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The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft and the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. The implants in this system are made of PEEK-OPTIMA®, Tantalum, and Titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy.

The Alta ACDF System is intended for stand-alone use in cervical intervertebral body fusion and must be used with the titanium alloy screws which accompany the implant.

This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the Alta ACDF System.

This document describes the 510(k) premarket notification for the "Alta ACDF System" which is an intervertebral body fusion device. The purpose of this submission is to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the existing Alta ACDF System.

Based on the provided text, there is no acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a performance study for a new device or software. This submission is for an expanded indication for an existing device.

Here's why and what information is available:

This is not a submission for a new device requiring performance metrics against acceptance criteria. The "Alta ACDF System" itself was previously cleared (K112388). This 510(k) (K152622) is specifically to expand the indications for use to include allograft as a bone graft material.

Therefore, the submission states:

• "The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices."
• "No changes are being made to the existing device as subject of this Premarket Notification, aside from the expanded indications; therefore, no additional testing was required or performed."

Instead of a new performance study with acceptance criteria, the manufacturer relies on demonstrating substantial equivalence to predicate devices and referencing published clinical data to support the safety and effectiveness of using allograft in similar devices.

However, I can extract information related to the rationale for the expanded indications:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
There was no dedicated "test set" for this submission as no new testing was performed on the device. Instead, the submission relies on "Published retrospective clinical data for cervical interbody fusion devices similar to the subject device." The specific sample size, country of origin, or how individual data points were selected from this published literature is not detailed in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set or ground truth established by experts for a performance study. Clinical outcomes were drawn from published retrospective data.

4. Adjudication method for the test set:
Not applicable. No new test set requiring adjudication was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a spinal implant device, not an AI or imaging device involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a spinal implant device, not an algorithm.

7. The type of ground truth used:
For the expanded indication, the "ground truth" (or supporting evidence) for the safety and effectiveness of allograft in cervical fusion is based on published clinical outcomes from retrospective studies of similar cervical interbody fusion devices.

8. The sample size for the training set:
Not applicable. No training set was used as this involved no new performance study or algorithm training.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

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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:

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.

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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.

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When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.

When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.

The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft. Furthermore, the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. All implants in these systems are made of PEEK-OPTIMA®, tantalum, and titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Solitaire-C spacer is a stand-alone device that must be implanted with the Solitaire-C titanium screws that are part of the system.

The Solitaire®-C Cervical Spacer System and C-Thru™ Anterior Spinal System implants are offered in sterile packed versions while the Breckenridge® Small Intervertebral Body Fusion is packaged non-sterile, to be sterilized by the end user.

This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the aforementioned cervical intervertebral body PEEK spacer systems (both stand-alone devices and devices which require supplemental fixation).

The provided text is a 510(k) summary for medical devices (cervical intervertebral body fusion systems) and does not describe acceptance criteria for device performance in the context of an AI/ML algorithm or a study that evaluates such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for expanded indications related to bone graft types.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC/standalone studies is not present in the document.

The document states:

• "The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices."
• "Published retrospective clinical data for cervical interbody fusion devices similar to the subject devices was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes were made to the existing devices; therefore, no additional testing was required or performed."

This indicates that no new performance studies (clinical or non-clinical) were conducted for the purpose of this 510(k) submission, as the submission primarily pertains to expanding the indications for use of existing devices to include allograft. Therefore, there are no specific device performance metrics or acceptance criteria presented in the context of a new study on the device's efficacy or safety.

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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.

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The Lineum OCT Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lineum OCT Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

The Lineum OCT Spine System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusions. The system can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The implants are designed for the occiput, cervical, and/or upper thoracic spine (Occiput – T3) and consist of medical grade titanium alloy and CoCrMo alloy, similar to the predicate device.

The provided document is a 510(k) premarket notification summary for a medical device called the "Lineum OCT Spine System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data focusing on mechanical and material properties, rather than clinical efficacy studies often seen with AI/ML devices. As such, the information required for a detailed AI/ML device study description (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

The document discusses mechanical performance data, not AI/ML algorithm performance. Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets them, sample sizes for AI/ML tests, ground truth details, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission.

Here's what the document does provide regarding performance data:

Performance Data (Mechanical)

Study Details (Mechanical Testing):

• Study Type: Non-clinical mechanical construct and component testing.
• Standards Used: Based on ASTM F2706 (Standard Test Method for Static and Fatigue Testing of a Spinal Orthosis for the Occiput-Cervical-Thoracic Spine) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Anterolateral Cervical Spine Fusion Constructs).
• Purpose: To support the substantial equivalence of the modified Lineum OCT Spine System to its predicate device.
• Conclusion: The mechanical testing provided demonstrates the substantial equivalence of the subject Lineum OCT Spine System.

Missing Information (Not applicable to this type of device submission):

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective or prospective) for an AI/ML algorithm.
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with/without AI assistance.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML algorithm.
• Sample size for the training set (for an AI/ML algorithm).
• How the ground truth for the training set was established (for an AI/ML algorithm).

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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.

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The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.

The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.

The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.

Here's a breakdown of the acceptance criteria and the study details for the MaxAn® Anterior Cervical Plate System, based on the provided text:

Important Note: The provided document is a 510(k) summary for adding MR Conditional labeling to an already cleared device (MaxAn® Anterior Cervical Plate System). Therefore, the "study" described herein specifically pertains to MR compatibility, not the primary clinical effectiveness or safety of the spinal fixation itself, which would have been established in the original K080646 submission. The information below reflects what's available in this specific document.

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 specified in this 510(k) summary. The document refers to "testing conducted" according to ASTM standards, which would imply a number of device samples were used for each test. Specific quantities are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is bench testing (mechanical and MR compatibility), not human or animal studies, so "retrospective or prospective" is not applicable in the typical clinical sense. The tests were performed to evaluate the physical properties of the device components.

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

• This information is not applicable as the "ground truth" for these tests is the direct measurement of physical properties against established ASTM standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and technicians executing the tests and interpreting the raw data, but their number and specific qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

• This is not applicable. As these are bench tests measuring physical properties, there is no "adjudication method" in the sense of reconciling differing expert opinions. The outcome is determined by whether the measured physical property (e.g., heating, displacement) falls within the acceptable limits defined by the ASTM standard.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. This submission pertains to MR Conditional labeling for a device, which involves bench testing, not clinical performance comparison with human readers.

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

• This is not applicable. The device is a physical spinal implant, not an algorithm or AI system. The testing performed is to assess the physical device's compatibility with an MRI environment.

7. Type of Ground Truth Used

• The "ground truth" used for these tests is the objective measurements of physical forces, temperatures, and image artifacts as defined and evaluated against the specified ASTM (American Society for Testing and Materials) standards. These standards provide the accepted methodology and limits for determining MR compatibility and mechanical performance.

8. Sample Size for the Training Set

• This is not applicable. The device is a physical implant, not an AI model requiring a training set.

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

• This is not applicable for the same reason as point 8.

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When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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 spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had at least six weeks of non-operative treatment. The Biomet Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") 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). Implants with 20 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.

When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Biomet Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Biomet Fusion System implants consist of a spacer body with screws for additional fixation. The Biomet Fusion System the spacer body is made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-C,Hz-O-C,Hz-O-C,Hz-CO-). The Biomet Fusion System implants include an anterior plate and screws made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136-08 and ISO 5832-3. The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Biomet Fusion System is provided non-sterile.

The implants included in this application are intended for us in lumbar intervertebral body fusion. The implants have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of each implant have a series of transverse grooves formed to improve stability and fixation once the device is inserted.

The purpose of this 510(k) Notification is to seek clearance for a modification to the Lanx Fusion System, for additional configurations. The new implants are also referred to as the Biomet Fusion System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Fusion System, broken down by your requested categories:

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

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

The document does not explicitly state the sample sizes for the mechanical tests. For the cadaveric study, the sample size is not specified. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.

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)

This section is not applicable as the studies were primarily mechanical and cadaveric performance tests, not studies requiring expert interpretation of diagnostic images or clinical outcomes.

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

Not applicable for mechanical and cadaveric performance tests. The "ground truth" for these tests is determined by the physical properties and behavior of the device under specific, standardized conditions.

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 such study was conducted or mentioned in this document. This is a medical device (spinal implant) and the performance evaluation focuses on its mechanical properties and functionality, not diagnostic interpretation by human readers with or without AI assistance.

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

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

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

For the mechanical tests, the "ground truth" is defined by the acceptance criteria of the relevant ASTM standards. For the cadaveric study, the "ground truth" would be the observed physical performance and stability of the device within the cadaveric specimens, measured against pre-defined performance metrics (though these specific metrics are not detailed in the summary).

8. The sample size for the training set

This is not applicable as the Biomet Fusion System is a physical medical device undergoing mechanical and cadaveric testing, not an AI or algorithm that requires a training set.

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

Not applicable for the same reasons as point 8.

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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.

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