(335 days)
The EndoLIF® Delta-Cage and DoubleWedge-Cage are intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with autogeneous bone and implanted via a posterior or posteriolateral approach. The EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment with an EndoLIF® cage.
The EndoLIF® devices are interbody fusion devices that have a hollow center chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The product family includes cages of a variety of lengths, widths, heights, and lordotic to suit the individual pathology and anatomical conditions of the patient. The device footprint allows for posterior or posterolateral surgical approaches for insertion. All implant components are made from titanium alloy Ti6A14V ELI using electron beam melting additive manufacturing technology. The EndoLIF® product family is being expanded to include the Delta-Cage and DoubleWedge-Cage implant configurations.
The product family also includes instruments to allow for implant size trialing and insertion.
The EndoLIF® devices are provided in sterile form. All implants are intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device (EndoLIF® Delta-Cage and DoubleWedge-Cage) and an assessment of its substantial equivalence to a predicate device. This type of FDA submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance testing demonstrating the new device's engineering characteristics are comparable to the predicate. It does not refer to clinical studies demonstrating patient outcomes or the performance of an AI algorithm.
Based on the provided information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Summary) |
|---|---|
| Static Compression (ASTM F2077) | Met all specified criteria |
| Static Compression Shear (ASTM F2077) | Met all specified criteria |
| Dynamic Compression (ASTM F2077) | Met all specified criteria |
| Static Torsion (ASTM F2077) | Met all specified criteria |
| Dynamic Torsion (ASTM F2077) | Met all specified criteria |
| Subsidence (ASTM F2267) | Met all specified criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., how many devices were subjected to static compression). These are in vitro mechanical performance tests, not clinical trials with patient data. The "data provenance" refers to the results of these standardized mechanical tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The "ground truth" for these types of engineering performance tests is defined by the technical specifications and requirements of the ASTM standards, not by expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiologic readings). Here, the performance is determined by meeting objective engineering specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is an intervertebral body fusion cage, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these tests is the set of established physical and mechanical properties and performance thresholds defined within the respective ASTM standards (F2077 and F2267). The device's performance is compared against these engineering criteria.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" is used in the development of machine learning models. This document describes mechanical testing of a medical implant, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
Summary of the Study:
The study referenced in the document is a series of benchtop, in vitro mechanical performance tests conducted according to established ASTM standards (F2077 and F2267). These tests evaluated the EndoLIF® Delta-Cage and DoubleWedge-Cage's static compression, static compression shear, dynamic compression, static torsion, dynamic torsion, and subsidence characteristics. The purpose of these tests was to demonstrate that the new device has a "safety and effectiveness profile that is similar to the predicate device" by meeting all specified criteria within these engineering standards. The conclusion was that the design testing demonstrated the performance of the device is "equal to the legally marketed predicate devices."
§ 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.