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The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:

• 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
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

When used as an intervertebral body fusion device, the MC+ Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with the device. The MC+ Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation is required to properly utilize this system.

When used as a vertebral body replacement device. the MC+ Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

The ROI Partial Vertebral Body Replacement System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. ROI Partial Vertebral Body Replacement implants may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize the system.

When used as an intervertebral body fusion device. the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The ROI-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as an intervertebral body fusion device, the ROI-T Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.

The ROI-T implants may be implanted singularly or in pairs.

The LDR Spine implant systems identified above are medical devices designed to stabilize and promote fusion in the cervical and thoracolumbar spine. The materials used in their manufacture are titanium alloy (ASTM F136), tantalum (ASTM F560), and PEEK OPTIMA® LT1.

The purpose of this 510(k) submission is solely to add MR Conditional labeling to LDR Spine's vertebral body replacement and interbody fusion cage systems (ROI, MC+, ROI-A, ROI-C, ROI-T), and to update the steam sterilization recommendations for all non-sterile instruments, cases, and trays for the above listed vertebral body replacement and intervertebral body fusion cages, as well as the Easyspine pedicle screw system.

The subject device systems remain unchanged relative to their predicates with respect to indications for use, material, design and performance characteristics.

The provided text is a 510(k) Summary for LDR Spine USA devices, specifically focusing on adding MR Conditional labeling and updating steam sterilization recommendations. It does not describe the acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based diagnostic or prognostic device.

Instead, the document details non-clinical performance data for MR compatibility and sterilization validation for physical implant systems.

Therefore, I cannot extract the requested information as it pertains to AI/algorithm-based device performance. The document focuses on:

1. MR Compatibility Testing:

   • Acceptance Criteria (Implied): Meeting ASTM recommendations for MR-Conditional labeling in terms of device heating, magnetically induced displacement, and MRI artifacts.
   • Study: Non-clinical performance testing conducted on ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants.
   • Methods: Described in ASTM F2052-06, ASTM F2213-06, ASTM F2119-07, and ASTM F2182-09.
   • Reported Performance: Test results indicate that the PEEK interbody fusion cages and anchor plates (where applicable) and vertebral body replacement devices meet these ASTM recommendations.

2. Steam Sterilization Validation:

   • Acceptance Criteria: Achieving a Sterility Assurance Level (SAL) of 10^-6 (although the document states 10^-8, which is an even higher level of assurance) when exposed to a steam sterilization cycle meeting recommended parameters.
   • Study: Steam sterilization validation for non-sterile devices associated with the EasySpine pedicle screw system and the ROI, MC+, ROI-A, ROI-C, and ROI-T implants.
   • Methods: Performed in accordance with AAMI TIR12, ANSI AAMI ST79, ISO 17655-1, and AAMI TIR 39.
   • Reported Performance: Confirmed that the non-sterile devices achieved a SAL of 10^-8.

Regarding the specific points of your request for an AI/algorithm device:

1. Table of acceptance criteria and reported device performance: Not applicable to this document's content.
2. Sample size for the test set and data provenance: No test set in the context of AI/algorithm is described. The tests were on physical implant samples.
3. Number of experts and their qualifications: Not applicable. Testing involved engineering and lab evaluations.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This document is not about human reader performance with or without AI.
6. Standalone performance study: Not applicable. This refers to the physical properties of the implants, not an algorithm's standalone performance.
7. Type of ground truth used: Not applicable in the AI/algorithm sense. The "ground truth" for MR compatibility is adherence to ASTM standards and for sterilization is achieving a specific SAL.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

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