(113 days)
BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft 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 implants may be 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 supplementation, which has been cleared by the FDA for use in the lumbar spine.
The subject BEE® PLIF Cage is a lumbar interbody fusion device. BEE® PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE® PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE®PLF 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 BEE® PLIF implants in contact with components of other manufacturers with the exception of autograft materials. BEE® PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.
This document is a 510(k) summary for the NGMedical GmbH BEE® PLIF Cage, an intervertebral body fusion device. It details the device's characteristics, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "met the predetermined acceptance criteria" without providing specific numerical criteria. It only lists the tests performed and confirms compliance.
| Acceptance Criteria (Not explicitly stated in numerical values within the document) | Reported Device Performance |
|---|---|
| Biocompatibility standards (per ISO 10993-1) | Biocompatibility evaluation was performed and the device met the criteria. |
| Mechanical properties (per ASTM F2077 for static/dynamic axial compression, static/dynamic compression shear, static/dynamic torsion) | Device met predetermined acceptance criteria. Non-clinical bench performance testing demonstrated substantial equivalence to previously cleared devices. |
| Subsidence (per ASTM F2276) | Device met predetermined acceptance criteria. |
| Expulsion resistance | Device met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing for mechanical performance and biocompatibility. It does not involve a "test set" of patient data or clinical trials in the way an AI/software device would. Therefore, the concepts of sample size for a test set, country of origin, or retrospective/prospective data are not applicable here. The "sample" for testing would refer to the number of physical devices or material samples subjected to the mechanical and biocompatibility tests. This number is not specified in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable. The device is a physical implant, not an AI/software device requiring human expert ground truth for a test set. Ground truth for mechanical testing is established by engineering standards and measurements.
4. Adjudication Method for the Test Set:
Not applicable, as this is a physical device and not an AI/software requiring human adjudication of its output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This is a physical medical implant, not an AI/software system that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" is defined by the objective measurements and engineering standards outlined in ASTM F2077 and ASTM F2276, as well as the specifications for biocompatibility in ISO 10993-1. These are physical and chemical properties measured against established benchmarks.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical implant. There is no "training set" in the context of an AI/software algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
In summary, the provided document describes the FDA clearance for a physical medical device (interbody fusion cage) based on substantial equivalence to predicate devices and performance bench testing, not on clinical data involving patient cohorts or AI algorithm performance.
§ 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.