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The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC or ERC 2P). The Nail is available in various diameters, lengths and screw-hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model) to allow for compression fracture reduction techniques.

This document is a 510(k) premarket notification for the "PRECICE Trauma Nail System" and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/medical device.

Therefore, the requested information (1-9) about acceptance criteria and study results cannot be extracted from this document, as it describes a clearance process for a medical device rather than a comprehensive performance study that would typically include such details.

Specifically:

• No acceptance criteria or device performance table is provided. The document states "Non-clinical testing of the PRECICE Trauma Nail System included design verification testing to ensure the device meets the retraction (compression) force and distraction force required for the humerus and cadaveric design validation testing to ensure the device can be inserted into the medullary canal and fixed to the humerus using the humeral specific instruments." This describes the types of tests performed, but not specific numerical acceptance criteria or the reported performance.
• No information on sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, or how ground truth for the training set was established is present. These details are typically found in clinical validation studies for diagnostic or AI-driven devices, which this is not.

The document primarily focuses on:

• Indications for Use: "The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones."
• Substantial Equivalence: The device is deemed substantially equivalent to the "PRECICE® Trauma Nail System" (K142599) based on "same indications for use, technological characteristics, principles of operation, designs, and on in vitro testing performed."
• Technological Characteristics: The device is described as a titanium intramedullary nail with a telescoping portion, an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing, adjusted non-invasively by an External Remote Controller (ERC).
• Non-clinical Testing: Mechanical testing (according to ASTM F1264-03), gamma radiation sterilization cycle validation (ISO 11137-2), shelf life testing, O-ring seal performance, and biocompatibility (ISO 10993-1) were performed on the predicate device and found applicable. Design verification and cadaveric design validation specific to the humeral models were also conducted for the current submission.

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The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.

This document describes the PRECICE Trauma Nail System, which is an intramedullary nail for fixing long bone fractures, pseudoarthrosis, mal-unions, and non-unions. The submission is a Special 510(k) focusing on modifications to an already cleared predicate device (PRECICE Trauma Nail System, K113695).

Based on the provided text, the device itself is a mechanical intramedullary nail system and thus the studies performed are not human-in-the-loop AI studies, nor does the device rely on AI/ML, algorithms, or data for ground truth establishment. Instead, the studies are focused on demonstrating the mechanical and functional equivalence of the modified device to its predicate.

Here's an analysis based on the provided text, with clarifications where the requested information is not applicable to this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, etc.). The "performance" here refers to the physical and functional attributes of the modified nail.

Study Details:

The study described is not a clinical trial or an AI/ML performance study. It's a benchtop and engineering study demonstrating that the modifications to the PRECICE Trauma Nail System (specifically, adopting design changes from the PRECICE Intramedullary Limb Lengthening System and adding an 8.5mm diameter) do not alter the substantial equivalence to the previously cleared predicate PRECICE Trauma Nail System. The core studies (mechanical, design verification, magnetic field safety, packaging/shelf-life, sterilization, biocompatibility) were performed on the referenced PRECICE Intramedullary Limb Lengthening System, and these results were deemed applicable because the modified PRECICE Trauma Nail is identical in design to the PRECICE Nail in that system, with the only difference being the pre-distraction feature.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of "test set" for data-driven AI/ML models. The "test set" here refers to the actual physical devices (or components) subjected to various engineering and performance tests. The document doesn't specify the exact number of nails or components tested, but it implies standard engineering testing practices where a sufficient number of samples are used to ensure statistical confidence in results (though specific numbers aren't provided in this summary).
• Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective clinical data for AI/ML. The "data" comes from laboratory and benchtop testing of the specific medical device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context is established by engineering specifications, validated test methods, and regulatory standards for mechanical and material performance, not by expert consensus on clinical findings. The evaluation is done by engineers and scientists, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" in an engineering context would refer to internal validation and review processes by qualified engineers to ensure test protocols were followed and results were interpreted correctly, but this is not typically detailed in 510(k) summaries in the same way as clinical adjudication.

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 not an AI/ML device and does not involve human readers or image interpretation.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering specifications, material properties, and performance standards for intramedullary fixation rods. For example, the ground truth for mechanical testing would be the breaking point, fatigue life, or magnetic field compatibility as defined by relevant ISO or ASTM standards, and comparative performance to the predicate device's established performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth.

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The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use. The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod.

I am sorry, but the provided text does not contain information regarding acceptance criteria or details about a study that proves the device meets acceptance criteria.

The document is a 510(k) summary for the Ellipse PRECICE Trauma Nail System, primarily focusing on:

• Product Description: What the device is and its components (intramedullary rod, locking screws, external remote controller).
• Indications for Use: What the device is intended for (closed fracture fixation, pseudoarthrosis, mal-unions, and non-unions of long bones).
• Substantial Equivalence: How the device is similar to previously cleared devices (predicates) and therefore deemed safe and effective. It explicitly states that the purpose of the premarket notification is to provide labeling for fracture fixation and that substantial equivalence is based on similar indications and technological characteristics.
• FDA Clearance Letter: Official communication from the FDA confirming the 510(k) clearance based on substantial equivalence.

There is no mention of specific acceptance criteria, test results, device performance metrics, or study designs to prove that the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets.

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