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The ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for:

1. Small Hand Bone Fractures
2. Carpal and Metacarpal Fractures
3. Tarsal and Metatarsal Fractures
4. Distal Metatarsal Osteotomies (Austin Chevron, Scarf)
5. Interfragmentary Radius and Ulna Fractures
6. Osteochondral Fractures
7. Intra-articular fractures
8. Arthrodesis of small joints
9. Reconstructive osteotomies in small carpal or tarsal bones
10. Osteochondritis Dissecans
11. Oblique fractures of the fibula
12. Metatarsal osteotomies and other reconstructive surgeries in the foot

The ODi Ultimate Compression Screw™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. The Ultimate Compression Screw System™ consists of three screw components designed to be used as an assembly. The device has been designed to offer a wide range of compression, and screw sizes to address varving fracture and bone fragment geometries. The assembly consists of the following:

• Proximal Screw Component .
• Distal Screw Component .
• Internal Compression Screw t
  The screw components are equivalent in design to currently marketed standard compression bone screws. The thread form and defining screw features conform to ISO 5835, Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread Dimensions.
  Initially, ten screw lengths will be available in 3.5 mm, 4.5 mm and 6.5 mm diameters, offering a range of fracture compression from 14.0 mm to 58.0 mm. The components are self-tapping and are designed to be manually inserted using commonly available (e.g. American Orthopedic) surgical instruments.
  All device components are manufactured from titanium alloy, Ti-6Al-4V, per ASTM F136 and provided in detail as follows:
  Proximal Screw Component
  The proximal screw component is provided in outer diameters of 3.5 mm, 4.5 mm and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation.
  Distal Screw Component
  The distal screw component is provided in outer diameters of 3.5 mm, 4.5 mm, and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation.
  Internal Compression Screw
  The 2.0 mm internal compression screw is designed to seat within the proximal component and thread into the distal component. As the internal compression screw is threaded into the distal screw component, it draws the proximal and distal screw components together, thereby achieving fracture fixation.
  Note that the internal compression screw is designed to universally fit all proximal and distal screw sizes. This gives the system a modularity that allows the surgeon to select the proximal and distal screw combination that best addresses the fracture geometry.

The provided document is a 510(k) Premarket Notification for a medical device, the ODi Ultimate Compression Screw System™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the document does not describe detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way that might be expected for novel or high-risk devices.

Instead, the document focuses on demonstrating that the device is substantially equivalent to existing, approved devices by meeting established material standards and having comparable indications for use.

Here's an analysis based on the information provided and the nature of a 510(k) submission:

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

The document explicitly states: "No performance standards applicable to the fixation bone screw have been established by FDA." Instead, the primary "acceptance criteria" discussed are compliance with established material standards and substantial equivalence to predicate devices.

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

• Not applicable / Not explicitly stated. This document does not describe a clinical trial or a specific "test set" of patient data for performance evaluation in the typical sense for proving efficacy. The assessment relies on engineering adherence to material standards and design equivalence.

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

• Not applicable. There is no "ground truth" establishment in the context of clinical expert review mentioned, as this is a device based on material and mechanical equivalence, not diagnostic accuracy or clinical outcomes based on a "test set." The FDA's review process inherently involves experts (engineers, scientists from the Orthopaedic Device Section), but their role is in evaluating the 510(k) submission against regulatory requirements and predicate devices, not creating ground truth from patient data.

4. Adjudication method for the test set:

• Not applicable. This document does not describe a test set that would require an adjudication method.

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 a bone screw, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

• Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The type of ground truth used:

• For the device's design and material, the "ground truth" is established through industry standards and specifications:
  • ASTM F136-84 (for material chemical and mechanical requirements).
  • ISO 5835 (for screw thread form and defining features).
• For indications for use, the "ground truth" is based on the established and approved indications of predicate devices (Acutrak Fixation System, Herbert/Whipple Bone Screw, Universal Compression Screw). The device's indications are stated to be "comparable to those for approved and marketed devices."

8. The sample size for the training set:

• Not applicable. This document doesn't describe a 'training set' in the context of machine learning or deep learning. The device's design and manufacturing rely on established engineering principles and material science.

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

• Not applicable. As above, no training set for an algorithm is described.

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