(184 days)
MEDICREA® INTERNATIONAL IB3D ALIF device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IB3D ALIF Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.
The provided text is a 510(k) premarket notification for a medical device called "IB3D ALIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial with defined acceptance criteria and human reader studies (MRMC studies).
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, and other specifics typically found in studies proving a device meets such criteria (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, training set details).
The requested information is not available in the provided text because this is a 510(k) submission for a physical implant (an intervertebral body fusion device), not a software or AI-driven diagnostic device.
Here's an explanation of why the requested information is absent and what is typically provided in a 510(k) for a physical device:
- Acceptance Criteria and Device Performance (Table): Not applicable in the context of AI software. For this device, "performance" relates to mechanical strength, biocompatibility, and intended function as an intervertebral body fusion device, which are tested against standards like ASTM F2077 and F2267. The document states "no new worse-case implant was created" by FEA, and expulsion testing was conducted, but specific pass/fail criteria or detailed results are not explicitly listed in this summary.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (for test set), Training Set Details: These questions are specifically relevant to the evaluation of AI or imaging diagnostic software. The IB3D ALIF is a physical implant. Its evaluation for 510(k) clearance primarily involves:
- Mechanical Testing: Such as finite element analysis (FEA) and expulsion testing to ensure the device can withstand forces and maintain placement.
- Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
- Materials Comparability: Demonstrating the materials are the same as previously cleared predicate devices.
- Indications for Use Comparability: Showing the device is intended for the same patient population and conditions as predicate devices.
- Sterilization Validation: Ensuring the device can be sterilized effectively.
In summary, the provided document relates to a physical medical device (an implant) and not an AI or software-based diagnostic tool. As such, the concept of "acceptance criteria" and "studies" as understood for AI/software in the prompt are not relevant to this 510(k) submission.
§ 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.