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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 SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

The provided document is a 510(k) premarket notification for a medical device called the SOLE™ Medial Column Fusion Plate. This documentation focuses on establishing substantial equivalence to existing predicate devices through non-clinical performance data and does not involve AI or machine learning. Therefore, many of the requested criteria (e.g., sample size for test/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for AI) are not applicable to this submission.

However, I can extract the acceptance criteria and the study type used to prove the device meets these criteria based on the information provided in the "Performance Analysis" section.

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

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

The document primarily relies on bench testing and engineering assessments and a review of current clinical literature on predicates and similar devices. It does not describe a clinical study with human subjects, therefore, traditional "test set" and "data provenance" in the context of clinical data are not applicable. The bench testing would involve physical samples of the device; the number of samples is not specified.

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)

Not applicable. This is a device submission based on non-clinical performance data and substantial equivalence to predicates, not a study requiring expert-established ground truth for diagnostic accuracy.

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

Not applicable. No clinical test set requiring adjudication 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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

For the mechanical performance testing, the "ground truth" or reference for acceptable performance are the specified requirements of the referenced ASTM and ISO standards. For the substantial equivalence argument, the performance of the predicate devices serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations.

The subject device implants, bone plates and bone screws, are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.

These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).

JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:

• Acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes or data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table and information based on the provided text.

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The G-Beam™ Fusion Beaming System is intended to be inserted in the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions. It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus. Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).

Components and instrumentation included in the G-Beam™ Fusion Beaming System and the predicate device are both internal fracture fixation systems, as defined in 21 CFR 888.3040.

The provided text describes Orthofix Srl's G-Beam Fusion Beaming System and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices through technical characteristics and mechanical performance testing rather than clinical studies or AI algorithm evaluation. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the given text.

However, based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The text indicates that the device met or exceeded requirements established by test protocols and applicable standards. However, specific numerical acceptance criteria and precise performance values (e.g., specific load capacities, fatigue cycles) are not detailed in the provided summary.

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

The text refers to "mechanical testing" and "tests were performed" but does not specify the sample size of the devices or components used for these tests. Data provenance is not described in terms of country of origin or retrospective/prospective; it's related to laboratory testing results.

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

This information is not applicable as the device is a physical medical implant, not an AI-powered diagnostic device requiring expert interpretation of results for ground truth.

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

Not applicable, as this refers to adjudication of expert opinions for ground truth in diagnostic studies, which is not relevant for this device's evaluation.

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. The G-Beam Fusion Beaming System is a physical implant, not an AI system for image interpretation or diagnosis.

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

Not applicable. No AI algorithm is involved.

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

For mechanical testing, the "ground truth" is defined by the requirements of the standards (e.g., specific load magnitudes, displacement limits, fatigue life) within the scope of the testing protocols. For pyrogenicity, it's the absence of bacterial endotoxins as defined by the USP and ANSI/AAMI standards.

8. The sample size for the training set

Not applicable. There is no AI model requiring a training set.

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

Not applicable. There is no AI model requiring a training set or its associated ground truth establishment.

Summary of the Study performed (Mechanical and Pyrogenicity Testing):

Study Purpose: To demonstrate that the G-Beam Fusion Beaming System is substantially equivalent to legally marketed predicate devices in terms of mechanical performance and non-pyrogenicity.

Methodology:

• Mechanical Performance Testing:
  • Standards Used: ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices" and ASTM F-543-13 "Standard Specification and Test Methods for metallic bone screws".
  • Outcome: "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure."
• Pyrogenicity Testing:
  • Standards Used: USP 38: 2014 "Bacterial endotoxin test (LAL)", USP 38: 2014 "Medical devices – bacterial endotoxin and pyrogen tests", and ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing".
  • Outcome: "tests were performed according to the following international standards" to establish non-pyrogenicity.

Results/Conclusion: All testing met or exceeded the requirements as established by the test protocols and applicable standards. The mechanical properties of the subject device were found to be "equivalent or better than the predicate device." The device was found to be "substantially equivalent to the predicate device" in terms of safety and effectiveness, and "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

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