(87 days)
The InFront Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be use with autograft bone.
The InFront Lumbar Interbody Fusion System consists of cages of various lengths, widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The InFront Lumbar Interbody Fusion System is to be used with supplemental fixation. The leading edge consists of bullet nose. The cephalad/caudal opening is large to allow for bone through growth. In addition, there are 2 large holes on each side to facilitate bone and to aid in visualizing the fusion mass. The teeth are slanted away from the direction of insertion of the implant to minimize implant migration. The superior and inferior surfaces are convex to better fit the vertebral endplates.
The device is offered in 3 general configurations, specifically shaped for posterior, transforaminal or lateral surgical approaches. The posterior approach configuration is available in 508 possible sizes, with lengths from 22mm, widths from 8mm to11mm, heights from 7mm to 16mm and lordosis angles of 0°, 4° and 8°. The transforaminal approach configuration is available in 720 possible sizes, with lengths from 22mm to 36mm, widths from 9mm to 12mm, heights from 7mm to 18mm and lordosis angles of 0°, 4° and 8°. The lateral approach configuration is available in 330 possible sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°.
The InFront Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.
This document is a 510(k) Pre-Market Notification from the FDA for the InFront Lumbar Interbody Fusion System. It does not describe a study involving an AI/Machine Learning device or any associated acceptance criteria, human reader studies, or ground truth establishment based on expert consensus, pathology, or outcomes data.
Instead, this document is for a traditional medical device (an intervertebral body fusion device) and focuses on demonstrating its substantial equivalence to currently marketed predicate devices. The "studies" mentioned are non-clinical tests designed to assess the mechanical properties of the device to ensure it meets performance standards typical for such implants.
Therefore, I cannot fulfill your request for the specific AI/Machine Learning-related information, as it is not present in the provided text.
Here's a breakdown of what is available regarding the device's assessment:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table with quantitative acceptance criteria and reported device performance from a clinical study or AI performance evaluation. Instead, it states that the device was tested as described in "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" with specific ASTM standards. The conclusion is that the device is "substantially equivalent" to predicate devices, implying it met the necessary performance standards without explicitly listing them here.
2. Sample size used for the test set and the data provenance:
Not applicable in the context of an AI/ML device. The "test set" here refers to the physical devices subjected to non-clinical mechanical testing, not a dataset of patient information. No patient data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert labels, pathology results) is not relevant to this type of device submission. The "truth" in this context is adherence to engineering standards and substantial equivalence to existing devices.
4. Adjudication method for the test set:
Not applicable. There's no adjudication process described for the mechanical tests.
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:
No. This is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for AI/ML ground truth. The "ground truth" for this device's safety and effectiveness is established through its compliance with existing mechanical testing standards and demonstrated substantial equivalence to predicate devices already on the market and deemed safe and effective.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
Summary of Device Assessment from the Document (Non-AI/ML context):
- Acceptance Criteria (Implied): The device's mechanical properties (static compression, dynamic compression, subsidence, expulsion) must meet the performance standards outlined in ASTM F2077-11, ASTM F2267-04, and ASTM Draft F04.25.0202, and be "substantially equivalent" to legally marketed predicate devices.
- Reported Device Performance: The document states, "Based on the results of the testing and comparisons performed, InFront believes that the subject InFront Interbody Fusion System is substantially equivalent to the predicate systems it was compared to." Specific quantitative results are not provided in this summary.
- Study Description: The study involved non-clinical mechanical testing of the InFront Lumbar Interbody Fusion System according to established ASTM standards.
- Tests Performed:
- Static Compression ASTM F2077-11
- Dynamic Compression - ASTM F2077-11
- Subsidence - ASTM F2267-04
- Expulsion - Per ASTM Draft F04.25.0202
- Data Provenance: The "data" comes from engineering tests performed on the physical device, not patient data.
- Ground Truth: The "ground truth" is adherence to established engineering and material standards and demonstrated mechanical performance comparable to predicate devices.
- Tests Performed:
§ 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.