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The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or Traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine: and
  · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.

Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

This FDA 510(k) summary describes a new medical device, the ASTRA-OCT Spine System, and its substantial equivalence to a predicate device. The information provided is for a traditional medical device (spinal implant) and does not include acceptance criteria or a study proving device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

The document states:

• "No clinical studies were performed" for the ASTRA-OCT Spine System.
• The substantiation for equivalence is based on non-clinical mechanical testing and comparison to predicate systems.

The requested information is typically found in submissions for AI/ML powered devices, which are assessed differently from traditional hardware devices like the ASTRA-OCT Spine System.

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The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization 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 neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX-DL Spine System with APEX Spine System Components 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-DL Spine System with APEX Spine System Components 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-DL Spine System with APEX Spine System Components 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.

When used for posterior non-cervical pediatic patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double Lead Thread Screws in the cannulated and non-cannulated versions and in regular and reduction (extended tab) versions. APEX-DL Spine System is a low profile thoracolumbar implant for use with wide range of patient statures. The APEX-DL Spine System Polyaxial screws feature a friction head, which is designed to provide precise reduction mechanism as a result of easier rod capturing. The APEX-DL Spine System also includes Lordosed Percutaneous Rods. The APEX-DL Spine System is compatible with the APEX Spine System 5.5mm and 6.0mm rods, hooks, side-by-side connectors, iliac connectors, cross connectors, and washers.

The APEX-DL Spine System is a spinal implant for immobilization and stabilization of spinal segments. The document indicates that no clinical studies were performed. The acceptance criteria and testing are based on non-clinical (mechanical) tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined as demonstrating mechanical properties that are "equal or higher" than the identified predicate devices, based on the testing standards.

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

• Sample Size: Not explicitly stated in the provided document. For each of the ASTM tests listed, a specific number of samples (implants/constructs) would have been used, but this detail is not provided.
• Data Provenance: The data is from non-clinical (mechanical) testing conducted presumably by SpineCraft, LLC or a contracted testing facility. It is not patient or human data; therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. This is a non-clinical, mechanical testing study, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging or diagnostic context. The "ground truth" here is the objective measurement of mechanical properties according to established ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or imaging studies.

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

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. The provided document explicitly states, "No clinical studies were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective mechanical measurements according to recognized industry standards (ASTM F1717 and ASTM F1798). The performance is then compared to "predicate systems" as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

Not applicable. As described in point 8, there is no "training set" for this type of device evaluation.

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The ASTRA 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 (pseudo-arthrosis).

The ASTRA 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 ASTRA System is also a 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 radies), 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 AVANT Spine MIS instrumentation, the ASTRA 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), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

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

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

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

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

· degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
  · trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

The VELOX Anterior Cervical Plate is a medical device and is not subject to acceptance criteria in the same way an AI/ML diagnostic or prognostic device would be. Instead, its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Claim)

The "acceptance criteria" for a medical device like this are primarily demonstrating that its design, materials, and mechanical performance are equivalent or superior to predicate devices. The performance is reported in comparison to these predicates.

Explanation: In the context of a 510(k) submission for a traditional medical device, "acceptance criteria" are implied by the chosen predicate device's established safety and effectiveness. The manufacturer must demonstrate that the new device meets or exceeds the performance of these predicates.

Study Details (Non-Clinical)

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of the number of specific test articles. However, the study references "testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests" according to ASTM F1717-12. The ASTM standard itself would specify the number of samples required for each test.
   • Data Provenance: The testing was conducted by the manufacturer, SpineCraft, LLC, likely in a laboratory setting. The country of origin for the testing is implied to be within the USA, given the submitter's location in Westmont, IL, USA. This is a prospective non-clinical study designed for regulatory submission.

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

   • Not Applicable. This is a non-clinical mechanical performance study, not a clinical study involving human patients or expert interpretation of data. "Ground truth" in this context refers to the measured physical properties and performance characteristics determined by the mechanical tests, not expert consensus on medical conditions.

3. Adjudication method for the test set:

   • Not Applicable. As a non-clinical mechanical test, there is no expert adjudication process. The results are quantitative measurements against established engineering standards.

4. 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 device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing for regulatory approval.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical Test Results against ASTM Standards. The "ground truth" for this device's performance is derived from the objective measurements obtained through standardized mechanical testing (ASTM F1717-12). These results are then compared to the known performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. The design of the device is based on engineering principles and potentially prior experience with similar devices, but not a data-driven training set in the AI sense.

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

   • Not Applicable. No training set was used.

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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.

Ask a specific question about this device

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

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 ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors, .
• . deformity,
• pseudarthrosis, .
• . failed previous fusion,
• spinal stenosis. .

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.

The provided text is a 510(k) Premarket Notification for the ALTUM Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify numerical acceptance criteria from ASTM F1717-09, only that the device's performance was compared to predicate systems.

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

• Sample Size: Not explicitly stated for each test, but standard for mechanical testing involves multiple test specimens to ensure statistical validity.
• Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). There is no patient data involved, so country of origin or retrospective/prospective status is not applicable.

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

This question is not applicable. For mechanical tests of spinal implants, the "ground truth" is established by the specifications and performance characteristics defined in the ASTM standard (ASTM F1717-09) and the characteristics of the predicate devices. There are no "experts" in the sense of clinical specialists establishing ground truth for individual test outcomes (e.g., diagnosing a condition). The experts involved would be those who developed the ASTM standard and those who critically evaluate the mechanical test methodologies and results.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing does not involve adjudication as seen in clinical studies or image review. The results are quantitative measurements against predefined standards and comparative data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

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

This question is not applicable. The device is a physical medical implant (an anterior cervical plate), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence and meeting acceptance criteria for this medical device is based on:

• Standardized Mechanical Test Protocols: Specifically, ASTM F1717-09 outlines the methods for testing spinal implant constructs.
• Performance of Legally Marketed Predicate Devices: The ALTUM system's performance was compared directly to that of the Envision2 Anterior Cervical Plate System (K020649) and Spider Cervical Plating System (K052292). The "ground truth" for acceptable performance is considered to be the performance demonstrated by these existing, equivalent devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of device mechanical testing. The device is evaluated based on its physical properties and mechanical performance.

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

This question is not applicable, as there is no training set for this type of device evaluation.

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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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