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510(k) Data Aggregation
(55 days)
The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consists of metallic plates and screws that merge locking screw technology with conventional plating techniques. Locking screws provide the ability to create a fixed-angle construct while utilizing familiar AO plating techniques. A fixed-angle construct provides improved fixation in osteopenic bone or multifragment fractures where traditional screw purchase is compromised. The subject plates are available in various sizes in sterile configurations and are available in stainless steel and commercially pure titanium. The system also consists of implantable screws (K112583) that correspond to the subject device.
This is a 510(k) premarket notification for the DePuy Synthes 2.7mm LCP Plates (Modular Mini Fragment LCP System), a metallic bone fixation appliance. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Mechanical performance equivalent to existing DePuy Synthes 2.7mm LCP plates. | The evaluation supports that the mechanical performance of the subject devices are at least equivalent to that of the predicate devices. |
| MR Compatibility | Establish MR Conditional parameters. | Magnetic Resonance compatibility evaluation has been performed to establish the MR Conditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates. (Specific parameters not detailed in this document). |
| Endotoxin Content | Meet specified endotoxin requirement of 20 EU/device. | Endotoxin testing has been performed using the LAL test method to establish that the subject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of 20 EU/device. |
| Biocompatibility | Biologically safe when used as intended, in accordance with ISO 10993-1. | Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm LCP Plates are biologically safe when used as intended. |
| Indications for Use | Align with the indications for use of the predicate device (Synthes (USA) Modular Mini Fragment LCP System (K063049)). | The subject devices fully align with the indications for use compared to the predicate. |
| Material, Design, Operation | Substantially equivalent in regards to material, design, and operational principles to predicate and reference devices. | A comparison of the subject devices... demonstrated that they are substantially equivalent to the previously cleared Synthes (USA) Modular Mini Fragment LCP System (K063049), VariAx 2 Distal Radius Plating System (K141430) and the VariAx 2 Compression Plating System (K170727) from Stryker. |
| Safety and Effectiveness | Differences in technological characteristics compared to predicate devices do not raise any new questions of safety and effectiveness. | The non-clinical performance data as well as the comparison of design features... demonstrate that any differences... do not raise any new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a "test set" in the context of clinical data for the device's performance, as clinical testing was not necessary for the determination of substantial equivalence. The studies conducted were non-clinical (mechanical, MR compatibility, endotoxin, biocompatibility). Therefore, details like data provenance (country of origin), retrospective/prospective nature, and sample size for a test set (in a clinical sense) are not applicable or provided.
For the non-clinical studies:
- Mechanical Testing: The sample size for mechanical testing is not explicitly stated. The evaluation was a comparison to existing predicate plates.
- MR Compatibility: The sample size for MR testing is not explicitly stated.
- Endotoxin Testing: The sample size for endotoxin testing is not explicitly stated, but it involved testing the subject device(s).
- Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As clinical testing was not required for substantial equivalence, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for non-clinical tests would be the established performance standards or test methods (e.g., ISO 10993-1 for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done, as clinical testing was not deemed necessary for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone fixation appliance, not an algorithm or AI-based diagnostic tool. The performance evaluated was physical and biological characteristics of the implant, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies was based on established engineering principles, international standards, and regulatory requirements:
- Mechanical Performance: Comparison to the known mechanical performance of the legally marketed predicate device.
- MR Compatibility: Established guidelines for MR Conditional parameters.
- Endotoxin Testing: The specified endotoxin limit (20 EU/device) and the LAL test method.
- Biocompatibility: ISO 10993-1 series of standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI model, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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