(50 days)
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study with specific performance metrics. Therefore, the information typically requested for acceptance criteria and a study proving device performance (like sensitivity, specificity, or reader improvement with AI) is not directly available in this document.
Instead, the submission focuses on demonstrating that the new device, BonOs® Inject, is as safe and effective as the predicate device, OSTEOPAL® V, through comparative physical, chemical, and mechanical tests.
Here’s a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission proving substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not provided. Instead, the "performance" revolved around demonstrating equivalence to the predicate device in key physical, chemical, and mechanical properties.
| Characteristic/Test | Acceptance Criteria (Implicit: Equivalent to Predicate) | Reported Device Performance (BonOs® Inject) |
|---|---|---|
| Chemical Composition | Same as OSTEOPAL® V | Same chemical components |
| Physical Properties | Comparable to OSTEOPAL® V | Demonstrated through comparative tests |
| Mechanical Properties | Comparable to OSTEOPAL® V | Demonstrated through comparative tests |
| Intended Use | Same as OSTEOPAL® V | Treatment of pathological vertebral fractures via vertebroplasty or kyphoplasty |
| Safety & Effectiveness | Equivalent to OSTEOPAL® V | Demonstrated through comparative tests |
Note: The document states, "The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data." The specific values or direct comparisons for each property are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission does not detail a clinical "test set" in the way a diagnostic AI device would. The "tests" likely refer to bench-top laboratory tests for physical, chemical, and mechanical properties.
- Sample Size for Test Set: Not specified. The submission refers to "comparative tests" and "relevant data" but does not provide numbers for specimens or batches used in these tests.
- Data Provenance: Not specified, but the applicant is from Germany, so it's likely the tests were conducted in Germany or a related clinical setting. The device is also "successfully marketed in Europe."
- Retrospective or Prospective: Not applicable as these are not human subject studies in the traditional sense for evaluating device performance. These would be laboratory studies.
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 device is a bone cement, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here would be established by validated laboratory testing methods and standards for material properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or subjective assessments.
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 not a medical device involving AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant (bone cement), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context would be the established material properties and performance characteristics of the predicate device (OSTEOPAL® V), determined through standard laboratory testing methods and industry specifications for bone cements. The new device was then tested against these established benchmarks to demonstrate equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.”