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The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts:

• Cannulated screws of various lengths, which are positioned through bony fragments to provide stability to the fracture site during healing.
• A washer which provides a bearing surface for the cannulated screw head against the bone. The washer also prohibits migration of the screw head into the cortex.
  ODi will manufacture the implants from implant grade titanium alloys.

The provided text is a 510(k) Summary for the ODi 7.0mm Cannulated Screw System, which is a medical device. This type of document is a premarket notification to the FDA and primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than conducting a detailed performance study with acceptance criteria in the way a diagnostic AI device would.

Therefore, the information required to fill out the table and answer all questions for an AI device's acceptance criteria and study proving its performance is not present in this document.

Here's why and what information is available:

• This is a medical device clearance, not an AI/diagnostic software clearance. The ODi 7.0mm Cannulated Screw System is a physical orthopedic implant (screws and washers for bone fixation). Its "performance" is assessed through manufacturing specifications, material testing, and comparison to predicate devices, not through algorithmic accuracy metrics like sensitivity, specificity, or AUC as an AI diagnostic would be.
• The concept of "acceptance criteria" for this device is related to its physical properties, biocompatibility, and functional equivalence to predicate devices, not a statistical performance threshold.
• There is no "test set," "training set," "ground truth," "experts for ground truth," or "MRMC study" in the context of an AI device. These terms are specific to the validation of AI algorithms.

Therefore, it is not possible to complete the requested table and answer the questions based on the provided text.

However, I can extract the information that is relevant to the document's purpose:

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

• Acceptance Criteria (Implicit - from substantial equivalence): The device must be equivalent to predicate devices in Indications for Use, Device Design, Materials, Method of Manufacture, and Method of Sterilization.
• Reported Device Performance: The document states the device "is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization."

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

• Not applicable; this is not a study assessing diagnostic performance against a test set.

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.

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

• Not applicable.

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.

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

• Not applicable.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Summary of available information from the document:

• Device Name: ODi 7.0mm Cannulated Screw System
• Indications for Use: Fixation/stabilization of stable fractures of the proximal femur (pertrochanteric, basilar femoral neck, subcapital, and combinations), intercondylar femoral fractures, and tibial plateau fractures until bony union occurs.
• Predicate Devices: Examples include products from aaP Implants, Inc, Advanced Orthopaedic Solutions, DePuy/ACE, Inc., Magly Orthopedics, LLC, and Synthes, Inc. (K990776, K014185, K893512, K021662, K021932, K962011).
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices.

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