Search Results

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.

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.

Ask a specific question about this device

This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

LeForte Neuro System Bone Plate is made of unalloyed titanium (ASTM F67) and is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC.

The provided text is a 510(k) summary for the Jeil Medical Corporation's "LeForte Neuro System Bone Plate." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in the manner of a clinical trial for an AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. The LeForte Neuro System Bone Plate is a physical medical device (bone plate) made of titanium, not an AI or software device.

The "study" presented here is a comparison to a predicate device to establish substantial equivalence, which is a regulatory pathway for physical devices.

Here's a breakdown of what is available in the provided text in relation to your prompt, and why specific points are not applicable:

1. Table of acceptance criteria and the reported device performance:

• Not Applicable in the context of an AI/software device study. This document doesn't present performance metrics against specific quantitative acceptance criteria like sensitivity or specificity.
• Instead, the "performance" is demonstrated by showing similarity in material, dimensions, characteristics, and intended use to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not Applicable. There is no "test set" in the context of an AI/software device study described here. The evaluation is based on the device's design, materials, and intended use, compared to an already-approved predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. "Ground truth" from experts for a physical bone plate isn't established in the way it would be for an AI diagnostic device. The "truth" here is based on engineering specifications and clinical consensus on the function of such devices.

4. Adjudication method for the test set:

• Not Applicable. No test set requiring adjudication in the context of AI/software device evaluation.

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:

• Not Applicable. This is a physical bone plate, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable in the AI/software sense. The "truth" for this device is its adherence to material standards (ASTM F67 for unalloyed titanium), manufacturing quality according to MDD(93/42/EEC) and ISO 14630:1997, and its functional equivalence to the predicate device.

8. The sample size for the training set:

• Not Applicable. No training set exists for a physical hardware device like a bone plate.

9. How the ground truth for the training set was established:

• Not Applicable. No training set.

Summary of the Device and its "Acceptance" (Regulatory Equivalence):

The LeForte Neuro System Bone Plate is deemed acceptable by the FDA through the 510(k) pathway by demonstrating "Substantial Equivalence" to a legally marketed predicate device.

Predicate Device: Synthes (USA) Neuro Plate and Screw System (K042365)

Table of Comparison (Regulatory "Acceptance Criteria" for Substantial Equivalence):

Conclusion from the 510(k) Summary (Page 2):
"In all respects, the LeForte Neuro System Bone Plates are the equivalent of currently marketed devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of the predicate device."

The Study that Proves Acceptance Criteria:

The "study" is the 510(k) premarket notification process itself, which relies on demonstrating the LeForte Neuro System Bone Plate is substantially equivalent to the predicate device. This is achieved by:

• Engineering Comparison: Directly comparing the materials (unalloyed titanium), intended use, single-use status, sterility, and classification to the predicate device.
• Risk Analysis: Stating that the potential adverse effects and complications are identical to those of the predicate device and common to all devices of this type.
• Manufacturing Quality: Jeil Medical Corporation states it "utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC." While not a clinical study, this indicates adherence to recognized quality system standards.

In essence, the device "meets the acceptance criteria" because its characteristics, as detailed in the submission, are found by the FDA to be sufficiently similar to a previously cleared device, indicating that it is as safe and effective.

Ask a specific question about this device

The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Leforte system bone plate is made of unalloyed Titanium (ASTM F67-95 G1) and is manufactured and intended for internal fixation of small bones (toc, foot, finger, hand etc.) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton). Jeil Medical Co., Ltd. utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630. 1997 from the device design to manufacturing and QC..

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the "Leforte System Bone Plate," a medical device used for internal fracture fixation. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already on the market, not to prove specific performance against acceptance criteria in a study.

The document focuses on:

• Device Identification: Proprietary and classification names, product code.
• Equivalent legally marketed devices (predicates): Osteo BOS™ System, Lorenz Small Fragment System, and Syntec-Taichung Non-sterile Titanium Mimi Plate.
• Indications for Use: Internal fracture fixation of small bones (toe, finger) and reconstruction of Mandible & Maxilla.
• Description of the Device: Material (unalloyed Titanium, ASTM F67-95 G1) and manufacturing standards (MDD 93/42/EEC and ISO 14630.1997).
• Potential Adverse Effects and Complications: A list of common adverse effects associated with bone fixation devices.
• Safety and Effectiveness, comparisons to predicate devices: A table comparing the Leforte System Bone Plate to its predicates based on classification, applicant, 510(k) number, material, and intended use. The key takeaway from this section is the conclusion of substantial equivalence.
• Conclusion: States that the Leforte System Bone Plates are equivalent to currently marketed devices, made of the same materials, and have similar dimensions and characteristics, with identical potential adverse effects.
• FDA Clearance Letter: A letter from the FDA confirming the substantial equivalence determination for the K023360 submission.
• Indications for Use Statement (from FDA): Reconfirms the intended uses.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text. The document is an FDA submission for substantial equivalence, which is a regulatory pathway that relies on demonstrating similarity to existing devices rather than new performance studies against predefined acceptance criteria.

Ask a specific question about this device