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The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.

In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.

This document is a 510(k) Summary for the OLYMPIC Posterior Spinal Fixation System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices primarily based on non-clinical testing.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it lists the types of non-clinical tests performed and states a general conclusion of equivalence to predicate devices. The "acceptance criteria" are implied by the standards cited for each test.

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

• Sample Size for Test Set: Not applicable as the study involved non-clinical bench testing rather than human or animal subjects. The "test set" here refers to the physical device components and constructs subjected to mechanical testing. The specific number of samples for each test (e.g., how many constructs were tested for static bending) is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on actual device components. The location where these tests were conducted is not specified, but the applicant (Astura Medical, LLC) is based in Carlsbad, CA, USA.

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 study is a non-clinical, mechanical performance evaluation of a spinal fixation system. "Ground truth" in the sense of expert clinical consensus or pathology is not relevant for this type of testing. The performance is measured against engineering standards (ASTM).

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

Not applicable. As this is a non-clinical, mechanical testing study, there is no adjudication of findings by experts. The results are objective measurements against defined engineering standards.

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. This document explicitly states: "No clinical studies were performed." Therefore, an MRMC study related to AI assistance is not relevant.

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

No. This device is a physical spinal implant, not a software algorithm or AI device.

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

The "ground truth" for the non-clinical tests are the established mechanical performance requirements and limits defined by the cited ASTM standards. The device's performance is compared against the performance of predicate devices and the requirements of these standards to demonstrate substantial equivalence, not against clinical expert consensus or pathology data.

8. The sample size for the training set

Not applicable. There is no training set for this device, as it is a physical medical implant and not an AI/ML algorithm.

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

Not applicable. There is no training set.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® 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 CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal system components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, those components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.

This document describes a 510(k) submission for the CD HORIZON® Spinal System, focusing on expanding its pediatric indications. It is a medical device application and does not contain information about software or AI device acceptance criteria, nor does it detail a study proving device performance against such criteria.

Therefore, I cannot provide a response with the requested information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to previously cleared devices, rather than performance metrics of a novel device.

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The PASS LP Spinal Systems include a pedicle system 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:

• Fractures .
• . Dislocation
• . Failed previous fusion (Pseudoarthrosis)
• . Spinal stenosis
• . Degenerative spondylolisthesis with objective evidence of neurological impairment
• . Spinal deformations such as scoliosis or kyphosis.
• . Loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of 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.

The PASS LP also includes hooks and rods and sacral/iliac screws 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, illac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of a new component: 'Revision Post and Nut' and Illiac Link for Ø6mm rod

This document describes device modifications to the MEDICREA INTERNATIONAL's PASS LP Spinal System, specifically the addition of a 'Revision Post and Nut' and an 'Iliac link' for a Ø6mm rod. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a novel AI device or a comparative effectiveness study involving human readers. Therefore, many of the requested criteria related to AI performance, expert-established ground truth, and human reader studies are not applicable or cannot be extracted from the provided text.

Here's the breakdown of information based on your request, as much as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and "reported device performance" in this context refer to engineering performance tests for mechanical equivalence, not clinical or diagnostic performance. The acceptance criteria are implicitly met by "demonstrated substantially equivalent performance" to the predicate.

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

• Sample Size: Not explicitly stated in the provided text. For mechanical testing, this typically refers to the number of test articles (e.g., number of screws, posts, or links) subjected to the tests.
• Data Provenance: The tests were carried out according to ASTM standards (F1798 and F1717), which are international standards for material and product testing. The location where the tests were performed is not specified, but the manufacturer is based in France. The data is retrospective in the sense that it represents laboratory test results, not clinical data from patients.

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 mechanical implant, and the "ground truth" for its performance is established through standardized engineering tests (ASTM F1798, F1717) comparing its mechanical properties to a predicate device. It does not involve expert interpretation of images or clinical outcomes that would require a panel of human experts for ground truth establishment.

4. Adjudication method for the test set

• Not Applicable. As this involves mechanical testing for substantial equivalence, there is no "adjudication method" in the sense of reconciling divergent expert opinions. The outcome is determined by adherence to specified test protocols and comparison of results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of human readers improve with AI vs without AI assistance

• Not Applicable. This submission is for a medical implant (spinal system components), not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. This is a hardware implant, not an algorithm or software device. Standalone algorithmic performance is not relevant.

7. The type of ground truth used

• Mechanical Testing Standards and Predicate Performance: The "ground truth" for demonstrating substantial equivalence is based on the established mechanical performance characteristics of the legally marketed predicate device, as measured and verified through standardized ASTM tests (F1798 and F1717). The new components must perform equivalently to these established benchmarks.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device or its evaluation. This is not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical 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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.

The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.

The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.

The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.

The provided text describes the Implanet S.A.'s IMPLANET Spine System, a spinal fixation device. However, it does not contain information related to software or AI/ML performance, acceptance criteria, or studies for such, as the device is a physical implant. The document is a 510(k) summary for a medical device (spinal fixation system) that primarily focuses on mechanical and material properties, biocompatibility, and manufacturing standards.

Therefore, I cannot provide the requested information about acceptance criteria and studies for a digital health device. The document describes:

1. Device Description: Physical components like polyaxial and monoaxial pedicle screws, rods, transverse connectors, and hooks, all made of Ti6Al4V titanium alloy.
2. Technological Characteristics: Substantially similar to other pedicle screw-based systems.
3. Performance Data: This section only refers to bench testing (static and dynamic mechanical tests), sterility validation, shelf life validation, and biocompatibility testing. It specifically states that these tests were performed on the previous version of the device (Calypso System) and some biocompatibility tests were reperformed on the current version.
4. Substantial Equivalence: Concludes that the device is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, and principles of operation, with minor differences raising no new safety or effectiveness issues.

Conclusion:

The provided text does not contain any information about:

• Acceptance criteria related to AI/ML performance.
• Reported device performance for AI/ML.
• Sample size for test sets in an AI/ML context.
• Data provenance for AI/ML training/testing.
• Number or qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm-only performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size or establishment of ground truth for a training set in an AI/ML context.

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The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine:

• Fractures .
• Dislocation .
• Failed previous fusion (Pseudoarthrosis) .
• Spinal stenosis .
• Degenerative spondylolisthesis with objective evidence of neurological impairment .
• Spinal deformations such as scoliosis or kyphosis. .
• Loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of 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.

The PASS LP also includes hooks and rods and sacral/iliac screws 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, deformilies or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft . Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks,sacral plates, iliac screws, clamps, nuts and crosslink components.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

This device submission (K132575) is for a modification to an existing device, the PASS LP Spinal System (K123138), by adding "Precontoured S-Rods" and "Unit Rods". As such, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than conducting a new comprehensive performance study against a specific set of acceptance criteria in the traditional sense.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In this 510(k) submission, the "acceptance criteria" are implied through the concept of "substantial equivalence." The sponsor asserts that the modified components (Precontoured S-Rods and Unit Rods) are equivalent to existing, legally marketed predicate devices based on their mechanical soundness, geometric similarity, and material properties. There are no explicit quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) mentioned in this document that would typically be associated with a new device's performance study. Instead, the approach is to show that the new components are comparable to already-approved ones.

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

• Sample Size: Not applicable. No performance testing involving a "test set" of patient data or clinical samples was conducted.
• Data Provenance: Not applicable. The demonstration of substantial equivalence was based on descriptive information and comparison to predicate devices, not on data derived from patient studies.

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

• Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was used, and therefore no adjudication was required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This submission does not involve an AI device or a comparative effectiveness study with human readers.

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

• Standalone Performance: No. This submission does not involve an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical or diagnostic performance. For this device filing, the "ground truth" for demonstrating substantial equivalence is the established performance and safety of the predicate devices. That is, the predicate devices are considered safe and effective, and the new device components are shown to be equivalent to them.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This submission does not involve an AI device or machine learning model that requires a training set.

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

• Ground Truth Establishment: Not applicable. No training set was used.

Summary of the Study:

The "study" in this context is a descriptive comparison for substantial equivalence, not a performance study in the traditional sense involving clinical data or benchmarks. The core of the demonstration is the following statement:

"Descriptive information is sufficient to demonstrate the substantial equivalence of the subject rods. No performance testing was necessary."

This means that the manufacturer presented engineering and design documentation (e.g., blueprints, material specifications, mechanical properties of the materials) for the new "Precontoured S-Rods" and "Unit Rods." They then compared this descriptive information to similar characteristics of already-approved predicate devices (PASS LP Spinal System K123138, USS, Click'X, VAS, Dual-Openin, Small Stature K022949, BacFix Spinal fixation System K983260).

The FDA's decision to clear the device (K132575) indicates that they agreed that this descriptive comparison was sufficient to establish substantial equivalence for the addition of these specific components to an existing system, and that no new performance testing (such as mechanical or clinical studies) was required.

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The EXPEDIUM, VIPER, and VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM, VIPER, and VIPER2 Spine System is intended for noncervical pedicle fixation and nonpedicle 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle 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 in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® and VIPER® and VIPER® 2 Spine Systems consist of titanium rods, pedicle screws, connectors, hooks, and extended tab implants, which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain implants will be packaged in sterile multi-packs for customer convenience.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary, there is no performance data or studies provided to establish acceptance criteria for a device's performance. This submission is for modifications to an existing spinal system (EXPEDIUM®, VIPER®, and VIPER2® Spine Systems) where the primary change is the sterilization method.

The summary explicitly states: "Performance data is not provided in this submission."

Therefore, I cannot populate the requested table or answer the specific questions related to performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement because this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices based on identical design, materials, indications, and technology, with the only modification being the terminal sterilization method via gamma radiation. In such submissions, the FDA typically accepts the existing safety and effectiveness profile of the predicate device if the changes are deemed not to alter these fundamental aspects.

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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Nextgen Altius OCT Spine System. The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks. lateral connectors, plugs. fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to expand the indications for use for Polaris Spinal System using previous cleared system components.

This document describes a 510(k) submission for the Polaris Spinal System, a medical device. The information provided heavily focuses on the comparison to predicate devices to establish substantial equivalence rather than detailing specific device performance or clinical studies with acceptance criteria for a novel AI or diagnostic device.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or are not explicitly stated in the provided text. The document is primarily a regulatory submission demonstrating equivalence, not a detailed performance study report.

Here's an analysis based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Not Applicable: The document does not specify quantitative acceptance criteria (e.g., "must achieve X N-m of torque" or "failure rate must be below Y%"). The "reported device performance" for mechanical strength is a statement that it was "previously tested" and "already demonstrated," indicating compliance with prior standards or predicate device performance, but no specific values or criteria are provided in this summary.

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

The document does not describe a "test set" in the context of a clinical study with a specific sample size.

• Mechanical Testing: While mechanical tests per ASTM F1717 were performed, the sample size for these tests is not mentioned.
• Clinical Literature Assessment: This involved reviewing "published clinical data." The number of patients or studies included in this assessment is not specified, nor is the country of origin, or whether it was retrospective or prospective. It's a review of existing data, not a new data collection.

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

This information is not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical literature assessment likely involved review by the regulatory affairs team, but not in the context of establishing "ground truth" for a device performance study.

4. Adjudication Method for the Test Set

This information is not applicable as no "test set" requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or mentioned. This device is a surgical implant, not a diagnostic imaging AI, so such a study would not typically apply in this direct comparison context.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable. The Polaris Spinal System is a physical implant, not an algorithm. Standalone performance for mechanical devices relates to their physical integrity and function under simulated use, which is addressed by the ASTM F1717 testing.

7. Type of Ground Truth Used

• Mechanical Testing: The "ground truth" for mechanical testing would be the physical properties and performance metrics defined by the ASTM F1717 standard.
• Clinical Efficacy (for pediatric pedicle screw fixation): The "ground truth" was derived from a "clinical literature assessment," meaning conclusions drawn from existing published clinical data and expert consensus in the medical community about the safety and effectiveness of pedicle screw fixation for the stated conditions.

8. Sample Size for the Training Set

This information is not applicable, as there is no "training set" in the context of a medical device like this. Training sets are relevant for machine learning algorithms.

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

This information is not applicable, as there is no "training set" for this device.

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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-SI 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, 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.

Except for the ARI staples, the Range Spinal System.is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to incorporate additional screws and rods into the system.

The provided text is a 510(k) summary for the K2M Range Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study where a device's performance is measured against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document.

The document states:

• Acceptance Criteria/Reported Device Performance: Not explicitly defined or reported in terms of specific performance metrics. The claim is based on substantial equivalence to predicate devices.
• Study Proving Acceptance Criteria: The study proving substantial equivalence is an "Engineering rationales were used to compare the modified implants to predicate devices that were previously tested in static compression, static torsion and dynamic compression in accordance with ASTM F 1717." This is a mechanical engineering comparison, not a clinical study involving human or animal data.
• Sample Size for Test Set and Data Provenance: Not applicable as it's an engineering comparison to predicate devices, not a test set for an algorithm or a clinical trial.
• Number of Experts and Qualifications: Not applicable as no ground truth was established by experts for a test set.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No MRMC study was performed or mentioned.
• Standalone Performance Study: No standalone clinical performance study was done; the evaluation relied on substantial equivalence through engineering rationales.
• Type of Ground Truth Used: The ground truth used is the ASTM F 1717 standard for mechanical testing, which served as the benchmark for comparing the modified implants to the predicate devices.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on engineering comparisons and previous testing of predicate devices against established ASTM standards, rather than presenting a performance study against novel acceptance criteria with clinical data.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system. the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (F1-S1) as an adjunct to fusion in skeletally mature patients," It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.

The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 5.5mm and 6.0mm lined rods in cobalt chrome, and a 6.35mm lined rod in titanium alloy.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CD HORIZON® Spinal System, structured according to your request:

It's important to preface this by stating that this document is a 510(k) summary for a spinal implant system, not a medical device that generates data (like an AI algorithm or diagnostic tool). Therefore, many of the requested points, particularly those related to machine learning studies (e.g., test sets, ground truth establishment, expert consensus, MRMC studies), are not applicable to this type of submission. This document focuses on the mechanical and material properties of the device and its substantial equivalence to previously cleared devices.

Acceptance Criteria and Device Performance Study for CD HORIZON® Spinal System (K131321)

This 510(k) pertains to a modification of an existing spinal system, specifically the addition of new sizes of lined rods. The "acceptance criteria" here are primarily based on the demonstration that these new components do not introduce new risks and maintain the fundamental scientific technology and performance characteristics of the predicate devices.

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

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

• Not applicable. This submission is for mechanical components, not an algorithm or diagnostic device tested on clinical data. The "test set" here refers to components undergoing non-clinical (e.g., mechanical, materials) testing, not a patient dataset.
• The document implies that testing was conducted on manufactured components, but does not specify the sample size of tested rods, nor does it refer to "countries of origin of data" or "retrospective/prospective" studies in a clinical data sense. The provenance of the testing data would be internal Medtronic labs.

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

• Not applicable. "Ground truth" in the context of expert consensus on diagnostic images or clinical outcomes is not relevant here. The "ground truth" for this device would be established engineering standards, material specifications (e.g., ASTM standards), and established biomechanical performance metrics for spinal implants. Expertise would come from engineers, materials scientists, and quality assurance personnel involved in device design and testing, not clinical experts establishing a ground truth from patient data.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving discrepancies in expert interpretations of clinical data or image annotations. This is not performed for mechanical device testing. Compliance with engineering standards and specifications would be internally verified and validated.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, how much human readers improve with AI vs without AI assistance.

• Not applicable. This is a hardware implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are completely irrelevant to this submission.

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

• Not applicable. This is a hardware implant. There is no algorithm or standalone performance to evaluate.

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

• For this type of device, the "ground truth" relies on engineering specifications, material science standards (e.g., ASTM F1537 for cobalt chromium, ASTM F136 for titanium alloy), and biomechanical testing standards. The goal is to demonstrate that the new components meet these established engineering criteria and perform comparably to predicate devices in terms of mechanical integrity, fatigue strength, and biocompatibility.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning model.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

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The CREO™ Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO™ 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis. Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO™ Stabilization System is intended for treatment of 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO™ 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO™ 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO™ Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ÉLLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO™ Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

The CREO™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO™ implants mate with 4.75mm, 5.5mm, and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the tconnectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.

CREO™ Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. All other CREO™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.

Here's a breakdown of the acceptance criteria and the study information for the CREO™ Stabilization System, 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

The provided 510(k) summary does not mention a test set in the context of clinical data for a pre-market notification. The "Performance Data" section specifically refers to mechanical testing, not patient or image data. Therefore, there is no information on sample size for a test set, data provenance, or retrospective/prospective nature of such a study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission relies on mechanical testing against established standards and predicate device equivalence, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on mechanical performance and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable as the device is a physical spinal stabilization system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Mechanical Testing Standards: Adherence to ASTM F1717.
• FDA Guidance: Compliance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004.
• Predicate Device Performance: The underlying assumption is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as #8.

Summary of the Study:

The "study" that proves the CREO™ Stabilization System meets its acceptance criteria is primarily mechanical testing. This testing was conducted in accordance with:

• ASTM F1717: A standard specific to spinal implant mechanics.
• "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004: FDA's specific recommendations for spinal system submissions.

The results of this mechanical testing demonstrated "substantial equivalence" to the predicate devices (REVERE® Stabilization System, REVERE® 4.5 Stabilization System, Medtronic CD Horizon® Spinal System, Synthes USS, and DePuy VIPER® 2 System). This equivalence means the CREO™ system is considered to be "as safe, as effective, and perform as well as or better than the predicate device." The study did not involve clinical trials with human subjects or AI algorithm performance evaluations.

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