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The XIA® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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 subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

The Stryker Spine Sierra Mertz family of spinal implant systems (referred to as "the subject devices" in the document) is seeking an MR Conditional labeling claim.

Here's an analysis of the acceptance criteria and study proving device conformance, based on the provided text:

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 in the provided text. The document refers to "the subject devices" which is a family of 20 different spinal systems. It's implied that various components within these systems were subjected to testing.
• Data Provenance: The document does not specify the country of origin of the data. The study was a prospective test conducted to establish MR Conditional labeling for the devices.

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

This is not applicable as the study involved physical testing for MR compatibility according to a standard (ASTM F2503), not human expert evaluation of medical images or data.

4. Adjudication Method for the Test Set

This is not applicable for this type of physical device testing. The results are based on adherence to the parameters set by the ASTM F2503 standard.

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 submission is for spinal implants and their MR compatibility, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable, as the device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test was compliance with the ASTM F2503 standard for MR compatibility. This standard defines specific parameters and limits for evaluating the safety and performance of medical devices in an MRI environment, such as magnetic field interactions, RF-induced heating, and image artifact.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device clearance for physical implants, not a machine learning or AI model that requires a training set.

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

This is not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed was a MR Compatibility testing per ASTM F2503. The FDA document states: "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." This indicates that the physical and electrical properties of the spinal implant systems, when subjected to MRI conditions outlined in the ASTM F2503 standard, did not pose unacceptable risks (e.g., excessive heating, dangerous magnetic force, or significant image artifacts) and thus were deemed MR Conditional. The purpose of this testing was to establish the MR Conditional labeling claim for the devices.

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The Opus™ Spinal System is intended for 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 and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Opus™ Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The Opus™ Spinal System is also intended to be used in conjunction with the Multi-Axis Cross Connectors.

The Opus Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V).

Here's an analysis of the acceptance criteria and study information for the Opus™ Spinal System based on the provided document:

This document is a 510(k) summary for an additional indication for the Opus™ Spinal System. It primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about AI/ML device performance, human reader studies, ground truth establishment, or training data for such applications.

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

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 a "test set" in the context of clinical data or image-based diagnostics. The testing involved mechanical performance on device constructs. The sample size for these mechanical tests is not explicitly stated in the provided text. The provenance is the testing facility, not 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 device is a spinal fixation system, not a diagnostic AI/ML device. Ground truth, in this context, would relate to mechanical engineering standards and material properties, not expert interpretations of medical images or clinical outcomes in the usual AI/ML sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. This document describes mechanical testing, which relies on engineering standards and measurements, not expert adjudication in the same way.

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. No MRMC studies were performed related to 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 spinal implant; there is no algorithm or standalone performance in the context of AI/ML.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on mechanical engineering standards and benchmark performance of the predicate device. The goal was to demonstrate "comparable mechanical properties" to the legally marketed predicate device (OSS/Diapason and Xia® Titanium Hooks).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that utilizes a "training set."

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

Not applicable. There is no training set for this device in the AI/ML context.

Summary of Device and Study Focus:

The Opus™ Spinal System's 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (OSS/Diapason and Xia® Titanium Hooks) for additional indications. This equivalence is primarily supported by mechanical performance data (static and fatigue tests) showing "comparable mechanical properties" between the Opus™ Spinal System constructs and the predicate device. The document does not describe any clinical trials, human-in-the-loop studies, or AI/ML performance evaluations.

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The Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus "Spinal System.

Indications For Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Opus™ Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature . patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The Opus" Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V). The plates for the Opus™ Spinal System range from 41-75 mm in length. Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.

The provided text describes a 510(k) submission for a modification to the Opus™ Spinal System, specifically adding longer plates. The submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. There is no information in the provided text about a study involving human readers, AI, or ground truth derived from expert consensus, pathology, or outcomes data, as the device is a spinal fixation system, not a diagnostic or AI-driven tool.

Therefore, many of the requested categories are not applicable to this type of device and study.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample size (number of test specimens) used for the fatigue testing. The data provenance is implied to be from internal testing by Howmedica Osteonics Corp, located in Allendale, NJ, USA. The testing is for a device modification, implying a prospective evaluation of newly manufactured components.

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 mechanical performance is established through standardized engineering tests, not expert human interpretation.

4. Adjudication method for the test set

Not applicable. Mechanical testing does not involve 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 medical device (spinal implant), not a diagnostic imaging or AI-assisted system. No human reader or AI interaction is described.

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

The ground truth for this device is based on mechanical testing standards and direct physical measurement of properties like fatigue resistance, ensuring the modified device maintains structural integrity and performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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When used as a pedicle screw fixation system of the non-cevical posterior spine in skeletally mature patients, the Opus" Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The Opus" Spinal System is a spinal fixation device for the noncervical spine. All components are manufactured from ISO 5832/3 (equivalent to ASTM F-136-96) titanium alloy (Ti6Al-4V ELL). The system consists of conical and cylindrical screws, rods, lateral connectors, and plates.
Bone Screws: These screws are threaded at both the distal and the proximal ends. The distal aspect of the screws features cancellous bone threads. The proximal aspect of the screws features standard metric threads. The area between the proximal and distal threads has a hexagonal cross-section used to remove the screw. Screws are available in a variety of diameters and lengths. Additionally, the screws are available in extended proximal length and/or extended hexagonal section configurations.
Rods: The spinal rods are 6mm in diameter and range in length from 40mm to 480mm. A 600mm rod is also available. Rods are assembled to the screws through the use of a lateral connector and a rod nut.
Plates: The plates have 2 or 3 holes and their lengths range from 41mm to 75mm. Plates are assembled to the screws through the use of a washer and a plate nut.

The provided text describes a 510(k) premarket notification for the Opus™ Spinal System, a medical device for spinal fixation. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific performance criteria.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense (e.g., sensitivity, specificity, AUC for an AI/diagnostic device) does not apply here. Instead, the "acceptance criteria" are related to mechanical and material equivalence to the predicate device, and the "study" is a comparison of these properties.

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

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a spinal fixation system, the "acceptance criteria" are implicitly tied to demonstrating mechanical and material equivalence and safety/effectiveness comparable to a predicate device. There are no explicit performance metrics like sensitivity or specificity.

Study Information

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

   • No human subject test set or data provenance is mentioned as this device relies on mechanical testing and material comparison to a predicate, not clinical performance data.

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

   • Not applicable. Ground truth for a clinical test set is not relevant for this 510(k) submission type.

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

   • Not applicable. There is no clinical test set requiring adjudication.

4. 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/diagnostic device.

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

   • Not applicable. This is a spinal implant, not an algorithm.

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

   • For the mechanical aspects, the "ground truth" would be the established mechanical and material specifications of the predicate device and industry standards (e.g., ISO 5832/3, ASTM F-136-96). The "study" involves demonstrating that the Opus™ Spinal System's mechanical and material properties meet or exceed these established benchmarks, or are comparable to the predicate.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

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