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The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:

• Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
• . Non-unions and malunions
• Normal and osteopenic bone .
• Osteotomies .

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   The provided text does not include information on specific sample sizes for the non-clinical tests. The tests were performed on "AxSOS 3 Ti Locking Plate System components" but the number of components tested for each criterion is not specified.

   The data provenance is from non-clinical laboratory testing conducted for the AxSOS 3 Ti Locking Plate System components. The location of the laboratory or the specific country of origin for the testing data is not explicitly stated, but the sponsor is Stryker Trauma AG, Switzerland. The study type is non-clinical (benchtop) testing, not related to patient data, so "retrospective or prospective" does not apply in the typical sense.

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

   This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring expert interpretation of medical images or data. Ground truth was established through standardized engineering tests.

4. Adjudication method for the test set:

   This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring human interpretation or adjudication.

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:

   No MRMC comparative effectiveness study was done. This submission explicitly states, "Clinical testing was not required for this submission." The study focused solely on non-clinical mechanical performance.

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

   No standalone (algorithm only) performance study was done. This device is a physical bone fixation system and does not involve AI algorithms.

7. The type of ground truth used:

   The ground truth used was based on results from standardized biomechanical and mechanical tests. This includes measurements of static strength, dynamic fatigue, shear-off properties, insertion forces, and pull-out resistance, all compared against established performance benchmarks or predicate devices.

8. The sample size for the training set:

   This information is not applicable as this submission is for a physical medical device (bone plates and screws) and does not involve an AI algorithm with a training set.

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

   This information is not applicable as this submission is for a physical medical device and does not involve an AI algorithm with a training set or associated ground truth establishment.

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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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