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The ORTHOLOC™ 3Di Midfoot/Flatfoot 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: Flatfoot Osteotomies - Lateral column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - Medial Displacement Calcaneal Osteotomy (MDCO) 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

Wright Medical's ORTHOLOC™ 3Di Midfoot/Flatfoot System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. The subject plates are modified from the DARCO Locking Bone Plate System (K061808) or the CLAW II Polyaxial Compression System (K113014). The system contains 23 plates belonging to 1 of 8 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes, and some plates have non-locking compression slots and kwire holes. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm ORTHOLOC™ 3Di locking and ORTHOLOC™ non-locking screws.

Here's a breakdown of the acceptance criteria and the study information for the ORTHOLOC™ 3Di Midfoot/Flatfoot System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• "Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di Midfoot/Flatfoot plates were found not to represent a new worst-case in bending for any of the eight plate styles evaluated when compared to the most similar DARCO or CLAW II plates." |
  | - Maintain mechanical equivalence to predicate devices. | - "A dimensional engineering analysis was also provided in order to help establish mechanical equivalence." |
  | Safety and Effectiveness: | |
  | - New design characteristics do not raise new questions of safety or effectiveness. | - "The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness." |
  | - Perform at least as well as the predicate devices. | - "From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate systems." |
  | Intended Use: | |
  | - Indications for use are similar to or supported by predicate devices, without altering the intended therapeutic effect. | - "The indications statement is similar to the DARCO predicate system's indications for use statement and has been tailored to the intended use of the subject device..."
• "The addition of these specific examples of osteotomies and arthrodeses does not alter the intended therapeutic effect of the subject device."
• "Some of these procedures are part of a predicate indications statement, and the others are supported by technologically similar predicates designed and marketed for these procedures." |
  | Material Composition: | |
  | - Plates made from biocompatible and established materials (Titanium alloy). | - "The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3..."
• "The subject plates are made from titanium alloy (Ti6AlaV), while some of the corresponding predicate plates are commercially pure titanium or stainless steel." (Implies material is acceptable as it's a difference noted without a safety concern). |
  | Functional Features: | |
  | - Polyaxial locking feature offers equivalent or improved functionality compared to existing predicate features where applicable. | - "The subject plates have a new polyaxial locking feature that offers locking up to 15° off-axis."
• "The subject's locking feature is similar to the locking feature of the predicate CLAW II and identical to the locking feature for ORTHOLOC™ 3Di Hallux (K120359)." (Implies functionality is acceptable due to similarity or identity to predicate/equivalent devices). |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" in the context of clinical data or human evaluation. The mechanical performance evaluation involved all eight plate styles within the system, comparing them to "the most similar DARCO or CLAW II plates."
• Data Provenance: The mechanical performance data is based on non-clinical evidence, specifically "mechanically validated FEA analysis" and "dimensional engineering analysis." This implies the data is derived from engineering simulations and analyses, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective distinction in the typical clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the provided document details a 510(k) submission primarily relying on non-clinical, engineering-based performance testing for substantial equivalence. There is no mention of "experts" establishing "ground truth" for a test set in the context of clinical outcomes or human diagnostic accuracy.

4. Adjudication Method for the Test Set

• This information is not applicable for the same reasons as #3. Mechanical and dimensional engineering analyses do not typically involve adjudication by human experts in this manner.

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

• An MRMC comparative effectiveness study was not done. This submission is for a medical device (bone plate system), not an AI diagnostic or assistive technology.

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

• A standalone performance study of an algorithm was not done. This device is a physical bone plate system, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance testing was based on established engineering principles and validated finite element analysis (FEA) models, compared against the known performance characteristics of the predicate devices. It also relied on dimensional engineering analysis to establish mechanical equivalence. Essentially, the "truth" was defined by established mechanical performance standards and direct comparison to predicate devices' known mechanical properties.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" in the context of an AI algorithm described in this 510(k) submission. The mechanical analysis relies on the design parameters of the eight plate styles in the system and their comparison to predicate device designs.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no training set for an AI algorithm. The mechanical "ground truth" for comparing the new plates to predicates would be derived from the pre-existing design specifications, material properties, and established performance data of the predicate devices.

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