(30 days)
PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
PALACOS® R+G pro is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The bone cement powder and liquid of PALACOS® R+G pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R+G pro is available in one size: 75 g and is for single use. The PALACOS® R+G pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun
Based on the provided text, the device is PALACOS® R+G pro, a radiopaque bone cement with gentamicin. This document is a 510(k) summary for its premarket notification.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format as would be seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it describes a series of nonclinical tests performed according to international standards (ISO standards) to demonstrate that the PALACOS® R+G pro is substantially equivalent to a legally marketed predicate device (PALACOS® R+G, K031673). The reported device performance is that it characterized per ISO 5833, measured according to Dynstat test method, validated per ISO 11135, and performed per ISO 10993. The conclusion is that it is "substantial equivalent to PALACOS® R+G."
Given the nature of this medical device (bone cement), the "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Stability of liquid components | Characterized per ISO 5833 |
| Maximum temperature | Characterized per ISO 5833 |
| Setting time | Characterized per ISO 5833 |
| Intrusion | Characterized per ISO 5833 |
| Compressive strength | Characterized per ISO 5833 |
| Bending modulus | Characterized per ISO 5833 |
| Bending strength | Characterized per ISO 5833 |
| Impact strength | Measured by Dynstat method |
| EtO sterilization validation | Validated per ISO 11135 |
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation, genotoxicity, chemical characterization) | Performed per ISO 10993 |
2. Sample size used for the test set and the data provenance
The document indicates that nonclinical tests were performed. No specific sample sizes for these tests (e.g., number of test specimens for mechanical strength) are detailed in this summary. The data provenance is from Heraeus Medical GmbH, Germany. The tests are inherently prospective as they are conducted specifically for the purpose of demonstrating equivalence for this new product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a bone cement, not a diagnostic or AI device that requires expert adjudication for ground truth establishing. The "ground truth" for this device's performance is established through physical and biological testing against established standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3. Testing of physical properties and biocompatibility does not involve human adjudication in the described manner.
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 question is not applicable. The device is a bone cement, not an AI or diagnostic tool. No MRMC study was performed or is relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a bone cement, the "ground truth" for its performance and safety is established through:
- Compliance with international standards: ISO 5833 for mechanical properties, ISO 11135 for sterilization, and ISO 10993 for biocompatibility.
- Physical and chemical characterization: Direct measurements of properties like stability, temperature, setting time, strength, etc.
8. The sample size for the training set
This question is not applicable. There is no concept of a "training set" for a physical medical device like bone cement. The manufacturing process and formulation are developed, and then the final product is tested against standards.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.”