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TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.

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

The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.

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

An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.

6. Standalone (Algorithm Only) Performance Study

A standalone study was not performed, as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.

8. Sample Size for the Training Set

This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

The R&R Ring Fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Ring Fixator design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.

Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.

The R&R Unilateral Mini Fixator is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression / distraction and early weight bearing, The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.

The provided text is a 510(k) summary for the R&R External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance results as would be typical for a software or AI/ML device.

Therefore, many of the requested categories for describing acceptance criteria and study details are not directly applicable to this type of regulatory submission. The 510(k) process for this device relies on demonstrating that the new device has "the same intended use as legally marketed predicate device(s) and the same technological characteristics as the predicate device(s), OR the same intended use as legally marketed predicate device(s) and different technological characteristics than the predicate device(s) and information submitted by the 510(k) submitter does not raise new questions of safety and effectiveness." It is not about meeting specific performance metrics from a controlled study with predefined acceptance criteria in the manner of an AI/ML device.

Here's an attempt to address the request based on the available information, noting where the information is absent due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to predicate devices, not on presenting specific performance data against predefined acceptance criteria for a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present. The 510(k) summary does not describe a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present. No such ground truth establishment process for a test set is described.

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

This information is not present. No adjudication method for a test set 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

This information is not present. The R&R External Fixation System is a physical medical device (an external fixator), not an AI/ML device, so an MRMC study related to "human readers improving with AI" is not applicable.

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

This information is not present. As it's a physical device, this concept is not applicable.

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

This information is not present. No ground truth for a study is described. Regulatory clearance for this type of device often relies on mechanical testing, biocompatibility testing, and comparison to predicate devices, rather than clinical studies requiring "ground truth" as might be understood for diagnostic AI.

8. The sample size for the training set

This information is not present. No training set is described as this is not an AI/ML device.

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

This information is not present. No training set or associated ground truth establishment is described.

Summary of Relevant Information from the K052005 510(k) Summary:

While the detailed study information you're asking for isn't in this document, here's what the 510(k) does provide regarding the device and its regulatory clearance:

• Device: R&R External Fixation System (Ring Fixator and Unilateral Mini Fixator)
• Intended Use: For various orthopedic applications including fracture fixation, limb lengthening, and deformity correction of long bones (tibia, fibula, femur, humerus, radius, ulna) and small bones (metacarpal, metatarsal, ulnar, calcaneal).
• Classification: Class II, Product Code KTT (Single/multiple component metallic bone fixation appliances and accessories).
• Equivalent Devices (Predicates):
  • True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048)
  • DFS® MiniFixator (EBI, K951357/K970290)
  • Small Bone External Fixation System (Acumed)
• Regulatory Basis: The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent" to the predicate devices for its stated indications for use. This determination means the device does not raise new questions of safety and effectiveness compared to existing, legally marketed devices.
• Approval Date: September 6, 2005.

The 510(k) process for this type of device typically involves demonstrating that the new device has similar design, materials, and mechanical properties to predicates, and that any differences do not raise new safety or effectiveness concerns, often supported by design comparisons, risk analysis, and non-clinical performance testing (e.g., fatigue, static strength, and biocompatibility testing) rather than clinical studies with "test sets" and "ground truths" as described for AI devices.

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