(60 days)
The CONFIDENCE SPINAL CEMENT SYSTEM® is intended for percutaneous delivery of the CONFIDENCE™ High Viscosity Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
When the CONFIDENCE™ High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the 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 turnors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VERTEBROPLASTIC Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
CONFIDENCE® Spinal Cement System: The CONFIDENCE cement is a self-curing, polymethylmethacrylate (PMMA) radiopaque bone cement. Its package includes two sterile components: a sachet containing powder polymer and an ampoule containing liquid monometer.
VERTEBROPLASTIC™ Radiopaque Bone Cement: The VERTEBROPLASTIC Radiopaque Bone Cement is a self-curing methyl methacrylate cement consisting of a powder polymer component and a liquid monomer component. The powder component is contained within a foil pouch and the liquid component in a sterile ampoule within a blister pack. The blister pack and the foil pouch are held securely on a card insert that is sealed into a peelable pouch.
The provided FDA 510(k) summary (K201831) focuses on obtaining clearance for magnetic resonance compatibility labeling for the CONFIDENCE® Spinal Cement System and the VERTEBROPLASTIC™ Radiopaque Bone Cement. The document primarily describes the non-clinical testing performed to establish MR compatibility, rather than clinical performance for their primary intended use (treatment of certain vertebral fractures).
Therefore, the requested information specifically regarding acceptance criteria and performance related to the therapeutic efficacy or diagnostic accuracy of the device is not present in this document. The study described is about the device's behavior in an MR environment.
Here's an analysis based on the provided document for the MR compatibility study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MR Compatibility) | Reported Device Performance (Summary) |
|---|---|
| Safety in the Magnetic Resonance Environment | Demonstrated compatibility conditions in the MR environment. |
Note: The document refers to the standard ASTM F2503 for "Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." This standard outlines methods for testing and labeling medical devices for safe use in MRI. Specific quantitative thresholds from ASTM F2503 (e.g., maximum temperature increase, displacement force, image artifact size) are not explicitly detailed in this summary, but the general acceptance criterion is "safety in the MR environment."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests within the summary. However, non-clinical bench testing typically involves multiple samples to ensure reproducibility and statistical confidence.
- Data Provenance: Not applicable as this was a non-clinical, bench-top study conducted in a controlled lab environment, not involving human or animal subjects or
data from a specific country or in a retrospective/prospective manner in the traditional sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable. This was a non-clinical engineering/physics study to measure device behavior in an MR environment, not a clinical study requiring expert diagnosis or
interpretation to establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was a non-clinical engineering/physics study. The "ground truth" (i.e., the device's behavior in an MR field) is determined by direct measurement
against the specifications of the ASTM F2503 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing human reader performance with medical
AI/imaging devices, which is not the subject of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for physical medical devices and their MR compatibility, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the MR compatibility study, the "ground truth" is defined by the technical specifications and safety limits outlined in the ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The device performance is measured against these established engineering and safety standards.
8. The Sample Size for the Training Set
- Not applicable. This was a non-clinical bench study, not an AI or machine learning model development where training sets are used.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there was no training set in this non-clinical submission.
§ 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.”