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The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weightbearing and against more than sedentary activity; and arthrodesis of the hip.

The UltiMax Haig II Nail System is manufactured from titanium (6AI-4V ELI) per ASTM F136 and is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), and is available in 130 ° 135 ° 140 ° 145 ° and 150 ° angles. These are manufactured and tested per ASTM specifications F787. The bone screw hole pattern is offset and 5.0mm cortical screws are used. The most proximal hole accepts a large diameter (7.0mm) cannulated screw. The plates are available in 3 hole, 5 hole, 6 hole, 8 hole, 10 hole, 12 hole and 14 hole lengths. The UltiMax Haig II Nails are available in 65-125mm (5 mm increments) lengths. The nails are tri-flanged with a series of holes in the proximal end. These holes serve as an enhancement to cement delivery. The Haig II Nail is implanted by direct impaction. Once implanted an adaptor is threaded on the distal end of the nail. A syringe containing a low viscosity bone cement is inserted into the adaptor and cement is delivered into the nail. The cement is pushed through the holes in the proximal end of the nail and dispersed into the femoral head.

The provided text describes a medical device, the UltiMax Haig II Nail System, and its clearance for market by the FDA. However, it does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for an AI/ML device.

The "Test Results" section is very brief and refers to mechanical testing, not performance related to a diagnostic or predictive algorithm. There is no mention of an algorithm, AI, or machine learning in the provided documents.

Therefore, many of the requested fields cannot be filled. I will answer based on the information available related to the device's clearance.

Acceptance Criteria and Device Performance for the UltiMax Haig II Nail System

The provided documentation does not detail "acceptance criteria" and "reported device performance" in the context of a typical AI/ML study, as the device in question is a physical orthopedic implant. The "acceptance criteria" here refer to its mechanical and material compliance with established ASTM standards for metallic nail-plate appliances, and its substantial equivalence to predicate devices for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the mechanical testing. The document states "The UltiMax Haig II Nail System has been tested..." but does not quantify how many units were tested.
• Data Provenance: The testing was conducted by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida, USA. This is a prospective test specifically for this device.

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

Not applicable. This device is an orthopedic implant, and its "ground truth" is based on objective mechanical properties and material composition, measured against established engineering standards (ASTM F787, F136). It does not involve expert interpretation or diagnosis for "ground truth."

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

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. No AI/ML component is mentioned for this medical device.

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

Not applicable. No AI/ML component is mentioned for this medical device.

7. The type of ground truth used

For this physical device, the "ground truth" is objective, quantifiable mechanical performance and material properties as defined by ASTM standards, along with a comparison of its design functionality to predicate devices. It is based on engineering standards and direct physical measurement.

8. The sample size for the training set

Not applicable. There is no AI/ML component and thus no "training set."

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

Not applicable as there is no training set mentioned.

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