(96 days)
Refobacin 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Refobacin® Bone Cement R is a fast setting acrylic cement containing gentamicin, 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.
This document describes the 510(k) premarket notification for Refobacin® Bone Cement R, a polymethylmethacrylate (PMMA) bone cement, and its substantial equivalence to the predicate device PALACOS® G.
Acceptance Criteria and Study Details:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance against specific acceptance criteria for a novel device. As such, the structure of the provided information is geared towards comparing the subject device to its predicate.
Here's an attempt to extract and organize the information based on your request, understanding that a direct "acceptance criteria" table and a "study proving performance" in the typical sense for a brand new AI/diagnostic device are not present in this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit - Substantial Equivalence to Predicate) | Reported Device Performance (Refobacin® Bone Cement R) |
|---|---|---|
| Mechanical Properties | Comparable to PALACOS® G | "The results showed that Refobacin® Bone Cement R possesses mechanical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable) |
| Chemical Properties | Comparable to PALACOS® G | "The results showed that Refobacin® Bone Cement R possesses... chemical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable) |
| Physical Properties | Comparable to PALACOS® G | "The results showed that Refobacin® Bone Cement R possesses... physical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable) |
| Handling Characteristics | Comparable to PALACOS® G | "The results showed that Refobacin® Bone Cement R possesses... handling characteristics necessary to fulfill the intended use." (Reported as compliant and comparable) |
| Bacterial Endotoxin Limit | Met pyrogen limit specifications | "BET demonstrated the pyrogen limit specifications have been met." |
Explanation: In a 510(k) submission for a bone cement, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as a predicate device already on the market. The device performance is deemed acceptable if it performs comparably or better than the predicate across critical parameters, and meets relevant standards for safety (like endotoxin testing).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involves "comparative in-vitro testing" with the predicate device. For materials like bone cement, this typically involves a series of standardized tests (e.g., strength, fatigue, curing time, temperature release) run on multiple samples of both the subject and predicate material. The "sample size" here refers to the number of specimens tested for each characteristic.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the tests are "in-vitro," meaning conducted in a lab setting, not clinical patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a bone cement, not an AI/diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance is established through standardized laboratory testing and material science metrics.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Testing is objective and based on established material science methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a medical device (bone cement), not an imaging or diagnostic AI system that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical medical device (bone cement), not an algorithm. The in-vitro testing could be considered "standalone" in the sense that it evaluates the material properties independently of a human user; however, it's not an "algorithm-only" performance as you would describe for software.
7. The Type of Ground Truth Used
- Objective Laboratory Measurements and Standards Compliance: The "ground truth" for bone cement performance is established through objective, measurable physical, chemical, and mechanical properties (e.g., compressive strength, bending strength, fatigue resistance, setting time, temperature profile, residual monomer content, radiopacity, endotoxin levels). These are compared against established industry standards and the performance of the predicate device.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary from the Document:
The 510(k) submission for Refobacin® Bone Cement R relies on non-clinical comparative in-vitro testing to demonstrate substantial equivalence to PALACOS® G. The tests evaluated mechanical, chemical, physical, and handling characteristics. Additionally, Bacterial Endotoxin Testing (BET) confirmed that pyrogen limits were met. No clinical data was required for this determination. The document concludes that "Refobacin® Bone Cement R is substantially equivalent to PALACOS® G for the primary intended use of fixation of prosthetic components as described in the device labeling" due to similarities in design, function, indications for use, and fundamental scientific technology, and that it "does not introduce any new risks of safety or efficacy."
§ 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.”