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When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plute Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium allov, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

This document describes a medical device, the VERTEX® Reconstruction System, and its regulatory clearance. It does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) summary for a medical device (spinal fixation system), which outlines its description, indications for use, and substantial equivalence to previously cleared devices. It details the physical components of the system and their intended use in spinal fusion.

Here's how the requested information maps to the provided text, and why most of it is absent:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance metrics or acceptance criteria typically associated with clinical trials or AI/ML model validation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is a hardware implant, not an AI/ML software. The "testing" mentioned refers to mechanical testing of the physical components for substantial equivalence, not a clinical test set of 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" in the context of an AI/ML test set is not relevant to this hardware device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's regulatory clearance is simply that its mechanical properties and materials are substantially equivalent to predicate devices, and its indications for use are similar.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

Key takeaways from the document, relevant to regulatory clearance (but not AI performance criteria):

• Device Type: Spinal fixation system (hardware).
• Purpose: Adjunct to fusion of the occipitocervical and thoracic spine (Occiput-T3).
• Key Clearance Mechanism: Substantial Equivalence to predicate devices (listed as K042789, K070742, K071942, K080805, K082728, K090714, and portions of CD HORIZON® Spinal System K043488).
• "Study" Mentioned: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." This refers to laboratory mechanical tests, not clinical studies with patients or data sets.

In summary, this document does not contain the information you requested about acceptance criteria and a study proving device performance as typically understood for AI/ML medical devices. It is a 510(k) summary for a physical implantable device, cleared based on substantial equivalence demonstrated through mechanical testing.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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; pseudarthritis; and/or failed previous fusion.

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

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY®rods and screws: DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors: and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The provided document is a 510(k) summary for the
CD HORIZON® Spinal System. This type of regulatory submission is for a medical device and is not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices, which is the primary requirement for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device).

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not directly applicable to this type of document because it is not a clinical study or an AI/algorithm performance study.

However, I can extract information related to the demonstration of substantial equivalence, which serves a similar purpose in the regulatory context of this device.

Here's a breakdown of the available information in the context of your request:

I. Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are not quantitative performance metrics as in a clinical trial. Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has "similar technological characteristics" and is "as safe and effective" as the predicate.

The "reported device performance" is not given as numerical results from a clinical study, but rather implied through mechanical testing and risk analysis compared to predicate devices.

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

• Test Set Sample Size: Not applicable. This document refers to mechanical testing and risk analysis, not a clinical "test set" of patients or data in the way an AI algorithm study would. The focus is on the new components themselves.
• Data Provenance: The document does not specify country of origin for the mechanical test data. It is a regulatory submission to the US FDA. The "study" is a collection of engineering tests and a risk analysis, not a clinical data study. It is retrospective in the sense that it evaluates new components against established predicate devices and materials.

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

• Number of Experts: Not applicable. This is not a study requiring expert clinical review to establish ground truth. Substantial equivalence is determined by regulatory bodies (FDA) based on submitted engineering data and comparison to predicates.
• Qualifications of Experts: N/A.

IV. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication are mentioned.

V. 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

• MRMC Study: Not applicable. This is a spinal implant system, not an AI diagnostic tool.

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

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm.

VII. The type of ground truth used

• Ground Truth Type: Not applicable in the traditional sense of a clinical study. For a medical device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the history of safe and effective use of the predicate devices.

VIII. The sample size for the training set

• Training Set Sample Size: Not applicable. No training set is relevant for this type of device submission.

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

• Ground Truth Establishment for Training Set: Not applicable.

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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.

Ask a specific question about this device

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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The Xia® Spinal System and Xia® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

The Stryker Spine Xia Spinal System consists of Ø6mm rods, Monoaxial and Polyaxial screws, Hooks, Blockers, and Monoaxial and Polyaxial Cross Connectors. The Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components of both systems are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterior/anteral non-cervical spinal fixation.

This submission is intended to address a line extension to both the Xia® Titanium and Xia® 4.5 Spinal Systems (K060361). The line extension for the Xia® Titanium Spinal System includes:

• . A new Ø6mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy (Vitallium®).
  The line extension for the Xia® 4.5 Spinal System includes:
• New Ø4mm monoaxial titanium alloy screw in lengths of 20mm to 40mm in five 미 millimeter increments,
• 트 New Ø4mm polyaxial titanium alloy screw in lengths of 20mm to 40mm in five millimeter increments, and
• New Ø 4.5mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy . (Vitallium®).

The provided text describes a 510(k) submission for a line extension to the Xia® Titanium Spinal System and Xia® 4.5 Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, AUC, etc.).

Instead, this submission is for a medical device (spinal system components), and the "study" mentioned refers to mechanical testing to demonstrate comparable mechanical properties to predicate devices. The acceptance criteria for such a device would typically involve satisfying specific mechanical and material properties as stipulated by relevant ISO standards or FDA guidance for spinal implants.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "Mechanical testing also demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criterion was "comparable mechanical properties" to the predicate devices, and the reported performance was that this comparison was met. However, no specific quantitative criteria (e.g., minimum bending strength, fatigue life, etc.) or specific performance values are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   This information is not available in the provided text. Mechanical testing typically involves material samples or prototypes, not patient-derived 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):
   This information is not applicable and not available in the provided text. "Ground truth" in the context of this device's mechanical testing refers to established engineering standards and material science principles, not expert clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and not available in the provided text, as it pertains to clinical data adjudication, not 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:
   This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an AI/ML-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable and not available in the provided text. This device is a physical 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 typically defined by established engineering standards and material specifications for spinal implants. The submission implies that the mechanical properties of the new components were compared against those of the predicate devices, which are presumed to meet such standards.

8. The sample size for the training set:
   This information is not applicable and not available in the provided text. "Training set" is relevant for AI/ML models, not for mechanical testing of physical implants.

9. How the ground truth for the training set was established:
   This information is not applicable and not available in the provided text. See point 8.

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