Search Results
Found 2 results
510(k) Data Aggregation
(85 days)
P980048 S003, P960025, K072120
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.
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).
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.
Ask a specific question about this device
(102 days)
The VERTEBRON Interbody Fusion System is indicated for use 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 VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.
The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.
The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively.
The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The VERTEBRON Interbody Fusion System is an intervertebral body fusion device. The acceptance criteria and the study performed for this device are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Method |
|---|---|---|
| Conformity to ASTM F2077-03 for Interbody Fusion Devices (Mechanical Static and Dynamic Testing) | Meets mechanical performance requirements for interbody fusion devices | ASTM F2077-03: "Standard Test Methods for Intervertebral Body Fusion Devices" |
| Conformity to ASTM F2267 for Measuring Load Induced Subsidence | Meets load-induced subsidence resistance requirements | ASTM F2267: "Standard Test Methods for Measuring Load Induced Subsidence of an Interbody Fusion Device Under Static Axial Compression" |
| Material Specification: PEEK ASTM F2026-07e1 | Device comprised of PEEK conforming to ASTM F2026-07e1 | Material testing and documentation |
| Material Specification: Titanium Alloy (TI-6AI-4V) ASTM F136 | Not explicitly stated as used in this device's description, but acceptable if used. PEEK described as primary material due to radiolucent properties. | Material testing and documentation (if applicable) |
| Material Specification: Unalloyed Tantalum ASTM F560 (for markers) | Tantalum wire markers conforming to ASTM F560 are inserted. | Material testing and documentation |
| Implantation Approach Compatibility | Verified for use via anterior or posterior approach | Not a performance criteria directly, but an intended use parameter. |
| Compatibility with Supplemental Fixation Systems | Combined with cleared supplemental fixation systems (e.g., VERTEBRON PSS Pedicle Screw System) | Not a performance criteria for the device itself, but a condition of use. |
2. Sample Size for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with human subject data for efficacy or safety comparisons. The studies mentioned are primarily bench testing for mechanical properties.
- Sample Size: Not applicable for human data. For mechanical testing, the sample size would be determined by the ASTM standards (e.g., number of devices tested). This specific detail is not provided.
- Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated from laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The studies referenced are mechanical bench tests against established ASTM standards, not clinical studies requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a medical implant (interbody fusion system), not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. Standalone Performance Study
Yes, a standalone study in the context of mechanical performance was conducted. The device's mechanical properties were evaluated in a standalone manner (i.e., the device itself, without human interaction influencing performance in the test) against the specified ASTM standards. This is a "standalone" evaluation of the device's physical and mechanical characteristics.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device was based on widely accepted engineering and material standards (ASTM F2077-03 and ASTM F2267 for mechanical properties; ASTM F2026-07e1, ASTM F136, and ASTM F560 for material specifications). The device was evaluated against these predefined, objective standards for mechanical strength and material composition.
8. Sample Size for the Training Set
Not applicable. This device is an implanted medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation relies on engineering principles and bench testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component, there is no training set or ground truth required to be established for one.
Ask a specific question about this device
Page 1 of 1