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510(k) Data Aggregation
(59 days)
3DMetal Diaphyseal Femoral Cones
The 3DMetal Femoral Cones are indicated for use with Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows:
-Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis,
rheumatoid arthritis or polyarthritis.
-Post traumatic loss of joint configuration.
-Considerable loss of function of the knee joint.
-High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
-Primary implantation failure.
-Former revision arthroplasty.
The 3DMetal Diaphyseal Femoral Cones are sterile implantable devices intended to be used in the diaphyseal side of the femoral component in order to fill and reconstruct large bone deficiencies and cavitary defects in the diaphysis of the distal femur. The subject devices are available in four different sizes and they are to be cemented to the extension stem used in GMK Revision and GMK Hinge systems in Total Knee Arthroplasty procedures. Analogously to the reference devices, the 3DMetal Diaphyseal Femoral Cones are manufactured using Electron Beam Melting (EBM) process with titanium alloy powder.
The provided text describes a 510(k) premarket notification for a medical device called "3DMetal Diaphyseal Femoral Cones." This is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study evaluating AI performance or a comparative effectiveness study. Therefore, most of the requested information regarding AI-specific criteria, human readers, ground truth establishment for AI, and training set details are not applicable to this document.
However, I can extract information related to the device's acceptance criteria (in terms of performance testing) and the studies conducted to show it meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Device Performance / Result |
|---|---|
| Non-Clinical Studies | |
| Design Validation | |
| Design Rationale Shape, Dimension and Range of Product | Test Report B2 + Addendum was provided in support of compliance. The text states: "The slight difference in sizes between the subject and the predicate devices does not raise new question of safety or effectiveness as demonstrated by design validation testing." |
| Characterization Testing | |
| Dynamic Fatigue Test (according to IL 07.09.5173 rev.0) | Report 00812-009932-1 was provided. The text implies the device passed this test to demonstrate safety and performance. |
| Stereological evaluation (according to ASTM F1854-15) | Test Report 00812-009932-2 (Test report B3) was provided. This likely validates the porous structure (e.g., porosity of trabecular layer) to be comparable to the predicate. |
| Biocompatibility | The product material (Ti6Al4V) is "commonly used for implantable medical devices," implying established biocompatibility. (No specific report number given but implied through material selection). The submission states biocompatibility is shared with the predicate. |
| Sterility | The product is "sterile implantable devices." The submission states sterility is shared with the predicate. (No specific report number or method for this test is explicitly given in the provided text, but it's a standard requirement for sterile devices). |
| Shelf Life | The submission states shelf life is shared with the predicate. (No specific report number or method for this test is explicitly given in the provided text, but it's a standard requirement). |
| Packaging | The submission states packaging is shared with the predicate. (No specific report number or method for this test is explicitly given in the provided text, but it's a standard requirement). |
| Pyrogenicity: Bacterial endotoxin test (LAL test) | According to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ). The device is not labeled as non-pyrogenic or pyrogen free, implying it meets the general pyrogenicity requirements for its intended use, but not necessarily a "pyrogen-free" claim. |
| Pyrogenicity: Pyrogen test (according to USP chapter ) | For pyrogenicity determination. The device is not labeled as non-pyrogenic or pyrogen free, implying it meets the general pyrogenicity requirements for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The studies referenced (e.g., dynamic fatigue, stereological evaluation) would typically involve a specific number of device samples for testing, but the exact quantity is not detailed in this summary.
- Data Provenance: The studies are "Non-Clinical Studies" conducted to validate the device design and characterize its performance. This indicates laboratory testing of the device itself, not data derived from human subjects or clinical experience. The provenance is internal to the manufacturer (Medacta International SA), as these are design validation and characterization tests. These are prospective tests on newly manufactured samples of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a submission for a physical medical implant, not an AI or diagnostic device that requires expert-established ground truth from images or other data. The "ground truth" here is established by engineering standards, material science, and biomechanical principles validated through laboratory testing.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not a study involving human interpretation of data, there is no adjudication method in the sense of expert consensus. The results are determined by objective measurements from laboratory tests against predefined engineering specifications or recognized standards (e.g., ASTM, European Pharmacopoeia, USP).
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
- No. No MRMC comparative effectiveness study was done, as this is a physical medical implant, not an AI diagnostic or assistance device. The document explicitly states: "No clinical studies were conducted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is derived from established engineering standards, material specifications, and biomechanical principles. For example:
- Dynamic Fatigue Test: Ground truth is the endurance limit or fatigue life expected for the material and design under specified loads, often benchmarked against predicate devices or industry standards.
- Stereological Evaluation: Ground truth relates to the measured porosity and pore size distribution meeting predefined specifications for the 3DMetal structure, often against specific ASTM standards (e.g., F1854-15 mentioned).
- Biocompatibility: Ground truth is that the material (Ti6Al4V) is known and accepted as biocompatible for implantable devices, and this is confirmed by testing for specific biological responses (e.g., pyrogenicity).
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this device.
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