(120 days)
The Lanx Cervical SA System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be filled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.
The product includes the Lanx Cervical SA PEEK implant models with titanium components for additional fixation. All devices in the Lanx Cervical SA System are made of PEEK-OPTIMA® LT1 per ASTM F2026 and/or Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Lanx Cervical SA implants have a central cavity to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws and plates which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Cervical SA System is provided non-sterile.
The provided information describes a medical device submission (510(k) summary) for the Lanx Cervical SA Intervertebral Body Fusion System. The core of this document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance of a novel AI/software-as-a-medical-device (SaMD) through a clinical study with detailed acceptance criteria and expert reviews.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Source) | Reported Device Performance (Source) |
|---|---|---|
| Mechanical Performance | Per ASTM F2077: Static & Dynamic Compression, Static & Dynamic Compression Shear, Static & Dynamic Torsion | "In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section) |
| Per ASTM F2267: Subsidence | "In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section) | |
| ASTM Z8423Z (draft standard): Expulsion testing | "In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section) | |
| Flexion/Extension testing | "In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section) | |
| Wear debris analysis | "In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section) |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document describes mechanical performance testing of an implantable device, not a classification or diagnostic AI/SaMD. The "test set" in this context refers to the physical samples of the device used for mechanical stress tests according to ASTM standards. The specific number of physical units tested is not detailed, but it would adhere to the sample size requirements inherent in each ASTM standard. Data provenance is implicitly from the manufacturing facility where the device was produced for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Ground truth, in the context of expert consensus, pathology, or outcomes data, is not relevant here. The "ground truth" for mechanical testing is defined by the established parameters and failure modes specified in the ASTM standards. Experts involved would be engineers conducting and interpreting the mechanical tests according to standard protocols, not medical experts establishing diagnostic ground truth.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in diagnostic studies. For mechanical testing, the results are quantitative measurements against predefined criteria in the ASTM standards.
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 device is a physical intervertebral body fusion system, not an AI or SaMD requiring human reader studies.
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
- Mechanical Specifications/Standards: The "ground truth" for this device's performance is against established engineering and mechanical standards (e.g., ASTM F2077, F2267, F136, F2026, F560) which specify material properties, dimensions, and performance under various loads. The device must meet these predefined physical and performance characteristics.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set. The "ground truth" for mechanical criteria is established by recognized national and international engineering standards (ASTM).
§ 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.