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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); tumor, 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 can 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 LEUCADIA AUTOLOK™ Pedicle Screw System is a medical device. The provided text describes its indications for use and mentions biomechanical tests performed to demonstrate its equivalence to predicate devices. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI-powered device.

Here's a breakdown of what can be extracted from the given text and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

Missing Information: The specific quantitative acceptance criteria (e.g., specific load thresholds, displacement limits) stated in ASTM F1717-15 are not detailed in this document. The document only states that the device's performance was "equivalent" and "sufficient."

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

• Sample Size: Not specified for the biomechanical tests. Biomechanical tests typically use a determined number of test articles for each test condition.
• Data Provenance: Not specified. Biomechanical tests are conducted in a laboratory setting, not typically based on patient data provenance.

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 question is not applicable to the provided information. The document describes a traditional medical device (pedicle screw system), not an AI-powered diagnostic or decision support device. Biomechanical testing for such devices does not involve expert readers or establishing ground truth based on their interpretations.

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

This question is not applicable for the same reason as point 3.

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 question is not applicable for the same reason as point 3.

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

This question is not applicable as this is not an AI-powered device. The device itself (pedicle screw system) is a standalone implant.

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

For this type of device, the "ground truth" for proving performance is established through biomechanical testing standards (ASTM F1717-15 in this case). The "truth" is that the device meets the physical and mechanical requirements defined by these standards, which are considered sufficient for in vivo loading.

8. The sample size for the training set:

This question is not applicable as this is not an AI-powered device that requires a training set.

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

This question is not applicable as this is not an AI-powered device that requires a training set or ground truth in that context.

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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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