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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 Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:

• 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);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and;
• failed previous fusion (pseudoarthrosis)

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

The provided text describes the "Dali Spinal Fixation System," a Class III medical device for spinal fixation. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

• Static compression bending
• Static torsion
• Dynamic compression bending (in accordance with ASTM F1717-10)
• Gripping-push down (in accordance with ASTM F1798) |
  | Material Equivalence | The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537), which are the same materials used in predicate devices. |
  | Design Equivalence (substantially similar) | The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices, including similar design. |
  | Intended Use / Indications for Use | The device's intended use and indications for use as a non-cervical spinal fixation device (posterior pedicle fixation T1-S2/ilium, or anterolateral fixation T8-L5) for skeletally mature patients as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion are deemed substantially equivalent to legally marketed predicate devices. |
  | Overall Safety and Effectiveness | The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use. |

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

The document explicitly states: "Clinical data and conclusions were not needed for this device." This means there was no clinical test set involving human subjects. The evaluation was based on non-clinical (bench) testing. Therefore, there is no sample size for an clinical test set or data provenance (country of origin, retrospective/prospective clinical data).

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

Not applicable. As no clinical data was required or used, there was no need for experts to establish ground truth for a clinical test set. The acceptance was based on engineering and material equivalence to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set with human data requiring adjudication was performed.

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 device is a spinal fixation system (physical implant), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical medical implant, not a software algorithm.

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

For the non-clinical performance evaluation, the "ground truth" was established by standardized mechanical testing protocols (e.g., ASTM F1717-10 for dynamic compression bending, and ASTM F1798 for gripping-push down) and material specifications (ASTM F136 for Titanium alloy, ASTM F1537 for CoCrMo alloy). The "truth" was that the device met or exceeded the performance of the predicate devices under these controlled, quantifiable conditions.

8. The sample size for the training set

Not applicable. This device is a physical implant evaluated through bench testing and comparison to predicate devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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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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