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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.

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