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The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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 the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is also indicated for pedicle screw fixation for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the confirmed by by history and radiographic disc studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is a rod-based system designed to interface with various spinal anatomies. The 5.50mm Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a 5.50mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The polyaxial screw washers are available in 2 sizes. The smaller washer size is for use with the APEX Polyaxial Screws with shaft diameter from 4.75mm to 7.00mm and the larger washer size to be used with the APEX Polyaxial Screws with shaft diameters 7.75mm and 8.50mm.

Here's a breakdown of the acceptance criteria and study information for the SpineCraft APEX Spine System 5.5mm Rod & Polyaxial Screw Washers (K092825), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the given 510(k) summary. The document focuses on mechanical and dynamic testing, not clinical studies with human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable as the "test set" here refers to mechanical testing of the device itself, not a clinical dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for 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

An MRMC study is not applicable to this type of device (spinal fixation system) or the testing described (mechanical and dynamic performance). This device is hardware, not an AI diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is not an algorithm or AI system.

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

For the mechanical and dynamic testing, the "ground truth" would be established by engineering standards and validated test methods. This involves material specifications (e.g., ASTM F-136, ISO 5832-3 for Ti-6Al-4V) and specific mechanical test protocols designed to simulate in vivo conditions and evaluate properties like fatigue life, static strength, and torsional rigidity. The results are then compared to established performance benchmarks for similar devices or predicate device performance.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as the device is not an AI/ML algorithm.

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The APEX Spine 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 or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The APEX Spine System is a rod-based system designed to interface with various spinal anatomies. The system consists of spinal rods, monoaxial screws, polyaxial screws, bolt-type pedicle screws, various lateral connectors, and various cross (transverse) connectors.

The provided text describes the APEX Spine System, a spinal fixation system, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, is not applicable to this submission. The submission pertains to a traditional medical device (spinal implants) and relies on mechanical and dynamic testing for performance data, as opposed to clinical study data involving human readers or AI algorithms.

Here's a breakdown of the relevant information from the provided text for a traditional medical device:

1. Acceptance Criteria and Device Performance (for this traditional device):

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

• Not applicable. This submission describes a physical medical device (spinal implants) and its mechanical and dynamic testing, not a study involving a test set of data. The "test set" here refers to the physical samples of the device and predicate devices used in mechanical testing.

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

• Not applicable. Ground truth is not established by experts in the context of mechanical testing for a physical device. Performance is determined by objective engineering standards and measurements.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data analysis, not for mechanical testing of a physical 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:

• Not applicable. An MRMC study is relevant for AI/ML-powered diagnostic or assistive devices involving human readers. This submission describes a physical spinal implant.

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

• Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used:

• Not applicable/Objective Mechanical Measurements. For this device, "ground truth" would be the scientifically established physical and mechanical properties and performance standards for spinal fixation systems.

8. The sample size for the training set:

• Not applicable. Training sets are used for machine learning algorithms.

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

• Not applicable. Training sets and their ground truth are specific to machine learning.

Summary of the Study and Device Proof:

The APEX Spine System's compliance is demonstrated through mechanical and dynamic testing. The study's objective was to show that the device's performance is substantially equivalent to legally marketed predicate devices. The performance data explicitly states: "The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices." This statement serves as the proof that the device meets the implicit acceptance criterion of being mechanically equivalent or superior to existing, cleared devices.

The basis for substantial equivalence also relies on similarities in design, material, manufacturing standards, intended use, indications, and contraindications compared to the predicate devices. The fundamental scientific technology is described as "identical to previously cleared systems."

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OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoPore TCP should be gently packed into the defect/void without under-filling or over-filling. OsteoPore TCP is a Jonne graft substitute that resorbs and is replaced with bone during the healing process.

The OSTEOPORE TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.

The provided text does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document is a 510(k) summary for a bone void filler (OsteoPore TCP), focusing on its substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods. The document primarily establishes the device's regulatory classification, intended use, and its equivalence to an already approved product based on design, material, and function.

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