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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.

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