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Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.

The Synthes MultiLoc Proximal Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the proximal humerus for the fixation of fractures. The system features intramedullary nail devices, as well as 4.5mm bone screw and end cap accessories. The nails are cannulated, are offered in 8.0mm and 9.0mm diameters, and 160mm in overall length. The nail, screw, and end cap devices are composed of titanium alloy. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc proximal locking screws. The 4.5mm MultiLoc Screws which are used to facilitate the proximal locking of the nail construct can be interlocked with existing Synthes 3.5mm Locking Screws to enhance the stability of the construct.

This document describes the Synthes MultiLoc Proximal Humeral Nailing System, a medical device for fixing proximal humerus fractures. However, it does not include information about acceptance criteria or a study demonstrating device performance against such criteria in the manner requested (e.g., accuracy, sensitivity, specificity, or clinical outcomes in a human population).

The primary focus of this 510(k) summary is to establish substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and therefore does not require a new Premarket Approval (PMA).

Here's a breakdown of what is and is not in the provided text, in relation to your questions:

Summary of Information Provided vs. Requested:

The document details the engineering and material characteristics of the device and compares them to predicate devices to establish substantial equivalence, rather than providing performance metrics against pre-defined acceptance criteria for a diagnostic or AI device.

Detailed Response to Your Questions:

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

   • Not provided. The document does not contain a table of acceptance criteria (e.g., clinical efficacy rates, accuracy metrics) or reported performance data in terms of human clinical outcomes. Instead, it describes in vitro mechanical testing results to demonstrate comparable performance to predicate devices from an engineering standpoint.
   • The "performance" discussed is related to mechanical strength and material characteristics (bending strength, torsional strength, dynamic fatigue strength) compared to predicate devices, not clinical efficacy in a patient population.

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 / Not provided. The "test set" in this context refers to in vitro mechanical testing, not a clinical data set. Therefore, concepts like country of origin or retrospective/prospective do not apply. The document does not specify the sample size used for the mechanical tests, only that they were performed "in comparison with the predicate devices."

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 provided. This device is an implantable medical device, not a diagnostic or AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing would be the physical properties and performance under specific loads, measured by engineering methods.

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

   • Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies or studies involving human judgment (e.g., reading images), which is not the nature of the testing described here.

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:

   • No. An MRMC study is not relevant for this type of implantable device. This study focuses on physical and mechanical properties.

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

   • Not applicable. This is an implantable hardware device, not an algorithm.

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

   • Mechanical properties and material characteristics. The "ground truth" for demonstrating substantial equivalence for this device relies on ASTM F1295-05 standard and in vitro mechanical tests, comparing the device's physical performance (bending strength, torsional strength, dynamic fatigue strength) to predicate devices.

8. The sample size for the training set:

   • Not applicable / Not provided. This medical device is not an AI/ML algorithm that requires a "training set."

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

   • Not applicable / Not provided. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.

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