Search Results

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys System is intended for:
• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Atlanto/axial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1 -T3). They are not intended to be placed in the cervical spine.

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.

The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.

This document is a 510(k) Premarket Notification from the FDA to Stryker Corporation regarding their OASYS® System for spinal interlaminal fixation. It is a clearance letter and a 510(k) summary, not a study evaluating device performance against acceptance criteria in the way a diagnostic AI device or software might be assessed.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided text. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and engineering analysis, rather than clinical performance metrics.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "engineering analysis" to show that new longer length transition rods do not affect performance, but does not provide specific acceptance criteria or performance metrics for the OASYS system itself.
2. Sample sized used for the test set and the data provenance: Not applicable. The "study" mentioned is an "engineering analysis," not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this type of submission is typically based on pre-established engineering standards and comparisons to predicate devices, not on expert consensus from a clinical test set.
4. Adjudication method: 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. This is a spinal fixation device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: For this type of device, the "ground truth" for substantial equivalence is derived from established mechanical and material properties, and comparison to the predicate device's design and performance.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.

The purpose of this submission is to expand the use of the OASYS® System to include the use of screws in the posterior cervical spine.

The provided text is a 510(k) summary for the Stryker OASYS® System, a spinal fixation device. It outlines the device's indications for use, technological characteristics, and a summary of performance data. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new AI/software-based medical device study.

Therefore, most of the requested information regarding acceptance criteria, specific study design details like sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or software devices, cannot be found in this document.

However, I can extract the following information based on the provided text:

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

The document does not specify quantitative acceptance criteria in the typical sense for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence through mechanical testing and comparison with predicate devices.

• Published literature
• Mechanical testing per ASTM F1717 (Static/Dynamic Compression Bending)
• Mechanical testing per ASTM F1798 (Static/Dynamic Torsion) |
  | Material/Geometric Equivalence | The subject OASYS® System shares the same materials, geometries, and fundamental scientific technologies as the predicate devices. None of these characteristics have been altered, augmented, or otherwise changed. |

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 is a medical device for spinal fixation, and the "test set" refers to mechanical testing of the physical device, not an AI model's dataset. The document does not provide sample sizes for the mechanical tests, nor does it refer to data provenance in the context of clinical 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. This is a physical medical device. "Ground truth" in this context would implicitly refer to established engineering standards for mechanical strength and durability. Expertise is inherent in the design, manufacturing, and testing process against these standards, but the document does not specify a number of experts for "ground truth" establishment in the way it would for clinical AI validation.

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

Not applicable. This is a physical medical device. Mechanical testing results are objective measurements against established standards, not subject to human adjudication methods like those used for expert consensus in clinical image interpretation.

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 document pertains to a physical spinal fixation system, not an AI or imaging diagnostic 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:

Not applicable. This is not an algorithm or software-only device.

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

The "ground truth" for the performance of this physical device is based on established engineering standards (ASTM F1717 & F1798) for mechanical testing (static/dynamic compression bending; static/dynamic torsion) and the characteristics of legally marketed predicate devices by which substantial equivalence is claimed.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of an AI/software study.

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

Not applicable, as there is no training set mentioned or implied for this physical medical device.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys System is intended for:
· Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Spinal Stenosis
• · Fracture/Dislocation
• Atlanto/axial fracture with instability
• · Occipitocervical dislocation
• · Revision of previous cervical spine surgery
• Tumors
  When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1 -T3 ). They are not intended to be placed in the cervical spine.

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

The Stryker Spine OASYS® System can be linked to the Xia® System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.

The provided text describes a 510(k) premarket notification for the Stryker Spine OASYS® System, a spinal interlaminal fixation orthosis. The submission is for a modification to an already legally marketed predicate device (Stryker Spine OASYS® System: K111719) and therefore does not include a comprehensive study on a new AI device or a detailed acceptance criteria table with reported device performance metrics in the way one might expect for a new diagnostic device.

Instead, the submission focuses on demonstrating that a modification to an existing device (the addition of screws with a modified drive mechanism) does not negatively affect the device's performance compared to the predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a table of reported device performance values against those criteria, as it's a 510(k) for a modification to an existing device rather than a de novo submission for a novel device or AI diagnostic.

However, the "Summary of Performance Data" section implies the acceptance criteria for this specific modification:

2. Sample Size for Test Set and Data Provenance

The document states an "engineering analysis was performed." This is typically a mechanical test, not a clinical study involving a "test set" of patients or data in the way an AI diagnostic would require. Therefore, there's no information on a patient-based sample size or data provenance (country of origin, retrospective/prospective). The "test set" would likely refer to the physical screws and system components used in the engineering analysis.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic outcome. The "ground truth" here would be the physical integrity and mechanical performance of the modified screws and system components, assessed through engineering principles and testing.

4. Adjudication Method

Not applicable, as this is an engineering analysis, not a study involving expert readers and diagnostic assessments.

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

Not conducted. This is not an AI device, and no human-in-the-loop performance or comparison to human readers is described.

6. Standalone Performance

Not applicable. This is not an AI algorithm but a physical medical device. The "engineering analysis" would represent the standalone evaluation of the modified components' mechanical performance.

7. Type of Ground Truth Used

The ground truth used is based on engineering and mechanical testing standards and performance benchmarks, comparing the modified components to the previously cleared predicate device. This would involve stress tests, fatigue tests, and other mechanical property assessments to ensure the new square drive mechanism does not compromise the device's integrity or function.

8. Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

9. How Ground Truth for the Training Set was Established

Not applicable.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYS® System is intended for: Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Spinal Stenosis; Fracture/Dislocation; Atlanto/axial fracture with instability; Occipitocervical dislocation; Revision of previous cervical spine surgery; Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and Tumors.

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine.

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.

The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and polyaxial screws of Xia® II and Xia® 3 Systems via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® Spinal System, Xia 4.5 System and SR90D System.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of the addition of the saddle connector.

This document focuses on a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS® System, specifically the addition of a saddle connector. As such, the acceptance criteria and study described are for the mechanical performance of the device and its components, not for an AI/software device or a comparative effectiveness study in a clinical setting.

Here's a breakdown of the requested information based on the provided text:

• Static Compression Bending
• Dynamic Compression Bending
• Static Torsion
• Dynamic Torsion | "Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending testing, Dynamic Compression Bending testing, Static Torsion testing and Dynamic Torsion testing per ASTM F 1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004." |

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: The document does not specify exact sample sizes (e.g., number of saddle connectors or spinal constructs tested). It notes "Oasys System components" were tested. Mechanical performance testing typically involves multiple samples for statistical validity, but the precise numbers are not provided.
• Data Provenance: The data is generated from in vitro laboratory mechanical testing, conducted in compliance with ASTM F1717. The country of origin of the data is not explicitly stated but would likely be where Stryker Spine conducts its R&D and testing, presumably in the US based on the submission to the FDA. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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 this type of submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards established by ASTM F1717 and the FDA's guidance document for spinal systems. The "experts" are the engineers and technicians who conduct the tests and compare the results to established benchmarks and predicate device performance. Explicit numbers or qualifications of such experts are not details typically included in a 510(k) summary for mechanical testing.

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

This question is not applicable to a mechanical performance study. Adjudication methods like "2+1" typically refer to reconciling expert opinions in clinical or image-based studies. For mechanical testing, the "adjudication" is based on objective measurements and comparison against pre-defined acceptance criteria (e.g., within a certain percentage of predicate device performance, or exceeding minimum strength requirements).

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. This 510(k) is for a physical medical device (surgical implant component) and its mechanical performance, not a software/AI device or a diagnostic tool involving human readers.

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

This question is not applicable. This 510(k) is for a physical medical device and its mechanical performance, not an algorithm or AI.

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

The "ground truth" for this study is defined by:

• ASTM F1717 Standard: This standard specifies the methodology and parameters for testing spinal implant constructs. Adherence to this standard ensures a defined benchmark for testing.
• Predicate Device Performance: The performance of the predicate device serves as the direct comparative "ground truth" for demonstrating substantial equivalence. The new component's mechanical performance is considered acceptable if it is substantially equivalent to that of the already-marketed predicate device.
• FDA Guidance: The "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004" provides the regulatory framework and recommendations for demonstrating substantial equivalence for spinal systems.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML study that uses training sets. The "training" in mechanical testing refers to the established testing methodologies and standards (ASTM F1717).

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

This question is not applicable as there is no "training set" in the context of this mechanical performance study. The standards (ASTM F1717) and regulatory guidance (FDA) serve as the established benchmarks against which the device's performance is measured, ensuring safety and effectiveness through substantial equivalence to predicate devices.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -13), the Stryker Spine OASYS® System is intended for:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation o
• Atlanto/axial fracture with instability
• Occipitocervical dislocation -.
• Revision of previous cervical spine surgery .
• t Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spinc OASYS® System can also be linked to the Xia" System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The Stryker Spine OASYS® System can also be linked to the Xia® System. SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYS® System, which consists of the addition of a new midline occiput plate, bone screws. and a Vitallium® rod

The provided text is a 510(k) summary for a line extension to the Stryker Spine OASYS® System. It describes the device, its intended use, and a comparison to predicate devices, but does not include any information about acceptance criteria or a study proving the device meets those criteria.

The filing is a "Special 510(k)" which implies that the device is a modification of an already cleared device and demonstrates substantial equivalence through design controls and performance testing. However, the details of these tests, acceptance criteria, and their results are not present in the provided document.

Therefore, I cannot fulfill your request for the following information based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
4. Adjudication method 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. This is a spinal fixation system, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Testing has demonstrated that the additional midline occiput plate, bone screws and Vitallium® rod have equivalent mechanical properties to the predicate OASYS® System K032394. K072568, and K052317." This statement indicates that mechanical testing was performed to show equivalence, but the specifics of that testing (e.g., test methods, parameters, acceptance criteria, raw data) are not detailed in this summary.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYS® System is intended for:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation .
• Atlanto/axial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• Tumors .

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spine OASYS® System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® Spinal System, Xia 4.5 System and SR90D System via the rod-to-rod connectors.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYS™ System, which consists of the addition of a cross connector plate and associated components (connector blocker and nut).

The provided text is a 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS® System, introducing a cross connector plate and associated components. This document is not for a new medical device that utilizes AI or produces performance metrics in the way your request describes. Therefore, most of the requested information regarding acceptance criteria and studies proving the device meets them (especially related to AI performance, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this type of submission.

Here's a breakdown of what can be extracted from the document based on your request, and why other parts are not provided:

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

Explanation: This 510(k) is for a line extension of an established spinal fixation system, not a device with a measurable performance output like an AI algorithm. The acceptance criteria are implicit: the new components must be mechanically equivalent to the predicate, made of the same materials, and address the same indications for use without raising new questions of safety or efficacy. The "study" proving this is a mechanical testing comparison.

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

• Sample Size for Test Set: Not applicable. This submission describes mechanical testing of components, not a clinical study on human subjects where a "test set" of data would be used. The "test set" would refer to the physical components tested in a lab, but the number is not specified.
• Data Provenance: Not applicable. The "data" comes from mechanical testing of manufactured components, not patient data.

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

• Not applicable. There is no "ground truth" to be established by experts in the context of mechanical testing of a spinal implant. The "ground truth" is determined by established engineering standards and tests.

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

• Not applicable. Adjudication methods are used for resolving disagreements in expert assessments of medical images or other clinical data, which is not relevant here.

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 not an AI-powered device and no reader studies were performed.

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

• Not applicable. This is not an algorithm or AI device.

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

• Type of Ground Truth: Mechanical testing standards and engineering specifications. The "ground truth" for proving substantial equivalence lies in demonstrating that the mechanical properties of the new components match those of the predicate and that the materials are identical.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no training set.

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

• Not applicable. As there is no training set for an AI model, this question does not apply.

Summary regarding the device:

This 510(k) document is a regulatory submission for a mechanical medical device (spinal implant components), specifically a line extension. It focuses on demonstrating substantial equivalence to a predicate device by showing that the new components have the same intended use, materials, and equivalent mechanical properties. The regulatory pathway is based on established engineering principles and material science, not on clinical performance metrics, AI algorithms, or human reader studies.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYSTM System is intended for:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Atlanto/axial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spine OASYS™ System™ can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

This 510(k) adds new polyaxial screw components (non-biased and cancellous styles) to the existing OASYSTM System. The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.

The provided text is a 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. This document focuses on the substantial equivalence of device modifications (new polyaxial screw components) to existing predicate devices, demonstrating equivalence through mechanical testing.

Therefore, this type of submission (a 510(k) for a device modification) does not typically involve the kinds of studies and data points (such as AI performance metrics, expert adjudication, ground truth establishment, or multi-reader multi-case studies) that would be relevant for a new diagnostic or AI-powered medical device.

The study described here is mechanical testing to demonstrate the equivalence of the modified components to the predicate devices.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI-focused detailed response:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: The document does not specify the sample size for the mechanical testing.
• Data Provenance: Not specified. Mechanical testing is typically laboratory-based, not reliant on human clinical data provenance (e.g., country of origin, retrospective/prospective).

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

• Number of Experts: Not applicable. Mechanical testing for medical devices relies on engineering standards and measurements, not expert consensus for "ground truth" in the clinical sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Mechanical testing involves objective measurements rather than subjective adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation, not for mechanical device components.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This document concerns a physical device, not an algorithm.

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

• Ground Truth Type: For mechanical testing, the "ground truth" is defined by established engineering standards, material properties, and biomechanical performance specifications. These are objective and measurable, not derived from clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This submission describes mechanical testing for device modification, not a machine learning model.

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

• Training Set Ground Truth: Not applicable.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYSTM System is intended for:

• Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondvlolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation ●
• Atlanto/axial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• Tumors .

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spine OASYSTM System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of two rod-to-rod connectors (axial and parallel versions) used to link the 3.5mm OASYS™ System rods with the Xia® 4.5 Spinal System rods (510(k) numbers #K050461 and #K060361). The Xia® 4.5 Spinal System rods will retain their original cleared name.

This document is a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. It does not describe a study proving a device meets acceptance criteria in the traditional sense of a clinical or performance study with numerical targets. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition and validated mechanical properties.

Therefore, the requested information elements related to clinical study design, ground truth, expert adjudication, sample sizes for test/training sets, and comparative effectiveness studies are not applicable in this context.

Here's a breakdown of the available information:

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

The primary "acceptance criterion" for this 510(k) is demonstrating equivalent mechanical properties to the predicate device.

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 document describes a Special 510(k) submission for a line extension, not a clinical study involving human or animal subjects that would require a "test set" and associated data provenance in this manner. The "testing" mentioned refers to mechanical property validation on the device components themselves.

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. See point 2. The "ground truth" here is the established mechanical properties of the predicate device.

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

• Not applicable. See point 2.

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 submission is for spinal fixation components, not an AI or imaging device involving human readers or AI assistance.

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

• Not applicable. This submission is for spinal fixation components, not an algorithm or software device.

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

• The "ground truth" in this context is the established mechanical properties of the predicate device, as determined by engineering standards and testing, and the material composition of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this type of device submission.

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

• Not applicable. There is no "training set" in the context of this type of device submission. The "ground truth" for demonstrating substantial equivalence (as described in point 7) would have been established through engineering design, material specifications, and standardized mechanical testing processes.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Stryker Spine OASYSTM System is intended for:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis ●
• Fracture/Dislocation .
• Atlanto/axial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• Tumors .

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spine Oasys System can be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.

This submission is intended to address a line extension to Stryker Spine OASYS™ System. The line extension includes a new range of Titanium alloy axial & parallel rod-to-rod connectors, standard hooks & rods as well as new CP Titanium rods. The new range of Titanium alloy axial and parallel rod-to-rod connectors will also facilitate the linkage between Stryker Spine OASYS™ and SR90D Systems.

The provided text describes a 510(k) submission for a line extension to the Stryker Spine OASYS™ System. It focuses on the mechanical and design equivalence to a predicate device rather than clinical performance or acceptance criteria based on device performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance (especially clinical performance with metrics like sensitivity, specificity, or reader improvement) is not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document does not provide a table of acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" appear to be based on the substantial equivalence to a predicate device (Stryker Spine OASYS™ System (K032394)) with respect to:

• Indications for Use: The subject components share the same indications for use as the predicate device.
• Material: The subject components share the same material (Titanium alloy) as the predicate device.
• Basic Design Concepts: The subject components share basic design concepts as the predicate device.
• Mechanical Properties: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."

Therefore, the reported "performance" is that the new components are comparable or equivalent to the predicate device in these aspects. No specific numerical performance metrics are provided.

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

Not applicable. This was a 510(k) for a line extension of an existing spinal fixation system, relying on mechanical equivalence and material properties rather than clinical performance data from a test set of patient cases. No clinical test set data or provenance is mentioned.

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. No clinical test set was described that would require expert ground truth establishment.

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

Not applicable. No clinical test set was described.

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 medical device (spinal fixation system), not an AI/software device. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a medical device (spinal fixation system), not an algorithm.

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

Not applicable. The ground truth for this submission was based on the specifications and performance of the predicate device, demonstrated through mechanical testing for "comparable mechanical properties."

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No training set for an algorithm is mentioned.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine Oasys System is intended for: Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Spinal Stenosis; Fracture/Dislocation; Atlanto/axial fracture with instability; Occipitocervical dislocation; Revision of previous cervical spine surgery; and Tumors.

When used with the occipital plate the bone screws are limited to occipital fixation. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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.

The Stryker Spine Oasys System can also be linked to the Xia Spinal System via the rod to rod connector.

The Stryker Spine Oasys System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.

The provided text describes a 510(k) premarket notification for the Stryker Spine Oasys System, a spinal fixation appliance. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, meaning they do not require a new scientific study demonstrating efficacy. Instead, substantial equivalence is often shown through similarities in intended use, materials, design, and mechanical testing that demonstrates comparable properties to the predicate device.

Therefore, the typical structure for reporting acceptance criteria and study results for AI/ML devices is not applicable here because this is a mechanical medical device, and the submission focuses on substantial equivalence rather than novel performance metrics.

Here's how to address the request based on the provided document:

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

   • For a spinal fixation system, performance is typically assessed through mechanical testing against established standards and comparison to a predicate device, rather than diagnostic accuracy metrics like sensitivity or specificity.
   • The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate device."
   • Acceptance Criteria (Implied): The mechanical properties of the Stryker Spine Oasys System should be comparable to or meet the performance of the predicate device.
   • Reported Device Performance: Mechanical testing demonstrated comparable mechanical properties to the predicate device.

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

   • This is not a data-driven study with a "test set" in the context of AI/ML. The "test set" here refers to the physical devices undergoing mechanical testing. The sample size for such testing would typically be determined by relevant ASTM or ISO standards for spinal implants, but this specific detail is not provided in the summary.
   • Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here would be the results from mechanical engineering tests.

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 this context would be defined by engineering specifications and direct physical measurements during mechanical testing, often performed by engineers or technicians.

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

   • Not applicable. Adjudication methods are relevant for subjective human interpretations of data, such as image reviews. Mechanical testing results are objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a physical medical device, not an AI/ML system, so MRMC studies involving human readers or AI assistance are irrelevant.

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

   • Not applicable. This is a physical medical device.

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

   • For mechanical testing, the "ground truth" would be established engineering standards (e.g., ISO, ASTM) and the direct physical properties and performance of the predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set" in the AI/ML sense.

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

   • Not applicable.

Summary based on the provided information for the Stryker Spine Oasys System:

This 510(k) submission for the Stryker Spine Oasys System does not involve an AI/ML device or a clinical study in the traditional sense of evaluating diagnostic performance. Instead, it demonstrates substantial equivalence to existing legally marketed devices based on shared intended use, materials, design, and comparable mechanical properties as shown through laboratory testing.

Ask a specific question about this device