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The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Device Description

The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.

AI/ML Overview

This FDA 510(k) Premarket Notification is for a medical device (intramedullary nail system), not an AI/ML software device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (such as those involving sensitivity, specificity, AUC, human reader studies, and ground truth establishment) are not applicable.

The document demonstrates substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, not through clinical performance metrics related to diagnostic accuracy or human interpretation.

Here's an analysis based on the provided document, but understand that the questions about AI/ML performance metrics are not relevant to this type of device clearance:

1. Table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" revolve around demonstrating comparable mechanical properties to predicate devices, ensuring safety and performance in a biological and mechanical context. The document states that testing was performed per ASTM standards.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary from Text)
Mechanical Strength/Fatigue	Met or Comparable to Predicates: "Substantial equivalence is supported by the results of mechanical testing including static 4-point bending, static torsion, static axial compression, dynamic axial compression, and dynamic bending fatigue (for both the nail and screw components of the system) per ASTM F1264 and ASTM F543. Mechanical testing methods, data, and reports are provided in this submission." The implication is that the device performed comparably to or within acceptable limits derived from the predicate devices' performance as per these standards.
Material Compatibility	Met: All implants are manufactured from Ti-6Al-4V ELI per ASTM F136, a standard biocompatible material commonly used in medical implants and in some predicate devices.
Sterilization	Validated: "All Adaptable Ortho Innovations Intramedullary Nail System implants are delivered sterile and a gamma irradiation sterilization was performed to validate the sterilization dose and ensure a Sterility Assurance Level (SAL) of 10^-6."
Packaging/Shelf Life	Validated: "Packaging validation was performed to validate a 1 year shelf life for the Adaptable Ortho Innovations Intramedullary Nail System implant through real-time and accelerated aging techniques." "The validation study also validated the integrity of the packaging following sterilization and distribution testing."
Indications for Use	Comparable: The indications for use are described and compared to predicate devices, showing substantial clinical equivalence.
Technological Characteristics	Comparable: A detailed comparison table (Table 1) is provided, showing similarity in classification, regulation, product code, material, implanted components, implant location, lengths, diameters, and screw dimensions. Key difference (adjustable length) is addressed by stating that once adjusted, it's equivalent in form and function to single-piece nails.

Regarding the AI/ML specific questions:

Sample sizes used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML diagnostic. Testing involves physical samples of the nail system for mechanical property evaluation. The number of samples tested would be dictated by the relevant ASTM standards (e.g., F1264, F543).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established through engineering and material science standards (e.g., ASTM standards for material properties, strength, fatigue).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for image interpretation, which is not relevant here.
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 not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering standards, material specifications, and validated mechanical performance data (e.g., yield strength, fatigue life, torsional rigidity) obtained from physical testing of the device and its components.
The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary:

The acceptance criteria for the Adaptable Ortho Innovations Intramedullary Nail System focused on demonstrating substantial equivalence to legally marketed predicate devices through robust mechanical testing (adhering to ASTM standards), material characterization, sterilization validation, and packaging/shelf-life validation. The FDA's clearance is based on the premise that these non-clinical tests are sufficient to establish that the device is as safe and effective as its predicates.

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