(130 days)
The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels and should have received at least six months of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation.
NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone ALIF System includes additively manufactured interbody and traditionally machined fixation screw implants. The interbody and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the interbody 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 300-700µm pores. The inferior/superior aspects of the interbody incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with turn lock mechanisms which secure the screws to the interbody component.
The provided text describes the NEXXT MATRIXX® Stand Alone ALIF System, a medical device, and the basis for its 510(k) clearance by the FDA. However, the text details the substantial equivalence to a predicate device based primarily on mechanical performance testing, and does not describe acceptance criteria related to an AI/Machine Learning device or a study involving human readers or ground truth for AI model training.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance (for AI/ML performance)
- Sample size used for the test set and the data provenance (for AI/ML performance)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI/ML performance)
- Adjudication method (for AI/ML performance)
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size (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 (for AI/ML performance)
- The sample size for the training set (for AI/ML training)
- How the ground truth for the training set was established (for AI/ML training)
The document focuses on the mechanical performance testing of an intervertebral fusion device, not an AI/ML diagnostic or assistive device.
Here's the relevant information that is available regarding the device's performance testing, which is mechanical in nature:
1. Acceptance Criteria and Device Performance (Mechanical Testing)
The document states that the mechanical testing was performed according to ASTM F2267 and ASTM F2077. While specific numerical acceptance criteria are not explicitly detailed (e.g., "must withstand X N of compression"), the conclusion is that the device's performance is "substantially equivalent" to predicate devices. This implies that the device met the performance standards established by these ASTM norms and demonstrated comparable performance to already cleared devices.
| Acceptance Criteria (Implied by standard and equivalence) | Reported Device Performance (Summary) |
|---|---|
| Per ASTM F2267 and F2077 | Device demonstrated substantial equivalence to predicate devices in: |
| - Subsidence resistance | - Subsidence testing |
| - Static compression | - Static compression testing |
| - Dynamic compression | - Dynamic compression testing |
| - Static compression shear | - Static compression shear testing |
| - Dynamic compression shear | - Dynamic compression shear testing |
| - Expulsion properties | - Expulsion testing |
| - Screw pushout properties | - Screw pushout testing |
2. Sample size used for the test set and the data provenance
The document mentions "worst case NEXXT MATRIXX® Stand Alone ALIF System devices" were mechanically tested. However, the exact sample size (e.g., number of devices tested for each mechanical test) is not specified. The data provenance is implied to be from laboratory testing as part of the device's development and regulatory submission.
3 - 7. Information related to AI/ML studies, expert ground truth, MRMC, or standalone AI performance
This information is not applicable as the document is for a physical orthopedic implant (intervertebral fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) software or diagnostic device.
8. The sample size for the training set
Not applicable, as this is a physical medical device, not an AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device, not an AI/ML model.
§ 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.