(47 days)
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.
This document (K193370) is a 510(k) premarket notification for a medical device called the "Nexxt Matrixx® System," specifically adding an anterior lumbar interbody fusion (ALIF) device. It is not a K medical device submission for an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be extracted from this document because it is not relevant to this type of traditional medical device submission.
The "Performance Data" section in the document states:
"The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF is substantially equivalent to the predicate."
This indicates that the performance evaluation for this traditional device involved dimensional analyses to demonstrate substantial equivalence to a predicate device, not the kinds of clinical performance studies typically required for AI/ML devices.
Therefore, for your specific request:
- A table of acceptance criteria and the reported device performance: Not applicable in the context of AI/ML performance. The success criterion here is "substantially equivalent" based on dimensional analyses.
- Sample sized used for the test set and the data provenance: Not applicable. Dimensional analyses would involve measuring the device itself, not a patient test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "ground truth" in the AI/ML sense for a physical implant's dimensional analysis.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for a physical device's characteristics would be its specifications and physical measurements.
- The sample size for the training set: Not applicable.
- 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.