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The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text describes a 510(k) premarket notification for the "LITe® Plate System," a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or AI-driven performance.

Therefore, many of the requested categories related to AI device performance evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant and its ability to meet established ASTM standards for orthopedic devices. The "study" demonstrating this is mechanical testing.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in terms of clinical patient data. For mechanical testing, the number of samples tested per condition is not explicitly stated, but typically follows standard testing protocols for ASTM standards.
• Data provenance: Not applicable in the context of clinical or image data. The "data" pertains to mechanical test results.

3. 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 devices is established by engineering specifications and recognized consensus standards (like ASTM F1717-14), not by expert human readers.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing results are objective measurements against defined standards, not subjective assessments requiring adjudication.

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 a mechanical implant, not an AI diagnostic device.

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

• Not Applicable. This is a mechanical implant, not an AI diagnostic device.

7. The type of ground truth used:

• Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on meeting the specifications outlined in ASTM F1717-14 and demonstrating comparable mechanical properties and functional equivalence to its predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a mechanical implant, not an AI device that requires a training set.

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

• Not Applicable.

Summary of the Study:

The "study" referenced in the document is a risk analysis and mechanical testing comparison to predicate devices, not a clinical trial or AI performance study. The submission aimed to demonstrate substantial equivalence to already approved devices.

The key points of the study are:

• Mechanical Testing: The device underwent static and dynamic compression testing per ASTM F1717-14, static torsion testing per ASTM F1717-14, and buttress plate expulsion testing.
• Acceptance Criteria for Mechanical Testing: Predefined acceptance criteria associated with these tests were met. These criteria would be derived from the ASTM standards and comparisons to predicate device performance.
• Comparison to Predicates: The LITe® Plate System was compared to its primary predicate (Stryker Spine, LITe® Plate System, K142699) and additional predicates (Stryker Spine, CENTAUR™ Spinal System, K994347, K001844). The comparison covered intended use, material composition, principles of operation, and design.
• Conclusion: The risk analysis performed demonstrated that any minor differences between the LITe® Plate System and its predicates do not impact device performance, leading to the determination of substantial equivalence.

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The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifureation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation); Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion

The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text is a 510(k) summary for a medical device called the LITe® Plate System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with specific metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human reader improvement with AI
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the K142699 document refers to non-clinical mechanical testing, not a study of an AI/algorithm's diagnostic or predictive performance.

It states:
"Nonclinical testing was performed to demonstrate that the LITe® Plate System is substantially equivalent to its predicate devices. The following testing and analysis was performed:

• Static and dynamic compression testing per ASTM F1717-14
• Static torsion testing per ASTM F1717-14
• Buttress plate expulsion testing"

This type of testing is to ensure the physical integrity and mechanical properties of the orthopedic implant meet established standards for similar devices, not to assess the performance of a diagnostic algorithm or AI system.

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