(141 days)
When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.
The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.
The NeoFuse™ HA Enhanced PLIF/TLIF devices are intervertebral body fusion devices made from PEEK-OPTIMA HA Enhanced (HA PEEK). Each device may include an optional Titanium Insert containing through holes to increase graft volume. The implants are available in various heights to accommodate patients' anatomy. The implants are provided non-sterile with surgical instruments to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), or titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
This is a notification of intent to market a medical device, specifically an intervertebral body fusion device called NeoFuse™ HA Enhanced PLIF/TLIF. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a standalone study with acceptance criteria, human expert validation, or clinical efficacy data on the device's performance in a diagnostic or interpretive task.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.
Here's why and what information is provided:
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Acceptance Criteria and Reported Device Performance:
- This document does not specify "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or interpretive task.
- The "performance" reported is related to bench testing for mechanical properties.
- Table of Acceptance Criteria and Reported Device Performance: This cannot be created as such. The document states:
- "Test results demonstrated that the devices are substantially equivalent to the predicate devices."
- "Performance bench testing and comparisons have demonstrated NeoFuse is substantially equivalent to the predicate devices in regards to Indications for Use, Dimensions, Function, Materials, Mechanical Testing, and Technology Characteristics."
- The criteria for "substantial equivalence" are based on comparing the mechanical test results of the NeoFuse to those of the predicate devices, ensuring they perform similarly under test conditions. Specific numerical values for these criteria are not provided in this summary.
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Sample Size used for the test set and the data provenance:
This information is not applicable and not provided. The "test set" here refers to the physical devices undergoing mechanical bench testing, not a dataset of patient images or clinical outcomes. The provenance would refer to the testing lab and standards (ASTM F2077 and ASTM F2267). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly through standardized testing, not established by human experts. -
Adjudication method for the test set:
This information is not applicable and not provided. Mechanical testing results are objective measurements, not subject to human adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this device is a physical intervertebral body fusion device, not an algorithm. -
The type of ground truth used:
The "ground truth" for the mechanical testing would be the actual physical measurements obtained from the standardized ASTM tests. This is not "expert consensus, pathology, or outcomes data." -
The sample size for the training set:
This information is not applicable and not provided. There is no AI algorithm being trained for this device. -
How the ground truth for the training set was established:
This information is not applicable and not provided.
In summary, this document is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through comparisons of materials, design, and mechanical bench testing to legally marketed predicate devices, rather than through clinical studies involving human performance or AI algorithms.
§ 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.