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The ALIF Interfixated System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with deseneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The ALIF Interfixated System is intended for use with autograft. The ALIF Interfixated System 10°-20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the ALIF Interfixated System.

The NuVasive ALIF Interfixated System is an interfixated interbody system manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive ALIF Interfixated System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The ALIF Interfixated System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The ALIF Interfixated System 10° - 20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The provided text describes a medical device, the NuVasive ALIF Interfixated System, and its clearance by the FDA, primarily focusing on its substantial equivalence to predicate devices. However, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/algorithm-driven device.

The information provided is typical for a 510(k) submission for a physical medical implant (an intervertebral body fusion device). It focuses on:

• Substantial Equivalence: Comparing the new device to existing legally marketed predicate devices.
• Mechanical Performance Testing: Static and dynamic compression, torsion, push-out, and subsidence testing, which are standard for orthopedic implants to ensure mechanical integrity. These tests are against established ASTM standards for implants, not "acceptance criteria" for an AI's performance as you've defined them.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria in terms of algorithmic performance (e.g., sensitivity, specificity, AUC) for an AI device.
2. Sample size for the test set and data provenance: No such data is mentioned as the "device" here is a physical implant, not an AI.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to this type of device submission.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

For a medical device that is an AI/algorithm, a 510(k) summary would typically include detailed performance metrics such as sensitivity, specificity, positive predictive value, negative predictive value, and potentially F1-score or AUC, along with details about the validation study design, ground truth establishment, reader studies (if human-in-the-loop), and data characteristics. This document, however, describes a physical implant.

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