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The Innovasis Px HA™ PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px HA implant is intended to be packed with autograft.

The Innovasis Px HA™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Implants are manufactured by Innovasis from Invibio® PEEK-OPTIMA® HA Enhanced*. Hydroxyapatite (HA) is fully integrated into the PEEK-OPTIMA. The device is radiolucent allowing straightforward assessment of the fusion process, while tantalum spheres are located around the periphery of the device to allow implant visualization during and after surgery.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays.

The provided document is a 510(k) summary for the Innovasis Px HA™ PEEK IBF System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a novel artificial intelligence/machine learning device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. The document primarily discusses the non-clinical performance testing of the physical device.

Here's the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a numerical or categorical format for a defined study endpoint. Instead, it states that "Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the Px HA PEEK IBF is capable of performing in accordance with its intended use." It implies that meeting the standards of these ASTM tests demonstrates acceptable performance. However, specific numerical thresholds or target performance metrics are not listed.

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

• Sample Size for Test Set: Not specified. The document mentions "Performance testing" on "devices" and "new and artificially aged devices" but does not provide specific sample quantities used for these tests.
• Data Provenance: Not applicable in the context of clinical data. The performance tests are stated as non-clinical, likely mechanical and material testing conducted in a lab environment.

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

This information is not applicable. The ground truth for this device is based on standardized mechanical testing performed in a laboratory, not on expert interpretations of medical data.

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

This information is not applicable, as the evaluation is based on objective mechanical tests, not subjective interpretations 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:

This information is not applicable, as this document is not about an AI device.

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

This information is not applicable, as this document is not about an AI device.

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

The ground truth for the non-clinical performance tests is based on established engineering and material science standards (ASTM F2077-11, ASTM F2267-04, ASTM F560-13, ASTM F983-86, ASTM F2026-14, ISO 17665-1:2006). These standards define the methodologies and expected performance characteristics for intervertebral body fusion devices.

8. The sample size for the training set:

This information is not applicable, as this document is not about an AI device.

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

This information is not applicable, as this document is not about an AI device.

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CERVICAL INTERBODY FUSION DEVICE

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.

LUMBAR INTERBODY FUSION DEVICE

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

VERTEBRAL BODY REPLACEMENT

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (TI-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. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of TI-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique.

This document is a 510(k) premarket notification for the "Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System". It concerns the clearance for the use of allogenic bone graft with the existing C-Plus cervical intervertebral body fusion device.

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

This document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, the basis for clearance is substantial equivalence to a predicate device (Pioneer IBF/VBR System K133455) and a literature analysis. The "performance" in this context refers to demonstrating that the expanded indication (use of allogenic bone graft) poses no new risks and is equivalent to the established performance with autogenous bone graft.

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

• Sample size for the test set: Not applicable and not explicitly stated. The submission relies on a "literature analysis of published clinical data" rather than a new test set generated for this 510(k). The literature analysis would have encompassed various studies, each with its own sample size.
• Data provenance: Not specified in terms of country of origin or whether the individual studies in the literature analysis were retrospective or prospective. The submission only states it's "published clinical 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 submission relies on a literature analysis, not a new study with a ground truth established by experts specifically for this submission. The "ground truth" (clinical outcomes) would have been established within the original published studies by the researchers and clinicians involved.

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

Not applicable. No new test set or adjudication process was performed for this 510(k) submission.

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/imaging device.

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 AI/imaging device.

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

The "ground truth" implicitly referred to in the literature analysis would be the clinical outcomes data from previously published studies on cervical interbody fusion devices using allogenic bone graft. This would include fusion rates, pain reduction, adverse events, etc.

8. The sample size for the training set

Not applicable. No new algorithm or model was trained for this submission. The device is a physical implant.

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

Not applicable. No new algorithm or model was trained for this submission.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the Mecta-C Intervertebral Body Fusion Device. This type of submission relies on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies with human participants or AI performance metrics. Therefore, many of the requested criteria related to studies involving AI, human readers, ground truth establishment for clinical data, and specific sample sizes for training/test sets are not applicable to this document.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The Mecta-C device aims to demonstrate "similar" or "substantially equivalent" mechanical performance according to specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of mechanical performance tests conducted according to established ASTM standards. These tests compare the Mecta-C Intervertebral Body Fusion Device to identified predicate devices (Vu cPOD and Bengal Cage).

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

• Sample Size for Test Set: The document does not specify the exact number of Mecta-C devices or predicate devices used in each mechanical test. Mechanical testing typically involves multiple samples (e.g., 5-10 per test condition) to ensure statistical significance, but these details are not provided in this 510(k) summary.
• Data Provenance: The data provenance is from mechanical laboratory testing, not human or clinical data. The tests were performed to ASTM standards, which are international standards. The country where the testing took place is not explicitly stated, but Medacta International SA is based in Switzerland and Medacta USA is in California.

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

• Not Applicable. For mechanical testing of medical devices, "ground truth" is established by the physical properties and performance characteristics of the predicate devices and the specifications of the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's ambiguity in human interpretation of data. For mechanical tests, the results are quantitative measurements against predefined criteria in the ASTM standards.

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

• No. This is a mechanical device submission, not an AI or imaging diagnostic device. MRMC studies analyze human reader performance, often in conjunction with AI.

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

• No. This refers to AI algorithm performance. This submission is for a physical implantable device.

7. The Type of Ground Truth Used:

• Objective Mechanical Performance Data: The "ground truth" in this context is the quantitative mechanical performance data obtained from testing both the Mecta-C device and the predicate devices according to established ASTM standards (ASTM F2077 for various compression/shear/torsion tests and ASTM F2267 for subsidence). The FDA's acceptance of "substantial equivalence" relies on the Mecta-C device's performance falling within acceptable limits relative to these predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence. This concept applies to machine learning algorithms.

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

• Not Applicable. See point 8.

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The FORZATM Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZATM Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix Inc. Firebird™ Pedicle Screw System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.

The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F-2026 with Tantalum markers as described by ASTM F-560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, Tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The implants are offered in two geometric shapes: straight and curved, and offered in lordotic profiles to restore the natural curvature of the spine. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with supplemental fixation system. The FORZATM Spacer System implants are provided sterile. The FORZATM Spacer System trials and instruments are provided non-sterile.

The Orthofix Inc. FORZA™ Spacer System is an intervertebral body fusion device. The acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical mechanical testing.
• Sample Size for Test Set: Not explicitly stated as a number of devices/implants, but it refers to "mechanical testing of the Orthofix Inc. FORZATM Spacer System." The testing was conducted "in accordance to ASTM F2077-03 standard for Static & Dynamic Compression testing and ASTM F2267-04 standards for Subsidence testing." ASTM standards typically specify the number of samples required for such tests.
• Data Provenance: The data is generated from laboratory mechanical testing of the device itself. It is not patient data, thus, country of origin or retrospective/prospective designation are not applicable in this context.

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

• This information is not applicable as the ground truth for mechanical testing is established by adherence to universally accepted engineering standards (ASTM F2077-03 and ASTM F2267-04) and the physical properties of the materials and device design, not by expert human interpretation of medical data.

4. Adjudication Method for the Test Set

• This information is not applicable as the test set involves mechanical engineering tests against objective standards, not interpretation by human adjudicators.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intervertebral spacer) and relies on mechanical testing and comparison to predicate devices, not on a study with human readers interpreting imaging or clinical outcomes.

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

• This information is not applicable. This device is a physical implant, not an algorithm or a software device. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.

7. The Type of Ground Truth Used

• The ground truth for the mechanical performance testing is established by objective engineering standards and specifications. Specifically, the device's performance was compared against the requirements and methodologies outlined in:
  • ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) for Static and Dynamic Compression.
  • ASTM F2267-04 (Standard Test Method for Measuring the Compressive Properties of PEEK and Tantalum Markers) for Subsidence.
  • The "ground truth" for substantial equivalence is also derived from the established characteristics and performance of the identified predicate devices.

8. The Sample Size for the Training Set

• This information is not applicable as there is no "training set" in the context of a physical medical device submission based on mechanical testing and predicate device comparison. Device design and manufacturing processes are iteratively developed, but this is not analogous to an AI training set.

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

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

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