(130 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 prior to 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.
The provided text describes the LnK Cervical Interbody Fusion Cage System and its 510(k) submission (K143360) to the FDA. This document is a premarket notification for a medical device, specifically an intervertebral body fusion device, which falls under Class II.
It's important to understand that a 510(k) submission, especially for a Class II device like this, typically focuses on demonstrating substantial equivalence to a previously legally marketed predicate device rather than conducting extensive clinical trials or complex AI performance studies. Therefore, the information you're requesting regarding AI performance analysis, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance will not be found in this type of document. These are common components of submissions for devices with novel algorithms, AI/ML components, or higher risk classifications, which this device does not appear to have.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing to demonstrate the device's mechanical integrity and safety, comparing it to an existing predicate device.
Here's the breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance standards of the predicate device and the relevant ASTM standards for interbody fusion devices. The reported device performance is a declaration of equivalence and testing according to these standards.
| Acceptance Criteria (Implicit) | Reported Device Performance and Basis for Equivalence |
|---|---|
| Material Composition: Use of biocompatible and mechanically sound materials. | The device uses PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum, identical to the predicate device. |
| Mechanical Performance: Meets established standards for spinal interbody fusion devices. | Mechanical performance of the additional components is stated to be the same as the predicated LnK Cervical Interbody Fusion Cage System (K120840). The device was tested according to ASTM F 2077 (Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing) and ASTM F 2267 (Static Subsidence testing under Axial Compression). The change in sterilization method (gamma irradiation) is stated as "not effect on mechanical performance." Therefore, mechanical test data of the predicate device (K120840) was substituted for these additional components. |
| Sterilization Method: Ensures sterility without compromising device integrity. | The sterilization method is gamma irradiation, following ISO 11137. This is a change from the predicate, but it's asserted not to affect mechanical performance. |
| Intended Use and Indications: Consistent with established medical practice for similar devices. | Identical intended use and indications as the predicate device (K120840). Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C3 to C7), for fusion with autograft bone and supplemental fixation, after 6 weeks of non-operative treatment. |
| Design and Features: Functionally equivalent to a legally marketed predicate device. | The device is described as "same product in all aspect, except sterilization" compared to the predicate device (K120840). Available in a variety of sizes and configurations identical to the predicate. |
Non-AI / Non-Algorithm-Based Information from the Document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes performance based on mechanical testing of the physical device components according to ASTM standards, not clinical patient data or data sets for an algorithm. Therefore, "sample size for the test set" would refer to the number of physical devices or components tested, which is not specified but would be dictated by the ASTM standards.
- Data provenance: Not applicable in the sense of patient data. The mechanical tests are laboratory-based.
- Retrospective or prospective: Not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for an AI/algorithm is not being established here. The "truth" is whether the physical device meets mechanical performance specifications, which is determined by objective physical measurements according to validated test methods (ASTM standards), not expert interpretation of outputs.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for clinical outcome adjudication or image interpretation, not mechanical testing of physical implants.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not contain an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" is defined by the validated and standardized mechanical testing protocols (ASTM F 2077 and ASTM F 2267) which establish the pass/fail criteria for various mechanical stresses (axial compression, shear, torsion, expulsion, subsidence).
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The sample size for the training set:
- Not applicable. This device does not involve a training set for an algorithm.
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How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is for a traditional medical implant, and the approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance (mechanical testing) and material and design comparisons, not AI/ML performance studies.
§ 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.