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The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:

• Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
• Fusions of the joints and bone (hand, foot, long-bone)
• Correction of bone or soft tissue deformities
• Correction of segmental or non-segmental bone, soft tissue defects or bone loss
• Neutralization of fractures stabilized with limited internal fixation
• Adult and Pediatric subgroups except newborns

The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

The provided document is a 510(k) summary for the Revolution External Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria in the same way a drug or novel high-risk device might.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria related to device performance metrics for a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document reports on "Performance Testing" but does not explicitly state acceptance criteria or detailed performance results in table format.
• Sample size and data provenance for a test set: Not applicable, as this is a mechanical device undergoing performance testing, not a study involving patient data.
• Number and qualifications of experts for ground truth: Not applicable for mechanical performance testing.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a mechanical implant, not an AI or imaging diagnostic device.
• Standalone performance: While the device's mechanical performance is tested "standalone," the nature of the information isn't a human-in-the-loop setting.
• Type of ground truth used: Not applicable. Performance testing for mechanical devices involves measuring physical properties against engineering standards.
• Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

The document states:
"Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device."

This indicates that:

• Type of testing: Mechanical performance testing.
• Specific tests: ASTM F1541 (Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implants) and "torque to failure testing."
• Purpose: To demonstrate that the modified device's performance is equivalent to that of the predicate device (K181630) and a reference device (K152171), ensuring that "the differences in geometry versus the predicate do not raise different questions of safety and effectiveness."

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through mechanical performance tests against recognized standards and comparison to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for an AI or diagnostic device.

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The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:

• · Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
• · Fusions of the joints and bone (hand, foot, long-bone)
• · Correction of bone or soft tissue deformities
• · Correction of segmental or non-segmental bone, soft tissue defects or bone loss
• · Neutralization of fractures stabilized with limited internal fixation
• · Adult and Pediatric subgroups except newborns

Revolution is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus.
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
A plating system consists of a stacked welded plate module and a footplate. These two plates are connected by four super-struts attached by the surgeon to give the best support for the patient. Once assembled, the module is attached to the patient's limb with half-pins or wires. The halfpins are threaded pins with a buttress thread form. Half pins come in three sizes, 4mm, 5mm, and 6mm. Half pins comes in 215mm overall length, but various thread lengths to encompass the size of the bone. Wires come In 1.8mm in diameter and come in 400mm overall lengths. They're meant for traction to the bone. These are inserted through or to the bone and attached to the frame to create a stable construction patient's limb thereby allowing the surgeon to correct or repair the patient's indications.

This document describes Revolution External Plating System, an external fixator. The following is an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria

2. Sample Size and Data Provenance

This document does not describe a clinical study involving human patients, but rather non-clinical mechanical performance testing. Therefore, there is no information on sample sizes for a test set in the context of human data or data provenance (e.g., country of origin, retrospective/prospective). The "test set" in this case refers to the physical devices tested.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is a mechanical performance study of a device, not a study requiring expert interpretation of data or images to establish ground truth.

4. Adjudication Method

Not applicable, as this is a mechanical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes mechanical testing of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, in the sense that the mechanical tests were performed directly on the Revolution External Plating System device itself, without human intervention in the device's function during the test. The "performance" being evaluated is the mechanical integrity and strength of the device.

7. Type of Ground Truth Used

The ground truth for this study is not clinical outcomes or expert consensus, but rather the physical properties and mechanical strength standards as defined by ASTM F1541 and compared against legally marketed predicate devices. The "truth" is whether the device can withstand specified mechanical stresses.

8. Sample Size for Training Set

Not applicable. This is not an AI/machine learning model where a "training set" of data is used. The "training" for this device would be its design and manufacturing process.

9. How Ground Truth for Training Set Was Established

Not applicable. As noted above, this is not an AI/machine learning context. The design of the device (if that were considered a 'training set') would be based on engineering principles, material science, and the existing predicate devices.

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