(91 days)
The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand PLIF 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 nonoperative treatment.
The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
The Zavation eZspand™ Interbody System devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
This document is a 510(k) Premarket Notification for a medical device called the "Zavation eZspand™ Interbody System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. As such, it does not typically involve the type of detailed acceptance criteria and clinical study data that would be used for a new medical AI device.
Therefore, many of the requested categories for AI device evaluation (such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this document.
However, I can extract the information that is available about the device's performance evaluation against established standards.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Testing | ASTM F2077: | Demonstrated substantial equivalence to predicate devices. |
| - Static Axial Compression | ||
| - Dynamic Axial Compression | ||
| - Static Compression Shear | ||
| - Dynamic Compression Shear | ||
| ASTM F2267: | Demonstrated substantial equivalence to predicate devices. | |
| - Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression | ||
| Static Pushout Test | Demonstrated substantial equivalence to predicate devices. | |
| - Test Method for Intervertebral Body Fusion Devices | ||
| Technological Characteristics | - Basic Design | Similar to predicate devices |
| - Sizes (length, width, min/max height) | Similar to predicate devices | |
| - Material (titanium alloy) | Similar to predicate devices | |
| - Mechanical Safety and Performance | Similar to predicate devices | |
| - Intended Use | Similar to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a biomechanical testing study conducted in accordance with the listed ASTM standards. The conclusion is that the "Zavation eZspand™ Interbody System devices are similar to the predicate systems with respect to technical characteristics, performance and intended use." This demonstrates substantial equivalence to previously cleared devices.
Additional Information (where applicable from the provided text):
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Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. Biomechanical testing generally uses a specified number of physical samples of the device and predicate devices.
- Data Provenance: The testing was "in accordance with" ASTM standards. The location of the testing facility or specific data origin is not provided. It's not clinical data, so country of origin for patients isn't relevant here. This is a retrospective comparison against established standards and predicate device data, not a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device relying on expert-annotated ground truth. The "ground truth" here is the performance metrics defined by the ASTM standards and the performance of the predicate devices.
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Adjudication method for the test set: Not applicable. This is not an AI device with human review of outputs. Performance is measured objectively according to test methods.
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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 physical medical device, not an AI diagnostic/interpretive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
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The type of ground truth used:
- For biomechanical performance: Established ASTM standards for intervertebral body fusion devices, and the performance characteristics of the predicate devices.
- For technological characteristics: Specifications and design features of the predicate devices.
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The sample size for the training set: Not applicable. This is a physical device, not an AI device requiring a "training set."
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How the ground truth for the training set was established: Not applicable.
§ 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.