(337 days)
OGM® 1 is a PMMA bone cement 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.
OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to OGM® 1 and OGM® 1A®. This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data.
OGM® bone cements without Gentamicin
OGM® 1 is polymethylmethacrylate (PMMA) bone cement:
- OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).
OGM® bone cements with Gentamicin
OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).
This document describes the acceptance criteria and study results for two PMMA bone cements, OGM® 1 and OGM® 1A. These devices were evaluated against various standards to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance (OGM® 1 & OGM® 1A) |
|---|---|---|
| Mechanical Properties | ||
| Stability of liquid component | ISO 5833, ASTM F2118, ASTM F451 requirements | Characterized; ISO 5833 requirements fulfilled; ASTM F451 requirements met; Mechanical characteristics similar to predicate devices in side-by-side testing (ASTM D732, ASTM F2118, ISO 5833) |
| Maximum Temperature | ISO 5833 | Characterized |
| Setting Time | ISO 5833 | Characterized |
| Intrusion | ISO 5833 | Characterized |
| Compressive Strength | ISO 5833 | Characterized |
| Bending Modulus | ISO 5833 | Characterized |
| Bending Strength | ISO 5833 | Characterized |
| Material/Chemical Properties | ||
| Endotoxin | USP Endotoxin Reference Standard (limit value 20 EU/device) | Results meet the limit value (20 EU/device) for both OGM® 1 and OGM® 1A |
| Gentamicin Release Profile (OGM® 1A) | Compared to predicate device (K023103) | No significant difference observed; Results are similar when compared to predicate device |
| Antibacterial Efficiency (OGM® 1A) | AATC | Efficient against E. Coli |
| Chemical Composition (overall) | Similar to predicate devices | Similar, with noted differences in X-ray contrast medium (barium sulfate vs. zirconium dioxide) and presence/absence of chlorophyll. Subject device (OGM® 1A) contains 1g gentamicin sulfate, while primary predicate (Palacos® R+G) contains 0.5g. |
| X-Ray Contrast Medium | Use of commercialized bone cement X-ray contrast medium | Contains barium sulfate as X-ray contrast medium (both barium sulfate and zirconium dioxide are acceptable for this purpose) |
| Biocompatibility | ||
| Biocompatibility Testing | ISO 10993 | Biocompatibility testing performed (cytotoxicity, irritation, acute systemic toxicity, subacute systemic toxicity, implantation, genotoxicity). Results demonstrate biological safety for OGM® 1 (as OGM® 1A regarded as worst case). |
| Sterilization | ||
| Ethylene Oxide Sterilization | ISO 11135 | Validated as per ISO 11135 |
| Sterility Assurance | DIN EN ISO 11135-1 and DIN EN ISO 10993-7 | Sterilized with an established method (ethylene oxide). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each mechanical or chemical test. The tests were performed "side by side mechanical testing" (page 7, 8) and "subject device and secondary predicate device contains 1g gentamicin sulfate, on the contrary primary predicate device contains 0.5g gentamicin sulfate. Gentamicin sulfate is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens. As per gentamicin sulfate ratio is higher than the primary predicate device antibacterial efficacy can be considered as substantially equivalent to primary predicate device. Antibacterial efficacy tests are performed to subject device. On the other hand, release ratio of Gentamicin is important both in dosage and total release duration. OGM® 1A is subjected to Gentamicin release test comparatively with the predicate device. Lastly, gentamicin has a negative effect on product mechanical and physical properties. ISO 5833 tests are applied to OGM® 1A and demonstrated compliance." (page 12) implying comparative testing.
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory-based, non-clinical tests conducted by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes non-clinical performance and safety testing of a medical device (bone cement). The "ground truth" for these types of studies is typically based on established international standards (e.g., ISO, ASTM, USP) and scientific principles, not on expert consensus interpreting subjective data. Therefore, individual experts are not involved in establishing ground truth in the same way they would be for studies involving diagnostic image interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is based on objective measurements against established international standards and specifications. There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document pertains to the premarket notification (510(k)) of a bone cement, which involves non-clinical performance and safety testing, not diagnostic imaging or human-in-the-loop AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a medical device (bone cement), not a software algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth for the performance and safety studies is based on:
- International Standards: ISO 5833, ASTM F2118, ASTM F451, ISO 11135, ISO 10993, DIN EN ISO 11135-1, DIN EN ISO 10993-7.
- Pharmacopoeial Standards: USP Endotoxin Reference Standard.
- Antibacterial Testing Standards: AATC.
- Comparison to Predicate Devices: For chemical compositions and gentamicin release profiles (OGM® 1A).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as in 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.”