(102 days)
The DORADO™ Wide 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 contiguous 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™ Wide 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™ Wide 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 contiguous 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 expulsion.
This submission (K091638) is for a spinal intervertebral body cage, a medical device, not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study components related to AI performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.
The "acceptance criteria" for this device are based on its substantial equivalence to previously cleared predicate devices and its compliance with relevant guidance documents and mechanical testing. The submission does not involve clinical data or AI performance metrics.
Here's a breakdown of the relevant information from the provided document, adapted to the context of a traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Basis for Equivalence |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate devices L2-S1, DDD, Grade I spondylolisthesis/retrolisthesis, posterior approach, autogenous bone graft, supplemental fixation, skeletally mature, 6 months non-operative treatment. | The Dorado™ Wide IBC has been shown to be substantially equivalent to predicate devices (K072289, P960025) in terms of indications for use. The stated intended use aligns with the predicate devices. |
| Technological Characteristics | Substantially equivalent to predicate devices in terms of function, operating principles, and materials. | Comparison of function, operating principles, and materials to K072289 and P960025 demonstrated substantial equivalence. |
| Materials | Materials are equivalent to those used in predicate devices. | Stated as equivalent to predicate devices. (Specific materials not detailed in summary, but assumed to be comparable to cleared devices). |
| Performance (Mechanical Testing) | Meets criteria defined in "Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007." | Demonstrated to meet criteria defined in the guidance document for Intervertebral Fusion Devices. |
| Regulatory Compliance | Compliance with 21 CFR 888.3080 (Intervertebral body fusion device) and Class II Special Controls. | The device was evaluated in accordance with the FDA Guidance Document and classified as Class II, product code MAX. Received 510(k) clearance, indicating compliance. |
Regarding the AI-specific questions, these are NOT APPLICABLE to this traditional medical device submission:
- 2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI performance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert-derived ground truth for AI.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI performance.
- 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 an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's acceptance is primarily regulatory compliance, comparison to predicate devices, and mechanical testing results, rather than clinical outcomes or diagnostic accuracy.
- 8. The sample size for the training set: Not applicable. No training set for an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm.
Summary of the Study that Proves Acceptance Criteria are Met:
The "study" in this context is the 510(k) Pre-Market Notification process itself, which focused on demonstrating substantial equivalence to legally marketed predicate devices and compliance with relevant mechanical testing standards and guidance.
- Basis for Substantial Equivalence: The primary "proof" for the Dorado™ Wide Intervertebral Body Cage was the comparison of its indications for use, technological characteristics (function, operating principles, materials), and performance (mechanical testing) against established predicate devices:
- K072289: SpineFrontier Inc., Dorado Intervertebral Body Cage
- P960025: Saber Lumbar I/F Cage and Jaguar Lumbar I/F Cage
- Guidance Document Compliance: The device was evaluated in accordance with the "FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007." Compliance with the criteria defined in this document, particularly regarding mechanical testing, served as a key component of demonstrating safety and effectiveness.
- Clinical Data: The submission explicitly states: "Clinical data was not required for this device." This reinforces that the acceptance was based on non-clinical evidence of substantial equivalence and adherence to recognized standards.
In essence, the device met its acceptance criteria by demonstrating that it is as safe and effective as existing legally marketed devices through a thorough comparison of its design, materials, and performance with those predicates, and by conforming to relevant FDA guidance.
§ 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.