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The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies) 2. Trauma (including fractures) 3. Tumor 4. Spondylolisthesis 5. Spinal stenosis 6. Deformity (i.e., scoliosis, kyphosis, lordosis) 7. Pseudarthrosis 8. Failed previous fusions

The Biolign® Roto-Loc Cervical Plate system consists of cervical plates, locking caps, bone screws and all necessary instrumentation to implant the plate system. The system is manufactured from Titanium 6Al 4V (ISO 5832-3). A screw locking system is incorporated in the plate, allowing the surgeon to insert the screws, and afterwards locking the screws into place with the Biolign® Roto-Loc locking mechanism. This blocks the screw from backing out of the plate. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit to match patient pathology.

This document is a 510(k) summary for the Biolign® Roto-Loc Cervical Plate System. It describes a medical device, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML device performance, ground truth, sample sizes for training/test sets, expert adjudication, and multi-reader multi-case studies are not applicable.

Here's the relevant information from the document:

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

The document does not state specific acceptance criteria in quantitative terms for the mechanical testing results. Instead, it broadly states that "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression bending, and static torsion per ASTM F1717." This implies that the device's performance in these tests met the standards set by ASTM F1717, making it comparable to the predicate device.

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

This information is not provided in the document. The document refers to "mechanical testing" but does not detail the specific sample sizes of components tested or the provenance of any data beyond the manufacturer's location (South Africa).

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 a physical medical device, not an AI/ML system requiring expert-established ground truth for performance evaluation.

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

Not applicable for a physical medical device's mechanical testing.

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 physical medical device, not an AI/ML system.

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

Not applicable. This is a physical medical device.

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

Not explicitly stated in the context of "ground truth" as it applies to software. For a physical device, the "ground truth" for mechanical testing would be the physical properties and behavior of the device under stress, measured against engineering standards (like ASTM F1717).

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

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

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

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The Biolign® Tlif Interbody Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2 - S1). DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of non-operative therapy. The Biolign® TLIF Intervertebral fusion devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach. The Biolign® intervertebral fusion devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine for example posterior pedicle screw and rod systems.

The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems that have been cleared for in the cervical spine, such as Anterior Cervical plating systems.

The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign STACC ACIF system is intended to be used as a stand-alone system using the bone screws provided for fixation. It may also be used with supplemental fixation system that have been cleared for use in the cervical spine, such as cervical plating systems.

The Biolign TLIF device is a slightly curved cage manufactured from Invibio PEEK Optima LT1 with cavities which can be packed with autograft. The cage has tantalum markers which allow accurate and correct placement of the device. The cage is postero-laterally inserted. The cage incorporates a threaded introducer hole on each end and has serrated inferior and superior endplates. It is available in two footprints (30x13mm, and 36x13mm), two lordotic angles (5° and 10°), and a range of heights ranging from 6 - 12mm with 1mm intervals These sizing options allow selection for individual pathology and anatomical conditions. The device is used with supplemental fixation such as screw and rod systems. The Biolign® TLIF system is provided sterile.. The System is single use only.

The Biolign ACIF device is an anatomically correct cage manufactured from Invibio PEEK Optima LT1 with a central cavity which can be packed with autograft. The cage is available in two footprints (15 and 17mm) with a 10° lordotic angle. Cage heights range from 6mm-10mm with 1mm intervals. These sizing options allow selection for individual pathology and anatomical conditions. Tantalum radiographic markers enable clear x-ray control during placement and follow-up. The cage endplates are serrated. The Device is inserted below the anterior surface of the cervical vertebrae. It is used with supplemental cervical plating systems which have prominence from the spine (plate thickness). The Biolign® ACIF system is provided sterile The System is for single use only.

The Biolign® STACC ACIF Interbody Fusion Device is a stand-alone device and does not rely on additional fixation such as cervical plates. The device is an anatomically shaped ring, with a central cavity which can be packed with autograft. It is manufactured of Invibio Peek Optima LT1. Two Tantalum pins are placed in the device to enable radiographic visualization for placement and follow-up evaluations. The superior, and inferior endplates of the device are serrated. Two fixation screws per cage are used as supplemental fixation. These screws are placed into the cage and purchase into the vertebral endplates. The fixation screws are manufactured of Titanium 6Al4V ELI. The footprint of the cage is available in one size (17 x 14mm), and in heights ranging from 5.5 - 9.5mm with 1mm intervals. The cage is available in a domed (superior endplate is domed, and inferior endplate has 3° lordosis angle) and a tapered version (8° lordosis - 4° per endplate) The device is implanted using an anterior approach and after implantation does not stand prominent from the cervical spine. It lies below the anterior surface of the cervical spine. The Biolign® STACC ACIF system is supplied sterile. The System is for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biolign® Intervertebral Body Fusion Systems:

It's important to note that this document is a 510(k) Summary, which demonstrates substantial equivalence to a predicate device, rather than a full pre-market approval (PMA) application that would typically require extensive clinical trials. Therefore, the information regarding "acceptance criteria" and "study" is framed within the context of demonstrating substantial equivalence through non-clinical (bench) testing, rather than clinical efficacy.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their substantial equivalence to predicate devices, specifically in terms of design, function, performance, material, sterilization, and intended use. The key performance criteria are primarily mechanical properties, demonstrated through bench testing.

Study Details

Given this is a 510(k) submission, the "study" primarily refers to non-clinical (bench) testing to demonstrate substantial equivalence, rather than clinical trials.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not specify the exact sample sizes (e.g., number of cages tested) for the bench tests. It refers to "testing performed" as per ASTM standards.
   • Data Provenance: The testing was conducted by Elite Surgical Supplies, which is based in South Africa. The document doesn't specify if the testing was done in South Africa, but it's implied the company managed the tests. The data is retrospective in the sense that it supports an existing product design against established standards.

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

   • Not Applicable. For non-clinical bench testing, "ground truth" is established by adherence to recognized international standards (e.g., ASTM F2077, ASTM F2267) and engineering principles, rather than expert human consensus on image interpretation or pathology results. The "truth" is the measured mechanical property compared against acceptable limits derived from predicate device performance or standard requirements.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data review, especially in cases of conflicting expert opinions on diagnoses or outcomes. For bench testing, the results are quantitative measurements interpreted against pre-defined engineering criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. MRMC studies are clinical studies involving multiple human readers evaluating medical images, often to compare diagnostic accuracy with and without AI assistance. This document explicitly states: "Clinical data and conclusions were not needed for this device."

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

   • No. This device is a physical intervertebral cage, not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of AI does not apply.

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

   • For the non-clinical (bench) testing, the "ground truth" refers to engineering specifications and established biomechanical standards (e.g., ASTM standards). The performance of the predicate device also serves as a comparative "ground truth" for substantial equivalence.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

   • Not Applicable. As there is no training set, there is no ground truth to establish for it.

In summary, the provided document focuses on demonstrating the substantial equivalence of the Biolign® Intervertebral Body Fusion Systems to existing predicate devices through comprehensive non-clinical bench testing. The "acceptance criteria" are intrinsically tied to meeting the mechanical performance characteristics and design specifications comparable to these legally marketed predicate devices, as guided by FDA recommendations and ASTM standards. No clinical studies, expert consensus reviews for ground truth, or AI-specific performance metrics are relevant or discussed in this 510(k) summary.

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The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Removal of the implants after the attainment of a solid fusion is optional.

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.
The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

This document describes a 510(k) premarket notification for the Vertefix® Pedicle Screw Spinal System, seeking to demonstrate substantial equivalence to a predicate device. As such, the study design focuses on comparative performance against the predicate rather than establishing novel acceptance criteria and reporting performance for an AI-powered device.

Therefore, many of the typical questions for AI acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's an attempt to address the relevant points based on the provided text, and explicitly state when information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This is a mechanical device, not an AI/software device that uses "data" in the typical sense for a test set. The "testing" referred to is mechanical testing of physical components (e.g., construct testing per ASTM F1717, thread pullout testing). The sample size for these mechanical tests is not specified 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. Ground truth in the context of an AI device typically refers to clinical diagnosis or outcome verified by experts. For a mechanical implant device, the "ground truth" is defined by established engineering standards (like ASTM F1717) and successful performance in those tests. Expert consensus for clinical diagnosis is not relevant here.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, particularly in clinical assessments where multiple readers might disagree. For mechanical testing against objective standards, adjudication is not a standard practice.

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 mechanical spinal implant system, not a diagnostic or prognostic AI tool that would assist human readers.

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

• Not Applicable. This is a mechanical device. There is no algorithm.

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

• The "ground truth" for this device's performance is established by conformance to recognized industry standards (e.g., ASTM F1717) for mechanical testing and the material specifications (ASTM F136). The equivalence to a predicate device, which has already established safety and efficacy through its own testing and clinical use, serves as the primary benchmark.

8. The sample size for the training set

• Not Applicable / Not Provided. As a mechanical device, there is no "training set" in the computational sense. The design and testing are based on engineering principles and performance standards, not machine learning.

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

• Not Applicable. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Vertefix® Pedicle Screw Spinal System meets its acceptance criteria is primarily a bench-top mechanical evaluation demonstrating substantial equivalence to a legally marketed predicate device.

1. Original System Testing: The original Vertefix® Pedicle Screw Spinal System underwent construct testing according to ASTM F1717. This testing demonstrated "substantial equivalence to the predicate systems and other marketed systems" in terms of mechanical performance.
2. Material Conformance: The components are fabricated from Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136, which establishes material quality and safety.
3. Modified System Justification: For the modified system (with a 5.5mm rod), a full re-test against ASTM F1717 was not performed. The rationale provided was that this change was expected to "perform slightly better than the already tested Vertefix Spinal System." However, thread pullout testing was performed specifically to "prove the thread design" of the modified system.
4. Comparative Analysis: A comparative analysis against various predicates (including the original Vertefix system) was performed, concluding that there are "no significant differences... which would adversely affect the use of the product" in terms of design, function, materials, operational principles, and intended use.

In essence, the "study" for this 510(k) submission is a combination of prior mechanical testing, material standardization, and a reasoned argument supported by specific additional testing (thread pullout) and comparative analysis to demonstrate that the new device is as safe and effective as a legally marketed predicate.

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The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scollosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Removal of the implants after the attainment of a solid fusion is optional.

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.

The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

The provided document is a 510(k) summary for the Vertefix® Pedicle Screw Spinal System, which is a medical device for spinal fixation, not an AI/ML-driven diagnostic or therapeutic device. As such, the concept of "acceptance criteria" based on device performance metrics like sensitivity, specificity, or AUC, and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance, is not applicable here.

Instead, this document describes a traditional medical device submission where "acceptance criteria" would refer to demonstrating substantial equivalence to a legally marketed predicate device through engineering performance testing (e.g., biomechanical testing) and material characterization. The "study" proving acceptance criteria would be these engineering tests.

Here’s an explanation tailored to the information provided for this type of medical device:

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

   Acceptance Criteria	Reported Device Performance
   Demonstration of Substantial Equivalence:	The Vertefix® Pedicle Screw Spinal System was determined to be substantially equivalent to the following predicate devices: OPTIMA™ Spinal System (K051971), Denali™ Spine System (K042635), and XIA™ Spine System Hooks (K001319).
   * Design, Function, Materials, Operational Principles, and Intended Use: No significant differences compared to predicate devices that would adversely affect use.	The device's design, function, materials, operational principles, and intended use were deemed substantially equivalent to the predicate devices and other currently marketed spinal fixation systems.
   * Biomechanical Performance: Compliance with ASTM F1717 for spinal implant constructs.	Biomechanical testing in accordance with ASTM F1717 demonstrated substantial equivalence to the predicate systems and other marketed systems.
   * Material Composition: Fabrication from titanium alloy (Ti-6Al-4v ELI) conforming to ASTM F 136.	Vertefix® Spinal System components are fabricated from titanium alloy (Ti-6Al-4v ELI) that conforms to ASTM F 136.

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 in the context of device performance in biomechanical testing for spinal implants. The "sample size" would refer to the number of test articles (e.g., pedicle screws, rods) subjected to various mechanical loads as per ASTM F1717. This information is typically detailed in the full test reports, which are not part of this 510(k) summary.
   • Data Provenance: Not applicable in the context of biomechanical testing. The tests are conducted under laboratory conditions.

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. Ground truth, in the AI/ML context, does not apply to the biomechanical testing of a spinal implant. The "ground truth" for this device is established by engineering standards (e.g., ASTM F1717) and material specifications.

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

   • Not applicable. Adjudication methods are typically for clinical or interpretation studies, not for the biomechanical assessment of a physical device.

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 would be performed for a spinal fixation system.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • For this device, the "ground truth" for demonstrating safety and effectiveness lies in its adherence to established engineering standards (like ASTM F1717) for biomechanical performance and material standards (like ASTM F136) for material composition, as well as its substantial equivalence in design and intended use to predicate devices already on the market.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

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

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