(154 days)
NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The subject NGM WAVE PLIF Cage is a lumbar interbody fusion device. The NGM WAVE Cage is manufactured from PEEK-Optima™ Natural LT1 and tantalum (pins) per ASTM F560. The NGM WAVE Cage is an expandable interbody fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. NGM WAVE Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device.
It is not allowed to use NGM WAVE implants in contact with components of other manufacturers with the exception of autograft or allograft materials.
WAVE PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NGM WAVE PLIF Cage:
This document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI device or a study involving human readers or AI performance metrics like sensitivity/specificity. Instead, it concerns the mechanical and biological performance of an intervertebral body fusion device. Therefore, several points in your requested output format (like MRMC studies, AI effect size, ground truth for training/test sets as typically applied to AI, etc.) are not applicable here.
However, I can extract the relevant information regarding the device's performance testing and acceptance criteria as provided.
Acceptance Criteria and Device Performance for NGM WAVE PLIF Cage
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." | A biocompatibility evaluation was performed and met the requirements. |
| Mechanical Performance: Conformance to ASTM F2276. | All tests confirmed that the product met the predetermined acceptance criteria. Non-clinical bench performance testing demonstrated substantial equivalence to previously cleared devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but standard for bench testing of medical devices.
- Data Provenance: The tests are "non-clinical bench performance testing," meaning they were conducted in a laboratory setting. The manufacturer is NGMedical GmbH, located in Nonnweiler, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device (interbody fusion cage), not an AI diagnostic tool. Ground truth in this context refers to established engineering standards (ASTM, ISO) and laboratory measurements, not expert human interpretation of images or clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Testing involves objective measurements against established standards, not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device. No human readers or AI assistance are involved in the performance evaluation described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device. There is no algorithm.
7. The Type of Ground Truth Used
- Engineering Standards and Measurements: The ground truth for the performance testing is based on established international and American standards for medical device biocompatibility (ISO 10993-1) and mechanical testing (ASTM F2276). Performance is measured objectively and compared against the requirements specified in these standards or against predicate device performance.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI model. Device design and development follow engineering principles and material science, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.