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SHELL Cages are 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. SHELL Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. SHELL Cages are 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.

The WAVE/LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level 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 I spondylolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage 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.

Device Description

The SHELL was especially adapted to the local anatomy in order to secure the surgical result as possible. Its caudal side is flat, its cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The A/P view is trapezoidal. There are x-ray pins at the four edges, which slightly protrude the cage in order to maximize rotational fixation.

The LOOP is a banana-shaped implant with optimized tip design and an integrated swivel joint for the instrument fixation. Both factors facilitate the implantation. The radial orientated fixation teeth define the direction of implantation and secure the implant position. LOOP is shaped with a 6° lordosis.

The WAVE is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6° lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Function: The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The WAVE Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF). The LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the AMT Interbody Fusion Devices:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with specific acceptance criteria in the context of diagnostic performance or clinical outcomes. The "acceptance criteria" here refer to mechanical strength and similarity to predicate devices, not AI/algorithm performance.

Description of Acceptance Criteria and Study

The AMT Interbody Fusion Devices (SHELL, WAVE, LOOP Cages) demonstrate their suitability for market by undergoing nonclinical bench testing to demonstrate mechanical strength and by establishing substantial equivalence to previously cleared predicate devices. The "acceptance criteria" primarily revolve around meeting established mechanical standards for interbody fusion devices and demonstrating that the device's technological characteristics, indications for use, and materials are comparable to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Material Compliance	PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification)	The devices are made of PEEK-OPTIMA LT1 polymer, which complies with ASTM F2026.
Mechanical Strength	ASTM F2077/F2267 (Standard Test Methods for Intervertebral Body Fusion Devices)	The devices "meet required mechanical strengths" as indicated by tests performed according to ASTM F2077/F2267. Specific numerical targets or results are not provided but are stated to be met.
Indications for Use (Substantial Equivalence)	Same indications as previously cleared devices.	The SHELL, WAVE, and LOOP Cages have indications for use that are either identical or substantially similar to the predicate devices (e.g., DDD at specific spinal levels, use with autograft bone, supplemental fixation, non-operative treatment duration).
Design/Technology (Substantial Equivalence)	Similar designs and materials as previously cleared devices.	The devices are described as having "similar designs" and the "same material" (PEEK-OPTIMA LT1) as predicate devices. Variations in geometry (e.g., SHELL, LOOP, WAVE shapes) are acknowledged but deemed acceptable in comparison to predicates.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a pre-market notification (510(k)) for a medical device that is a physical implant, not an AI/software device. Therefore, the concept of a "test set" and "data provenance" as typically applied to AI performance studies does not directly apply here.

Test Set: Not applicable in the context of AI/algorithm performance. The "test" involved ex-vivo mechanical testing of the physical implant devices. The sample size for these mechanical tests (e.g., number of devices tested for ASTM F2077/F2267) is not specified in the summary.
Data Provenance: Not applicable in the context of AI/algorithm performance. The "data" comes from bench testing of the physical medical devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is a physical implant, and its performance is evaluated based on engineering and material standards (e.g., ASTM standards) through mechanical testing, not through expert-labeled ground truth for an algorithm.

4. Adjudication Method for the Test Set

Not applicable. There is no human annotation or adjudication process described for the mechanical testing of a physical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical interbody fusion device.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

No, a standalone performance study (in the context of an algorithm) was not done. This document pertains to a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the device's technical performance is based on established engineering standards and material specifications. Specifically:

Mechanical Integrity: Compliance with ASTM F2077/F2267 as objective, quantitative benchmarks for intervertebral body fusion devices.
Material Composition: Conformance to ASTM F2026 for PEEK-OPTIMA LT1 polymer.
Substantial Equivalence: Comparison to the known characteristics (indications, materials, design principles) of existing, legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since there is no training set for an AI algorithm, there is no ground truth established for it.

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