(343 days)
BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic 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 two widths, one depth, seven heights, and three lordotic angles.
The provided document is a 510(k) summary for a medical device called "BEE Cages" (Cervical Cages), seeking to demonstrate substantial equivalence to a predicate device. It details product information, intended use, and a summary of non-clinical and clinical testing.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Safety | Equivalent or greater strength values compared to predicate and other devices cleared for cervical spine use. Tests performed according to ASTM F2077 and ASTM F2267. |
| Fusion Development | Lattice structure did not obstruct the development of fusion. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "non-clinical tests" and "clinical evidence" without specifying explicit test set sample sizes for the mechanical tests or the clinical evidence portion.
- Non-clinical (Mechanical) Tests: Performed on the BEE Cervical Cages. The sample size for these specific tests (ASTM F2077, ASTM F2267) is not explicitly stated, but these standards typically involve multiple samples to ensure statistical validity.
- Clinical Evidence: The document states that "Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the development of fusion." No details are given regarding the country of origin, whether it was retrospective or prospective, or the number of patients/cases involved in this clinical evidence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "clinical evidence" but does not detail how the ground truth for this evidence was established, nor the involvement or qualifications of experts in that process.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned in the document. The document focuses on demonstrating substantial equivalence through non-clinical mechanical testing and general clinical evidence related to fusion, not a comparative analysis of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical intervertebral body fusion device, not an AI algorithm. Therefore, a standalone algorithm performance study was not conducted.
7. The Type of Ground Truth Used
- Non-clinical (Mechanical) Tests: The "ground truth" for the mechanical tests is based on the results obtained from standardized ASTM test methods (ASTM F2077 for intervertebral body fusion devices and ASTM F2267 for measuring load-induced subsidence). The acceptance criteria are implicitly derived from these standards and comparison to predicate device performance.
- Clinical Evidence: The ground truth for the "clinical evidence" regarding fusion development is based on clinical outcomes reported in the evidence provided. The exact nature of this outcome data (e.g., imaging reports, surgical reports, patient follow-up) that confirmed fusion is not detailed beyond the statement itself. Pathology or direct outcomes data details are not specified.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical implant.
§ 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.