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The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.

Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla)

The provided text is a 510(k) summary for the Jeil Medical Corporation's "Leforte System Bone Screw." This document describes the device, its intended use, and compares it to legally marketed predicate devices to establish substantial equivalence.

However, the document does not describe a study with acceptance criteria and device performance results in the way typically expected for a clinical or performance study of an AI/software device. Instead, it focuses on demonstrating equivalence to existing hardware devices based on material, design, and intended use.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information provided in this 510(k) summary.

I will fill in the available information and explicitly state when a requested piece of information is not present in the provided text.

Acceptance Criteria and Study Details for Leforte System Bone Screw

This 510(k) summary for the Jeil Medical Corporation's Leforte System Bone Screw focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the context of an AI/software device. The "acceptance criteria" here are implicitly met by demonstrating that the device is made of the same materials and has similar dimensions, characteristics, and intended use as legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a hardware device seeking substantial equivalence, specific quantitative "acceptance criteria" and "device performance" metrics typically associated with AI/software studies (like sensitivity, specificity, F1-score) are not provided. Instead, the "performance" is assessed by comparison to predicate devices across key attributes.

Conclusion from the document: "In all respects, the Leforte System Bone Screws are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices."

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

• Sample Size (Test Set): Not applicable. This summary does not describe a clinical or performance test set for evaluating the device against ground truth data. The "test" is the comparison against existing, legally marketed predicate devices.
• Data Provenance: Not applicable. The "data" here refers to descriptions and specifications of the predicate devices and the proposed device.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or clinical outcomes, is not established as part of this submission's comparison. The "ground truth" for substantial equivalence is the regulatory clearance status and characteristics of predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication method

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This is a hardware device (bone screw), not an AI/software device that would involve human readers or AI assistance.

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

• Standalone Performance: No. This is not an algorithm or AI device.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established regulatory status, material specifications, and intended uses of the identified predicate devices (Twist off™ Screw, Aesculap Titanium Alloy Bone Screws, K3 Bone Screw System). The LeForte System Bone Screw demonstrates "substantial equivalence" to these devices.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. There is no "training set" as this is a hardware device, not a machine learning model.

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

• Ground Truth Establishment (Training Set): Not applicable.

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