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BEE HA 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 more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA 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 subject BEE HA Cage is an anterior cervical interbody fusion device. BEE HA Cage is manufactured from Hydroxyapetite (HA) Enhanced PEEK-OPTIMA™ HA Enhanced Optima. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. BEE HA implants are not to be used with any components from other manufacturers with the exception of use with autogenous and/or allogeneic bone graft.

This document is a 510(k) premarket notification for the BEE HA Cage, an intervertebral body fusion device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader performance study. The provided text discusses mechanical and biocompatibility testing for a medical implant, not an AI or diagnostic software.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study involving human readers with AI assistance. The document refers to:

• Mechanical testing according to ASTM F2077 and ASTM F2276.
• Biocompatibility evaluation based on ISO 10993-1.

These tests are standard for a physical medical implant to ensure its safety and performance. The document states that "All tests confirmed that the product met the predetermined acceptance criteria." However, it does not specify what those criteria were (e.g., specific load capacities, displacement limits for mechanical tests) or detail the results of these tests in a table as requested for an AI device.

To answer your specific questions in the context of an AI/human reader performance study, the document:

1. Does not provide a table of acceptance criteria and reported device performance for an AI system.
2. Does not discuss sample sizes for test sets, data provenance, or training sets in the context of an AI system.
3. Does not mention experts or adjudication methods for ground truth because it's not an AI diagnostic device.
4. Does not include information on MRMC comparative effectiveness studies or effect sizes for human readers with and without AI.
5. Does not discuss standalone algorithm performance.
6. Does not mention the type of ground truth used for an AI system.
7. Does not specify training set size or how ground truth was established for a training set (as these concepts are not applicable to this physical device submission).

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