(107 days)
The Ayers Rock Cervical interbody fusion system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Ayers Rock Cervical interbody fusion devices are to be used with autogenous bone graft and implanted via an open, anterior approach. The Ayers Rock Cervical interbody fusion system is to be used with supplemental fixation.
The Avers Rock Cervical interbody fusion system consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical interbody fusion system is manufactured from PEEK-OPTIMA® LT1 polymer and contains tantalum radiopaque markers. The Ayers Rock Cervical interbody fusion system is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
This document is a 510(k) Premarket Notification from the FDA for the "Ayers Rock Cervical interbody fusion system." It describes the device, its indications for use, and the testing performed to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through mechanical testing. The specific performance requirements are derived from established ASTM standards and an industry norm.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Static Compression (ASTM F2077-14) | Met original performance requirements |
| Static Compression Shear (ASTM F2077-14) | Met original performance requirements |
| Static Torsion (ASTM F2077-14) | Met original performance requirements |
| Dynamic Compression (ASTM F2077-14) | Met original performance requirements |
| Dynamic Compression Shear (ASTM F2077-14) | Met original performance requirements |
| Dynamic Torsion (ASTM F2077-14) | Met original performance requirements |
| Subsidence (ASTM F2267-04, reapproved 2011) | Met original performance requirements |
| Expulsion testing (recognized industry norm) | Met original performance requirements |
| Bacterial Endotoxin Testing (USP34 and NF 29) | Performed (implies met, as no issues were reported that would prevent 510(k)) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific mechanical test (e.g., number of devices tested for static compression). It also does not mention the data provenance in terms of country of origin or whether the study was retrospective or prospective, as this is a materials/mechanical performance study, not a clinical study involving human subjects or medical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of device (interbody fusion system) in a 510(k) submission based on mechanical testing is established by adherence to recognized industry standards (ASTM) and a "recognized industry norm" for expulsion testing. Expert consensus on medical imaging or clinical outcomes is not relevant for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human interpretation of data where adjudication methods like 2+1 or 3+1 would be used. The acceptance is determined by meeting the specified mechanical and material performance criteria defined by the 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 is not a study involving human readers or AI. It is a mechanical performance study of an intervertebral body fusion device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-driven device. It is a physical medical implant.
7. The Type of Ground Truth Used
The ground truth used for this study is based on established engineering and material science standards and recognized industry norms. Specifically:
- ASTM F2077-14: Standard Test Methods for Intervertebral Body Fusion Devices.
- ASTM F2267-04 (reapproved 2011): Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
- USP34 and NF 29: United States Pharmacopeia and National Formulary standards for bacterial endotoxin testing.
- Recognized industry norm: For expulsion testing.
These standards define the expected performance characteristics for interbody fusion devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct mechanical and material testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device and study. The "ground truth" (i.e., acceptable performance levels) for the mechanical testing is established by the specified ASTM standards and industry norms.
§ 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.