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The ORTHOLOC® 3Di Foot Plating Reconstruction System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• · Calcaneo-Cuboid (CC) Fusion
• Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

• · Opening base wedge osteotomy
• · Closing base wedge osteotomy
• · Crescentic osteotomy
• Proximal Chevron osteotomy
• · Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• · Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant
• Flatfoot Osteotomies
• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

The ORTHOLOC® 3Di Foot Reconstruction System Line Extension (ORTHOLOC® 3Di CrossCHECK Module) is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The implants included in this system are designed to provide highly anatomic and versatile plating options for an array of fusions and stabilizations. The plates include straight, right, and left configurations, as well as locking and non-locking screws.

The provided document is a 510(k) premarket notification for a medical device called the ORTHOLOC® 3Di Foot Plating Reconstruction System. This document focuses on demonstrating the substantial equivalence of the new device to previously approved predicate devices, primarily through non-clinical performance testing. It does not describe a study involving a device that uses artificial intelligence (AI), machine learning (ML), or any software-based diagnostic or prognostic capabilities that would require acceptance criteria related to accuracy, sensitivity, specificity, or reader studies.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this particular submission.

Here's an analysis based on the available information:

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)

• Sample Size: The document does not specify a "sample size" in the context of clinical data or patient outcomes, as the assessment was based on non-clinical engineering performance testing (static bending). For the non-clinical testing, the sample size would refer to the number of physical devices or components tested. This information is not explicitly provided in the summary.
• Data Provenance: Not applicable, as this was non-clinical engineering testing, not human data.

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. The ground truth for engineering performance testing (e.g., bending strength) is established by engineering standards and measurement equipment, not clinical expert consensus.

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

Not applicable. Adjudication methods are typically for clinical studies with expert reviewers, not non-clinical engineering tests.

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, an MRMC comparative effectiveness study was not done. This device is a metallic bone fixation appliance, not an AI-powered diagnostic or decision support system.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance assessment was established through engineering standards and measurements (e.g., measuring static bending strength) in comparison to established performance of predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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