Search Results

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement

The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.

This document describes a 510(k) premarket notification for the Biomet Spine Fusion System. The submission is to add a tantalum marker to the cam locking mechanism of the existing device. This is a modification to an existing device, not a new AI/ML-enabled device, and therefore does not include the detailed performance study information typically associated with AI/ML device submissions.

Here's a breakdown of the information provided, tailored to the requested categories where applicable:

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

Mechanical testing on the predicate device (K151483) was conducted and demonstrated substantial equivalence to its own predicate devices. |
| Safety and Effectiveness: The modifications should not raise new safety or performance questions. | The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions. The minor differences in the new components (tantalum marker) do not raise any new issues of safety or effectiveness. |
| Intended Use & Indications for Use: Maintain the same intended use and indications for use as the predicate. | The modified Biomet Spine Fusion System implants included in this submission have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Biomet Spine Fusion System (K151483). |

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: Not applicable. For this specific 510(k) submission, there isn't a "test set" in the context of clinical data for an AI/ML device. The evaluation was primarily engineering analysis and mechanical testing comparison to a predicate device.
• Data Provenance: Not applicable. The "data" here refers to mechanical testing results and engineering analysis, not patient data.

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

• Not applicable. This is not an AI/ML device requiring expert ground truth for image or clinical interpretation. The evaluation was based on engineering and mechanical testing standards.

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

• Not applicable. As above, there is no "test set" in the sense of clinical data 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 is not an AI/ML device.

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 (expert consensus, pathology, outcomes data, etc):

• For the predicate device's mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267) and the performance criteria outlined in FDA guidances (Spinal System 510(k)s, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device). For the current submission, the ground truth is simply the established safety and performance of the predicate device (K151483) against which the minor modification is compared via engineering analysis.

8. The sample size for the training set:

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

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

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

In summary, this 510(k) is for a minor modification (adding a tantalum marker) to an existing, previously cleared spinal fusion device. The "study" proving the device meets acceptance criteria is an engineering analysis, which determined that the modification did not alter the mechanical performance or safety/effectiveness of the device and thus no new mechanical testing or clinical studies were required beyond what was done for the original predicate device.

Ask a specific question about this device

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement.

The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.

The provided document describes a 510(k) premarket notification for the Biomet Spine Fusion System, indicating it is a medical device submission to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this type of regulatory submission. The performance assessment here is primarily based on mechanical testing, not human reader performance or clinical outcomes.

Here's the information that can be extracted and a clear statement about what is not available based on the provided text:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics in a clinical context. Instead, it states that:

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

• Sample Size for Test Set: Not applicable in the context of this mechanical testing study. The performance data refers to results from physical tests of the device components.
• Data Provenance: Not applicable. The data is generated from mechanical testing of the device components, not from patient data, and thus does not have a country of origin or a retrospective/prospective classification in the typical sense of a clinical study.

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 this context, would relate to clinical outcomes or expert diagnoses, which are not part of this mechanical testing. The "ground truth" for mechanical testing would be the established engineering specifications and performance limits of the predicate device.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for clinical trials or studies involving expert assessment, which is not described here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical intervertebral body fusion device and does not involve AI or human image readers.

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

No, a standalone (algorithm-only) performance evaluation was not done. This device is a physical implant, not a software algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" is established by engineering safety and performance standards (e.g., ASTM F2077, ASTM F2267) and the performance specifications of the legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties are equivalent to or better than those of the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set. The "training" in product development for such a device refers to engineering design and testing iterative processes, not data training.

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

Not applicable, as there is no training set in the context of machine learning. The design and testing of the device are based on established engineering principles, material science, and regulatory guidance for spinal implants.

Ask a specific question about this device

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System ("Biomet Spine Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement

The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The Biomet Spine Fusion System is intended to be sterile.

This document describes the Biomet Spine Fusion System, an intervertebral body fusion device. The provided text is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study.

Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and training set information) are not available from this regulatory submission. This document primarily details mechanical testing and comparison to predicate devices.

Here's a breakdown of the information that is available and what is not available based on the provided text:

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

Note: The specific numerical acceptance criteria for "met or exceeded predicate device performance" are not provided in this document.

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

• Sample Size: Not applicable. The "tests" mentioned are mechanical performance tests of the device itself, not clinical trials on patient data.
• Data Provenance: Not applicable. These are laboratory mechanical tests on the device.

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

• Not applicable. Ground truth as typically understood in a clinical study (e.g., diagnosis, outcome) is not relevant for the mechanical tests described.

4. Adjudication method for the test set

• Not applicable. Mechanical tests do not involve adjudication by experts.

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 MRMC comparative effectiveness study was done. This device is an intervertebral body fusion system, not an AI or imaging diagnostic tool.

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

• Not applicable. This is a medical implant, not an algorithm. The performance tests are for the physical device.

7. The type of ground truth used

• Not applicable in the clinical sense. For mechanical tests, the "ground truth" would be the engineering specifications and performance benchmarks derived from the relevant ASTM standards and predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

• Not applicable.

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