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The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The Huvex Interspinous Fixation System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different Huvex Interspinous Fixation implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided.

The provided document is a 510(k) summary for the Huvex Interspinous Fixation System. It describes the device, its intended use, and that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe acceptance criteria, the specific study design to prove acceptance criteria were met, or detailed performance results in the format requested.

It states general categories of tests performed but lacks the quantitative details needed to answer all parts of your request.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states:

• "Static & Dynamic compression, Static torsion, and Static tension testing in accordance with a modified ASTM F1717 setup"
• "Static grip testing with a modified ASTM F1798 setup"
• "were conducted to demonstrate substantial equivalence to the predicate system(s)."

It does not provide specific acceptance criteria values (e.g., maximum deflection, fatigue cycles survived, ultimate load) or the quantitative performance results (e.g., "Device A survived X cycles," or "Device A withstood Y N of compression"). It only indicates that these tests were performed and deemed sufficient for substantial equivalence.

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

Not available in the provided document. The document does not specify the number of samples (implants) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not relevant for mechanical bench testing of an implant; these tests are typically conducted in a lab environment.

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

Not applicable. This question pertains to clinical studies involving human interpretation or pathology. The provided document describes mechanical bench testing of a medical implant, not a diagnostic device or a clinical study that requires expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This question relates to clinical studies and expert review for ground truth, not mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The Huvex Interspinous Fixation System is a surgical implant, and no MRMC study would be performed for its clearance.

6. Standalone Performance Study

The document describes standalone mechanical performance testing as part of its substantial equivalence claims. The tests mentioned (Static & Dynamic compression, Static torsion, Static tension, Static grip) are performed on the device itself (or device constructs) without a human in the loop. The "performance and SE determination" section says, "The Huvex Interspinous Fixation System has been demonstrated to be substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use." This implies that the device's mechanical performance, in isolation, was evaluated against established standards or predicate device performance.

However, specific quantitative results from these standalone tests are not provided in this summary.

7. Type of Ground Truth Used

Not applicable in the sense of clinical ground truth. For mechanical testing, the "ground truth" or reference is typically defined by:

• ASTM standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Constructs) are mentioned, albeit as "modified" setups. These standards define the methodology for testing.
• Predicate device performance: The goal is to demonstrate "substantial equivalence" to predicate devices, meaning the device performs comparably mechanically. The performance of the predicate device acts as the benchmark.

8. Sample Size for the Training Set

Not applicable. Surgical implants undergo mechanical testing, not algorithm training using a "training set" of data in the AI sense.

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

Not applicable. As above, there is no "training set" for this type of device and evaluation.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through mechanical bench testing. It lists the types of tests conducted and the standards referenced but does not provide the quantitative acceptance criteria or specific performance results that would directly answer your request in detail.

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The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.

The provided text describes a medical device, the DIO Medical IVA Cage, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to acceptance criteria, device performance, sample size, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable to this document. These questions are typically relevant for evaluating AI/ML models in medical imaging or diagnostics.

The document focuses on the mechanical and material properties of an intervertebral body fusion device and its comparison to existing devices to demonstrate substantial equivalence for regulatory approval.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance:

• Acceptance Criteria: The device underwent testing according to specific ASTM standards:
  • ASTM F2077: Static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing.
  • ASTM F2267: Subsidence testing.
• Reported Device Performance: The document states that "Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as [list of predicate devices]." However, specific quantitative performance metrics (e.g., exact load limits, displacement values, or fatigue life) from these tests are not provided in this summary. The summary only confirms that the testing was performed and deemed sufficient to show substantial equivalence.

2-9. Not Applicable (AI/ML Device):

The following questions are not applicable as the document describes a physical medical implant, not an AI/ML software device:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Relevant Information:

The DIO Medical IVA Cage is an intervertebral body fusion device. Its acceptance criteria are based on compliance with established ASTM standards for mechanical properties (ASTM F2077 and ASTM F2267). The study performed was a series of mechanical tests to demonstrate that the device performs equivalently to previously approved predicate devices in terms of safety and effectiveness. The specific numerical results of these tests and the test sample sizes are not detailed in this 510(k) summary but are implied to have met the necessary thresholds for substantial equivalence.

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The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. And consist of:

1. Cervical interbody fusion Device (Galaxy ACIF cage), which may be implanted as a single device via an anterior approach.

2. Lumbar Interbody Fusion Device (Galaxy PLIF, TLIF and ALIF), which may be implanted.

• o Bilaterally via a posterior(PL1F) approach;
• As a single device via a transforaminal(TLIF) approach; 0
• As a Single device via Anterior (ALIF) approach. o

The implants are made of polyether-ether-ketone (PEEK-OPTIMA LTI) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).

The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes the "Galaxy (ACIF, PLIF, TLIF and ALIF) Peek Cage" device, an intervertebral body fusion device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the devices were tested according to these standards, implying that they met the requirements of these standards. However, it does not provide specific numerical results or explicit pass/fail criteria for each test. The acceptance criterion is implicitly meeting the requirements of the stated ASTM standards.

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

• Sample size: Not specified. The document states "The Galaxy (ACIF, PLIF, TLIF and ALJF) Peek Cage devices were tested according to the ASTM 2077...", but does not mention how many devices were tested for each scenario.
• Data provenance: Not explicitly stated. The tests are described as "Performance Data," which typically implies laboratory testing of the device itself, rather than human clinical data. This would be prospective testing on manufactured devices.

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

• This information is not applicable to the provided study. The study described is a mechanical performance study of the device itself, not a study involving human interpretation or diagnosis where expert ground truth would be needed.

4. Adjudication method for the test set:

• This information is not applicable to the provided study. As it's a mechanical performance study, there is no human adjudication involved. The "ground truth" is determined by established engineering test standards (ASTM).

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 to the provided study. The document describes a mechanical performance study of an intervertebral body fusion device, not an AI-assisted diagnostic tool.

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

• This information is not applicable to the provided study. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

• Engineering Standards: The ground truth for the performance data is based on established engineering standards for mechanical testing of spinal implants, specifically ASTM 2077 and ASTM 2267. These standards define the methodology and expected performance characteristics for such devices.

8. The sample size for the training set:

• This information is not applicable. The context is a mechanical medical device, not a machine learning algorithm.

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

• This information is not applicable. As above, it's a mechanical device, not an AI/ML algorithm.

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The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plate are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed self-drilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments

The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

The provided text is a 510(k) summary for the Rex Anterior Cervical Plate System. It describes the device, its intended use, and its performance data, primarily focusing on its substantial equivalence to predicate devices.

However, the document does not contain information related to a study proving the device meets acceptance criteria in the context of AI/ML performance, such as sensitivity, specificity, or F1 score. The performance data mentioned refers to mechanical tests (static compression, torsion, and fatigue) performed according to ASTM F1717 to characterize the physical properties of the cervical plate components.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to AI/ML device performance. The document focuses on regulatory approval for a physical medical device based on material, design, and operational principles, and substantial equivalence to existing predicate devices.

Here's what I can extract from the provided text, acknowledging the lack of AI-specific performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information, there is no mention in the provided text for:

• Sample size for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any AI/ML model.
• How ground truth for the training set was established.

This document is a 510(k) summary for a spinal implant, which is a hardware device, not an AI/ML software device. The "performance data" refers to the physical and mechanical characteristics of the plate system.

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The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.

The Rexious Hook System is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system. The Rexious Hook System implant components are fabricated from titanium alloy (Ti6A14V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Rexious Hook System can be used in the posterior plane providing unilateral modes of fixation. The Rexious Hook System design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic location and orientation.

The Rexious Hook System's acceptance criteria and the study proving it meets these criteria are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these tests were "submitted to characterize the subject Rexious Hook System components." This implies that the device successfully met the performance benchmarks outlined in the ASTM F1717 standard for these specific tests, as the FDA granted substantial equivalence.

2. Sample Size and Data Provenance for Test Set

The provided text describes performance testing conducted according to ASTM F1717. However, it does not specify explicit sample sizes for these tests. The data provenance is not explicitly stated as 'retrospective' or 'prospective,' but given that it involved characterizing device components in a laboratory setting per ASTM standards, it is inherently a controlled, prospective engineering study. The study was conducted by DIO Medical Co., Ltd. in South Korea.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a medical device like a spinal fixation system) does not typically involve the establishment of ground truth by clinical experts in the same way an AI/ML model study would. The acceptance criteria are based on engineering performance standards (ASTM F1717), which are evaluated through physical testing, not expert consensus on clinical data. Therefore, this section is not applicable.

4. Adjudication Method for Test Set

As the evaluation is based on objective physical performance tests against established standards (ASTM F1717), there is no adjudication method in the context of clinical expert review. The results are quantitative measurements interpreted against the ASTM F1717 standard's requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or reported in the provided documentation. This type of study is more relevant for diagnostic devices or AI algorithms that assist human interpretation, not for mechanical implantable devices.

6. Standalone Performance Study (Algorithm Only)

This point is not applicable. The Rexious Hook System is a physical medical device, not a software algorithm, so a "standalone (algorithm only)" study is not relevant. The performance studies conducted were on the physical device components.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the objective, quantifiable material and mechanical properties and performance criteria outlined in the ASTM F1717 standard (e.g., static compression bending, static tension, static torsion, and dynamic compression). These standards serve as the benchmark for the device's acceptable performance.

8. Sample Size for Training Set

There is no "training set" in the context of an AI/ML algorithm for this device. The development process would involve engineering design, material selection, and iterative physical prototyping and testing, not a data training set.

9. How Ground Truth for Training Set was Established

As there is no training set, this question is not applicable. The device's design and manufacturing are based on established engineering principles and materials science, with performance verified against industry standards like ASTM F1717.

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The Rexious Spinal Fixation System is a posterior pedicle screw system 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 Rexious Spinal Fixation 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the context of AI/ML or diagnostic performance. Instead, it is a 510(k) summary for a spinal fixation system, focusing on substantial equivalence to predicate devices for regulatory approval.

Key points from the document regarding "performance data":

• No new testing: "The addition of components to the system did not introduce a new worst case construct, and therefore no additional testing was performed."
• Substantial Equivalence: The conclusion is based on establishing substantial equivalence to predicate devices (e.g., Fixpine II System (K100765)) in terms of design, materials, indications, intended use, packaging, labeling, and performance.

Therefore, none of the specific questions related to AI/ML device performance (acceptance criteria, sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be answered from this document. The "Performance Data" section in this submission refers to the mechanical performance and safety of the spinal implant, which is assessed through comparison to an existing device rather than through a clinical study with acceptance criteria as typically defined for diagnostic or AI/ML-driven devices.

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The Fixpine II System is a posterior pedicle screw system 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 Fixpine II System 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Fixpine II System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.

The Fixpine II System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.

The Fixpine II System is a pedicle screw spinal fixation system. Its acceptance criteria and performance are established through mechanical bench testing.

1. Acceptance Criteria and Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the bench tests. It refers to "worst-case Fixpine II system structure" testing but does not provide specific numbers of units tested.
• Data Provenance: The data is generated from mechanical bench testing conducted by the manufacturer, DIO Medical Co., Ltd. The country of origin for the data is implicitly South Korea, where the manufacturer is located. The study is prospective in the sense that the tests were performed specifically to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This device's performance evaluation is based on mechanical bench testing against established ASTM standards and comparison to predicate devices, not on expert-established ground truth from clinical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of data by multiple experts. The Fixpine II System's evaluation relies on objective mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. MRMC studies are used to evaluate the impact of a device (often AI-assisted) on human reader performance in interpreting medical images or data. The Fixpine II System is a spinal implant, and its evaluation does not involve such human-in-the-loop performance assessment.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical spinal implant, not an algorithm or software. A standalone performance study as described would apply to AI/ML software.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is based on established engineering and biomechanical standards, specifically:

• ASTM F1717-04: Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model. This standard defines the methodologies and expected performance characteristics for such devices.
• Predicate Device Performance: Performance of legally marketed devices (4CIS® Vane Spine System and GSS Pedicle Screw System) which the subject device aims to be substantially equivalent to.

8. Sample Size for the Training Set:

Not applicable. The Fixpine II System is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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