(150 days)
The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Opacity + is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
This document is a 510(k) summary for a medical device called "Opacity + Cement." It describes the device, its intended use, and its equivalence to a predicate device. This type of regulatory document typically focuses on demonstrating substantial equivalence to pre-existing devices based on established non-clinical performance standards rather than detailed clinical studies with specific acceptance criteria that would assess improvement over human readers or standalone AI performance.
Therefore, many of the requested categories are not applicable or not explicitly stated in this 510(k) summary. I will fill in what can be inferred or stated directly from the text and mark the rest as "Not Applicable (N/A)" or "Not Stated (NS)".
Acceptance Criteria and Study Details for Opacity + Cement (K080873)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Nonclinical Performance (Stability/Compliance) | Compliance with ISO 5833 "Implants for surgery - acrylic resin cements" | Final properties of Opacity + Bone Cement are stable and in compliance with ISO 5833. |
| Nonclinical Performance (Similarity to Predicate) | Similar to predicate devices | Final properties are similar to predicate devices. |
| Substantial Equivalence | Modifications do not change intended use or fundamental scientific technology. | Modifications do not change the intended use or fundamental scientific technology. |
| Substantial Equivalence | Modifications do not raise new issues of safety or effectiveness. | Modifications do not raise any new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not Stated (NS) – The document refers to "test data," but a specific sample size for a test set (e.g., number of cement samples tested) is not provided.
- Data Provenance: Not Stated (NS) – The country of origin of the data or whether it was retrospective or prospective is not specified. It is implied to be laboratory-based nonclinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not Applicable (N/A) – Ground truth in this context typically refers to clinical diagnosis or outcome, which is not the focus of this nonclinical performance evaluation. The "ground truth" for the nonclinical tests would be the established chemical and mechanical properties as defined by ISO 5833, not expert consensus.
- Qualifications of experts: Not Applicable (N/A)
4. Adjudication method for the test set
- Adjudication method: Not Applicable (N/A) – Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance studies, not for nonclinical material property testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No – This document pertains to bone cement, not an AI or imaging device that would involve human readers.
- Effect size: Not Applicable (N/A)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not Applicable (N/A) – This device is a bone cement, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Nonclinical performance standards (e.g., ISO 5833). The "ground truth" for the device's properties (e.g., strength, setting time) would be defined by the specifications laid out in the ISO standard.
8. The sample size for the training set
- Sample size for training set: Not Applicable (N/A) – This is not an AI/machine learning device, so the concept of a "training set" is not relevant. The cement formulation is developed through research and development, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
- How ground truth was established: Not Applicable (N/A) – As above, the concept of a training set and its ground truth does not apply to this device. The properties of the cement are established through material science principles and manufacturing specifications to meet the requirements of the ISO standard.
§ 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.”