear Fenestrated Screws are implanted with components of the CarboClear Pedicle Screw System.
The CarboClear Fenestrated Screws are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker.
The CarboClear Fenestrated Screws are supplied sterile, and are intended for single use.
The High V+ Bone Cement is a self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.Ndimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.
The provided text is an FDA 510(k) Premarket Notification for CarboFix Orthopedics Ltd.'s CarboClear® Fenestrated Pedicle Screws and High V+ Bone Cement. This document is a regulatory submission for medical devices, specifically focusing on demonstrating substantial equivalence to predicate devices, rather than an AI development and validation study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML medical device. It focuses on the physical and chemical properties and intended use of the bone cement and pedicle screws.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance (for an AI/ML device).
- Sample sizes used for a test set or data provenance for AI/ML.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication methods for AI/ML test sets.
- MRMC comparative effectiveness study results.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for a training set (AI/ML).
- How ground truth for a training set was established (AI/ML).
The "Performance Data" section solely refers to bench testing for mechanical integrity and compatibility of the screws and bone cement, such as axial pullout strength, insertion/removal torque, and static bending/torsion tests, as well as characterization of cement flow and bolus formation. These are standard tests for physical medical devices, not AI/ML algorithms.
§ 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.”