(245 days)
BEE Cervical Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cervical Cages are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in various sizes and configurations to be accommodate for varying patient anatomy. The BEE Cervical Cages are fabricated using a Direct Metal Printing (DMP) via additive manufacturing (AM) process using Ti-6Al-4V ELI powder.
The provided text describes the regulatory clearance (K231371) for the BEE Cervical Cage, a medical device used for intervertebral body fusion. It outlines the device's indications for use, its technical specifications, and the rationale for its substantial equivalence to previously cleared devices.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on mechanical performance testing for the device. The reported performance is that the devices met the predefined acceptance criteria for each test. Specific numerical results are not provided in this regulatory summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Original Clearance (K200429): | |
| Compression per ASTM 2077-18 | Met predefined acceptance criteria. |
| Compression shear per ASTM 2077-18 | Met predefined acceptance criteria. |
| Torsion per ASTM 2077-18 | Met predefined acceptance criteria. |
| Subsidence per ASTM 2267-04 | Met predefined acceptance criteria. |
| Expulsion per ASTM 2267-04 | Met predefined acceptance criteria. |
| Subject Device (K231371 - Size Expansion): | |
| Dynamic compression shear per ASTM 2077-18 | Results met the predefined acceptance criteria. |
| Subsidence per ASTM 2267-04 | Results met the predefined acceptance criteria. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (number of devices) used for each mechanical test. The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset for an AI algorithm. The provenance of the data is from performance testing conducted by NGMedical GmbH. It is a retrospective evaluation of a device, where the testing is performed to demonstrate substantial equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The "ground truth" for this device is established through mechanical engineering standards (ASTM standards) and a comparison to predicate devices, not through expert human interpretation of data like in an AI/imaging study.
4. Adjudication method for the test set
This question is not applicable. Mechanical testing against industry standards (ASTM) does not involve adjudication methods like those used for expert consensus in medical image interpretation. The outcome is determined by whether the device meets the specified mechanical thresholds.
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 is not applicable. The device is a physical intervertebral fusion cage, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical implant, not an AI algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established mechanical engineering standards (ASTM) and a comparison to the performance of predicate devices. The device's safety and effectiveness are inferred by its ability to meet these standards and demonstrate substantial equivalence in design and performance to devices already cleared for market.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a physical medical device. The device's design is based on engineering principles and previous successful designs, not on machine learning training data.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
§ 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.