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The Xia® Spinal System is 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASON™ 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.

This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Xia Stainless Steel Uni-Planar Screws.

This document, K080928, is a Special 510(k) Premarket Notification for a line extension to the Xia® Spinal System, specifically the addition of Stainless Steel Uni-Planar Screws. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device through material, design, and functional equivalence, often relying heavily on mechanical testing rather than clinical study data.

Due to the nature of this submission (a line extension for a spinal fixation system, focusing on new uni-planar screws), the traditional "acceptance criteria" and "device performance" in terms of clinical accuracy (like in AI/diagnostic devices) are not directly applicable in the same way. Instead, acceptance criteria would relate to the mechanical properties and safety of the new components, proving they are comparable to or meet the standards of the predicate device. The "study" would be mechanical testing.

Here's an analysis based on your categories, adapted for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Mechanical testing also demonstrated comparable mechanical properties to the predicate device." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values (e.g., stiffness thresholds, fatigue limits, etc.) within the provided text. Such detailed results would typically be found in the full 510(k) submission, not necessarily in the public summary.

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

• Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal screws, "sample size" refers to the number of screws or constructs tested in various mechanical tests (e.g., static compression, fatigue). These are typically bench-top tests, not human subject tests.
• Data Provenance: The data would be generated from prospective bench-top laboratory mechanical testing conducted by the manufacturer (Stryker Spine). There is no mention of country of origin of data, as it's not a clinical study involving patients from specific geographical locations.

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

This question is not applicable in the context of this device and submission type. Ground truth, typically established by experts (like radiologists for imaging or pathologists for pathology), is relevant for diagnostic or AI-driven devices. For a spinal implant, the "ground truth" for mechanical performance is established by recognized material science and biomechanical engineering standards (e.g., ASTM, ISO standards) and comparison to the predicate device's established performance. The "experts" would be the biomechanical engineers and quality assurance personnel conducting and interpreting the mechanical tests. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert consensus processes to resolve disagreements, particularly in diagnostic assessments. Mechanical testing involves objective measurements against predefined criteria or comparison to predicate device performance; there's no "adjudication" in this sense.

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 question is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data, especially in the context of AI assistance. This submission is for a physical orthopedic implant (spinal screws), not a diagnostic or AI device.

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

This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for mechanical testing is established by:

• Industry Standards: Adherence to recognized national and international testing standards for spinal implants (e.g., ASTM F1717 for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F2077 for Mechanical Testing of Spinal Intervertebral Body Fusion Devices, or similar which ensure appropriate stress, fatigue, and torsional testing).
• Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Xia® Spinal System) serves as the benchmark against which the new line extension components are compared. The "ground truth" is that the new device must perform at least as well as or comparably to the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are used in machine learning for AI algorithms.

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

This question is not applicable for the same reasons as #8.

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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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUSTM 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 Xia® Spinal System contains the same Stainless Steel and Titanium alloy components described in the predicate Xia® Spinal System submission cited above. The Xia® 4.5 Spinal System contains the same Titanium alloy components described in the predicate Xia® 4.5 Spinal System submission cited above. This submission adds an additional indication statement, but no new components.

The provided document is a 510(k) summary for the Stryker Spine Xia® and Xia® 4.5 Spinal Systems. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested in your prompt.

Therefore, I cannot provide the requested information from this document. The document primarily discusses:

• Device Description: The Xia® and Xia® 4.5 Spinal Systems contain Stainless Steel and Titanium alloy components and are adding an additional indication statement.
• Intended Use: Anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: Stryker Spine Xia® Spinal System (K053115), Stryker Spine Xia® 4.5 Spinal System (K052761), Medtronic Sofamor Danek's CD Horizon System (K032033).
• Technological Characteristics: Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed.
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

This type of submission typically relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) to demonstrate equivalence rather than a human-in-the-loop clinical study with experts establishing ground truth, as would be common for AI/diagnostic devices.

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The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia® Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia® Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6mm diameter rods from the DIAPASON™ 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 Fixation System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, and Connectors. The components are manufactured from either Titanium material (Ti alloy and CP Titanium) or Stainless Steel.

This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Titanium alloy and Stainless Steel 4.0 mm diameter spinal screws.

The provided 510(k) Premarket Notification is for a medical device, specifically a line extension to the Xia® Spinal System, rather than an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts) are not applicable or described in this document.

The document focuses on establishing substantial equivalence to predicate devices through comparisons of intended use, material, basic design concepts, and mechanical properties.

Here's an analysis based on the information provided, framed as if it were an AI/ML device for illustrative purposes, but highlighting that these specific criteria are not met by the document itself.

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

Since this is a line extension for a spinal fixation system, the "acceptance criteria" are not quantitative performance metrics like those for AI/ML. Instead, they relate to demonstrating that the new components perform similarly to the predicate devices and meet established safety and effectiveness standards for spinal implants.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The "testing" involved mechanical evaluations of the physical components. The document doesn't specify the number of screws or rods tested, but rather states that "Mechanical testing also demonstrated comparable mechanical properties." This refers to laboratory-based physical tests, not a dataset of patient information.
• Data Provenance: Not applicable for an AI/ML test set. The "data" comes from mechanical test results of the manufactured spinal system components.

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

• Not Applicable. For a medical device like a spinal implant, ground truth regarding its mechanical performance is established through standardized engineering tests (e.g., fatigue, static strength) and comparison to established predicate devices. There wouldn't be "experts" establishing a diagnostic ground truth in the way a radiologist would for an AI algorithm. The regulatory body (FDA) reviews the test methods and results, and the qualifications of the engineers performing the tests would be relevant, but are not detailed here.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators when establishing ground truth for AI/ML datasets. For mechanical testing, the results are typically quantitative and objective, though statistical analysis and interpretation by qualified engineers would be involved.

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. MRMC studies are specifically designed to evaluate the impact of AI assistance on human reader performance in diagnostic tasks. This device is a surgical implant and does not involve human "readers" or AI assistance in this context.

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

• Not Applicable. This refers to a medical device's performance in a diagnostic or analytical capacity without human intervention. The Xia® Spinal System is a physical implant, not an algorithm.

7. The type of ground truth used

• Not Applicable in the AI/ML sense. The "ground truth" for this device's acceptance is based on:
  • Mechanical Testing Standards: Adherence to recognized industry standards for spinal implant performance (e.g., fatigue, static tests).
  • Predicate Device Performance: Direct comparison of the new devices' mechanical properties and intended use to existing, legally marketed predicate devices (Xia® Stainless Steel System, Xia® Spinal System, DePuy Inc., Moss Miami Spinal System). The presumption is that if the new device performs mechanically equivalent to a cleared predicate, it is safe and effective for its intended use.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical medical implant device in the AI/ML context.

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

• Not Applicable. As there is no training set mentioned typical for AI/ML development, this question is not relevant to the provided documentation.

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The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6mm diameter rods from the DIAPASON™ 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 Xia® Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). The components are manufactured from Titanium material (Ti alloy and CP Titanium). This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.

This 510(k) Premarket Notification (K052181) describes a line extension to the Xia® Spinal System. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics, statistical analysis, or comparison to a pre-defined threshold.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Technological Comparison: Stating that the subject components (new range of offset and rod-to-rod Titanium alloy connectors) share the "same intended use, material, and basic design concepts" as the predicate Xia Spinal System (K013823).
• Mechanical Testing: Mentioning that mechanical testing "demonstrated comparable mechanical properties to the predicate device." However, no specific data, acceptance criteria for this testing, or detailed study methodology are provided in this summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions related to acceptance criteria, sample sizes, ground truth, expert opinions, or comparative effectiveness studies based on the provided text. This type of 510(k) summary typically includes a high-level overview and directs the reviewer to the full submission for detailed testing results.

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The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

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

The Xia Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple. The components are manufactured from Titanium material (Ti alloy and CP Titanium). The purpose of this submission is to include cannulated polyaxial screws to the Xia Titanium Spinal System.

The provided document is a 510(k) premarket notification for a medical device (Xia® Spinal System with cannulated polyaxial screws), not a study report for an AI/ML powered device. Due to this, the document does not contain the information required to answer the prompt. The request asks for details like "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, which involves specific sections such as performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and comparative effectiveness studies. None of this information is present in the provided special 510(k) summary, as it pertains to a traditional orthopedic implant modification. Hence, I cannot extract the requested information from the given text.

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The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis. fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

This submission is intended to address a line extension to both the Xia Spinal System and the Xia Stainless Steel System. The line extension includes a Dual Staple and modified cross connectors. The new components will be used for anterior fixation.

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System and Xia Stainless Steel System. This regulatory submission is for medical devices, specifically spinal fixation appliances. For such devices, acceptance criteria and performance are typically demonstrated through mechanical testing and comparison to a predicate device, rather than clinical studies involving human patients, especially for line extensions that introduce minor modifications.

Therefore, many of the typical questions asked for AI/software-based medical devices regarding clinical study design are not applicable here.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The primary acceptance criterion for this line extension, which includes new components (Dual Staple and modified cross connectors), is to demonstrate mechanical equivalence to the existing predicate Xia Spinal System and Xia Stainless Steel System.

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

Not applicable in the context of this device and submission type. The "test set" here refers to the new components (Dual Staple and modified cross connectors) and their mechanical performance. The "data provenance" would relate to the specific mechanical testing methods and standards used, but this level of detail is not provided in the summary.

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

Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for subjective clinical assessments, not objective mechanical tests.

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 hardware medical device (spinal fixation system), not an AI/software device that assists human readers.

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

Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is the mechanical performance of the predicate devices as established through engineering testing. The new components must demonstrate mechanical properties comparable to these established devices.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning model.

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

Not applicable. This is a hardware medical device, not a machine learning model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a mechanical testing study. The summary states:

• "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."

This indicates that the new components (Dual Staple and modified cross connectors) underwent a series of standardized mechanical tests designed to assess their strength, durability, and other relevant physical characteristics. The results of these tests were then compared against the established mechanical performance data of the predicate Xia Spinal System and Xia Stainless Steel System components. By demonstrating "comparable mechanical properties," the manufacturer has shown that the new components are mechanically equivalent to the already approved devices, thus meeting the acceptance criteria for this line extension. The specific details of these mechanical tests (e.g., types of tests, number of samples, test parameters, specific standards followed) are not provided in this summary but would have been part of the full 510(k) submission.

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The Xia Spinal System, which includes the subject Xia Titanium Hooks, and the Xia Stainless Steel System are intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System and Xia Stainless Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint: (b) who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

This submission is intended to address a material modification to the Xia Stainless Steel Hooks. The subject components, named the Xia Titanium Hooks, are a line extension of the Xia Spinal System. The predicate Xia Stainless Steel Hooks are fabricated from stainless steel. The subject Xia Titanium Hooks are fabricated from titanium alloy. In addition, dimensional changes were made to the Xia Stainless Steel Hooks to create the subject Xia Titanium Hooks.

This document describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System, specifically the introduction of Xia Titanium Hooks. This is a medical device submission, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, and standalone performance) is not applicable.

The document primarily focuses on demonstrating substantial equivalence of the new titanium hooks to the already marketed stainless steel hooks through mechanical testing, not clinical performance.

Here's a breakdown of the applicable information:

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

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

This information is not applicable as this is a submission for a physical medical device (spinal hooks) and not a data-driven device like an AI algorithm. The evaluation was based on mechanical testing, not a clinical test set with 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)

This information is not applicable. Ground truth for mechanical testing of a physical device would involve engineering specifications, material properties, and standardized testing protocols, not expert clinical consensus.

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

This information is not applicable. Adjudication methods are relevant for clinical interpretations or AI output, not for mechanical testing of device properties.

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. This submission is for a physical medical 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. This is not an AI algorithm.

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

The "ground truth" for this submission would be defined by engineering specifications and validated mechanical testing standards. The new titanium hooks were tested to demonstrate "comparable mechanical properties" to the predicate stainless steel hooks, implying a comparison against established performance benchmarks for similar devices.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable. No training set was used.

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The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

This submission is intended to address a line extension to the Xia Spinal System which includes modifications to the Monoaxial and Polyaxial Screws and the addition of a Washer, Offset Connector and Staple.

The provided text describes a 510(k) premarket notification for a line extension to the Xia Spinal System. It is a submission to demonstrate substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the manner of an AI diagnostic device.

Therefore, the requested information elements (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) for an AI device are not applicable to this document.

The document primarily focuses on:

• Device Identification and Description: Detailing the Xia Spinal System and its modifications (line extension with new screws, washer, offset connector, and staple).
• Intended Use: Specifying the conditions and patient populations for which the system is indicated.
• Technological Comparison: Stating that the modified device shares the same intended use and basic design concepts as the predicate device, and that "mechanical testing demonstrated comparable mechanical properties to the predicate components."

There is no detailed reporting of specific acceptance criteria or quantitative performance metrics from a clinical study or a study directly addressing the performance of a diagnostic algorithm. The "study" mentioned is "Mechanical testing," which demonstrated "comparable mechanical properties to the predicate components." This indicates an engineering-focused equivalence comparison rather than a human-in-the-loop or standalone diagnostic performance study.

In summary, the provided document does not contain the information required to populate the table or answer the questions related to acceptance criteria and device performance as typically expected for a diagnostic device or AI algorithm.

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The Rods from the Osteonics® Spinal System and Opus Spinal System are intended to be used with the components of the Xia Spinal System.

The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the XIA Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The submission involves no change to the components themselves. This submission covers use of predicate OSS and Opus 6 mm diameter Rods with the predicate Xia Spinal System.

This 510(k) submission (K013688) focuses on allowing the use of previously cleared Osteonics® Spinal System (OSS) and Opus Spinal System rods with the Xia Spinal System. It does not describe a study involving an "AI device" or "algorithm" in the conventional sense of machine learning or diagnostic imaging. Instead, the "device" in question is a medical implant (spinal fixation system components). Therefore, acceptance criteria and study details related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of human readers with/without AI) are not applicable here.

However, I can extract the relevant information regarding the mechanical performance study conducted to demonstrate the safety and effectiveness of using these combined components, which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's the information structured to best fit your request, adapting the columns where necessary:

Acceptance Criteria and Reported Device Performance

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The description refers to "Construct fatigue testing," implying multiple test specimens were subjected to fatigue loads. Data provenance is not applicable in the human subject or imaging sense; this is a laboratory-based mechanical test.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized testing protocols (e.g., ASTM standards for fatigue testing of medical implants) and measured physical properties by engineers. No human expert "ground truth" establishment in the diagnostic sense is mentioned.

3. Adjudication method for the test set: Not applicable. This is mechanical testing, not a clinical review of images or data requiring adjudication among experts.

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 submission for a physical medical device (spinal implant components), not an AI diagnostic or assistance tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm involved. "Standalone" performance here refers to the mechanical integrity of the device itself.

6. The type of ground truth used: For mechanical properties, the "ground truth" is typically defined by established engineering standards and material specifications that define acceptable performance limits (e.g., fatigue life, stiffness, strength) for spinal implants. The comparison is against predicate constructs (existing, legally marketed spinal systems). The phrase "comparable mechanical properties" indicates the tested construct's performance met or exceeded the performance of the predicate devices.

7. The sample size for the training set: Not applicable. This is a mechanical test for a physical device, not an AI or machine learning model that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as no training set exists for this type of submission.

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The Xia™ Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia™ Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar-first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as a pedicle screw fixation system, the Xia™ Spinal System is also 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, spinal tumor and failed previous fusion (psuedoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal System is indicated for patients with degenerative disc disease of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.

The Xia™ Spinal System C-C Adaptor is a line extension to the Xia™ Spinal System. It consists of a C-C Adaptor with a set screw. The Xia™ Spinal System C-C Adaptor is a lateral connector. When used with a Xia™ Spinal System I-Connector, it allows for attachment of a hook to the longitudinal rod. The components are manufactured from titanium alloy.

The provided text describes a 510(k) premarket notification for the Xia™ Spinal System C-C Adaptor. This notification focuses on demonstrating substantial equivalence to a predicate device through information on intended use, materials, design, operational principles, and mechanical testing.

However, the document does not contain information about:

• A table of acceptance criteria and reported device performance in the context of clinical or diagnostic accuracy. The "performance" mentioned is limited to meeting mechanical functional requirements.
• Sample sizes for test sets (clinical performance), data provenance.
• Number of experts used or their qualifications for establishing ground truth for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used (clinical/diagnostic).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the submission relies on mechanical testing results and substantial equivalence to a predicate device for market clearance.

Here's a breakdown of what is provided and what is missing for your request:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria Mentioned: The document states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." This implies that predefined mechanical performance criteria exist, but the specific values or thresholds are not detailed in this summary.
• Reported Device Performance: The summary explicitly states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." However, the actual test results (e.g., specific load capacities, fatigue cycles, etc.) are not provided. This is a summary and likely refers to detailed test reports submitted separately to the FDA.

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

• The document describes mechanical testing, not clinical performance studies involving a test set of patient data. Therefore, this information is not applicable/provided in the context of clinical or diagnostic accuracy.
• For mechanical testing, the "sample size" would refer to the number of devices or components tested. This is not specified.
• Data provenance (country of origin, retrospective/prospective) is not applicable as it's mechanical testing, not clinical data.

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/provided as the study described is mechanical testing, not a study requiring expert clinical interpretation for ground truth.

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

• This information is not applicable/provided as the study described is 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/provided. The device is a spinal implant component, not an AI-powered diagnostic tool.

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

• This information is not applicable/provided. The device is a spinal implant component, not an algorithm.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" would be established by engineering standards and validated physical measurements using calibrated equipment. This is implied but not explicitly detailed as "ground truth" in the clinical sense.

8. The sample size for the training set:

• This information is not applicable/provided. The device is not an AI algorithm requiring a training set.

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

• This information is not applicable/provided. The device is not an AI algorithm.

Summary of the Study:

The study described for the Xia™ Spinal System C-C Adaptor is mechanical testing.

• Purpose: To demonstrate that the device meets mechanical functional requirements and supports substantial equivalence to the predicate Xia™ Spinal System L-Connector.
• Methodology: Mechanical testing was performed. Although the details of the specific tests (e.g., fatigue, static compression, torsional strength) and the number of samples are not provided in this summary, such tests are standard for spinal fixation devices.
• Outcome: The testing "demonstrates that the device will meet the mechanical functional requirements." This indicates a successful outcome in meeting predefined engineering performance standards.
• Reliance for 510(k) Clearance: The clearance is primarily based on equivalence in intended use, materials, design, and operational principles to the predicate, supported by these positive mechanical test results. The 510(k) process for devices like this typically relies heavily on non-clinical (mechanical, materials, biocompatibility) testing rather than human clinical trials or AI performance evaluations.

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