(23 days)
LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK. Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
LnK Cervical Interbody Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum.
This document is a 510(k) premarket notification for a medical device, the "LnK Cervical Interbody Fusion Cage System." It is a submission to the FDA seeking clearance to market the device, arguing for substantial equivalence to a previously cleared predicate device. Therefore, the document describes a study that proves the device meets the acceptance criteria, but it does not present a typical "study" in the sense of a clinical trial with human subjects and statistical performance metrics like sensitivity, specificity, or AUC for a diagnostic AI device.
Instead, the "study" referred to here is a set of mechanical performance tests conducted to demonstrate the physical and structural integrity of the interbody fusion cage and its equivalence to a predicate device.
Here's an breakdown based on your request, with the caveat that the "device performance" in this context refers to mechanical properties, not diagnostic accuracy:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Reference to K143360) |
|---|---|
| ASTM F 2077: Static and Dynamic Axial Compression | Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case. |
| ASTM F 2077: Static and Dynamic Compression-Shear Testing | Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case. |
| ASTM F 2077: Static and Dynamic Torsion Testing | Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case. |
| ASTM F 2077: Expulsion Testing | Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case. |
| ASTM F 2267: Static Subsidence Testing under Axial Compression | Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case. |
| Equivalence to Predicate Device (K143360) | Deemed substantially equivalent to K143360. The additional components (7° angle cages) are not worse case than the predicate's 0° angle components, as demonstrated through finite element (FE) analysis. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of individual devices tested for each mechanical test. However, it indicates that the "additional components" (the 7° angled cages) were compared to the already existing "LnK Cervical Interbody Fusion Cage System (K143360)".
- Data Provenance: The mechanical test data (for K143360) would be from laboratory testing. The Finite Element (FE) analysis is a computational method. The country of origin for the data generation is not explicitly stated for the testing, but the manufacturer is L&K BIOMED Co., Ltd. in the Republic of Korea. The data is "retrospective" in the sense that existing test data from K143360 is being leveraged for the new submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable in the context of this device and submission. This is a mechanical device, not a diagnostic one requiring expert interpretation of images or patient data to establish ground truth. The "ground truth" here is adherence to mechanical standards specified by ASTM.
4. Adjudication Method for the Test Set
- This question is not applicable. Mechanical tests for medical devices are typically pass/fail based on predetermined thresholds within the ASTM standards, not on human adjudication of ambiguous cases.
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
- This question is not applicable as this is a mechanical interbody fusion cage, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as this is a mechanical interbody fusion cage, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission are the performance requirements and test methods outlined in the ASTM standards (ASTM F 2077 and ASTM F 2267). The device's mechanical performance is compared against these engineering standards. For the new components, their performance against these standards is established by showing they are not a "worse case" than the predicate device, which itself met these standards.
8. The Sample Size for the Training Set
- This question is not applicable as this is a submission for a mechanical device, not a machine learning model that requires a training set. The "analogy" for a training set here would be the design and manufacturing processes that result in the device, and the testing of previous iterations or predicate devices.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the reasons stated above.
§ 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.