(148 days)
PALACOS® R pro 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.
PALACOS® R 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 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 pro is available in one size: 75 g and is for single use. The PALACOS® R 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.
The provided document is a 510(k) summary for a medical device called PALACOS® R pro, a PMMA bone cement. It is a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence, rather than a clinical study with acceptance criteria for device performance in human patients.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable within the context of this document, as it focuses on demonstrating bio-mechanical and material equivalence to an already approved device.
Here's an attempt to address your request based on the provided text, noting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the standards and tests applied to the predicate device and the reference device. The "reported device performance" indicates that PALACOS® R pro (or its relevant precursors) met these criteria, supporting substantial equivalence.
| Acceptance Criteria (Based on Predicate/Reference Device Standards) | Reported Device Performance (PALACOS® R pro / Reference Device) |
|---|---|
| Stability of liquid component (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Maximum temperature (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Setting time (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Intrusion (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Compressive strength (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Bending modulus (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Bending strength (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Impact strength (per Dynstat test method) | Measured (for PALACOS® R+G pro, considered worst-case) |
| Bending strength (per Dynstat test method) | Measured (for PALACOS® R+G pro, considered worst-case) |
| EtO sterilization validation (per ISO 11135) | Validated |
| Biocompatibility: Cytotoxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Irritation (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Sensitization (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Acute systemic toxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Genotoxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the individual non-clinical tests (e.g., number of specimens for compressive strength testing). It states that the tests were performed "per ISO 5833" and "per ISO 10993," which would implicitly define testing protocols and sample sizes within those standards.
- Test set sample size: Not explicitly stated for each test, but implied by adherence to ISO standards.
- Data Provenance: The manufacturer, Heraeus Medical GmbH, is located in Wehrheim, Germany. The tests appear to be conducted as part of the product development and regulatory submission process, which is inherently prospective for demonstrating compliance. The data refers to non-clinical laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here. The "ground truth" for these tests are the established parameters and thresholds defined by international standards (ISO 5833, ISO 11135, ISO 10993) for bone cement properties and sterilization/biocompatibility. These are objective measurements, not subjective expert assessments.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for reconciling differing expert opinions in clinical ground truth establishment. Here, the "truth" is determined by direct physical and chemical measurements against defined standard limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. MRMC studies are associated with evaluating diagnostic imaging devices where human readers interpret results, often to assess AI's impact on reader performance. This document concerns a bone cement, which is a therapeutic device, not a diagnostic one.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone cement, a material used in surgery, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established international standards and measurement methodologies for material properties, sterilization efficacy, and biocompatibility. For instance, compressive strength has a defined physical measurement and an acceptable range per ISO 5833.
8. The Sample Size for the Training Set
Not applicable. This device is a material product, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
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.”