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The APEX Spine System is intended to provide immobilization 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; 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX Spine System is also a sacraliliac 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).

When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The purpose of this submission is to add x-large and uniplanar pedicle screws, open iliac connectors and open-closed side-by-side connectors to the APEX Spine System. The APEX Spine System X-Large Screws are similar to the APEX screws and are available in a variety of diameters and lengths and can be used of the components of the previously cleared APEX Spine System. The APEX Uniplanar Pedicle Screw is similar in principle to the APEX Polyaxial Pedicle Screw; however the design restricts motion to the sagittal plane. The Open Iliac Connectors and Open-Closed Side-by-Side Connectors are utilized when pedicle screws are not vertically aligned.

The provided document describes a 510(k) submission for the APEX Spine System Line Extension, which is a spinal fixation system. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria related to a device's performance metrics like sensitivity, specificity, accuracy, etc.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML or diagnostic devices does not apply in this context. This submission focuses on mechanical performance and substantial equivalence.

Here's an analysis based on the information provided, framed to address the spirit of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a spinal implant system and not an AI/ML or diagnostic device, the acceptance criteria are based on mechanical testing standards and comparison to predicate devices, rather than performance metrics like sensitivity or specificity.

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

• Sample Size (Test Set): Not explicitly stated in terms of number of screws or constructs, but the testing was performed on representative samples of the new components (x-large and uniplanar pedicle screws, open iliac connectors, and open-closed side-by-side connectors) added to the APEX Spine System. The ASTM standards dictate specific specimen requirements for each test.
• Data Provenance: The mechanical testing was performed in a laboratory setting, not on patient data. Thus, there is no "country of origin" or "retrospective/prospective" distinction in this context.

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

• Ground Truth for Mechanical Testing: For mechanical performance criteria, the "ground truth" is established by the ASTM standards themselves. These standards are developed by committees of engineers, scientists, and medical professionals. Compliance with these established standards demonstrates mechanical integrity.
• Experts: While not explicitly listed as "experts" for ground truth in the conventional sense, the underlying expertise comes from the materials scientists and biomechanical engineers who perform and interpret the mechanical tests, as well as the committees that develop the ASTM standards.

4. Adjudication Method for the Test Set

• Mechanical Testing: Adjudication is not applicable in the sense of expert review for diagnosis. The "adjudication" is based on comparing the quantitative results of the mechanical tests against the established performance criteria (e.g., strength, durability) and against the performance of the predicate devices. If the new device meets or exceeds the predicate device's performance, it's considered acceptable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No MRMC study was done. This type of study is relevant for diagnostic devices or AI algorithms where human readers interpret medical images. The APEX Spine System is a physical surgical implant.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done

• Not applicable. This concept pertains to AI algorithms. The APEX Spine System is a medical device.

7. The Type of Ground Truth Used

• Ground Truth: For this device, the "ground truth" is primarily defined by established mechanical engineering principles, material science standards (ASTM), and the demonstrated performance of clinically accepted predicate devices. The goal is to show that the new components perform at least as well as existing, cleared devices.

8. The Sample Size for the Training Set

• Not applicable. This submission is not for an AI/ML device, so there is no training set in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The APEX Spine 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 the thoracic. Iumbar, 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration 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).

When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain 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), turnor, pseudoarthrosis, and failed prvious fusion in skeletally mature patients . Levels of fixation are for the thoracic. lumbar and sacral spine.

The purpose of this submission is to add cannulated screws to the APEX Spine System and add indications for use of the APEX Spine System in a posterior percutaneous approach and product code NKB. The APEX Spine System Cannulated Screws have exactly the same geometry of the APEX screws with the addition of a cannulation. The screws are available in a variety of diameters and lengths and can be used with the components of the previously cleared APEX Spine System.

Materials: Titanium alloy per ASTM F136

Function: The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.

The APEX Spine System is a pedicle screw spinal system. The submission (K110906) addresses the addition of cannulated screws to the system and new indications for use in a posterior percutaneous approach.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Bending
• Static Torsion
• Dynamic Compression Bending | Met: Results were "equal or higher than the predicate systems" for all tests (ASTM F1717-09). |
  | Material Composition:
• Titanium alloy per ASTM F136 | Met: The device utilizes Titanium alloy per ASTM F136. |
  | Biocompatibility: (Implicitly covered by substantial equivalence to predicates) | Met: Substantially equivalent to predicate devices with established biocompatibility. |
  | Sterility:
• Non-sterile, steam sterilized at hospital | Met: Device is non-sterile and intended for steam sterilization at the hospital. |

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "testing" and "results," implying a sufficient number of samples were tested to generate comparative data.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by the manufacturer or a contracted testing facility, following ASTM standards. This is a retrospective analysis in the context of device design and comparison to predicates.

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

• Not applicable. This submission focuses on the mechanical and material equivalence of a spinal implant system to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this submission does not involve human readers or clinical interpretation that would require an adjudication method. The "adjudication" here is the comparison of mechanical test results against established predicate device performance and ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is not applicable to a spinal implant system focused on mechanical performance and material composition.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a physical spinal implant, not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering/Performance Standards: The "ground truth" used for testing was primarily based on:
  • ASTM F1717-09: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
  • Predicate Device Performance: The performance of previously cleared spinal systems (e.g., APEX Spine System (K062513), Viper Spine System (K090648), Polaris Spinal System (K103393), Synthes Pangea System (K052123)).
  • Material Specifications: ASTM F136 for Titanium alloy.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this kinesiologic and material equivalence submission for a physical medical device. The device's design is based on established engineering principles and prior device knowledge, not a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question is not relevant. The "ground truth" in development of such a device is rooted in biomechanical principles, material science, and the established safety and effectiveness of predicate devices.

Summary of the Study Proving Acceptance Criteria:

The study summarized in K110906 is a non-clinical bench testing study designed to demonstrate the substantial equivalence of the modified APEX Spine System (with added cannulated screws and percutaneous approach indication) to its predicate devices.

• Study Name: Non-clinical Test Summary
• Study Type: Bench Testing, Mechanical Performance Comparison.
• Methodology:
  • Tests were conducted according to ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
  • Specific tests included: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
  • The "acceptance criteria" here were that the results of these tests for the new device configuration should be "equal or higher" than those of the predicate devices.
• Results: The new device configuration for the APEX Spine System with cannulated pedicle screws met these performance criteria, with results reported as "equal or higher than the predicate systems."
• Conclusion: Based on these non-clinical tests, the manufacturer concluded that the APEX Spine System with the added cannulated pedicle screws is substantially equivalent to the predicate devices in terms of intended use, design, materials, performance, and function. No clinical studies were performed for this submission, as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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The APEX Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 neurological impairment, fracture, dislocation, scoliosis, 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 sacraliliac 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 added Ø5.50mm and Ø6.0mm CoCr Spinal Rods are identical to the existing devices of the previously cleared APEX Spine System with recards to indications for use and function. The Ø5.50mm and Ø6.0mm CoCr 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 Ø5.50mm and/or Ø6.0mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The Ø5.50mm and Ø6.0mm CoCr Rods will be labelled as components of the APEX Spine System.

The provided text describes a 510(k) submission for the APEX Spine System with CoCr Rods. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating the performance of an AI model or diagnostic device against acceptance criteria.

Therefore, the input does not contain the information necessary to complete the requested table and details regarding acceptance criteria and studies proving device performance in the context of AI or diagnostic accuracy studies. The document explicitly states:

• "No clinical studies were performed."
• The non-clinical tests were ASTM standards for mechanical properties of spinal implants.

Given this, I cannot fill out the requested table or provide information about:

1. Acceptance criteria and reported device performance (in terms of diagnostic accuracy/AI performance): Not applicable, as this is a mechanical spinal implant, not an AI or diagnostic device. Performance is typically assessed through mechanical testing and substantial equivalence, not diagnostic metrics.
2. Sample size for the test set and data provenance: No clinical/diagnostic test set was used. Mechanical testing involved specific constructs.
3. Number of experts used to establish ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document is purely about the regulatory clearance of a physical medical device (spinal rods) based on material specifications, intended use, and mechanical testing, demonstrating substantial equivalence to predicates.

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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

• APEX Spine System: K062513 - SpineCraft
• MONARCH Spine System: K010576, K024348 - DePuy AcroMed, Inc.
• MOSS MIAMI Spinal System: K013296 - DePuy AcroMed, Inc. | The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is substantially equivalent to the listed predicate devices. The fundamental scientific technology is identical to previously cleared systems. |
  | Mechanical Performance: Mechanical and dynamic performance (e.g., strength, durability, fatigue resistance) must be at least comparable to, or better than, predicate devices. (Specific quantitative acceptance criteria are not provided in this summary, but are the underlying basis for the conclusion.) | "The test results demonstrate that the mechanical performance of the APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is at least comparable to, if not better than, those of the predicate devices." (Specific quantitative results are not provided in this summary.) |

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.

Ask a specific question about this device

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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