(111 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. LnK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to 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 supplied as sterile or non-sterile.
The LnK PLIF PEEK Cages are to be implanted via posterior approach. These devices are placed two implants 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. However, this kind of cage is to be implanted only one implant on 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 are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage can be used in an open approach and a percutaneous approach with MIS instrumentation.
This document describes the LnK Lumbar Interbody Fusion Cage System, which is a medical device. The information provided focuses on its substantial equivalence to previously marketed devices, rather than a study proving the device meets specific acceptance criteria through clinical performance.
Therefore, many of the requested categories for describing acceptance criteria and a study that proves the device meets them, especially those related to AI algorithm performance or clinical trials with human readers, are not applicable to this 510(k) summary as it is for a physical medical implant device.
However, I can extract information regarding the performance data that was presented to establish substantial equivalence.
This document describes the LnK Lumbar Interbody Fusion Cage System and asserts its substantial equivalence to a predicate device (primary predicate: LnK Lumbar Interbody Fusion Cage System K121096). The performance claim is based on mechanical testing, not a clinical study involving human readers or AI performance.
Here's the breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from generally accepted standards for interbody fusion cages) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Mechanical Performance: Resistance to static and dynamic axial compression (per ASTM F 2077) | LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Axial Compression. Mechanical performance of additional components is "same with predicated (K121096)." |
| Mechanical Performance: Resistance to static and dynamic compression-shear (per ASTM F 2077) | LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Compression-Shear Testing. Mechanical performance of additional components is "same with predicated (K121096)." |
| Mechanical Performance: Resistance to static and dynamic torsion (per ASTM F 2077) | LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Torsion Testing. Mechanical performance of additional components is "same with predicated (K121096)." |
| Mechanical Performance: Resistance to expulsion (per ASTM F 2077) | LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Expulsion Testing. Mechanical performance of additional components is "same with predicated (K121096)." |
| Mechanical Performance: Resistance to static subsidence under axial compression (per ASTM F 2267) | LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2267. This included Static Subsidence testing under Axial Compression. Mechanical performance of additional components is "same with predicated (K121096)." |
| Material Compatibility: Use of established biocompatible materials | Fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. Tantalum marker made to ASTM F560. Materials are the same as the predicate devices. |
| Functional Equivalence: Device design and indications for use are substantially equivalent to marketed devices. | The design features and indications for use for the subject device are substantially equivalent to the predicate devices (K121096 and K110783). |
Note: The document states that the mechanical performance of additional components is the "same with predicated (K121096)" and that "additional sizes are not worst case." This implies that direct testing data for the exact configuration of the new device showing it meets specific numerical thresholds of ASTM F2077 and F2267 is not explicitly detailed, but rather, equivalence is drawn from the predicate's performance and the nature of the "additional components" and sizes.
2. Sample size used for the test set and the data provenance
- Test Set Description: Not a "test set" in the context of an algorithm or clinical trial. The "test" refers to mechanical testing of the physical device.
- Sample Size: Not specified in terms of number of devices tested, but the testing was done on the "LnK Lumbar Interbody Fusion Cage System" and its "additional components."
- Data Provenance: The tests were conducted according to established ASTM standards (ASTM F 2077 and ASTM F 2267). The origin of this specific test data (e.g., in-house testing, third-party lab) is not mentioned beyond stating the company performed or submitted results for the device. The data is retrospective in the sense that it represents completed mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device being evaluated for mechanical properties and substantial equivalence, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Mechanical tests of physical devices do not typically involve adjudication in this manner. Compliance with ASTM standards, which have defined methodologies and acceptance criteria, is the basis.
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
- Not Applicable. This is a physical intervertebral body fusion device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical intervertebral body fusion device, not an AI or diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Performance Ground Truth: Compliance with established ASTM standards (ASTM F 2077 and ASTM F 2267) for intervertebral body fusion devices. These standards define the testing methodology and the expected mechanical behavior for such devices, serving as the "ground truth" for mechanical properties.
- Substantial Equivalence Ground Truth: The features and performance relative to the predicate device (K121096), which has already received regulatory clearance based on similar, previously accepted performance criteria.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical device being mechanically tested, not an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is a physical device being mechanically tested, not an algorithm.
§ 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.