(53 days)
Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.
The Synthes SynMesh consists of both flat mesh and preformed round and oval shaped mesh cylinders. The flat mesh is intended to be customized to a design and geometry that satisfies the patients anatomical defect. In addition, rings and screws are available to reinforce the cylinders. The preformed cylinders are offered in various sizes. The mesh and preformed cylinders are manufactured from commercially pure titanium (ASTM F67). Indication for use is in reinforcement of weak bony tissue in orthopedic surgical procedures.
Here's an analysis of the provided text regarding the SYNTHES SynMesh device, focusing on acceptance criteria and the study proving it, as per your request:
Acceptance Criteria and Study for SYNTHES SynMesh (K983766)
The SYNTHES SynMesh is a Class II medical device, and its clearance was based on Substantial Equivalence to a legally marketed predicate device, the DePuy Motech Surgical Titanium Mesh (K900138). This means that a direct study proving the device meets specific performance acceptance criteria in an independent manner was not performed in this submission. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (SYNTHES SynMesh) |
|---|---|---|
| Indications for Use | Indication for use is for the reinforcement of weak bony tissue in orthopedic surgical procedures. (Matching predicate device's indications) | The SYNTHES SynMesh is indicated for the same clinical indications as that of the DePuy Motech Surgical Titanium Mesh: "reinforcement of weak bony tissue in orthopedic surgical procedures." |
| Device Configuration | Similar range of dimensions and configurations (flat mesh, round/oval cylinders, rings, screws) to the predicate device. | The SynMesh offers flat mesh (90x112mm) and preformed cylinders (various sizes: ROUND X=15mm, H=30, 50, 70mm; OVAL X=17, Y=22, H=50, 70, 90mm; OVAL X=22, Y=28, H=50, 70, 90mm; OVAL X=26, Y=33, H=50, 70, 90mm) and rings (17x22, 22x28, 26x33, H=4.8mm) and screws (M3x6.5). The range of dimensional characteristics is "identical" to the DePuy Motech Surgical Titanium Mesh. |
| Material Composition | Commercially pure titanium (ASTM F67) (Matching predicate device's material) and established biocompatibility. | Manufactured from commercially pure titanium (ASTM F67). Material composition is "identical" to the DePuy Motech Surgical Titanium Mesh. CP Titanium is an "established biocompatible material." |
| Mechanical Characteristics | Hole to metal ratio and overall mechanical characteristics within the range of the predicate device. | The hole to metal ratio of the SynMesh system "falls within the range of hole to metal ratio of the DePuy Motech Surgical Titanium Mesh." Based on this information, the "mechanical characteristics fall within the range of mechanical characteristics of the DePuy Motech Surgical Titanium Mesh." |
| Sterilization | Compatibility with a recommended sterilization method for non-sterile devices. | Provided non-sterile; moist heat sterilization is recommended. (This would be expected to be consistent with practices for titanium implants). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, rather than performing an independent clinical or bench performance test with a specific sample size. The "test set" effectively refers to the predicate device's established performance.
- Data Provenance: Not applicable for a new, independent test set. The data provenance is from the previously cleared DePuy Motech Surgical Titanium Mesh (K900138), which would have had its own supporting data at the time of its clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No "ground truth" was established for a new test set in this 510(k) submission. The FDA's review process relied on the existing clearance of the predicate device and the presented comparative data.
4. Adjudication Method for the Test Set
- Not applicable. There was no independent test set requiring adjudication in this substantial equivalence submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is typically for evaluating diagnostic or interpretive devices involving human readers. The SYNTHES SynMesh is a surgical implant; therefore, an MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is not an algorithm or AI-based system. It's a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth," in the context of a substantial equivalence submission for a physical implant, is the established safety and effectiveness profile of the predicate device, based on its prior clearance and clinical use. No new "ground truth" was generated.
8. The Sample Size for the Training Set
- Not applicable. This concept is relevant to machine learning algorithms, which are not involved in the clearance of the SYNTHES SynMesh.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device submission.
Summary of the "Study" Proving Acceptance Criteria:
The "study" in this context is a comparative analysis demonstrating that the SYNTHES SynMesh is substantially equivalent to the DePuy Motech Surgical Titanium Mesh (K900138). This involved showing:
- Identical Indications for Use.
- Identical Material Composition (commercially pure titanium, ASTM F67).
- Identical Dimensional Characteristics (same range of flat mesh size, cylinder sizes, ring sizes, and screw definitions).
- Mechanical Characteristics within Range: The hole-to-metal ratio, and thus the inferred mechanical characteristics, were shown to fall within the range of the predicate device.
The premise is that if the new device is functionally, materially, and dimensionally equivalent to a device already deemed safe and effective, then it is also safe and effective. The FDA's acceptance of this submission is based on this comparative rationale rather than a de novo clinical trial or performance study.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.