(114 days)
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
The Aesculap CeSpace PEEK Spinal Implant System is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).
The provided text describes the regulatory clearance for the Aesculap CeSpace PEEK Spinal Implant System, which is a medical device. As such, the "acceptance criteria" and "device performance" discussed here refer to the mechanical and material performance of the implant, not to the performance of an AI-powered diagnostic device or algorithm. Therefore, many of the questions regarding AI-specific criteria (like AI-assisted improvement, standalone AI performance, training set details, or ground truth for diagnostic imaging) are not applicable to this document.
Here's an analysis of the provided text based on the questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Static testing per ASTM F2077 | Performed in accordance with ASTM F2077 |
| Dynamic testing per ASTM F1717 | Performed in accordance with ASTM F1717 |
| FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Recommendations | Testing performed as recommended by this guidance document |
| Material: PEEK-Optima | Manufactured from PEEK-Optima (per ASTM F2026) |
| Equivalence in shapes and sizes | Offered in the same range of shapes and sizes as predicate devices |
| Equivalence in materials | Material used is the same as that used to manufacture predicate devices |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. For mechanical testing of medical implants, the "test set" would refer to the physical implants or simulated constructs tested. The text only states that static and dynamic testing was "performed."
3. 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)
This information is not applicable to this type of device and testing. "Ground truth" in this context would refer to the established mechanical properties of the material and the device's ability to withstand forces, which are determined by engineering standards and laboratory testing, not by expert consensus in a clinical or image interpretation setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and testing. Adjudication methods typically relate to disagreements in human interpretation of data, which is not relevant for mechanical testing.
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
This information is not applicable as this is a physical medical implant, not an AI-powered diagnostic system.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable as this is a physical medical implant, not an AI-powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for proving its performance is established by engineering standards and specifications. Specifically:
- ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices
- ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (possibly, or a related standard for spinal fixation)
- ASTM F2026: Standard Specification for PEEK polymers (for material compliance)
- FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device: This document outlines specific recommendations and acceptance criteria for testing these devices.
The device's performance is measured against these established mechanical and material property standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical implant, not an AI model.
9. How the ground truth for the training set was established
This information is not applicable. This is a physical medical implant, not an AI model.
§ 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.