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The LEUCADIA™ 4.5 mm Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia™ 4.5 mm Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia™ 4.5 mm Pedicle Screw System consists of 4.5 mm diameter screws, which are available in 7 different lengths: 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. All sizes are able to receive 5.5mm connecting rods only. The Leucadia™ 4.5 mm Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ 4.5 mm Pedicle Screw System is a temporary implant system intended to be removed after solid fusion has occurred. Leucadia™ 4.5 mm Pedicle Screw System implant components are an addition to the existing Leucadia™ Pedicle Screw System (K110588 - S/E May 25, 2011). It should not be used with components from any other manufacturer. As with all orthopedic implants, Leucadia™ 4.5 mm Pedicle Screw System components should not be reused.

The Leucadia™ 4.5 mm Pedicle Screw System is intended to help correct, immobilize, and stabilize spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral space.

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

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

The sample size is not explicitly stated, but the testing involved biomechanical tests compliant with ASTM standards. The data provenance is from laboratory testing of the device and its predicate, conducted by Phygen, LLC, a US-based company. These are prospective tests performed specifically for this submission.

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

Not applicable. The ground truth for this device is based on standardized biomechanical testing (ASTM standards), not expert medical opinion on clinical images or patient data.

4. Adjudication method for the test set

Not applicable. This device relies on objective mechanical testing against established industry standards.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This is a medical device (spinal implant) and its performance is evaluated through biomechanical testing, not through human reader interpretation of data or images.

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

Yes, a "standalone" evaluation was performed, meaning the device's mechanical properties were tested independently without human interaction influencing the test results.

7. The type of ground truth used

The ground truth used for proving the device meets acceptance criteria is based on:

• Established ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F1717-10 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending, and ASTM F543-07 for Screw Pullout Tests. These standards define the methodologies and expected performance parameters for spinal implant devices.
• Comparative equivalence: The device's performance was compared against the predicate device (LEUCADIA™ Pedicle Screw System, K110588) and/or other similar implants, demonstrating equivalent mechanical properties sufficient for in vivo loading.

8. The sample size for the training set

Not applicable. This device is a mechanical implant; therefore, no "training set" in the context of machine learning or AI is relevant.

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

Not applicable, as there is no training set for this type of device.

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The LEUCADIA AutoLok™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia AutoLok™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Multi-axial AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The unique pedicle screw and set screw interface is designed to prevent backout of the set screw from the construct. The Leucadia AutoLok™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia AutoLok™ Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia AutoLok™ Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia AutoLok™ Pedicle Screw System components should not be reused.

The provided text describes a medical device, the LEUCADIA AutoLok™ Pedicle Screw System, and its substantial equivalence to a predicate device, rather than an AI/ML-driven device requiring extensive performance studies as outlined in your request. Therefore, most of the requested fields are not applicable to the information given.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the provided content.

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

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is a mechanical implant, and its performance was evaluated through biomechanical tests, not based on a clinical test set of patient 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): Not applicable. Ground truth for mechanical devices is established through engineering standards and testing, not expert consensus on clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a mechanical device's performance testing.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this mechanical device, the ground truth is established by the specified ASTM (American Society for Testing and Materials) standards for biomechanical properties.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary:

The LEUCADIA AutoLok™ Pedicle Screw System's acceptance criteria are based on its mechanical performance relative to a predicate device and established ASTM standards. The study proving this involved biomechanical testing, demonstrating equivalence to the predicate device. The information provided does not pertain to an AI/ML medical device, and therefore many of the requested fields are not relevant.

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The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia™ MIS Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia™ MIS Pedicle Screw System consists of a variety of rods and cannulated screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi-axial implant screws are supplied in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The ø1.7mm cannulation allows the screws to be implanted over a guidewire in a "mini open" or minimally invasive procedure. The Leucadia™ MIS Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ MIS Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia™ MIS Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia™ MIS Pedicle Screw System components should not be reused.

The provided text describes a medical device, the LEUCADIA™ MIS Pedicle Screw System, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based device. The document is a 510(k) summary for a physical spinal implant system.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample size for a test set, data provenance, or details about training sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is focused on the mechanical and material equivalence of a physical medical device.

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The DEL MAR® Monoaxial Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Del Mar® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Del Mar® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor-made to fit the patient's individual anatomy. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 6 mm, 7 mm, 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments from 30 to 120 mm in length. Additional components, such as a Single Piece Set Screw, Cobalt Chrome Rods ranging from 400 mm to 600 mm and several types of Deformity Connectors have been added. The Del Mar® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136 and Cobalt Chrome alloy per ASTM F1058.

The provided 510(k) summary (K110679) describes a spinal fixation system, not a device that generates performance metrics like sensitivity, specificity, or AUC, which are typically associated with AI/ML-based diagnostic or prognostic devices. Therefore, a direct application of the requested structured response for AI/ML device studies is not fully appropriate.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them, focusing on the mechanical and substantial equivalence aspects as presented in the document.

Acceptance Criteria and Reported Device Performance

Study Details (based on what's available for a non-AI/ML mechanical device):

The device is a mechanical spinal fixation system, and the "study" referred to in the document is a series of mechanical bench tests rather than a clinical study with human subjects, diagnostic accuracy endpoints, or AI/ML algorithm performance.

1. Sample size used for the test set and the data provenance: Not applicable in the context of human subjects or clinical data for this type of device. The "test set" would refer to the physical device samples subjected to mechanical testing. The provenance is the manufacturer (Phygen, LLC).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not expert medical consensus on human data.

3. Adjudication method for the test set: Not applicable. Mechanical tests have pass/fail criteria based on measured physical properties against established standards.

4. 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 a mechanical device, not an AI/ML diagnostic tool requiring human reader studies.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • For mechanical performance: Adherence to ASTM F1717-10 and ASTM F1798-97 (2008) standards for spinal implant mechanical testing. The "ground truth" is the established performance requirements within these standards.
   • For substantial equivalence: Comparison against the predicate device's previously cleared design, materials, and indications for use, as evaluated by the FDA.

7. The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI/ML model that undergoes a "training set" process.

8. How the ground truth for the training set was established: Not applicable.

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The LAGUNA® Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The provided text describes a spinal fixation system, not an AI/ML device. Therefore, many of the requested criteria, such as those related to AI algorithm performance (standalone performance, MRMC studies, training/test set details, ground truth establishment for AI), are not applicable.

However, I can extract information related to the device's performance testing based on the provided text.

The device is the "LAGUNA® Pedicle Screw System," a spinal fixation system.

Acceptance Criteria and Device Performance:

The provided text states that the device was evaluated through biomechanical tests. The acceptance criteria are implicitly that the device performs equivalently to other similar implants.

Study Details (Non-AI/ML specific):

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of number of devices tested, but the tests were "Biomechanical tests per ASTM F1717-10". These are laboratory tests on device components, not human or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biomechanical testing is defined by the ASTM F1717-10 standard, which specifies test methodologies and performance characteristics. It does not involve human expert consensus for "ground truth" in the way an AI assessment would.
• Adjudication method for the test set: Not applicable for biomechanical testing. The results are quantitative measurements against a standard.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used: The ground truth is defined by the performance requirements and methodologies outlined in the ASTM F1717-10 standard for biomechanical testing.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The LEUCADIA™ Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: severe spondylolisthesis (grade 3 and 4) at L5-S1; degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The LEUCADIA™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LEUCADIA™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 7 mm. 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments, ranging from 30 to 120 mm in length. The LEUCADIA™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The document provided is a 510(k) summary for the LEUCADIA™ Pedicle Screw System. It details the device's indications for use and states that biomechanical performance tests were conducted to demonstrate substantial equivalence to a predicate device.

However, the provided text does not include an acceptance criteria table, reported device performance metrics against specific criteria, or details regarding studies that would involve human readers, ground truth establishment, or sample sizes related to clinical or image-based performance. The study described is a series of biomechanical tests.

Therefore, many of the requested items cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for test set: Not applicable for biomechanical tests in the context of clinical or image-based studies. The "test set" here refers to the biomechanical testing of the device components.
• Data Provenance: The tests are biomechanical in nature, conducted on the device components themselves, not on patient data.

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

• Not applicable. Ground truth in this context would be related to biomechanical standards and measurements, not expert clinical assessment.

4. Adjudication method for the test set

• Not applicable. Biomechanical tests follow standardized protocols (e.g., ASTM F1717, F1798, F543). The "adjudication" is based on meeting the requirements of these standards or demonstrating equivalence to a predicate device.

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, a multi-reader multi-case (MRMC) study was not done. This device is a pedicle screw system, a physical implant, 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 (algorithm only) performance study was not done. This device is a physical implant.

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

• The "ground truth" for the biomechanical tests would be the quantitative measurements dictated by the ASTM standards (e.g., force, displacement, torque values) and comparison to established predicate device performance or industry benchmarks for in vivo loading sufficiency.

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.

Study details (from the document):

The study to "prove the device meets the acceptance criteria" involved the following biomechanical tests:

• Static Compression Bending Tests per ASTM F1717
• Static Tension Bending Tests per ASTM F1717
• Static Torsion Tests per ASTM F1717
• Dynamic Axial Compression Bending Tests per ASTM F1717
• Static Axial Gripping Capacity Tests per ASTM F1798
• Static Axial Torque Tests per ASTM F1798
• Static A-P Screw Pull Tests per ASTM F1798
• Static Screw Pullout Tests per ASTM F543

The conclusion of these tests was that the results were equivalent to the predicate device (LAGUNA® Pedicle Screw System, K083826 and K050060) and/or other similar implants and were deemed "sufficient for in vivo loading."

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