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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolatcral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pediale screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks. rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add 6.35mm implants to the system.

This FDA submission describes a spinal fixation system, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable.

The submission focuses on establishing substantial equivalence to previously marketed devices based on design features and material properties. The primary way this device meets its "acceptance criteria" is by demonstrating it is as safe and effective as existing, legally marketed spinal systems.

Here's an analysis based on the provided document, addressing the original prompt's categories where applicable for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. For mechanical testing, the "worst case components" were selected for testing, implying a representative sample of components or configurations were tested to cover the range of mechanical properties. The specific number of components or implants tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The mechanical test data would be generated in a laboratory setting (likely within the company or a certified testing facility).

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

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of outputs to establish ground truth. Substantial equivalence for this device is based on technical comparisons and mechanical testing against recognized standards.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication" in the sense of reconciling clinical interpretations for this type of device. The determination of "worst case" for mechanical testing would be an engineering assessment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a spinal implant.

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

• No, a standalone algorithm performance evaluation was not done. 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 mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and successful performance within those standards, demonstrating adequate strength and durability.
• For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML "training set."

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

• Not applicable. As there is no AI/ML component, there is no "training set" or ground truth for it.

Summary regarding the device's "acceptance":

The Range Spinal System gained FDA clearance (K141147) by demonstrating substantial equivalence to predicate devices already on the market. This means the FDA concluded that the new device is as safe and effective as the existing devices. The key elements for this determination were:

• Design and Material Comparison: The new components (6.35mm implants) were found to be "substantially the same" in design features and materials (Titanium Alloy and Cobalt Chrome per ASTM/ISO standards) as predicate devices.
• Mechanical Performance: The "worst case components" of the system were previously tested against established standards (ASTM F1717) for static compression bending, static torsion, and dynamic compression. The proposed new implants were determined by engineering analysis not to represent a "new worst case," implying they perform comparably or better than previously tested components and meet the required mechanical integrity.
• Intended Use: The indications for use are consistent with those of the predicate devices.

Essentially, the "study" for this device was a combination of engineering analysis and mechanical testing against industry standards, alongside a direct comparison of its technical characteristics and intended use to already cleared predicate devices.

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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

The provided text describes a 510(k) summary for the Everest Spinal System, which is a medical device. As such, the concept of "acceptance criteria" and "device performance" as it pertains to medical image analysis, AI algorithms, or diagnostic tools with quantifiable metrics like sensitivity, specificity, or AUC, is not directly applicable in this context.

Instead, for a spinal fixation system like the Everest Spinal System, "acceptance criteria" are typically met through demonstrating substantial equivalence to predicate devices based on design, materials, function, and mechanical performance. The "study" that proves the device meets these criteria is typically a mechanical testing study.

Here's an analysis based on the provided text, reinterpreting the request for a device like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense for this type of mechanical device. The "test set" would be the collection of components and configurations of the Everest Spinal System that underwent mechanical testing. The specific number of devices or test repetitions for each mechanical test (static compression bending, static torsion, dynamic compression) is not provided in this summary.
• Data Provenance: The mechanical tests were performed by K2M, Inc. to compare against predicate device performance. This is typically internal testing conducted according to recognized industry standards (ASTM F1717). This is a prospective evaluation of the new device components. The "country of origin of the data" would be the United States, where K2M is located.

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

• Not applicable. For mechanical testing of a spinal fixation system, "ground truth" is established by adherence to recognized international mechanical testing standards (e.g., ASTM F1717) and the physical measurements obtained during the tests. It does not involve human expert interpretation in the way radiological images would.

4. Adjudication Method for the Test Set

• Not applicable. This concept relates to reconciling discrepancies in human expert interpretations (e.g., in diagnostic studies). Mechanical testing results are determined objectively by instrumentation and adherence to test protocols, not through human adjudication.

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 study type is relevant for diagnostic devices (especially those involving AI or human interpretation of images/data). The Everest Spinal System is a physical implant, not a diagnostic tool or an AI-assisted system.

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

• Not applicable. This device does not involve an algorithm or AI. Its performance is purely mechanical.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements and Standard Compliance: The "ground truth" is defined by the objective physical measurements (e.g., load, displacement, cycles to failure) obtained during mechanical testing on the device components, compared against the established performance characteristics of predicate devices and the requirements of the ASTM F1717 standard.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a mechanical medical device like this, as it does not involve machine learning or AI.

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

• Not applicable. As there is no training set, this question is irrelevant for the Everest Spinal System.

In summary: The "study" proving the device met acceptance criteria was a mechanical testing study comparing the new components of the Everest Spinal System against predicate devices according to ASTM F1717 standards. The success criterion was that the new components performed "equally to or better than" the predicate devices in static compression bending, static torsion, and dynamic compression, and that their design and materials were substantially equivalent.

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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications;

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ): spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this 510(k) submission is to add minimally invasive implants.

Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:

Summary of Acceptance Criteria and Device Performance for the Everest Spinal System

It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.

1. Table of Acceptance Criteria and the Reported Device Performance

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

Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.

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

This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.

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 surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.

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

Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
• Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
• Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
• Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device submission.

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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 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.

In addition, the Fortex Pedicle Screw 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, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The purpose of this 510(k) submission is to add rods made of a different material to the Fortex Pedicle Screw System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared Fortex Pedicle Screw System.

Both the modified and predicate Fortex Pedicle Screw System consist of various screws, rods, and cross bar connectors that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion.

The components of the predicate Fortex.Pedicle Screw System are fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537, in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy rods does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text describes a 510(k) submission for the Fortex Pedicle Screw System, specifically focusing on the addition of rods made from a different material (cobalt chrome alloy). The submission aims to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria for a device performance study in the way you've outlined, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the performance data presented is for non-clinical mechanical testing to demonstrate the structural integrity and comparability of the modified device components.

Here's a breakdown based on the information available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This table reflects mechanical performance, not clinical or diagnostic performance criteria as typically found in studies for AI/diagnostic devices.

Information Not Found in the Provided Text:

The following points are pertinent to studies of diagnostic or AI-driven medical devices, but are not applicable to this 510(k) submission, which focuses on a change in material for a spinal implant system. Therefore, the requested information for these points is not available in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components for mechanical testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to 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: Not applicable. This is a spinal implant, not an AI or diagnostic device designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance metrics defined by ASTM F1717 standards.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Mechanical Testing):

The study involved non-clinical performance testing of the Fortex Pedicle Screw System. This included static and dynamic axial compression bending and static torsion tests. The tests were conducted according to ASTM F1717 standards. The performance of the modified system (with cobalt chrome alloy rods) was compared to the predicate system. The results demonstrated that the modified device functioned as intended and showed substantial equivalence in mechanical properties to the predicate devices. The purpose was to demonstrate that adding a new material (cobalt chrome alloy) for the rods does not introduce new safety or effectiveness concerns, and that its mechanical performance is comparable to an already cleared device.

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The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumba) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks. The purpose of this submission is to increase the range of screw sizes and to add connectors to enable use with Range Spinal System conponents.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

The provided 510(k) summary for the "Everest Spinal System" is for a physical medical device (spinal fixation system) and not for an AI/ML-driven device or software. Therefore, the questions regarding acceptance criteria, study design, ground truth, and reader studies that are typically applicable to AI/ML device performance evaluation do not directly apply in this context.

This summary focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical performance and material compatibility.

Here's an analysis of the provided information, framed as closely as possible to your request, but highlighting the differences for a physical device:

Acceptance Criteria and Device Performance (for a physical medical device)

Summary of Device Evaluation and Study for Substantial Equivalence:

The study presented is not an AI/ML algorithm validation study, but rather a comparative engineering and design study to demonstrate substantial equivalence of a physical medical device.

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

   • This is not applicable in the context of an AI/ML study. For a physical device, "test set" refers to physical prototypes or components of the Everest Spinal System. The document doesn't specify the exact number of components tested but implicitly suggests sufficient samples were used to conduct the required ASTM F1717 mechanical tests.
   • Data Provenance: The tests were conducted according to ASTM and ISO standards, implying a controlled laboratory environment. The "country of origin of the data" would be where these tests were performed, but this detail is not provided. It is a prospective generation of test data from manufactured components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not applicable. The "ground truth" for a mechanical device is established by objective, verifiable physical measurements and engineering standards (ASTM F1717, ISO standards). There are no human "experts" establishing a subjective ground truth in this type of study.

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

   • Not applicable. Mechanical tests are typically evaluated against predefined quantitative limits set by standards like ASTM F1717, not through human adjudication.

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 physical device, and no human "readers" or AI assistance are involved in its performance evaluation.

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

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

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

   • For this physical device, the "ground truth" is defined by established engineering performance standards (ASTM F1717) and material specifications (ASTM and ISO standards for Titanium Alloy and Chrome). The performance of the device is directly compared to these objective standards and to the performance of existing legally marketed predicate devices under the same test conditions.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model being trained.

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

   • Not applicable. No AI/ML model training occurred.

Conclusion for this Device:

The K2M Everest Spinal System demonstrated substantial equivalence by:

• Showing that its mechanical performance (static compression, static torsion, dynamic compression) was "equally to or better than" the predicate devices when tested according to ASTM F1717.
• Confirming its design features and sizing were "substantially the same" as predicate systems.
• Verifying its materials (Titanium Alloy and Chrome) met the relevant ASTM and ISO standards.
• Confirming its intended use aligns with the predicate devices.

This allows the FDA to conclude there are no significant differences that would adversely affect the product's use, thus granting 510(k) clearance based on substantial equivalence.

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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 EXPEDIUM 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 4.5mm and 6.35mm rods and are available in various geometries and sizes.

The provided text describes the EXPEDIUM Spine System, a medical device intended for spinal immobilization and stabilization. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a complete answer to your request regarding acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study against pre-defined acceptance criteria.

Here's a breakdown of what can be gleaned and what is missing, structured as requested:

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

Explanation: The document states that "Performance data per ASTM F 1717 were submitted." ASTM F 1717 is a standard specification for spinal implant constructs in vitro, likely involving mechanical testing (e.g., fatigue, static strength). However, the specific acceptance criteria (e.g., "must withstand X cycles at Y load," or "static strength must exceed Z N-m") and the device's measured performance against those criteria are not provided in this summary. The summary confirms that data was submitted to characterize the device, implying that a study was conducted, but it does not present the results or the pass/fail thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any test set. The ASTM F 1717 standard would typically define the number of constructs to be tested, but this detail is not present in the summary.
• Data Provenance: Not specified. It's an in-vitro mechanical test, so "country of origin of data" is less relevant than for clinical data, but the location of the testing facility is not provided. Retrospective or prospective classification is not applicable to an in-vitro mechanical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable to the device and performance data described. The device is a spinal implant system, and the performance data cited (ASTM F 1717) refers to mechanical properties, not diagnostic performance or clinical outcomes requiring expert interpretation to establish ground truth.

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

• Not applicable. As the performance data pertains to mechanical testing (ASTM F 1717), there is no need for expert adjudication. Mechanical tests follow standardized protocols.

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 implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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 system, not a software algorithm.

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

• Not applicable in the typical sense of ground truth for diagnostic devices. For mechanical testing (ASTM F 1717), the "ground truth" is established by the physical properties and behavior of the device components under controlled test conditions, measured against the specifications of the standard. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for this type of performance assessment.

8. The sample size for the training set

• Not applicable. There is no "training set" for a physical medical device undergoing mechanical performance testing. This concept applies to machine learning algorithms.

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

• Not applicable. (See point 8).

Summary of available information:

The 510(k) summary indicates that the EXPEDIUM Spine System is a Class III medical device intended for spinal immobilization and stabilization. It states that "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components." This implies that a study was conducted to evaluate the mechanical properties of the device according to the ASTM F 1717 standard. However, the specific details of this study, including the acceptance criteria, the actual performance results, sample sizes, or any form of "ground truth" that would be applicable to diagnostic or AI devices, are not present in the provided document. The document primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, allowing it to proceed to market without a full PMA.

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The EXPEDIUM 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 5.5mm rods and are available in various geometries and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPEDIUM Spine System, structured to answer your questions:

The provided document is a 510(k) summary for the EXPEDIUM Spine System, specifically for additions to the existing system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or performance against specific clinical acceptance criteria in the same way a PMA would. Therefore, the study details you're asking for, particularly concerning AI/algorithm performance and human reader improvement, are not applicable to this type of medical device submission. This document describes a surgical implant, not an AI/imaging device.

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

For a spinal implant system like the EXPEDIUM Spine System, "acceptance criteria" are not reported in terms of diagnostic performance metrics (like sensitivity, specificity, etc.). Instead, they relate to mechanical and material performance standards to ensure the device is safe and effective when implanted.

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

The document does not detail a "test set" in the context of clinical data, as it's not a clinical study designed to test diagnostic accuracy. The performance data relates to mechanical testing of the implant components. Therefore, information about sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable to this submission.

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

This is not applicable. The ground truth for mechanical testing is established by engineering standards and measurement techniques, not by expert clinician consensus on clinical cases.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish a ground truth from ambiguous cases.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an algorithm or software.

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

For this device, the "ground truth" for its performance is based on engineering standards and material science properties (e.g., strength, fatigue resistance, biocompatibility) as defined by standards like ASTM F 1537 (for material) and ASTM F 1717 (for mechanical testing of spine fusion constructs). There are no clinical outcomes data, pathology, or expert consensus used as ground truth for this type of submission's performance data.

8. The sample size for the training set

This is not applicable. This is a physical implant, not an AI model, so there is no "training set."

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

This is not applicable.

Summary of what the document does provide:

• Device Type: Spinal implant system (rods, screws)
• Purpose of Submission: Special 510(k) for additions to an existing system, demonstrating substantial equivalence to predicate devices.
• Key Performance Data: Mechanical performance data per ASTM F 1717, and material characterization per ASTM F 1537. This data ensures the device meets established engineering standards for strength, durability, and biocompatibility suitable for its intended use.
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: ASTM F 1537 implant grade cobalt-chromium-molybdenum alloy.

The document demonstrates that the new components for the EXPEDIUM Spine System are substantially equivalent to previously cleared devices based on their design, materials, and mechanical performance testing, not on clinical performance against diagnostic or AI-related metrics.

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