(136 days)
The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.
The Expandable Lumbar Interbody System is 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.
The NuVasive Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided document describes the NuVasive Expandable Lumbar Interbody System, a Class II medical device intended for intervertebral body fusion of the spine. The evaluation criteria for this device are based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI system. Therefore, many of the requested categories related to AI model evaluation are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated through testing) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Static and Dynamic Axial Compression per ASTM F2077 | No new worst-case for performance testing. |
| Compression Shear per ASTM F2077 | No new worst-case for performance testing. |
| Torsion Testing per ASTM F2077 | No new worst-case for performance testing. |
| Range of Motion Testing | No new worst-case for performance testing. |
| Lateral Collapse Testing | No new worst-case for performance testing. |
| Cadaver Testing | No new worst-case for performance testing. |
| Corrosion Testing per ASTM F2129 | No new worst-case for performance testing. |
| Overall Goal: Substantial Equivalence to Predicate Devices (NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359)) | The subject device was found to be substantially equivalent to the predicate devices in terms of safety and effectiveness, having similar indications for use, technological characteristics, and principles of operation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual tests. The document refers to various "testing" and "cadaver testing" without detailing the number of units or cadavers used.
- Data Provenance: Not explicitly stated. Nonclinical testing was performed, but the location or specific origin of materials/samples is not mentioned. This is a medical device, so the tests would be performed on engineered samples or cadaveric specimens, not retrospective or prospective patient data in the sense of an AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical medical device clearance, not an AI or diagnostic tool where expert ground truth is established for a test set. The "ground truth" here is compliance with established ASTM standards and comparable performance to predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Testing involves objective measurements against established technical standards, not subjective expert 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
- Not Applicable. This is not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- Technical Standards and Predicate Device Performance: The "ground truth" for this device's performance evaluation is established by:
- ASTM International Standards: F2077 (for static and dynamic mechanical testing), F2129 (for corrosion testing).
- Performance of Legally Marketed Predicate Devices: The "substantial equivalence" claim is based on demonstrating that the new device performs comparably to the NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359) without introducing new worst-case scenarios.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This device does not involve an AI model requiring ground truth for a training set.
Summary of the Study:
The study described is a nonclinical performance testing regimen designed to demonstrate the mechanical and material characteristics of the NuVasive Expandable Lumbar Interbody System. The methodologies employed are based on established ASTM standards for intervertebral body fusion devices. The primary objective was to show that the subject device performs similarly to or better than two specific predicate devices already on the market (NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359)) across various mechanical and environmental tests. The conclusion states that the device presents "no new worst-case for performance testing," thereby establishing substantial equivalence to the predicate devices in terms of safety and effectiveness. This type of clearance (510(k)) relies on demonstrating similarity to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software performance.
§ 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.