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The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

The provided document is a 510(k) premarket notification for a medical device called the SOLE™ Medial Column Fusion Plate. This documentation focuses on establishing substantial equivalence to existing predicate devices through non-clinical performance data and does not involve AI or machine learning. Therefore, many of the requested criteria (e.g., sample size for test/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for AI) are not applicable to this submission.

However, I can extract the acceptance criteria and the study type used to prove the device meets these criteria based on the information provided in the "Performance Analysis" section.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench testing and engineering assessments and a review of current clinical literature on predicates and similar devices. It does not describe a clinical study with human subjects, therefore, traditional "test set" and "data provenance" in the context of clinical data are not applicable. The bench testing would involve physical samples of the device; the number of samples is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a device submission based on non-clinical performance data and substantial equivalence to predicates, not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is described.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

For the mechanical performance testing, the "ground truth" or reference for acceptable performance are the specified requirements of the referenced ASTM and ISO standards. For the substantial equivalence argument, the performance of the predicate devices serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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