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510(k) Data Aggregation
(266 days)
ARKIN CONSULTING GROUP
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin. This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.
The LeForte System Bone Plate & Screw is a medical device intended for use in selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. This 510(k) summary provides details on the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like bone plates and screws which are compared to predicate devices for substantial equivalence, the "acceptance criteria" are typically demonstrating that the new device performs at least as well as, or equivalently to, the predicate device across defined engineering and material properties, and that it maintains the same intended use. The "reported device performance" refers to the results of the pre-clinical tests conducted on the new device.
| Parameter | Acceptance Criteria (Measured against predicate devices and pre-defined standards/design controls) | Reported Device Performance |
|---|---|---|
| Material | Plates: Pure Titanium (ASTM F67 Grades 1, 2, and 3) Screws: Titanium Alloy (ASTM F136) | Plates: Titanium ASTM F67 Grade 1, 2, 3 |
| Screws: Titanium Alloy ASTM F136 | ||
| Dimensions | Within ranges established for predicate devices and compliant with design specifications for new additional shapes/sizes | Plates: Length 5.2 ~ 223.5mm, Thickness 0.2~2.5mm |
| Screws: Outer (head) diameter 1.2 | ||
| Mechanical Strength | Performance comparable to predicate devices and acceptable for intended use based on industry standards and pre-defined design controls for mechanical properties (e.g., torsion, pull-out, bending, tensile strength). | Results of dimensional, torsion, pull-out, four-point bending, and tensile strength tests demonstrated compliance to pre-defined standards and Jeil Medical design controls. (Specific quantitative values are not provided in this summary but were likely included in the full submission). |
| Biocompatibility | Materials are well-established and used in predicate devices, implying biocompatibility. | Materials used (Pure Titanium, Titanium Alloy) are standard and recognized for biocompatibility in these applications. No new biocompatibility concerns were raised. |
| Sterilization | Non-sterile, single-use, consistent with predicate devices. | Supplied non-sterile, single-use. |
| Indications for Use | Same as predicate devices. The device is for selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. | Same as predicate devices. Device is for selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes pre-clinical testing which included dimensional, torsion, pull-out, four-point bending, and tensile strength tests. For such tests, the "test set" would refer to the physical samples of the LeForte System Bone Plate & Screw that were subjected to these mechanical evaluations.
- Sample Size: The document does not specify the exact number of samples used for each type of mechanical test (e.g., how many plates for four-point bending, how many screws for pull-out). This level of detail is typically found in the full test reports within the 510(k) submission, not typically in the summary. However, regulatory standards and good laboratory practices dictate that a sufficient number of samples are tested to ensure statistical significance and reliable results for each test.
- Data Provenance: The tests were conducted by the manufacturer, Jeil Medical Corporation. The location for these specific pre-clinical tests is not explicitly stated, but it is implied to be part of the manufacturer's internal testing process. The overall sponsor and manufacturer are based in Republic of Korea. The data is prospective in the sense that these tests were performed specifically for the purpose of this 510(k) submission to demonstrate the performance of the new device and its modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable in the context of this 510(k) summary. "Ground truth" established by experts is relevant for studies involving medical image analysis, clinical diagnoses, or subjective evaluations. For bone plates and screws, the "ground truth" for acceptance is based on objective, quantifiable engineering and material standards, as well as comparison to the performance of predicate devices, rather than expert clinical interpretation of results. The "experts" involved would be mechanical engineers, material scientists, and regulatory specialists defining and interpreting the test results against established standards.
4. Adjudication Method for the Test Set
This section is also not applicable for the type of pre-clinical mechanical testing described. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies where there are subjective assessments (e.g., by multiple readers/clinicians) that need to be resolved to establish a definitive ground truth. For mechanical tests, the results are objective measurements (e.g., load at failure, displacement, torque values) and do not require adjudication in the same manner.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) or image interpretation, where human performance is being evaluated and potentially augmented by technology. The LeForte System Bone Plate & Screw is a physical implant, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
There was no standalone (algorithm only) performance study done. This concept is applicable to AI or software medical devices; the LeForte System Bone Plate & Screw is a physical medical implant.
7. The Type of Ground Truth Used
As previously mentioned, the concept of "ground truth" for expert consensus, pathology, or outcomes data is not directly applicable here. The "ground truth" for this device's performance demonstration relies on:
- Established engineering standards: ASTM F67 (for pure Titanium) and ASTM F136 (for Titanium Alloy) provide the material specifications.
- Pre-defined design controls: Internal specifications for the mechanical properties and dimensions that the device must meet.
- Predicate device characteristics: The existing LeForte Neuro System Bone Plate and Screw served as the benchmark for material, design, and intended use equivalence.
The "ground truth" is that the new device, including its modifications, meets these established standards and performs comparably to the legally marketed predicate devices, thereby establishing substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The LeForte System Bone Plate & Screw is a physical device, and its approval is based on pre-clinical mechanical testing and comparison to predicate devices, not on data-driven model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8. There was no training set because no machine learning algorithm was developed or evaluated for this device.
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