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The LnK Posterior Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

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

The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The LnK Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks that can be used via an open surgical approach.

This document is a 510(k) premarket notification for the "LnK Posterior Cervical Fixation System", seeking clearance for device modifications (adding sizes and additional components) rather than the introduction of a new AI/software-based medical device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120879) primarily through material and mechanical performance testing for spinal implants.

Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The primary study cited to demonstrate the device's performance is Static Compression Bending Testing per ASTM F1717. This standard is used to evaluate the mechanical properties of metallic spinal implant constructs. While the specific numerical results of the testing (e.g., stiffness, yield strength, ultimate strength) are not provided in this summary, the document states:

"Static compression bending testing was performed per ASTM F1717."

And concludes:

"The LnK Posterior Cervical Fixation System is substantially equivalent to legally marketed predicates."

This implies that the results of the ASTM F1717 testing demonstrated performance comparable or superior to the predicate device, thus meeting the mechanical performance acceptance criteria for spinal fixation systems.

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

This is not applicable as the study is a mechanical performance test on physical devices, not a study evaluating an AI algorithm with a test set of data. The "sample size" would refer to the number of physical implants tested. This information is not provided in the summary but would typically be detailed in the full test report.

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

Not applicable. This is not an AI/software device requiring expert ground truth for data.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/software device requiring expert 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

Not applicable. This is a physical spinal implant system, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is a physical spinal implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" would be the established engineering standards and specifications outlined in ASTM F1717, which define acceptable mechanical properties for spinal implants. The physical measurements (e.g., load at failure, deflection) collected from the tested devices are compared against these engineering "truths."

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a physical medical device, not an AI algorithm.

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

Not applicable. There is no training set for a physical medical device.

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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 (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.

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When intended to promote fusion of the cervical spine (Cl-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies)

-Spondylolisthesis

-Spinal Stenosis

-Fracture/dislocation

-Revision of previous cervical spine surgery

-Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws 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 (C1-C7) spine.

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and Hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium allov. The components will be provided non-sterile.

The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System," a spinal interlaminal fixation orthosis. However, this document does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

Instead, the document primarily focuses on establishing substantial equivalence for a physical medical device (spinal fixation system) to existing predicate devices.

Here's a breakdown of why it doesn't fit the requested criteria:

• Type of Device: The device described is a physical implant (polyaxial screws, rods, hooks) for spine stabilization, not an AI/ML algorithm or software.
• Performance Data: The "Performance Data" section explicitly states, "Risk analysis was conducted and led to the determination that additional mechanical testing is not required in order to establish the substantial equivalency of the subject devices to the predicate devices." This indicates that no new performance study (like a clinical trial or algorithm performance evaluation) was conducted or detailed in this document to assess specific acceptance criteria. Substantial equivalence was based on technological characteristics and mechanical engineering analysis, comparing it to existing, already approved devices.
• Missing Information: All points requested in your prompt (table of acceptance criteria, sample size, data provenance, expert numbers, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are entirely absent because they are relevant to validating an AI/ML device, not a physical implant's substantial equivalence.

Therefore, I cannot extract the requested information from this document. This document is a regulatory submission for a traditional medical device, not an AI/ML product.

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The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis •
• Fracture/dislocation •
• Revision of previous cervical spine surgery .
• . Tumors

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

Hooks and Rods

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

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4–T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.

The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs.

The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.

The provided document describes a medical device called the "Reliance Posterior Cervical-Thoracic System," for which the FDA is confirming substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study proving a device meets the acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence for a medical implant device, which involves showing that the new device is as safe and effective as a legally marketed predicate device. For this type of device, the "acceptance criteria" are typically met through non-clinical testing and comparison to predicate devices, rather than through studies involving human readers or expert consensus on observations.

Here's an analysis based on the information provided, framed as closely as possible to your request, but acknowledging the different nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of clinical data for a test set. Instead, it refers to multiple test configurations for the mechanical testing of the device components. The number of samples tested for each mechanical property (e.g., number of constructs for static compressive testing) is not specified but would follow ASTM F1717 guidelines.
• Data Provenance: The data is generated from non-clinical laboratory testing of the device prototypes. No human data (e.g., country of origin, retrospective/prospective) is involved in this described performance evaluation.

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

• Not applicable in the context of this submission. The "ground truth" for the mechanical testing is based on the physical testing results against established international standards (ASTM F1717). No human experts are used to interpret clinical images or establish ground truth in a diagnostic sense for this type of submission.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set of clinical cases is described as this is not a study assessing diagnostic performance or human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• Not applicable. This submission does not include an MRMC study. It is a premarket notification for a spinal fixation device, focusing on mechanical properties and substantial equivalence to existing devices, not on human diagnostic performance with or without AI assistance.

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

• Not applicable. This device is a physical implant, not an algorithm or AI software. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical performance evaluation is based on established engineering and biomechanical standards (ASTM F1717) and the performance characteristics of the identified predicate devices. This includes material properties, mechanical strength under various loads, sterilization, and biocompatibility.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI/ML algorithm. Therefore, 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/ML algorithm, this question is not relevant.

In summary: The provided text details a 510(k) premarket notification for a spinal implant. The "acceptance criteria" discussed are related to the mechanical performance, materials, and intended use of the device, demonstrated through non-clinical testing and comparison to legally marketed predicate devices by showing "substantial equivalence." This is a different type of evaluation than those typically performed for AI-driven diagnostic devices.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic 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), spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

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

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the predicate K133374 Streamline OCT System.

The provided text is a 510(k) summary for the Streamline OCT Occipito-Cervico-Thoracic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, materials, technological characteristics, and performance.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, and study details like sample size, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

The section "Non-Clinical Performance Data" states: "Engineering analysis was sufficient to demonstrate that the subject components do not introduce new worst-case components. Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product and therefore, no new testing was required for the determination of substantial equivalence."

This indicates that no new performance studies were conducted for this specific 510(k) submission (K150254). Instead, it relies on prior testing of the predicate device (K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System) and engineering analysis.

Therefore, many of your questions cannot be answered from the provided text.

Here's an attempt to answer based on the available information and highlight what's missing:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the Streamline OCT Occipito-Cervico-Thoracic System. It generally states that "Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product."

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 provided in the document. As no new testing was reported for this submission, there is no mention of a test set sample size or data provenance.

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 provided. The device is a spinal fixation system, and the "ground truth" would relate to its mechanical performance and biocompatibility. Expert review might be part of the engineering analysis, but details are not given.

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

This information is not provided.

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

This is not applicable. The device is a medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a physical implant, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

The document implies that the ground truth for the predicate device's performance was established through engineering analysis and testing, which would typically include mechanical testing (e.g., fatigue, static strength), material characterization, and potentially pre-clinical studies or cadaveric testing. It does not refer to expert consensus, pathology, or outcomes data in the context of establishing performance for this 510(k).

8. The sample size for the training set

This information is not provided and is not relevant as this is a physical medical device, not an AI/ML device requiring a training set in that context.

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

This information is not provided and is not relevant for the same reasons as #8.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with 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 thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

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

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.

This document is a 510(k) premarket notification for a medical device called the SOLSTICE OCT System. It is an FDA submission for substantial equivalence to legally marketed predicate devices, not a study describing acceptance criteria and device performance in the context of an AI/software as a medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not available within this document. The document focuses on regulatory compliance for a physical spinal implant system.

The "Performance Data" section mentions "Mechanical Testing consisting of static and dynamic compression and torsion in accordance with ASTM 2706 as well interconnection testing was presented to show the substantial equivalence of the SOLSTICE OCT System." This refers to physical engineering tests, not clinical or algorithmic performance.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with 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 thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

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

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

This document is a 510(k) premarket notification for the SOLSTICE® OCT System, a spinal interlaminal fixation orthosis. The FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided (or lack thereof, as this is a 510(k) and not a clinical study report):

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed clinical performance metrics against predefined acceptance criteria for a novel device. Therefore, the acceptance criteria are largely related to mechanical performance and material specifications that demonstrate equivalence to the predicate, rather than clinical efficacy endpoints. Specific quantitative thresholds for static/dynamic compression and rod lockup are not provided in this document.

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

• This document describes mechanical testing of the device, not a clinical test set with patient data.
• The document does not specify the sample size for the mechanical tests (e.g., number of implant constructs tested).
• Data provenance is not applicable as it's mechanical benchtop testing, not human patient data.

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

• Not applicable. This pertains to mechanical testing, not clinical evaluation requiring expert ground truth for patient diagnoses or outcomes.

4. Adjudication method for the test set:

• Not applicable. This pertains to 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:

• Not applicable. This document is for a spinal implant, which is a physical device, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant here.

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

• Not applicable. This document is for a spinal implant, not a standalone algorithm.

7. The type of ground truth used:

• For the mechanical testing, the "ground truth" would be the engineering specifications and standards (e.g., ASTM F136 for material, and potentially other industry standards for static/dynamic compression and rod lockup of spinal instrumentation). The device's performance is compared against these standards or the performance of the predicate device.

8. The sample size for the training set:

• Not applicable. This document describes mechanical testing of a physical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set for a machine learning model is involved.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with 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 thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

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

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.

The provided text describes the SOLSTICE® OCT System, a spinal fixation system, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information. The document focuses on a mechanical device and its regulatory clearance based on substantial equivalence to existing devices, not on the performance metrics of an AI system.

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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 (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.

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The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation. The occipital bone screws are limited to occipital fixation only. The rod and hook components are in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in the T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The Caspian OCT/MESA Mini/ DENALI Mini Spinal System can also be linked to the RANGE® Spinal System using rod connectors or transitional rods.

The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add modified rods, plates and screws to the system.

This document is a 510(k) premarket notification from the FDA for a spinal fixation system. It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device. The document is about a mechanical spinal system, not a digital health product.

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