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The PRECICE UNYTE System is indicated for open and closed fracture fixation, corrective osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones.

The PRECICE UNYTE System is composed of the PRECICE UNYTE Nail (supplied sterile), locking screws, end cap, 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 PRECICE UNYTE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non-sterile and must be sterilized prior to use. The UNYTE Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The UNYTE 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.

The provided text is a 510(k) summary for a medical device (PRECICE UNYTE System) seeking clearance from the FDA. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or performance testing in the way an AI/ML device would be scrutinized.

Therefore, the typical metrics and study structures associated with AI/ML device acceptance criteria (e.g., sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies) are not present in this document.

The document states: "There are no technological or performance changes to the PRECICE UNYTE Nail being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE UNYTE Nail are applicable." This implies that the device's performance, as demonstrated by the predicate device, is considered sufficient and no new performance studies for the new device itself are explicitly detailed or required for this 510(k) submission.

However, I can interpret the existing information in the context of the requested questions, focusing on the equivalence aspect described in the document.

Interpretation based on the provided document:

The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to legally marketed predicate devices, as per FDA's 510(k) pathway. The "study" proving this is the comparison of indications for use, technological characteristics, and principles of operation between the PRECICE UNYTE System and its predicate/reference devices.

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

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of a clinical performance study as typically understood for AI/ML devices. This submission relies on demonstrating substantial equivalence to prior FDA-cleared devices, meaning performance data from those predicate devices is implicitly referenced.
• Data Provenance: Not specified as a separate test set. The provenance relates to the historical regulatory clearance of the predicate devices (K160267, K170346, K162927, K130625).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. Ground truth establishment by experts for a specific test set is not a component of this 510(k) submission, which focuses on device design and IFU equivalence to existing devices.

4. Adjudication method for the test set:

• Not applicable. The document does not describe a clinical study requiring an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done or described in this document. This is not typically required for a 510(k) submission demonstrating substantial equivalence for a mechanical orthopedic device.

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

• Not applicable. This device is a mechanical intramedullary fixation rod, not an algorithm, so the concept of "standalone performance" for an algorithm doesn't apply.

7. The type of ground truth used:

• Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of its predicate devices, implying their safety and effectiveness have already been established.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm being "trained" as part of this device or its submission.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

In summary: The provided document is an FDA 510(k) clearance letter and summary. It establishes the substantial equivalence of the PRECICE UNYTE System to existing legally marketed devices, primarily the PRECICE UNYTE System (K160267) and other PRECICE family products. The core "study" proving "acceptance criteria" is the detailed comparison and argument that the new device has "similar indications for use, technological characteristics, and principles of operation" to these existing devices, without significant technological or performance changes that would raise new questions of safety or effectiveness. Therefore, the specific types of performance studies and metrics requested in the prompt, typically associated with novel AI/ML software or clinical trials, are not present or applicable to this type of regulatory submission for a mechanical orthopedic implant.

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The AOS Antegrade and Retrograde Femoral Nail are intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip ioint, nonunions and malunions, fractures resulting from osteoporosis.

The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intentrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

AOS Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of long bones and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Nail Systems consist of titanium intramedullary nails, proximal and distal locking screws, and end caps.

This Special 510(k) proposes the addition of gamma terminally sterilized nails, screws, and end caps.

This document describes a Special 510(k) premarket notification for AOS Intramedullary Nails, focusing on the addition of gamma terminally sterilized nails, screws, and end caps.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided text does not include explicit acceptance criteria or reported device performance data in the manner typically seen for performance studies of medical devices that generate quantitative results (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific mechanical thresholds for implants tested against an established standard).

Instead, the document asserts substantial equivalence to predicate devices. The basis for substantial equivalence is that "The proposed nails have the same indications for use, geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6AI-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of the nails."

Therefore, the "acceptance criteria" can be inferred as meeting the criteria for substantial equivalence, primarily demonstrating that the change in sterilization method does not alter safety or effectiveness. The "reported device performance" is the assertion of equivalence to predicate devices, implying that their performance characteristics are maintained.

Inferred Acceptance Criteria:

• Maintenance of indications for use.
• Maintenance of geometry and design.
• Maintenance of fundamental scientific technology.
• Maintenance of material (Ti-6AI-4V ELI, per ASTM F136).
• Sterilization method (gamma terminal sterilization) does not negatively impact safety or effectiveness.

Reported Device Performance (based on substantial equivalence claim):

• The device performs effectively for intramedullary fixation of various long bone fractures, aligning with the predicate devices.
• Safety is maintained with the new sterilization method.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable (N/A). This submission is for a Special 510(k) based on substantial equivalence, not a performance study requiring a test set of data. The "test" is primarily a comparison against existing predicate devices and a justification that the change in sterilization does not alter performance.
• Data Provenance: Not explicitly stated as there is no new performance study with a test set. The data provenance implicitly refers to the information and performance of the established predicate devices, which are already legally marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable (N/A). No test set requiring expert ground truth establishment for performance evaluation is mentioned in this document.

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

• Not applicable (N/A). No test set or adjudication process is described.

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 comparative effectiveness study was not done. This device is an intramedullary nail, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

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

• Not applicable (N/A). No new performance study requiring ground truth is described. The "ground truth" for the device's efficacy and safety is derived from the established performance and regulatory clearance of the predicate devices.

8. The sample size for the training set:

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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