(27 days)
DePuy CMW 1, 2 and 3 Bone Cements are indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
DePuy CMW 1, 2 and 3 Bone Cements are self-curing cements. The cements allow the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made: Changes are being made to the formulation of the bone cement liquid components. A warning is being deleted from the labeling for DePuy CMW 3 Bone Cement.
This 510(k) submission (K053003) is for a Polymethyl Methacrylate (PMMA) Bone Cement, which is a Class II device. PMMA bone cements are considered low-risk and therefore exempt from extensive clinical trials. Instead, the primary method for demonstrating safety and effectiveness for such devices is through establishing substantial equivalence to legally marketed predicate devices.
The provided document does not contain details of a clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies, as it's a submission for a bone cement, not typically a device that undergoes such rigorous comparative effectiveness testing in the same way as, for example, an AI diagnostic tool.
Instead, the submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and explicitly stating where information is not present given the nature of the device and submission type:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is typically used for devices where specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device) are measured against predefined targets. For a bone cement, the "acceptance criteria" revolve more around physical, chemical, and biological properties, and demonstration of equivalency to existing legally marketed devices.
The document implicitly states the acceptance criteria as meeting the performance/characteristics of the predicate devices. The "reported device performance" is then the demonstration through various tests (often mechanical, chemical, biocompatibility) that the device meets these equivalent properties. However, specific numerical acceptance criteria and detailed performance results from such tests are not presented in this summary document. The summary states:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate devices regarding: | DePuy believes that the modified DePuy CMW 1, 2 and 3 Bone Cements described in this submission are substantially equivalent to the previously cleared and approved bone cements based on similarities in formulations, manufacturing methods and intended use. (This implies that underlying analyses, likely physical and chemical testing, were conducted to support these similarities, but the report does not detail the results of those tests). |
| - Formulations | (Not detailed in this summary but assumed to be demonstrated in the full submission) |
| - Manufacturing methods | (Not detailed in this summary but assumed to be demonstrated in the full submission) |
| - Intended use (fixation of prostheses to living bone) | Stated in Indications for Use, which aligns with predicate devices. |
| - Safety and Effectiveness (as demonstrated by similarity) | The FDA's substantial equivalence determination implies these criteria were met. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a bone cement. There isn't a "test set" of clinical cases in the way an AI diagnostic device would have for performance evaluation. The "test set" would refer to samples of the bone cement tested in vitro for its physical, chemical, and mechanical properties, or potentially in animal studies for biocompatibility. These details are not provided in the summary, which focuses on the regulatory outcome.
- Data Provenance: Not applicable in the context of this 510(k) summary. The "data" here would be from laboratory testing of the bone cement itself, rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth, in the AI/diagnostic sense, is not established for this type of device. The "ground truth" for a bone cement would be its inherent physical and chemical properties and its biocompatibility, confirmed through standard laboratory testing and manufacturing controls.
- Qualifications of Experts: Not applicable in the AI/diagnostic sense. The experts involved would be material scientists, chemists, and toxicologists who conducted the necessary laboratory and biocompatibility tests, and potentially orthopaedic surgeons validating the intended use and performance in surgical simulated environments. Their qualifications are not mentioned in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" that requires adjudication by human readers/experts in this submission.
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
- MRMC Study: No. This is a bone cement, not an AI diagnostic device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is a bone cement, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a bone cement, the "ground truth" would be established through a combination of:
- Physical and Chemical Characterization: Laboratory testing to confirm the material composition, viscosity, setting time, mechanical strength (e.g., compressive strength, fatigue strength), and other properties against recognized standards (e.g., ISO for bone cements).
- Biocompatibility Testing: In vitro and/or in vivo tests (often animal studies) to ensure the material is not toxic, allergenic, or otherwise harmful to living tissue.
- Comparison to Predicate Device Data: Demonstrating that the modified cement performs equivalently to the previously approved (predicate) bone cements across these various properties.
The summary itself does not detail these ground truths but implies they were used to establish "similarities in formulations, manufacturing methods and intended use."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- How Ground Truth Established: Not applicable, as there is no training set. If referring to the development and validation of the bone cement itself, the "ground truth" for its characteristics (as described in point 7) would have been established through well-defined material science and biocompatibility testing protocols, adhering to relevant industry standards and regulatory guidelines.
§ 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.”