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The CosmoLock Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

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

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

This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.

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

This information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

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

This information is not applicable/provided. No clinical studies were performed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document states, "No clinical studies were performed."

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

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

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

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

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

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion.

The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod connector.

The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The Stryker Spine TRIO® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO® Spinal Fixation System is indicated for: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® Spinal Fixation Sytem is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DDD) (Defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal Stenosis; Curvatures (i.e., Scoliosis, Kyphosis, and/or Lordosis); Tumor; Pseudoarthrosis and; Failed previous fusion. The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.

• Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.

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 submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.

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

Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.

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/software device and no MRMC study was conducted.

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

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

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

The "ground truth" for this submission relies on:

• Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
• Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
• Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis:
• Trauma (i.e. fracture or dislocation);
• Spinal stenosis;
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis: and
• Failed previous fusion.

The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA 4.5 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA 4.5 Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System consists of a variety of titanium Monoaxial & Polyaxial Bone Screws, Monoaxial & Polyaxial Reduction Screws, Hooks, Blockers, Rod Connectors, Dual Staples and Connectors. The existing components of the XIA 4.5 Spinal System were determined substantially equivalent through K050461 for class II indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, and K092605.

The expansion of indications for the XIA 4.5 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediation. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediation is not warranted.

This document (K121342) is a 510(k) premarket notification for the Stryker XIA® 4.5 Spinal System, seeking clearance for expanded indications, specifically for adolescent idiopathic scoliosis.

The acceptance criteria and study information indicate that the device's substantial equivalence relies on biomechanical testing and a clinical literature analysis, not on a clinical ground truth study as typically seen for AI/ML devices. Therefore, many of the requested fields are not applicable.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The submission relies on biomechanical testing and literature review rather than a clinical test set in the context of an AI/ML device.
• Data Provenance: Not applicable for a clinical test set. Biomechanical testing would have been conducted in a lab environment.

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. Ground truth from experts is not mentioned for this type of submission.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission.

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. This is a spinal implant, not an AI/ML diagnostic or assistive device.

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

• Standalone Study: No. This product is a physical spinal implant, not an algorithm.

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

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established performance characteristics of the predicate devices and the relevant ASTM standards for spinal implants. For the clinical literature analysis, the literature itself serves as the basis for comparison. No clinical "ground truth" as in pathology or outcomes data from a prospective study of this device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The AEGIS and AEGIS II Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.

The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.

The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.

The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.

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

Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.

4. Adjudication method for the test set

Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.

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 was a mechanical performance study of a spinal implant system, not a study 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 was mechanical testing of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).

8. The sample size for the training set

Not applicable. This was not a machine learning study with a training set.

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

Not applicable. There was no training set.

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The Xia Stainless Steel Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The provided document, K063428, is a Special 510(k) Premarket Notification for a device modification to the Xia® Stainless Steel Spinal System. It focuses on changing the material grade of previously cleared Xia long arm monoaxial and polyaxial screws. As such, the document primarily addresses substantial equivalence based on material, design, and intended use, rather than presenting a clinical study with acceptance criteria for device performance in the way a diagnostic AI device would.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document describes a modification to an existing device, and the demonstration of substantial equivalence relies on engineering analysis and testing to ensure the new material grade performs comparably to the predicate device, not on a clinical effectiveness study measuring human improvement with AI or ground truth established by experts.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies acceptance criteria through discussions of:
  • Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
  • No new types of safety or effectiveness problems raised by the material change.
  • Demonstration of substantial equivalence to predicate devices in terms of material, design, and indications for use.
  • Comparison of design features, materials, intended use, and performance characteristics.
    The specific quantitative pass/fail values for material properties (e.g., tensile strength, fatigue life) are not provided in this summary but would be part of the underlying engineering analysis.
• Reported Device Performance: The document states that "Engineering analysis and testing... was completed for the Stryker Spine Xia® Stainless Steel modified long arm screws." However, the results (i.e., specific performance metrics against quantitative criteria) are not reported in this summary. It only states that the testing was completed to demonstrate compliance.

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 document describes a modification to an existing mechanical device (spinal screws), not a diagnostic device involving a "test set" of patient data in the typical sense. The "testing" mentioned refers to engineering and laboratory analysis of the device's material and mechanical properties, not a clinical study on human subjects or a dataset for an AI algorithm.

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. As mentioned above, there is no "test set" requiring expert ground truth in the context of this device modification. Expert input might be involved in defining material specifications or testing protocols, but not in a manner consistent with an AI/diagnostic device evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 document is for a spinal implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This document is for a mechanical spinal implant.

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

• Not Applicable (in the context of AI/diagnostic devices). The "ground truth" for this device modification would relate to established material science properties, mechanical testing standards, and predicate device performance characteristics. For example, material composition would be verified against industrial standards, and mechanical strength would be measured against specific thresholds derived from biomechanical requirements.

8. The sample size for the training set

• Not Applicable. As this is not an AI/diagnostic device, there is no "training set."

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 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.

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The Xia® Spinal System and Xia® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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

The Stryker Spine Xia Spinal System consists of Ø6mm rods, Monoaxial and Polyaxial screws, Hooks, Blockers, and Monoaxial and Polyaxial Cross Connectors. The Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components of both systems are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterior/anteral non-cervical spinal fixation.

This submission is intended to address a line extension to both the Xia® Titanium and Xia® 4.5 Spinal Systems (K060361). The line extension for the Xia® Titanium Spinal System includes:

• . A new Ø6mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy (Vitallium®).
  The line extension for the Xia® 4.5 Spinal System includes:
• New Ø4mm monoaxial titanium alloy screw in lengths of 20mm to 40mm in five 미 millimeter increments,
• 트 New Ø4mm polyaxial titanium alloy screw in lengths of 20mm to 40mm in five millimeter increments, and
• New Ø 4.5mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy . (Vitallium®).

The provided text describes a 510(k) submission for a line extension to the Xia® Titanium Spinal System and Xia® 4.5 Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, AUC, etc.).

Instead, this submission is for a medical device (spinal system components), and the "study" mentioned refers to mechanical testing to demonstrate comparable mechanical properties to predicate devices. The acceptance criteria for such a device would typically involve satisfying specific mechanical and material properties as stipulated by relevant ISO standards or FDA guidance for spinal implants.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "Mechanical testing also demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criterion was "comparable mechanical properties" to the predicate devices, and the reported performance was that this comparison was met. However, no specific quantitative criteria (e.g., minimum bending strength, fatigue life, etc.) or specific performance values are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   This information is not available in the provided text. Mechanical testing typically involves material samples or prototypes, not patient-derived data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   This information is not applicable and not available in the provided text. "Ground truth" in the context of this device's mechanical testing refers to established engineering standards and material science principles, not expert clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and not available in the provided text, as it pertains to clinical data adjudication, not mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an AI/ML-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing, the "ground truth" is typically defined by established engineering standards and material specifications for spinal implants. The submission implies that the mechanical properties of the new components were compared against those of the predicate devices, which are presumed to meet such standards.

8. The sample size for the training set:
   This information is not applicable and not available in the provided text. "Training set" is relevant for AI/ML models, not for mechanical testing of physical implants.

9. How the ground truth for the training set was established:
   This information is not applicable and not available in the provided text. See point 8.

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