(57 days)
Biomet® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone.
Biomet® Bone Cement R is a fast setting acrylic cement, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X-ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.
The Biomet Bone Cement R device is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Biomet® Bone Cement R) |
|---|---|---|
| Non-Clinical Testing | Mechanical Characteristics | Met acceptance criteria (comparable to predicate) |
| Chemical Characteristics | Met acceptance criteria (comparable to predicate) | |
| Physical Characteristics | Met acceptance criteria (comparable to predicate) | |
| Handling Characteristics | Met acceptance criteria (comparable to predicate) | |
| Bacterial Endotoxin Limit | Met pyrogen limit specifications | |
| Cytotoxicity | Met acceptance criteria |
2. Sample Size and Data Provenance
- Test Set Sample Size: No specific numerical sample sizes are provided for the non-clinical tests. The tests were performed in-vitro.
- Data Provenance: The data appears to be from non-clinical laboratory testing (in-vitro). The country of origin for the data is not explicitly stated, but the sponsor, Biomet Inc., is located in Warsaw, Indiana, USA, suggesting the testing was likely conducted in the US or by a lab associated with the company. The data is prospective, generated specifically for this submission.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
- Number of Experts: Not applicable. The ground truth for the non-clinical tests is established by laboratory measurements against defined specifications, not by expert consensus in the same way clinical ground truth is.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. For non-clinical tests, results are typically determined by adherence to standardized protocols and measurement against pre-defined specifications. There's no mention of an adjudication process by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a bone cement, and the evaluation for substantial equivalence was based on non-clinical (in-vitro) performance data compared to a predicate device, not on human reader performance.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in the sense that the device's technical characteristics (mechanical, chemical, physical, handling) were assessed independently, and its biocompatibility (cytotoxicity, bacterial endotoxin) was also tested as an algorithm for its own performance. The non-clinical tests conducted evaluated the device's inherent properties. However, this is not a "standalone algorithm performance" in the context of AI/software, but rather standalone laboratory performance for a physical medical device.
7. Type of Ground Truth Used
- Ground Truth: For the non-clinical tests, the ground truth was based on:
- Defined specifications/standards: For mechanical, chemical, physical, and handling characteristics, the performance was compared to that of the predicate device (PALACOS® R), implying adherence to or equivalence with established performance profiles for bone cements.
- International standards: Bacterial Endotoxin Testing (BET) met "pyrogen limit specifications" (implying adherence to an accepted standard). Cytotoxicity testing was conducted "in accordance with ISO 10993-5," which establishes the ground truth for biocompatibility.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This submission is for a physical medical device (bone cement), not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical 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.”