(357 days)
The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).
HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ 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.
This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.
Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (HIGH V+) |
|---|---|---|
| Chemical Composition (Powder) | ||
| Polymethymethacrylate | Comparable to Vertecem (43.4% ± 1%) & Spineplex (11.5%) | 63.1% ± 1% |
| Benzoyl peroxide | Comparable to Vertecem (0.5% ± 0.1%) & Spineplex (1.5%) | 0.5% ± 0.1% |
| Barium sulfate | Comparable to Vertecem (30% +2% -3%) & Spineplex (30%) | 27.3% +2.1% - 1.9% |
| Hydroxyapatite | Comparable to Vertecem (10% ± 1%) | 9.1% +1.9% / -2.1% |
| Chemical Composition (Liquid) | ||
| Methylmethacrylate | Comparable to Vertecem (99.3% ± 1%) & Spineplex (97.4%) | 98.5% ± 1% |
| Dimethyl-paratoluidine | Comparable to Vertecem (0.7% ± 0.1%) & Spineplex (2.6%) | 1.5% ± 0.1% |
| Hydroquinone | Comparable to Vertecem (20ppm± 5ppm) & Spineplex (75ppm) | 20ppm± 5ppm |
| Physical Characteristics | ||
| Molecular weights (Powder) | Comparable to Vertecem (222,518 g/mole) | 534,511 g/mole |
| Cured cement | Comparable to Vertecem (394 552 g/mole) | 646,966 g/mole |
| Working phases @ 20°C (Mixing) | Comparable to Vertecem (3 min) | 0.5 min |
| Working phases @ 20°C (Waiting) | Comparable to Vertecem (11.5 min) | 3 min |
| Working phases @ 20°C (Application) | Comparable to Vertecem (25 min) | 9 min |
| Working phases @ 20°C (Setting time) | Comparable to Vertecem (30 min) | 16 min |
| Compressive strength | Comparable to Vertecem (80.3 MPa) | 81.91 MPa |
| Dynamic tension-compression mean fatigue | Comparable to Vertecem (4,317,676±1,237,780 cycles @ 7MPa) & Spineplex (3,799,425±1,990,989 cycles @ 7Mpa) | 4,627,970±847,458 cycles @ 7Mpa |
| Bending strength | Comparable to Vertecem (52.6 MPa) | 57.22 MPa |
| Bending modulus | Comparable to Vertecem (4173 MPa) | 3338.82 MPa |
| Radiopacity | Equivalent radiopacity (Predicate) | Equivalent radiopacity |
| Monomer elution testing | Similar release profile to Vertecem | Increase release till 10 minutes after mixing, then stabilization |
| Compliance Standard | ISO 5833 "implants for surgery - acrylic resin cements" | In compliance with ISO 5833. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
- Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a non-clinical (bench) study.
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
- Not applicable. This is a non-clinical (bench) study about a bone cement, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-clinical (bench) study of a physical material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."
8. The sample size for the training set
- Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device 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.”