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The Ventana® A Anterior Lumbar Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Ventana® A Anterior Lumbar System is intended for patients who have had at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

The Ventana® A Anterior Lumbar Interbody System may be used as a standalone device when used with three integrated fixation screws and has a lordotic angle of 20° or less. When an interbody device with fewer than three screws is used, supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

The Ventana® A Anterior Lumbar Interbody System is an integrated intervertebral body fusion device for use in lumbar spinal surgery. Ventana® A Anterior Lumbar Interbody System devices are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The devices include a lid which further facilitates the installation of bone graft.

The interbody devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001 and machined titanium alloy (Ti-6Al-4V ELI) components conforming to ASTM F136. The interbody device includes three screw holes to accept bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems.

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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.

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.

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