(177 days)
OSTEOPAL® V 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.
OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.
This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.
Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Property Standards | The initially cleared acceptance criteria (likely referring to the mechanical properties outlined in ISO 5833 and ASTM F451 for PMMA bone cement) were fulfilled. The document states that the evaluation demonstrated that "no new risks were identified, and the existing risks were not significantly modified." This implies the mechanical performance remained within acceptable limits after the modifications. |
| Biocompatibility | The materials' biocompatibility remains unchanged, implying it meets established acceptance criteria for biocompatibility. |
| Physical and Chemical Characteristics | These characteristics demonstrate substantial equivalence to the predicate device, suggesting they meet the same acceptance criteria as the predicate. |
| Packaging Stability and Integrity | Stability testing was performed, and the initially cleared acceptance criteria were fulfilled, indicating the packaging maintains integrity and the product remains stable over its shelf-life. |
| Sterility / Shelf-life | Evaluation of changes regarding sterility/shelf-life demonstrated no new risks or significant modification of existing risks. Stability testing was performed and fulfilled initial acceptance criteria. This implies the device maintains sterility and efficacy over its stated shelf-life. |
| MR Safety (due to modifications) | The device is designated as "MR Safe." This means it poses "no known hazards in all MR environments" because it is composed of "electrically nonconductive, nonmetallic, and nonmagnetic" materials. |
| Labeling Changes (Contraindications, Adverse Events, Warnings, Precautions) | Assessed in clinical evaluation and risk-based assessment. "It has been demonstrated that OSTEOPAL® V performs as intended if used as intended by the manufacturer and no unknown complications that have not yet been described in the instructions for use were found." This suggests the updated labeling accurately reflects the device's safety profile and intended use. |
| Risk Profile | A risk-based assessment (per DIN EN ISO 14971) concluded that "no new risks were identified, and the existing risks were not significantly modified" due to the modifications. This indicates that the device's overall risk profile remains acceptable and within established limits. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified 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)
This is not applicable as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" requiring adjudication by experts.
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
This is not applicable. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.
8. The sample size for the training set
This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).
9. How the ground truth for the training set was established
This is not applicable as there is no "training set."
§ 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.”