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The MaxTorque™ Cannulated Screw System is intended for fracture fixation of small and long bones.

The MaxTorque™ Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes but not limited to the following:

• Fractures of the tarsals and metatarsals .
• . Fractures of the olecranon, distal humerus
• Fractures of the radius and ulna .
• Patellar fractures .
• Distal tibia and pilon fractures .
• . Fractures of the fibula, medial malleolus, or calcis
• Tarso-metatarsal and metatarsal-phalangeal Arthrodesis .
• Metatarsal and Phalangeal osteotomies t
• Osteochondritis dissecans .
• Ligament fixation .
• Other small fragment, cancellous bone fractures and osteotomies .

This special 510(K) submission is a line extension to address modifications to the MaxTorque Cannulated Screw System. This line extension is to add smaller sizes to the system. The additional sizes are - ø 2.5mm, ø 3.0mm, ø 3.2mm diameter cannulated screws in various lengths. Washers for the ø 3.0mm screws, as well as guide wires and various orthopedic surgical instruments will also be added to the system.

The instruments classified as Class I devices under 21 CFR Parts 888.4300 and 888.4540 (Depth gage for clinical use and Orthopedic manual surgical instruments respectively) are exempt from premarket notification requirements.

The provided text describes a 510(k) summary for a medical device called the MaxTorque Cannulated Screw System line extension. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than presenting a detailed study with acceptance criteria and device performance results as typically found in clinical trial reports or engineering verification and validation studies.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

Based on the available information, here's what can be extracted and what cannot:

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

• Not Available: The document does not specify quantitative acceptance criteria or detailed performance results in the format of a table. The entire submission is built around demonstrating "substantial equivalence" to existing predicate devices (MaxTorque Cannulated Screw System K060428, Asnis Cannulated Screw System K000080, and K071092) based on design, intended use, performance, and operational principle. This implies that the performance is considered acceptable if it is comparable to these already approved devices, but specific numerical targets are not outlined.

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

• Not Available: The document does not describe a "test set" in the context of a performance study with a defined sample size. The FDA's 510(k) process for this type of device relies heavily on comparison to predicate devices, and often involves mechanical testing to ensure new sizes meet certain strength/durability standards, but these details are not provided here.

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/Not Available: This type of information is relevant for studies involving diagnostic or prognostic devices where expert interpretation establishes ground truth. For a cannulated screw system, "ground truth" would typically relate to mechanical properties (e.g., strength, fatigue) or successful surgical outcomes, not expert consensus on image interpretation. The document does not describe any such expert panel for a "test set" ground truth.

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

• Not Applicable/Not Available: Similar to point 3, adjudication methods like 2+1 are used in studies involving subjective assessments, often in diagnostic imaging. This is not relevant to the information provided about a bone fixation device.

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: An MRMC study is relevant to diagnostic interpretation by human readers. This device is a surgical implant for bone fixation and does not involve human "readers" or AI assistance in the way a diagnostic tool would.

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

• Not Applicable: This question is pertinent to AI/algorithm-driven devices. The MaxTorque Cannulated Screw System is a physical surgical implant, not an algorithm.

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

• Implied Mechanical/Biocompatibility/Clinical Equivalence: While not explicitly stated with details, for surgical implants new "ground truth" would typically involve:
  • Mechanical Testing: Demonstrating the new, smaller screws retain appropriate strength, torque, and fatigue properties comparable to the predicate devices and industry standards.
  • Material Equivalence: Confirmation that the materials (e.g., titanium alloy) are biocompatible and unchanged from the predicate.
  • Clinical Performance Equivalence: The primary "ground truth" from a regulatory perspective for a 510(k) is that the device is "substantially equivalent" in safety and effectiveness to legally marketed predicate devices, meaning it performs similarly in clinical use. The document states this equivalence is based on "indications, intended use, and design."

8. The sample size for the training set

• Not Applicable/Not Available: This question refers to training data for AI/machine learning models. This device is a physical implant. The concept of a "training set" is not relevant here.

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

• Not Applicable/Not Available: As above, this is not relevant to the described device.

In summary, the provided document is a 510(k) summary for a medical device line extension. Its primary purpose is to demonstrate substantial equivalence to existing devices for regulatory clearance, rather than to detail a comprehensive performance study with specific acceptance criteria, statistical evidence, and ground truth methodologies as might be found in a clinical trial report for a novel medical technology or an AI-powered diagnostic tool.

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