Search Results

When used as a lumbar intervertebral body fusion device, the Zavation Ti3Z Interbody implants are indicated for spinal fusion procedures to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The 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 Ti3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.

The Zavation Ti3Z Lumbar Interbody System implants are offered in five main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF with the choice of two different material options, allowing for multiple surgical technique options. Ti3Z Lumbar implants are additively manufactured from medical grade Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK Lumbar implants have an exterior that is manufactured from medical grade PEEK (polyethetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.

The Zavation Ti3Z Lumbar Interbody implants are available in a range of heights, widths, and lengths as well as parallel and lordotic angled implants, to accommodate variations in patient's anatomy. The internal body of the implants have a porous structure wile the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. All implants will be provided sterile.

The provided text is a 510(k) summary for the Zavation Ti3Z Lumbar Interbody System, which is a medical device for spinal fusion procedures. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria for a novel device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, and specific performance metrics like AI-assisted improvements are not present in this type of regulatory submission. This document aims to show that the new device (Ti3Z-PEEK Lumbar Interbody device, an addition to the existing system) is as safe and effective as existing legally marketed devices, primarily through mechanical testing and comparison of technological characteristics.

However, I can extract information related to the performance data mentioned:

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

The document does not explicitly state "acceptance criteria" with numerical values or specific thresholds that the device had to meet beyond demonstrating "substantial equivalence." The performance data section primarily lists the types of mechanical tests performed and the conclusion that the results "demonstrated that the Zavation Ti3Z-PEEK Lumbar spacer is substantially equivalent to the predicate devices."

• Static Axial Compression
• Dynamic Axial Compression
• Static Compression Shear
• Dynamic Compression Shear
• Static Torsion
• Subsidence
• Expulsion | "Mechanical test results demonstrated that the Zavation Ti3Z-PEEK Lumbar spacer is substantially equivalent to the predicate devices." |
  | Freedom from contaminants and adequate cleaning process in accordance with ASTM F 2847-10 components and ISO 10993-5:2009 for cytotoxicity. Includes:
• Gravimetric Analysis (ASTM F 2459-12)
• Cytotoxicity (ISO 10993-5: 2009)
• Total Organic Carbon
• Limulus Amebocyte Lysate (LAL) (Endotoxin) | "Process Validation test results demonstrate that the Zavation Ti3Z Lumbar Interbody System (...), Ti3Z Cervical Interbody System (...), and Zavation IBF System (...) are free from any possible contaminants and the cleaning process is adequate for implants to be provided sterile."
  "The Zavation TI3Z-PEEK Lumbar spacers' manufacturing, post processing, cleaning, sterilization, and packaging are identical to that of the Zavation IBF System (...), Zavation Ti3Z Cervical System (...), and Zavation Ti3Z Lumbar System (...) and fall under current validated procedures." |

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

The document does not specify the sample size for the mechanical tests. The data provenance is derived from mechanical testing performed internally (by Zavation Medical Products, LLC) to support the regulatory submission. It is not patient data or clinical trial data.

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 to mechanical performance testing of an implant device. "Ground truth" in this context would refer to the physical and chemical properties measured by standard testing methods. The "experts" would be the personnel performing the tests according to the ASTM and ISO standards, but their qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. Mechanical testing involves objective measurements rather than subjective interpretation requiring adjudication among multiple parties.

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-powered diagnostic or assistive tool.

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

Not applicable. This is a spinal implant device.

7. The type of ground truth used

For mechanical performance, the "ground truth" is established by standardized laboratory test methods (ASTM F2077, ASTM F 2847-10, ASTM F 2459-12, ISO 10993-5: 2009) that measure physical and chemical properties of the device.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for mechanical performance evaluation of a medical implant as described in this 510(k) summary. This is not a machine learning or AI device.

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

Not applicable, as there is no training set mentioned or implied.

Ask a specific question about this device

When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System 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 Ti3Z cervical 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.

For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.

The Zavation Ti3Z Cervical Interbody System implants are offered in two configurations: Ti3Z cervical implants are additively manufactured entirely from medical grade Titanium Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK cervical implants have an exterior that is manufactured from medical grade PEEK (polyetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001) and a wrought titanium pin (ASTM F136). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.

The Zavation Ti 3Z Cervical and Ti3Z-PEEK Cervical Interbody implants are available in a range of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of both constructs have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of the Ti3Z cervical implant are printed simultaneously. This modification seeks clearance for the addition of Ti3Z-PEEK cervical spacers. All implants will be provided sterile.

The provided text is a 510(k) premarket notification for a medical device, the Zavation Ti3Z Cervical Interbody System, specifically for the addition of a Ti3Z-PEEK cervical implant. It outlines the device description, intended use, materials, predicate devices, and performance data.

However, the questions you've asked are typically related to the performance evaluation of AI/ML-driven medical devices, often involving studies to assess diagnostic accuracy or clinical utility. The document describes a physical implantable device (intervertebral body fusion device) and its mechanical and manufacturing process validation.

Therefore, the provided document does not contain the information requested in your questions related to AI device performance evaluation. There is no mention of:

• AI/ML algorithms
• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Test sets, ground truth establishment by experts, or adjudication methods for AI
• Multi-reader multi-case (MRMC) studies for AI assistance
• Standalone algorithm performance
• Training sets for AI

The "Performance Data" section in the document refers to mechanical testing (e.g., ASTM F2077 for static/dynamic axial compression, torsion, shear; ASTM F2267 for subsidence/expulsion) and process validation (e.g., ASTM F 2847-10 for residues, cytotoxicity, TOC, LAL for contaminants). These are standard tests for spinal implants to demonstrate their structural integrity and biocompatibility, not for evaluating the diagnostic or assistive accuracy of an AI system.

In summary, the document details the regulatory submission for a physical medical implant and its mechanical and manufacturing properties, not an AI-powered device. Thus, it cannot provide answers to your specific questions about AI device acceptance criteria and performance studies.

Ask a specific question about this device

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.

Ask a specific question about this device

When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The 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.

For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.

The Zavation Ti 3Z Cervical Interbody implants offer a variety of heights, widths and lengths in the CIF configuration. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.

The Zavation Ti 3Z Cervical Interbody implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of the implants have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of each implant are printed simultaneously.

The provided text is a 510(k) summary for a medical device called the "Ti 3Z Cervical Interbody System." This document describes the device, its intended use, materials, and testing conducted to demonstrate its substantial equivalence to previously cleared predicate devices.

However, this document does not contain any information about a study that proves the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies (MRMC), or a comprehensive evaluation against specific diagnostic performance metrics (like sensitivity, specificity, etc.).

The "Performance Data" section of the document solely focuses on:

• Mechanical Testing: Demonstrating structural integrity and durability in accordance with ASTM F2077 (Static/Dynamic Axial Compression, Torsion, Subsidence, Expulsion). This is standard for implantable devices to ensure they can withstand physiological loads.
• Process Validation Testing: Ensuring the manufacturing process results in clean, sterile implants (ASTM F 2847-10, Gravimetric Analysis, Cytotoxicity, TOC, LAL). This is crucial for patient safety regarding biocompatibility and infection control.

The device described is a physical implant (intervertebral body fusion device) and not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training/test set details are not applicable to this specific 510(k) submission.

In summary, based on the provided document, there is no information available to answer the specific questions about acceptance criteria and study designs related to an AI/algorithm-driven device. The document is for a physical medical implant, and its "acceptance criteria" are based on mechanical and material biocompatibility standards, not diagnostic or AI performance.

Ask a specific question about this device