(40 days)
The F20 is indicated 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).
F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The 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 liguid 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 components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
The medical device described in the 510(k) summary is a bone cement called F20, intended for use in vertebroplasty and kyphoplasty procedures to fix pathological fractures of the vertebral body.
Here's an analysis of the acceptance criteria and study information provided in the document:
This document describes a non-clinical study for device F20 as depicted in the 510(k) summary provided.
1. A table of acceptance criteria and the reported device performance
The F20 bone cement’s performance was evaluated against the standards outlined in ISO 5833 "Implants for surgery - acrylic resin cements". The acceptance criteria are implicitly defined by compliance with this standard and similarity to predicate devices.
| Acceptance Criteria (Implicit from ISO 5833 & Predicate Comparison) | Reported Device Performance (F20) |
|---|---|
| Chemical Composition | Compliant with ISO 5833, similar to predicate devices |
| Powder Morphology | Compliant with ISO 5833, similar to predicate devices |
| Molecular Weights | Compliant with ISO 5833, similar to predicate devices |
| Handling Times | Compliant with ISO 5833, similar to predicate devices |
| Compressive Strength | Performed (per ISO 5833), compliant, similar to predicate devices |
| Dynamic Fatigue Test (Compression) | Performed, compliant, similar to predicate devices |
| Flexural Strength | Performed (per ISO 5833), compliant, similar to predicate devices |
| Flexural Modulus | Performed (per ISO 5833), compliant, similar to predicate devices |
| Viscosity or Extrusion Forces during Injection Phase | Performed, compliant, similar to predicate devices |
| Setting Time vs. Temperature | Performed, compliant, similar to predicate devices |
| Radiopacity | Performed, compliant, similar to predicate devices (high amount of radiopaque agent specifically mentioned in description) |
| Monomer Elution Testing | Performed, compliant, similar to predicate devices |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for compressive strength testing). It only states that tests were "conducted."
The data provenance is from non-clinical laboratory testing conducted by Teknimed SAS, the manufacturer, in France. The specific nature of the data is experimental results from material science and mechanical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there was no clinical study. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards (ISO 5833) and the performance characteristics of the predicate devices. The experts involved would be the engineers and scientists conducting these tests, but their number and qualifications are not specified.
4. Adjudication method for the test set
This information is not applicable as there was no clinical study involving subjective interpretation. The assessment was based on objective measurements against ISO standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone cement, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an AI algorithm. The performance evaluation was of the physical and chemical properties of the bone cement in a standalone non-clinical setting.
7. The type of ground truth used
The "ground truth" for the non-clinical tests was based on:
- Established scientific and engineering standards: Specifically ISO 5833 "Implants for surgery - acrylic resin cements."
- Performance characteristics of legally marketed predicate devices: Vertecem (K090435), Opacity+ (K080873), and Spine-Fix® (K045593). The F20 was shown to have similar properties to these predicates.
8. The sample size for the training set
This information is not applicable as this is not a machine learning or AI device. There is no concept of a "training set" for the evaluation of a bone cement's physical and chemical properties.
9. How the ground truth for the training set was established
This information is not applicable as this is not a machine learning or AI 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.”