(44 days)
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
The Lanx Fusion System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The implant has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The purpose of this submission is to expand the available plate options for the Lanx Lateral-SA implants. The Lanx Fusion System is provided non-sterile.
Here's an analysis of the provided text regarding the Lanx Fusion System, focusing on acceptance criteria and study details.
Based on the provided {0}-{5} text, this is a 510(k) summary for a spinal implant (Lanx Fusion System) seeking FDA clearance. The document describes the device, its intended use, and claims substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way a clinical study for an AI/CADe device would.
Instead, the "Performance Data" section specifically refers to bench testing and engineering analysis performed to demonstrate substantial equivalence for a medical device implant. It evaluates mechanical properties of the implant, not diagnostic accuracy in interpreting medical images or data.
Therefore, many of your requested points regarding AI/CADe system evaluation metrics (such as test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.
Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not provided:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Compliance with ASTM F2077 (static/dynamic compression, static compression shear, static torsion) "In all instances, the modified device met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F2077). Specific numerical performance values are not provided nor are the specific acceptance thresholds for these tests in this summary. Instead, it states the device met or exceeded the predicate device's performance. Compliance with ASTM draft expulsion testing standard Z8423Z (expulsion tests) "...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with Z8423Z). Specific numerical performance values are not provided. Compliance with ASTM F1877 (wear debris) "...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F1877). Specific numerical performance values are not provided. Substantial Equivalence to predicate device (K123767) "The modified Lanx Fusion System implants... have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Lanx Fusion System devices (K123767). The minor differences... do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties..." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes mechanical bench testing of an implant, not a clinical study involving a "test set" of patient data in the typical sense. The "performance testing" refers to physical tests on the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. Ground truth by medical experts is relevant for diagnostic devices or AI systems. This is an implant, and its performance is evaluated physically against engineering standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations. This is not a clinical study.
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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
- Not Applicable / Not Provided. MRMC studies are specifically for evaluating diagnostic performance, often for AI/CADe systems. This device is an implant for spinal fusion and replacement, not a diagnostic tool or an AI system.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This concept applies to AI algorithms. The Lanx Fusion System is a physical medical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance would be the established engineering standards (ASTM F2077, ASTM draft Z8423Z, ASTM F1877) and the performance characteristics of its predicate device.
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The sample size for the training set
- Not Applicable / Not Provided. This is a physical implant, not an AI system that requires a "training set."
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How the ground truth for the training set was established
- Not Applicable / Not Provided. As above, this is not an AI system. "Ground truth" for its design and manufacturing would come from engineering specifications, material properties, and regulatory standards.
§ 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.