(112 days)
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.
Cervical Cage Acceptance Criteria and Study Details
The provided document describes the Eisertech, LLC Cervical Cage, an intervertebral fusion device. The acceptance criteria and supporting study are focused on the device's mechanical performance and substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Design Requirements) | Reported Device Performance |
|---|---|
| Maintain spacing between two vertebral bones following cervical discectomy until fusion occurs. | The device output data showed performance meeting or exceeding the design input requirements for all conditions. (Based on testing per ASTM F2077 - static axial compression, dynamic axial compression, static torsion, dynamic torsion, and ASTM F2267 - resistance to subsidence, and expulsion testing). The Cervical Cage performs at least as safely and effectively as a legally marketed predicate device. |
| Withstand biomechanical loads expected in the spine. | "Test results relative to those loading conditions (e.g. design output data) were compared to the design input criteria. The device output data showed performance meeting or exceeding the design input requirements for all conditions." (Specific load values or thresholds are not detailed in the provided text, but the general claim of meeting or exceeding is made). |
| Provide mechanical support and protect bone graft from excessive loads. | "The Cervical Cage is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur." (This is a statement of intended function based on the design, with the performance confirmation being the overall mechanical testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the mechanical testing of the Cervical Cage. The phrase "the Cervical Cage was tested" implies a singular or small number of devices were tested for each scenario.
- Data Provenance: The data is from prospective bench testing of the device prototypes, conducted by Eisertech, LLC. The "country of origin of the data" is not explicitly stated but can be inferred as the USA, where Eisertech, LLC is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of device and study. The "ground truth" for the mechanical performance of an implant like the Cervical Cage is established through objective, standardized biomechanical testing against defined loads and established material properties, not through expert human interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints (e.g., radiology reads). For biomechanical testing, the results are typically quantitative and objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images. The Cervical Cage is a surgical implant, and its evaluation focuses on its mechanical integrity and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the testing described is a standalone (algorithm only without human-in-the-loop performance). The "algorithm" in this context refers to the device itself and its inherent mechanical properties, which were tested objectively without human involvement in interpreting the results beyond reading the quantitative data.
7. The Type of Ground Truth Used:
- The ground truth used for this mechanical performance study is based on engineering design requirements and established biomechanical standards (ASTM F2077 and ASTM F2267). These standards define the parameters and methodologies for testing intervertebral body fusion devices, and the device's ability to "meet or exceed" these accepted engineering benchmarks serves as the "ground truth" for its mechanical fitness.
8. The Sample Size for the Training Set:
- This information is not applicable. The Cervical Cage is a physical medical device, not an AI or software algorithm that undergoes machine learning training. There is no concept of a "training set" in this context. The design of the device would have involved engineering principles and potentially iterative prototyping and testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and mechanical properties would be established through engineering calculations, material science, and the aforementioned ASTM 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.