(110 days)
LnK Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. LtK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The LnK Lumbar Interbody Fusion Cage System is intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. The Tantalum marker used for this product is made to the voluntary standard of ASTM F560. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. LnK Lumbar Interbody Fusion Cage System Implants are single-use devices. They have to be used in a healthcare setting or a hospital.
The LnK PLIF PEEK Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left).
The LnK T-PLIF PEEK Cages which is used in transforaminal posterior lumbar interbody fusion technique. One T-PLIF cage is implanted in interbody space.
The LnK TLIF PEEK Cages are a "banana" shaped. Implants are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.
The LnK ALIF PEEK Cages are to be implanted via anterior approach.
The LnK DLIF PEEK Cages (LnK LLIF PEEK Cages/LnK Lateral PEEK Cages) are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage (LnK LLIF PEEK Cage/LnK Lateral PEEK Cage) can be used in an open approach and a percutaneous approach with MIS instrumentation.
The LnK ATP PEEK Cages are to be implanted via anterior lateral approach.
This document is a 510(k) premarket notification for the LnK Lumbar Interbody Fusion Cage System. It describes a medical device, which is an implant, and therefore the acceptance criteria and supporting studies are related to the physical and mechanical performance of the device itself, rather than diagnostic accuracy or human performance with AI assistance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table form that matches typical AI/ML device evaluations (e.g., sensitivity, specificity thresholds). Instead, for this type of medical implant, the criteria are adherence to ASTM standards and demonstrating mechanical performance equivalent to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant ASTM standards for intervertebral body fusion devices (F2077, F2267). | The LnK Lumbar Interbody Fusion Cage System was tested according to: |
- Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Compression-Shear Testing per ASTM F2077
- Static and Dynamic Torsion Testing per ASTM F2077
- Static Subsidence testing under Axial Compression per ASTM F2267
- Expulsion Testing (standard not specified, but implied) |
| Mechanical performance of additional components (new variations of the cage) must be equivalent to the predicate device (K151140). | Finite Element Analysis (FEA) was performed to demonstrate that theadditional components(new cage variations) do not introduce a new worst case in terms of mechanical performance. The mechanical test data of the primary predicate (K151140) was leveraged to demonstrate the performance of the subject components, indicating that the new components meet the same performance characteristics as the predicate device. |
| Material compliance for PEEK and Tantalum. | Fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. Tantalum marker made to the voluntary standard of ASTM F560. |
| Sterilization (Gamma) does not affect device performance. | Stated that "It is widely known that gamma sterilization does not affect the performance of the device." Therefore, only mechanical test data of non-sterilized cages was provided. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of an AI/ML device testing. For an implant, the "test set" would refer to the number of physical devices or models subjected to mechanical testing. The document does not specify a numerical sample size (e.g., number of cages tested) for the mechanical performance tests.
- Provenance: The tests were conducted on the physical devices (the LnK Lumbar Interbody Fusion Cage System) and their additional components. The materials (PEEK and Tantalum) are described by ASTM standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable. Ground truth in this context refers to the physical and mechanical properties of the implant, which are determined by engineering tests and adherence to established standards, not by expert interpretation of images or clinical data.
4. Adjudication Method
This is not applicable for a mechanical implant device. Adjudication methods like "2+1" are used in diagnostic studies to resolve disagreements among human readers or algorithms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically used for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI assistance on human reader performance. This document describes an implantable medical device.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
This is not applicable. This device is an implanted medical device, not an AI algorithm. Its "performance" is mechanical and biocompatible, not computational.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering and mechanical testing according to recognized industry standards (ASTM) and finite element analysis (FEA), demonstrating that the device meets specific physical requirements and is functionally equivalent to a previously cleared predicate device. Material specifications also form part of the ground truth.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is not an AI/ML device that requires a training set.
§ 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.