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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.

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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.

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