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The Dall-Miles Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy.

The Dall-Miles Cable Grip (A-Grip) described in this submission is a modification of the previously cleared Osteonics FX-Cablelok™ grip components. The two proximal hooks in the current grip have been reduced to one centrally positioned hook in the new grip. This central hook is available with and without a cannulated groove for the passage of cable. A hole in the central hook allows for the passage of cable that provides the vertical fixation feature of the device. The flares on the anterior and posterior limbs (used for the passage of cable during vertical fixation) have been removed. Two new designs have been developed to provide for vertical fixation. The first design incorporates a crimping mechanism in each of the distal hooks of the grip. The cable is passed through the grip and a "tension band" device (that is placed below the trochanter, similar to the existing FX-Cablelok sleeve design) and secured by crimping the hooks on the grip. The second design incorporates a crimping mechanism directly in the tension band component. With this design, the cable is passed through the grip and the tension band device and secured by crimping the tension band component. The standard method for horizontal fixation on the current design is still provided in both of the new designs.

This document is a 510(k) Pre-Market Notification submission for a medical device called the "Dall-Miles Cable Grip." It details modifications made to an existing device and argues for its substantial equivalence to previously cleared devices.

Based on the provided text, the device is a mechanical bone fixation device, not an AI or imaging-based diagnostic tool. Therefore, the questions related to AI studies, reader performance, ground truth, and sample sizes for training/test sets are not applicable to this submission.

The acceptance criteria for mechanical devices like this are typically based on:

• Safety and Efficacy: The device must perform its intended function without causing harm and achieve the desired clinical outcome.
• Biocompatibility: The materials used must be compatible with the human body.
• Mechanical Performance: The device must withstand the forces it will encounter in vivo without failure (e.g., strength, fatigue resistance).
• Sterilization: The device must be able to be effectively sterilized.
• Substantial Equivalence: The primary "study" proving acceptance for a 510(k) submission is typically a comparison to a legally marketed predicate device, demonstrating that the new device is as safe and effective.

Here's how the provided information relates to the acceptance criteria for a mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

The following points are not applicable to this 510(k) submission for a mechanical device.

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

• Not applicable. This is a 510(k) submission for a mechanical device, not an AI/diagnostic device that relies on a "test set" of clinical data in the same way. Performance is typically demonstrated through bench testing and comparison to predicates.

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. No "ground truth" establishment by experts in this context. The "ground truth" for a mechanical device largely revolves around its physical properties meeting engineering specifications and historical clinical performance of similar devices.

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

• Not applicable. No "test set" in the context of diagnostic performance.

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 is a mechanical bone fixation device, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for demonstrating safety and effectiveness of a mechanical implant typically comes from:
  • Bench Testing Data: Mechanical tests (tensile strength, fatigue, torsional strength, etc.) comparing the modified device to the predicate device and established engineering standards.
  • Biocompatibility Testing: Ensuring materials are safe for human implantation.
  • Clinical History of Predicate Devices: Relying on the established safety and effectiveness of the existing devices to which this modified device is substantially equivalent.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of device.

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

• Not applicable. There is no "training set."

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