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The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, ORTHROS™ MIS Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3sacrum/ilium.

The ORTHROS™ Posterior Stabilization System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the ORTHROS™ Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

The ORTHROS™ Posterior Stabilization System is a multiple component, posterior stabilization system which consists of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, cannulated polyaxial screws, reduction screws, cannulated reduction screws, locking caps, locking set screws, cross links, and associated manual surgical instruments. The ORTHROS™ Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking Caps and Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136.

The ORTHROS™ MIS Posterior Stabilization System is a multiple component, minimally invasive posterior stabilization system which consists of a variety of shapes and sizes of rods, cannulated percutaneous/MIS polyaxial screws, locking set screws, and associated manual surgical instruments. The ORTHROS™ MIS Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. The MIS polyaxial screws are intended for posterior use. Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136. The ORTHROS™ MIS System also utilizes select instrumentation from the ORTHROS™ Posterior Stabilization System.

The provided text describes a 510(k) submission for the ORTHROS™ Posterior Stabilization System and the ORTHROS™ MIS Posterior Stabilization System. This document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant system and does not contain information related to an AI/ML device.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI device, as these are not relevant to the content provided. The "Performance Data" section specifically refers to mechanical testing of the spinal implant, not performance of a software algorithm.

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Orthros Posterior Stabilization System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, Orthros Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

Orthros Posterior Stabilization System consist of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, locking caps and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps and locking set screws are used to connect screws to the rod. The rods are composed of titanium alloy, as specified in ASTM F136. All other implants are composed of titanium alloy, as specified in ASTM F136.

The provided text describes the Orthros Posterior Stabilization System, a medical device for spinal stabilization. The information primarily focuses on non-clinical testing for substantial equivalence, and therefore many of the requested details concerning software performance, AI algorithms, and human reader studies are not applicable.

Here's an analysis of the available information:

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. The document states "The following tests were performed," implying laboratory testing of device components, not patient data.
• Data Provenance: Not applicable, as no patient data was used. The tests were performed on the device components themselves in a laboratory setting.

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 non-clinical, mechanical tests is established by the specifications defined in the ASTM standards (F1717-13 and F543-07). No human expert consensus was needed.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) and not for objective mechanical 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

• No MRMC comparative effectiveness study was done. The device is a physical spinal implant system, not an AI software or imaging interpretation tool that would involve human readers.

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

• Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

• Ground Truth: Engineering specifications and performance thresholds defined by established ASTM (American Society for Testing and Materials) standards: ASTM F1717-13 (Standard Test Methods for Static and Fatigue Bending Properties of a Spinal Implant Construct) and ASTM F543-07 (Standard Specification for Metallic Medical Bone Screws).

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.

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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