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The XIA® 4.5 Spinal System is intended for anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e. fracture of dislocation)
• · Spinal Stenosis
• · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• · Tumor
• · Pseudarthrosis
• · 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 the aforementioned indications in skeletally mature patients as an adjunct to fusion.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.

Indications for Use (Power):
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation 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; pseudoarthrosis; and failed previous fusion.

The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are 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); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is intended for anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; 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 the aforementioned indications in skeletally mature patients as an adjunct to fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tunor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MANTIS® Spinal System, MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative dise 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is comprised of Monoaxial, Polyaxial and reduction bone screws, Cortical Trajectory (CT) bone screws (cannulated and non-cannulated), hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, growth connectors, and cross connectors to vertebrae of the spinal column.

The subject submission will introduce line extension of non-cannulated dual lead self-tapping Xia® Cortical trajectory (CT) bone screws, sub components of existing XIA® 4.5 Spinal System. Ø5.5, Ø 6.5, and Ø7.5 with a length of 35mm-70mm screws are to be added. The new components will be used in the same manner as the predicate XIA® 4.5 Spinal System.

The Xia® 4.5 Spinal System, including the new Xia® Cortical Trajectory implants, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument. The Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, are used with Stryker Spine Power Adaptor to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws.

The provided text describes a 510(k) premarket notification for the Stryker XIA® 4.5 Spinal System and Power Adaptor Instrument Accessory, which is a spinal fixation device.

Crucially, this document is a regulatory submission for a medical device (spinal system) and an accessory. It is NOT a study describing the performance of an AI/ML-based medical device against specific acceptance criteria for diagnostic or prognostic tasks.

Therefore, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "sample size for training set." These concepts are specific to the validation of AI/ML algorithms, not conventional spinal instrumentation.

The document discusses substantial equivalence to predicate devices based on design features, materials, and intended use, rather than a performance study against statistical acceptance criteria for an algorithm.

Based on the provided text, the device in question is a spinal system, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI/ML study, ground truth, expert opinions, etc.) is not applicable and not present in this document.

If you have a document describing an AI/ML device's performance study, I would be happy to analyze it for the requested criteria.

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The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e. fracture of dislocation)
• · Spinal stenosis
• · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• · Failed previous fusion

The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm 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, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Intended Use (Power):

To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia® Spinal Systems (Xia® Stainless Steel, Xia® II, Xia® Anterior, and Xia® Precision), Xia® 3 Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux Spinal System, and the ES2® Spinal System.

The Xia® 3 Spinal System is an orthopedic spinal system comprised a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae of the spinal column for the purposes of stabilization, or corrective action through the application of force. The system can be rigidly locked into a range of configurations specific to each patient. The Xia® 3 Serrato Line Extension introduces new dual lead screws, with an enhanced cutting flute (also referred to as serrations), offered in the following configurations: Polyaxial Screws, Medial BA Polyaxial Screws, Reduction Polyaxial Screws, and Cannulated Polyaxial Screws.

The Xia® 3 Spinal System, including the new Serrato bone screws, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument, Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws. The accessory indications for use were updated to reflect the indications for use of the Xia® 3 Spinal System.

I regret to inform you that the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them, particularly for a software/AI-based medical device.

This document is a 510(k) premarket notification for the Xia® 3 Spinal System - Serrato and Stryker Spine Power Adaptor Instrument Accessory. These are hardware medical devices (pedicle screw spinal systems and their associated instruments) used in spinal fusion surgery.

The information you've requested, such as sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are typically relevant to the validation of software as a medical device (SaMD) or AI/ML-based algorithms.

Here's a breakdown of why the information is not present and what is discussed instead:

• Device Type: The devices described are mechanical implants and surgical instruments. Their substantial equivalence is based on material properties, design, and mechanical testing, not on AI/ML performance.
• Acceptance Criteria & Performance: The "acceptance criteria" here are implicitly related to the mechanical and biocompatibility standards required for spinal implants. The "reported device performance" refers to the results of mechanical testing demonstrating that the new components (Serrato screws) perform equivalently to the predicate devices under various loads (compression, torsion, bending, etc.).
• Study That Proves Device Meets Acceptance Criteria: The study mentioned is primarily "Engineering analysis and applicable ASTM testing," specifically citing ASTM F1717-15, F1798-13, F2193-14, and F543-13. These are standards for mechanical testing of spinal implant systems.
• Missing Information (and why):
  • Table of acceptance criteria and reported device performance: While mechanical tests are performed, the document doesn't present them in a detailed table with specific pass/fail criteria and numerical results in this summary. It states compliance with "FDA's Guidance for Spinal System 510(k) May 3, 2004."
  • Sample sized used for the test set and the data provenance: For mechanical testing, this would refer to the number of devices tested, but it's not detailed here. There's no "data provenance" in the sense of patient data because it's not an AI/ SaMD.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is defined by engineering specifications and physical measurements, not expert consensus on data.
  • Adjudication method: Not applicable.
  • Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as there's no "reading" of data by human experts for an AI.
  • Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as there is no algorithm.
  • The type of ground truth used: For mechanical devices, ground truth is based on engineering specifications, material properties, and physical test results, not clinical pathology or outcomes data in the context of AI validation.
  • The sample size for the training set: Not applicable, as there's no training set for a mechanical device.
  • How the ground truth for the training set was established: Not applicable.

In summary, this document describes the regulatory submission for a physical spinal implant system and its accessories, not a software or AI-based medical device. Therefore, the information you're looking for regarding AI validation metrics is not present.

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To facilitate the placement of pedicle screws using the power technique (corded and cordless). the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached. the CD3 Cordless Driver 3 and RemB Univer provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia Spinal Systems (Xia Stainless Steel, Xia II. Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.

The Xia Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA 4.5. Xia 3. Radius Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3, XIA 4.5, Xia 3, and Radius Spinal Systems are 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; curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.

The line extension, which is the subject of this 510(k), consists of the addition of a power adaptor instrument accessory. The power adaptor is intended to facilitate the insertion of pedicle screws using the CD3 Cordless Driver 3 powered instrument. The STRYKER Spine Power Adaptor instrument, currently used with the RemB Universal Driver (corded), Power Adaptor (K111478) has the same design and function, differ only with respect to the power source used to operate (4 volt battery vs. Controller interface). Verification activities for fatigue insertion, interface and functional compatibility and comparison testing for profile and weight using the RemB Universal Driver, Power Adaptor (K111478) were found to be equivalent, all test reports are found in Section 18.3. This 510(k) supports a labeling update to include the option for pedicle screw insertion using cordless powered instrumentation (in addition to the existing manual and corded power insertion technique). To facilitate the insertion of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the CD3 Cordless Driver 3, identical to the RemB Univer (corded) Power Adaptor (K111478). The adaptors serve as a mechanical interface between the power driver and screwdriver instrument. When the adaptors are attached, the CD3 Cordless Driver 3 provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems: Xia Spinal System (Xia Stainless Steel, Xia II. Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal System. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.

The provided text describes a 510(k) premarket notification for a power adaptor instrument accessory. This device is an accessory to a spinal fixation system, intended to facilitate the insertion of pedicle screws using powered techniques (corded and cordless). The submission focuses on demonstrating substantial equivalence to a predicate device (RemB Universal Driver, Power Adaptor, K111478).

Here's an analysis of the acceptance criteria and study information, based solely on the provided text. It's important to note that this document is a summary and details of the actual test reports (TRP000002163 and DSGN-fm-5303) are not fully provided, only referenced.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes verification activities rather than explicit quantified acceptance criteria in the typical sense of a diagnostic device's sensitivity, specificity, or similar metrics. The primary acceptance criterion appears to be demonstrating equivalence and adequate performance compared to the predicate device and existing manual techniques through various bench tests.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of patient data or clinical cases. The testing described is bench testing using simulated conditions and materials. For "fatigue insertion over a simulated three year usage period," this implies a duration of testing rather than a discrete number of samples in the typical sense. It refers to "screw loading and screw insertion" events as part of the fatigue test, but no specific count is given.
• Data Provenance: The data provenance is from bench testing conducted by the manufacturer (Stryker Spine). It is not patient data, so concepts like "country of origin of the data" (for patients) or "retrospective/prospective" (for clinical studies) do not directly apply here. The testing is laboratory-based verification.

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

• Experts: The document mentions "safety evaluation testing... under simulated use conditions presented no quality/accuracy issues for screw placement." It also states "No significant differences were observed concerning the surgeon interface for usability and ergonomics between the two hand pieces." While these evaluations likely involved ergonomic assessment by individuals with surgical or engineering expertise, the document does not specify the number or qualifications of any "experts" used to establish a ground truth. The evaluations appear to be internal engineering and usability assessments rather than formal expert consensus panels.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This is not a study requiring adjudication of expert opinions or interpretations, as it is bench testing and engineering verification.

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 not a diagnostic device based on interpretation by human readers (e.g., AI in radiology). It is a surgical instrument accessory. Therefore, an MRMC comparative effectiveness study involving human "readers" or "AI assistance" is not relevant and was not performed.

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

• Standalone Performance: Not applicable. This device is a mechanical instrument accessory, not a software algorithm that performs diagnostic or analytical tasks. It is inherently used "human-in-the-loop" as a surgical tool.

7. The Type of Ground Truth Used:

• Ground Truth: The "ground truth" for this device's performance is established by engineering specifications, material properties, and functional performance benchmarks as demonstrated through bench testing. For example, "withstanding screw loading and screw insertion without loss of function" is verified against a predefined functional standard. "Compatibility with existing screwdriver instruments" is verified through direct operational testing. The "ground truth" is adherence to design and performance requirements.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development and verification rely on engineering design, materials science, and physical testing, not data training.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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