(198 days)
When used as a lumbar intervertebral body fusion device, the Zavation Ti 3Z Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients 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 Ti 3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.
The Zavation Ti 3Z Interbody implants offer a variety of heights, widths and lengths. There are five main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF. The different configurations allow for multiple surgical technique options. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.
The Zavation Ti 3Z 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.
This is a 510(k) summary for a medical device called "Ti 3Z Interbody System". This document does not contain information about an AI/ML device or software. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device cannot be extracted from the provided text.
The document discusses the substantial equivalence of the Ti 3Z Interbody System to predicate devices based on mechanical test results and process validation.
Here's what the document does provide regarding performance data and equivalence for this medical device, which is not an AI/ML system:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table with specific acceptance criteria and detailed performance results in the format requested for AI/ML. Instead, it states that "Mechanical test results demonstrated that the Zavation Ti 3Z Interbody System is substantially equivalent to the predicate devices." and lists the standards followed:
| Test Type | Standard Followed | Outcome |
|---|---|---|
| Static Axial Compression | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Dynamic Axial Compression | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Static Compression Shear | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Dynamic Compression Shear | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Static Torsion | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Subsidence | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Expulsion | ASTM F2077, Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices |
| Gravimetric Analysis | ASTM F 2847-10 (Reporting Assessment of Residues on Single Use Implants), ASTM F 2459-12 | Demonstrated freedom from possible contaminants; cleaning process adequate |
| Cytotoxicity | ISO 10993-5: 2009 | Demonstrated freedom from possible contaminants; cleaning process adequate |
| Total Organic Carbon | (Part of cleaning process validation) | Demonstrated freedom from possible contaminants; cleaning process adequate |
| Limulus Amebocyte Lysate (LAL) (Endotoxin) | (Part of cleaning process validation) | Demonstrated freedom from possible contaminants; cleaning process adequate |
2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device study. The "test set" would refer to physical devices tested, but specific quantities are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device study. Ground truth in this context would refer to material science and mechanical engineering standards.
4. Adjudication method: Not applicable as this is not an AI/ML device study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is not an AI/ML device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device study.
7. The type of ground truth used: For mechanical tests, the "ground truth" is established by the specified ASTM and ISO standards for mechanical properties and biocompatibility.
8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device study.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.