Search Results
Found 6 results
510(k) Data Aggregation
(162 days)
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-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 (0) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.
The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.
The Zavation IBF implants offers a variety of heights, widths, and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.
VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from Superior Polymers Magnolia PEEK, with tantalum markers, as specified in ASTM F2026 and F560. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The LABYRINTH implants offer a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026). The LABYRINTH implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The LABYRINTH device has a porous structure on the end plate and through the device. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided sterile.
The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The provided text describes several medical devices: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, and Zavation ALIF System. The 510(k) summary indicates that this submission is for the addition of an ion beam assisted deposition (IBAD) Titanium coating to previously cleared PEEK devices. The acceptance criteria and the study to prove the device meets these criteria are focused on the coating properties rather than the overall device performance for fusion, as the underlying PEEK devices were previously cleared.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Property Tested) |
|---|---|
| Not explicitly stated as acceptance criteria, but tested against ASTM standards | Tensile Bond Strength |
| Not explicitly stated as acceptance criteria, but tested against ASTM standards | Static Shear Strength |
| Not explicitly stated as acceptance criteria, but tested against ASTM standards | Shear Fatigue Strength |
| Not explicitly stated as acceptance criteria, but tested against ASTM standards | Tabor Abrasion Test |
Note: The document states "The specifications of the titanium coating are identical to that of the primary predicate device cleared in (K201367)." This implies that the acceptance criteria for these tests would be met if the results are comparable to the predicate device's coating performance. However, specific numerical thresholds for acceptance are not provided in this document. The conclusion states that "substantial equivalence to the cited legally marketed predicate devices" was demonstrated and "any differences between the subject devices and predicate devices do not impact the safety and effectiveness."
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 specify the sample size used for the coating property tests (Tensile Bond Strength, Static Shear Strength, Shear Fatigue Strength, Tabor Abrasion Test). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).
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. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations 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 section is not applicable. The document describes a 510(k) submission for an interbody fusion device with a new coating, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The document describes a medical device (interbody fusion system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the coating properties tests, the "ground truth" would be the established performance standards or specifications defined by the ASTM standards (ASTM F1147, ASTM F1044, ASTM F1160, and ASTM F1978) and the performance of the predicate device's coating (from K201367).
8. The sample size for the training set
This section is not applicable. The document describes bench testing of a medical device coating, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for the described bench tests.
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(278 days)
Zavation IBF System
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of PEEK devices coated with a plasma-spray Titanium coating. The Titanium coated implants will be provided non-sterile.
The provided text is a 510(k) summary for the Zavation IBF System, which is an intervertebral body fusion device.
Crucially, this document is a premarket notification for a medical device (an implant) and not for an AI/ML-based medical device. Therefore, the information requested in the prompt, such as acceptance criteria for AI model performance, sample sizes for test sets, ground truth establishment, MRMC studies, and training set details, is not applicable to this document.
The "Performance Data" section in the document refers to mechanical and material testing of the implant itself, specifically related to the addition of a titanium coating, and not to the performance of an AI algorithm.
To answer your request, if this were an AI device, here's what would be expected based on the prompt's structure:
Based on the provided document, it is not possible to answer the detailed questions regarding acceptance criteria for an AI/ML-based medical device, as this 510(k) pertains to a physical intervertebral body fusion implant, not an AI algorithm.
The "Performance Data" section in the document refers to the mechanical and material performance testing of the implant and its coating, not the performance of an AI algorithm.
If this document were for an AI/ML medical device, the information would typically include:
1. Table of Acceptance Criteria and Reported Device Performance:
This would typically list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, etc., along with the pre-defined target values (acceptance criteria) and the actual achieved performance of the AI model. Since this is a physical device, these metrics are irrelevant.
2. Sample Size and Data Provenance:
For an AI device, this would detail the number of cases (e.g., images, patient records) in the test set, their country of origin, and whether the data was collected retrospectively or prospectively. The current document makes no mention of AI test data.
3. Number of Experts and Qualifications for Ground Truth:
For an AI device, this would specify how many experts (e.g., board-certified radiologists, pathologists) annotated the test data to establish the "ground truth" (the correct diagnosis or finding). It would also detail their experience level. This is not applicable to a physical implant.
4. Adjudication Method for the Test Set:
This would describe how disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if they disagree). This is for AI model validation, not implant testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
If performed for an AI device, this would assess if human performance (e.g., radiologists' accuracy) improved when assisted by the AI compared to working without it. The effect size would quantify this improvement. Not applicable here.
6. Standalone (Algorithm Only) Performance:
This would describe the performance of the AI algorithm operating independently without human intervention. Not applicable here.
7. Type of Ground Truth Used:
For an AI device, this would specify how the "truth" was determined for the test cases (e.g., consensus of multiple experts, pathological confirmation, long-term patient outcomes). For a physical implant, ground truth relates to mechanical properties validated by ASTM standards.
8. Sample Size for the Training Set:
For an AI device, this is the number of data points used to train the algorithm. This is not mentioned as no AI is involved.
9. How Ground Truth for the Training Set was Established:
For an AI device, this would explain the process for labeling the data used to train the model, often involving similar expert annotation or established medical records. This is not applicable to this physical device.
What the document does describe under "Performance Data" (relevant to the physical implant):
The performance data listed relates to biocompatibility and mechanical testing of the Zavation IBF System implants, particularly concerning the addition of a titanium coating. This includes:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices:
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion (cervical)
- Dynamic Torsion (cervical)
- Coating properties evaluated using:
- ASTM F1147 (Tensile Bond Strength)
- ASTM F1044 (Shear Fatigue Strength)
- ASTM F1160 (Static Shear Strength)
- ASTM F1854 (Abrasion Test)
- ASTM F1978 (Metallurgical Testing and Image Analysis)
The document states that "no additional testing was performed for the purpose of this submission" because the new titanium coating's specifications were identical to an already cleared predicate device (K150061 Lucent Ti-Bond®), and the original Zavation IBF System (K181246) had already undergone the listed ASTM tests. This implies that the acceptance criteria for this modification were met by demonstrating equivalence to previously cleared devices through adherence to established ASTM standards for intervertebral body fusion devices and their coatings.
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(60 days)
Zavation IBF System
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of porous PEEK cervical devices. The implants will be provided sterile and non-sterile.
The provided text does not describe an AI/ML device, therefore, the requested information about acceptance criteria and study details for such a device is not present.
The document is a 510(k) premarket notification clearance letter from the FDA for the "Zavation IBF System," which is an intervertebral body fusion device. This type of device is a physical implant used in spinal surgery, not an AI/ML-driven software or diagnostic tool.
The "Performance Data" section mentions testing against ASTM standards (e.g., Static Axial Compression, Dynamic Axial Compression, Static Torsion, Dynamic Torsion, Subsidence, Expulsion). These are mechanical and physical performance tests relevant to an implantable device, not performance metrics for an AI/ML model.
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(61 days)
Zavation IBF System
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine. from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
This document is an FDA 510(k) summary for the Zavation IBF System. It states that the submission is for the "Addition of sterile packaged implants and instruments", and that "Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device." Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance tests. Instead, it relies on the substantial equivalence to a predicate device.
Given that, I cannot fulfill your request for the information outlined in your prompt as it is not present in the provided text.
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(30 days)
ZAVATION IBF SYSTEM
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new worst-case device. | Finite element analysis demonstrated that added components would not result in a new worst-case device. |
| Substantial equivalence to predicate devices (K112664 and K091088). | Results from finite element analysis demonstrated that the subject devices are substantially equivalent to the referenced predicates. |
| Compliance with ASTM F2077 (for FEA validation). | Finite element analysis method has been validated to testing performed per ASTM F2077. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a test set in the traditional sense of a clinical or observational study with human participants. The "test" here refers to the validation of a computational method.
- Sample size for the test set: Not applicable, as detailed above.
- Data provenance: Not applicable. The "study" is a finite element analysis, meaning it's a computational simulation rather than an empirical study gathering data from a specific population or geographic region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There's no mention of experts establishing ground truth for a test set in this context.
- Ground truth in this study: The "ground truth" for the finite element analysis (FEA) is the established engineering principles and material properties used in the simulation, and its validation against testing performed per ASTM F2077. This is a technical standard rather than an expert consensus.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission concerns an intervertebral body fusion device, not an AI-powered diagnostic or interpretive system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this engineering analysis is based on established engineering principles, material properties (PEEK Zeniva ZA-500, Tantalum alloy), and validation against a recognized industry standard (ASTM F2077). It is not an expert consensus, pathology, or outcomes data in the biological sense. The outcome of the FEA is whether the new configurations maintain mechanical integrity and don't create a "new worst-case device" compared to the predicates.
8. The Sample Size for the Training Set
Not applicable. This is an engineering analysis of a physical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set in this context.
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(101 days)
ZAVATION IBF SYSTEMS
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
The provided text describes a medical device, the Zavation IBF System, and its acceptance criteria as demonstrated through performance data. However, it does not describe a study involving an AI/algorithmic device or its performance against ground truth established by experts.
The "Performance Data" section specifically states: "Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed."
This indicates that the study performed was a mechanical test of the physical implant device, not a study evaluating an AI algorithm's diagnostic or predictive performance. Therefore, most of the requested information regarding AI device performance (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) cannot be extracted from this document because it is not relevant to the described studies.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance (Mechanical Testing)
| Acceptance Criteria (What was tested) | Reported Device Performance (How it met the criteria) |
|---|---|
| Static Axial Compression | Met criteria demonstrating substantial equivalence to predicate devices. |
| Dynamic Axial Compression | Met criteria demonstrating substantial equivalence to predicate devices. |
| Subsidence | Met criteria demonstrating substantial equivalence to predicate devices. |
| Expulsion | Met criteria demonstrating substantial equivalence to predicate devices. |
| Compliance with ASTM F2077 | Testing performed in accordance with this standard. |
| Compliance with ASTM F2267 | Testing performed in accordance with this standard. |
Explanation of Missing Information for AI/Algorithmic Devices:
- Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing of a physical implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
- Adjudication method for the test set: Not applicable.
- 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 document is not about an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties and performance standards (like ASTM F2077 and F2267) which the device must meet or exceed, or demonstrate equivalence to predicate devices.
- The sample size for the training set: Not applicable. (No AI training set.)
- How the ground truth for the training set was established: Not applicable. (No AI training set.)
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