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The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:

• · Intertrochanteric and subtrochanteric fractures
• · Segmental fractures
• Comminuted fractures
• Pathological fractures
• · Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union, and delayed union
• · Surgically created defects such as osteotomies

The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:

• . Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
• Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
• Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
• Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.

This document describes the Pro-X1™ Trochanteric Nailing System, a device for fracture fixation in the femur. However, the provided text does not contain the kind of information that would be used to assess the performance of an AI/ML medical device, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies.

The document is a 510(k) summary for a physical medical device (an intramedullary rod system), not an AI/ML-driven diagnostic or prognostic tool. The performance data presented refers to non-clinical bench testing for mechanical properties, not clinical accuracy or utility in an AI context.

Therefore, I cannot provide the requested information in the format of AI/ML device performance.

The "acceptance criteria" discussed in the document are about the mechanical performance of the physical device (e.g., fatigue, bending, torque, pull-out strength) and its substantial equivalence to a predicate device based on these mechanical characteristics.

Here’s a summary of what is available in the document, which pertains to a traditional medical device:

Device: Pro-X1™ Trochanteric Nailing System

Intended Use: Fracture fixation in the femur in adults with osteopenia or osteoporosis.

Predicate Device: X-BOLT IM Hip Nail System (K181640)

Reference Device (for comparison, but not direct predicate): Howmedica Osteonics Corp.'s Gamma 3 Nail System (K034002)

Non-Clinical Performance Data (Bench Testing):

Substantial Equivalence Conclusion: The Pro-X1™ Trochanteric Nailing System is substantially equivalent to the X-BOLT IM Hip Nail System (K181640) based on:

• Same intended use
• Same fundamental scientific technology
• Similar functional and technological characteristics via similar operational principles
• Evaluation of risk and performance data demonstrating it is as safe and effective for its intended use.

Missing Information (as pertains to AI/ML device assessment):

1. A table of acceptance criteria and reported device performance (in an AI/ML context)
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

This document describes a traditional medical device and its mechanical testing, not an AI/ML product.

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The intended use of the Gamma3® Nail System includes the following:

Trochanteric Gamma3® Nail: The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.

Long Length Gamma3® Nail: The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.

The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.

The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.

This 510(k) Premarket Notification describes a line extension to an existing intramedullary nail system (Gamma3 Nail System). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a regulatory submission for a medical device and focuses on establishing substantial equivalence to previously cleared predicate devices. Substantial equivalence claims are based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The document primarily serves to inform the FDA that the new components (line extension) are within the scope and safety profile of the already approved Gamma3 Nail System.

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