(77 days)
The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. The system is comprised of devices of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist implant pullout.
The provided text describes the 510(k) summary for the DORADO™ Intervertebral Body Cage, a medical device. It does not contain information related to software/AI performance or studies involving human readers or expert consensus for ground truth. Therefore, I cannot fulfill all parts of your request as the information is not present in the provided document.
However, I can extract information related to the device's performance testing and acceptance criteria as described for this physical medical device.
Acceptance Criteria and Study for DORADO™ Intervertebral Body Cage
The provided document describes the mechanical performance testing of the DORADO™ Intervertebral Body Cage to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating an AI/software device. The "acceptance criteria" and "device performance" in this context refer to the mechanical properties and successful adherence to ASTM standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Static Compression | ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices" | Demonstrated comparable functional and performance characteristics to the predicate device. |
| Subsidence | ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" | Demonstrated comparable functional and performance characteristics to the predicate device. |
| Push-out Resistance | ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Methods for Intervertebral Body Fusion Devices." Draft #2 - August 29, 2000 | Demonstrated comparable functional and performance characteristics to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "Representative samples of the device were tested." Specifically, the "17mmx25mm device was selected for testing to support the addition of the 17mm device." This implies a limited number of devices were tested per dimension to represent the entire product line.
- Data Provenance: Not applicable in the context of clinical data. This refers to mechanical testing conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the study involved mechanical testing of a physical device, not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication Method
Not applicable for mechanical testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable as this is a physical medical device, not an AI/software diagnostic tool.
6. Standalone Performance
The testing performed was for the standalone mechanical integrity of the device against established ASTM standards. The results "demonstrate comparable functional and performance characteristics to the predicate device."
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. These standards define the acceptable mechanical properties and testing methodologies.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical performance testing of a finished medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.