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

For pediatric patients, the Polaris Spinal 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: 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, Lineum 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 F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to update a contraindication related to the translation screws.

This document (K210275) is a 510(k) premarket notification for the Polaris Spinal System. It seeks clearance for a minor modification to the labeling related to a contraindication for translation screws, rather than a new device or significant design change requiring extensive performance studies.

Therefore, the typical battery of performance studies with large sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance evaluations are not applicable in this context.

The document explicitly states:

• "This submission is to update a contraindication related to the translation screws." (Page 3)
• "The purpose of this submission is to seek clearance for minor modifications to the labeling related to the translation screw." (Page 4)
• "No changes were made to any physical component of the Polaris Spinal System." (Page 5)
• "A risk assessment was conducted due to new information from a complaint. That risk assessment led to the inclusion of a contraindication to the labeling." (Page 5)
• "Per the FDA Guidance, The Special 510(k) Program, a Special 510(k) is appropriate when it is a change to the manufacturer's own device and performance data is not needed to evaluate the change." (Page 5)
• "Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates." (Page 5)

Given this, the requested information about acceptance criteria and detailed study designs (as they would apply to a new or significantly modified device) is not present in this 510(k) submission.

The "study" in this case was a risk assessment driven by a complaint, leading to a labeling change. It was not a performance study of the typical kind for a medical device.

Here's how to interpret the request in the context of this document:

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

• Acceptance Criteria (Implied): The acceptance criteria for this specific submission revolved around ensuring that the updated labeling (including the new contraindication) adequately addressed the identified risk and maintained the device's substantial equivalence to its predicates without introducing new safety or efficacy concerns. Since no physical changes were made, mechanical performance or clinical outcomes were not re-evaluated.
• Reported Device Performance: Not applicable in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity, computational speed). The "performance" here is that the risk assessment was completed, and the resulting contraindication was deemed appropriate to mitigate the identified risk.

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

• Not applicable. There was no "test set" of clinical data for performance evaluation. The basis for the change was "new information from a complaint" (Page 5). This suggests a single or very limited number of reported adverse events or observations that triggered the re-evaluation of risk and subsequent labeling update.

3. 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 performance study was not established. The "ground truth" for the labeling change was likely the outcome of an internal risk assessment by Zimmer Biomet's regulatory, engineering, and possibly clinical teams, based on the complaint information. The qualifications of these individuals are not detailed in the FDA letter.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was used.

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 device is a mechanical spinal fixation system, not an AI software.

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

• Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

7. The type of ground truth used:

• Not applicable for a performance study. The "ground truth" for the labeling change was the company's internal assessment of the risk associated with the translation screws, likely derived from post-market surveillance (a "complaint").

8. The sample size for the training set:

• Not applicable. No training set was used as this is not a learning algorithm.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization 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. 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, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), tumor, stenosis, pseudarthrosis, or failed previous fusion.

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

For pediatric patients, the Polaris Spinal 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 dominoes in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum 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 F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. The purpose of this Premarket Notification is to add modified Ø4.75mm multi-axial screws.

The provided document describes the clearance of the Biomet Spine Polaris Spinal System (K151974) by the FDA. It is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically found in a study proving acceptance criteria for a novel device (like specific performance metrics, sample sizes for test sets, expert consensus for ground truth, etc.) is generally not present in this type of submission.

Instead, the submission focuses on demonstrating that the new device (modified Ø4.75mm multi-axial screws for the Polaris Spinal System) is as safe and effective as its predicate device (Polaris Spinal System – K133746). This is primarily achieved through mechanical testing to verify that the modified components meet established standards for spinal implants.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Guidance and Standards): The device must meet the mechanical test requirements based on the worst-case construct testing according to "FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s" dated May 3, 2004, and ASTM standards. This implies demonstrating sufficient strength, durability, and resistance to wear for safe use as a spinal implant.

Reported Device Performance:

Note: The document explicitly states: "The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market for its intended use and has met all mechanical test requirements based on the worst-case construct testing." Specific numerical acceptance values or pass/fail thresholds for each test are not detailed in this summary, as is common for 510(k) summaries where the focus is on meeting recognized standards.

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

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. Mechanical testing is typically conducted on a representative sample of devices, but the exact number of units tested per configuration is not disclosed.
• Data Provenance: The mechanical testing was conducted by the applicant, Biomet Spine, to demonstrate compliance with FDA guidance and ASTM standards. This data is part of their submission to the FDA. It is not patient or clinical data, but rather engineering test data.

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

This question is not applicable to this type of submission. "Ground truth" in the context of mechanical testing refers to the physical properties and performance of the device under specific loads, as measured by standardized testing procedures. It does not involve human expert consensus in the way clinical diagnostic or image interpretation studies do. The "truth" is established by the test setup and measurement equipment's accuracy and precision, adhering to established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or image interpretation studies where there might be disagreement among human evaluators. Mechanical testing results are objective measurements derived from physical tests following defined protocols, not subject to human subjective interpretation requiring 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 device is a mechanical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to its evaluation.

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

Not applicable. This device is a mechanical spinal implant, not an algorithm or software. Its performance is evaluated through physical mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is defined by the objective performance parameters as measured against the specified ASTM standards and FDA guidance. These standards dictate acceptable loads, deformation, and fatigue life for spinal implants. The "truth" is whether the device physically withstands these tests as required by the standards, not a diagnostic or pathological determination.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of device development or evaluation.

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

Not applicable, as there is no training set for a mechanical spinal implant.

Ask a specific question about this device

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization 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. 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, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), turnor, stenosis, pseudoarthrosis, or failed previous fusion.

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

For pediatric patients, the Polaris Spinal 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, Lineum 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 F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to the Polaris Spinal System to include Hydroxyapatite (HA) Coated Screws and a variation in shaft geometry on the multiaxial screws.

This FDA 510(k) premarket notification describes the Biomet Spine, LLC's Polaris Spinal System. The provided document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria in the manner typically seen for software or AI medical devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission. This document describes a medical device, specifically a spinal fixation system, not a software algorithm or AI. The "performance data" refers to mechanical testing against established standards for spinal implants.

Here's the information extracted from the document based on the provided request format, with explanations where certain information is not present or not applicable:

Acceptance Criteria and Study to Prove Device Meets Criteria: Polaris Spinal System (K141804)

This 510(k) submission for the Polaris Spinal System focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria for a novel functionality. The "acceptance criteria" here are implicitly meeting the performance and safety profiles of the predicate devices as demonstrated through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. For mechanical testing of medical implants, "test sets" typically refer to the number of constructs or samples subjected to each mechanical test. The document mentions "worst-case construct testing" was performed, but does not specify the number of samples per test type.
• Data Provenance: Not applicable in the context of clinical data. The data provenance here refers to the mechanical testing conducted on the device components.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to recognized engineering standards (e.g., ASTM F1717) and internal protocols, not clinical expert consensus.
• Qualifications of Experts: Not specified. Testing would be performed by engineers and technicians specializing in biomechanical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance is judged against predefined criteria within the ASTM standards, not by expert adjudication.

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

• MRMC Study: No. This is not a software/AI device, but a physical implant. Therefore, MRMC studies are not relevant.

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

• Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this medical device submission is the adherence to established mechanical testing standards (specifically ASTM F1717) and FDA guidance documents for spinal systems and HA-coated implants. This ensures the device's physical properties meet recognized safety and performance benchmarks for spinal implants.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This refers to a physical device, not a machine learning model.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

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, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

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

For pediatric patients, the Polaris Spinal 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, Lineum 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 F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.

Here's a summary of the acceptance criteria and study information for the Polaris Spinal System - Translation Screw, 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 document describes mechanical testing as the primary method to demonstrate performance. For this, the sample size is not explicitly stated as a number of devices or constructs, but it mentions testing was performed on "worst-case construct testing." There is no information about country of origin or whether the data was retrospective or prospective, as this pertains to physical device testing rather than clinical data.

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

Not applicable. The performance data is based on mechanical laboratory testing against established ASTM standards and direct comparison to predicate devices, not on expert assessment of a test set.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective mechanical testing in a laboratory setting, not on human adjudication of cases.

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

No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (spinal fixation system modification). This document focuses on the mechanical substantial equivalence of a medical device, not the interpretive accuracy of human readers with or without AI assistance.

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

Not applicable. This device is a physical spinal implant, not an algorithm or AI system. Its performance is inherent in its mechanical properties and design.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• ASTM F1717 Standard: This standard dictates specific methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model. Compliance with this standard represents a recognized and accepted "ground truth" for mechanical performance in this domain.
• Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate devices (K131615, K123549, K090203, and K061441). The subject device's performance is compared directly to these.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device

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

For pediatric patients, the Polaris Spinal 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 turnor 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, Lineum 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 F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to add downsized components and additional rod and connector styles to the Polaris Spinal System.

Here's an analysis of the provided 510(k) summary regarding the Polaris Spinal System:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device "met all mechanical test requirements based on the worst-case construct testing." The specific numerical thresholds for these acceptance criteria are not provided in this summary but would be detailed in the full test reports referenced by the FDA's "Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004."

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

• Test Set Sample Size: Not explicitly stated. The document mentions "worst-case construct testing," implying that specific configurations were tested, but the number of samples per test type is not detailed.
• Data Provenance: This is a retrospective study in the sense that the testing was conducted on samples of the device components. The data is generated from laboratory mechanical testing, not from patient data or clinical trials. The country of origin of the data is implicitly the USA, where the testing was conducted to FDA guidance.

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

This document describes a mechanical performance study, not a study requiring expert interpretation of medical images or patient data to establish ground truth. Therefore, this section is not applicable. The "ground truth" here is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. As this is a mechanical performance study, there is no "adjudication method" in the clinical sense. The results are objective measurements against defined engineering standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging. This document describes mechanical testing of a spinal implant system.

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

No, a standalone performance study (in the context of an algorithm or AI) was not done. This document describes the mechanical performance of a physical medical device (spinal implant system).

7. Type of Ground Truth Used

The ground truth used for this study is based on established engineering standards and regulatory guidance for spinal implant testing, specifically:

• ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004

8. Sample Size for the Training Set

Not applicable. This is a study of a physical device's mechanical properties, not an AI or algorithm-based product that requires a training set.

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

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

Ask a specific question about this device

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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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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, kyphosis, 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/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

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, 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. 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 submission is a line extension to Polaris Spinal System to add other styles of multiaxial screw, including a screw with translating feature, and to provide the Polaris Spinal System sterile packed.

The provided document describes a 510(k) summary for the Biomet Spine Polaris Spinal System - Translation Screw, which is a non-cervical spinal fixation device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing performed was mechanical testing of the device hardware.

• Test Set Sample Size: Not applicable in the context of clinical data or algorithm performance.
• Data Provenance: Not applicable. The "data" comes from physical mechanical tests conducted on the device components.

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

Not applicable. Ground truth, in the context of algorithm performance, typically refers to expert-validated clinical diagnoses or outcomes. This submission focuses on mechanical performance data of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions for clinical ground truth. Mechanical testing has well-defined pass/fail criteria per ASTM 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, an MRMC comparative effectiveness study was not done. This device is a physical spinal fixation system, not an AI or imaging diagnostic tool.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing was the established pass/fail criteria defined by ASTM 1717-11a standard test methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device

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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista/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 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a noncervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

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, 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. 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 submission is a line extension to Polaris Spinal System to add another style of Ballista rods to the system.

The provided text describes a 510(k) premarket notification for the "Polaris Spinal System - Ballista II Rods," a non-cervical spinal fixation device. This submission is a line extension to add another style of Ballista rods to the existing system. The core assertion is that the new components are "substantially equivalent" to predicate devices, meaning they have the same or similar technological characteristics and do not raise new issues of safety or effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only 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 applicable in the context of this submission. The "study" here is primarily an engineering analysis and validation testing, not a clinical study on human subjects or a dataset in the typical sense for AI/machine learning.
• Data Provenance: Not applicable. The validation testing would have been performed in a laboratory setting by the manufacturer, Biomet Spine. The data is internal to the company.

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

• Number of Experts: Not applicable. This submission focuses on engineering analysis and mechanical/compatibility testing, not on establishing ground truth from expert interpretations of medical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no human interpretation of data requiring adjudication mentioned.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence from a mechanical and functional perspective, not on comparing human reader performance with or without AI assistance.

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

• No, a standalone study (in the context of an algorithm's performance) was not done. This is a hardware device submission, not an AI or software device submission.

7. The Type of Ground Truth Used:

• Ground Truth: The "ground truth" in this context is defined by established engineering principles, mechanical testing standards for spinal implants, and the functional compatibility requirements with existing instrumentation. This is engineering/performance data and manufacturing specifications.

8. The Sample Size for the Training Set:

• Not applicable. This submission does not involve an AI system with a "training set."

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

• Not applicable. This submission does not involve an AI system with a "training set."

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" in this context consists of an engineering analysis and validation testing.

• Engineering Analysis: This analysis was conducted to determine if new mechanical testing was required for the different style of rod. The conclusion was that because the new component combination did not create a "new worst-case construct" compared to the predicate devices, additional general mechanical testing of the rod itself was not deemed necessary to demonstrate substantial equivalence for the main mechanical properties.
• Validation Testing: This testing specifically verified the compatibility and functionality of the modified rods with the existing Polaris Spinal System instrumentation. This ensures that surgeons can safely and effectively use the new rods with the established toolset.

The overall approach to proving the device meets acceptance criteria (which is primarily substantial equivalence) relies on demonstrating that the new components maintain the same intended use, indications, technological characteristics, and principles of operation as legally marketed predicate devices, and that the minor modifications do not introduce new safety or effectiveness concerns, supported by engineering analysis and specific compatibility testing.

Ask a specific question about this device

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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista instruments are intended to be used with Ballista/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

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, 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.

This submission is a line extension to Polaris Spinal System to add longer Ballista rods to the system.

The provided document is a 510(k) summary for a medical device (Polaris Spinal System), not a study report detailing acceptance criteria and performance of an AI/ML powered device. Therefore, much of the requested information is not applicable.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or reported device performance in the manner typically found for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of device components based on an engineering analysis and validation testing.

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

• Sample size: Not explicitly stated as a numerical sample size. The "cadaver" testing for validation implies a very small sample, but no number is given. The engineering analysis is not based on a "test set" in the sense of patient data.
• Data provenance: The cadaver validation testing would be considered prospective, as it was conducted specifically for this submission. The engineering analysis is theoretical.

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

This is not applicable. The assessment primarily relied on engineering analysis and cadaver testing, not on expert interpretation of medical images or data from a "test set." The "ground truth" here is the physical performance and safety of the device components, validated by engineering principles and practical demonstration, rather than expert consensus on a diagnosis.

4. Adjudication method for the test set:

Not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic interpretation.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

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

7. The type of ground truth used:

• Engineering analysis: Based on established biomechanical principles and design specifications.
• Cadaver validation: Direct observation of the device's ability to be contoured and implanted.
• Substantial equivalence: Comparison to predicate devices with established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the typical machine learning sense.

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

Not applicable. There is no training set.

Ask a specific question about this device

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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista instruments are intended to be used with Ballista/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

The Polaris Spinal System may be used with the instruments in the Accu Vision 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, 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.

This submission is a line extension to Polaris Spinal System to add the combination of the multiaxial and fixed titanium screws (Ø4.0mm) with the CoCr rods in the system and to update the indications for use for the system.

This 510(k) submission describes a line extension for the Polaris Spinal System and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/algorithm performance.

The document discusses:

• Device Description: The Polaris Spinal System, a non-cervical spinal fixation device, and its indications for use.
• Line Extension: The submission is for adding a combination of multiaxial and fixed titanium screws (Ø4.0mm) with CoCr rods to the existing Polaris Spinal System and updating its indications for use.
• Performance Data: An "engineering analysis" was conducted to determine if a new worst-case construct was created by the new component combination. It concluded that no new worst-case construct was created, and therefore, "additional testing was not required to demonstrate substantial equivalence."
• Substantial Equivalence: The key determination is that the new components are substantially equivalent to previously cleared components within the Polaris Spinal System (K0902033, K091067, and K100220).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating device performance, as this document is a 510(k) for a hardware modification and marketing clearance, not a study evaluating an AI or algorithm's performance. The "performance data" mentioned is an engineering analysis to confirm that new mechanical testing was not needed due to the substantial equivalence of the new components to existing ones.

To answer your specific questions in the context of an AI/algorithm device, I would need a different type of document that describes a clinical or technical study designed to evaluate the performance of such a device.

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