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Lumbar Spine:

The Bluefin™ Interbody Cages - Lumbar are indicated for use with autograft in patients with degenerative disc disease (DDD) at one level 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 I spondylolisthesis at the involved level(s). Bluefin™ Interbody Cages – Lumbar are intended to be used with supplemental spinal fixation systems, such as pedicle screws. Patients should be skeletally mature and have six (6) months of nonoperative therapy prior to treatment with an intervertebral cage.

Cervical Spine:

The Bluefin™ Interbody Cages - Cervical are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Bluefin™ Interbody Cages – Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft. Bluefin™ Interbody Cages – Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Bluefin™ Interbody System consists of a variety of hollow vertebral body spacers designed for use in the cervical and lumbar spine. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine and cervical spine. It is available in heights from 5 - 12mm

The Bluefin™ Interbody Cervical Cage was developed for anterior cervical fusion. It is available in various footprints from 14 x 12mm up to 17 x 14mm and at 0 and 7 degree lordosis. The cages are trapezoidal in shape and includes x-ray markers for positioning. The subject device is made in various lengths and are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance

The Bluefin™ Posterior Lumbar Interbody Cage (PLIF) were developed as an implant for the posterior stabilization of the lumbar spinal column. These cages feature a convex bullet nose design and an axial void designed to hold autograft material. The subject device is made in various lengths and are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 16mm in height and 23mm to 37mm in length. The width varies from 9 to 11mm.

The Bluefin™ Transforaminal Lumbar Interbody Fusion (TLIF).Cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Bluefin™ TLIF cage is a banana-shaped implant featuring a convex, bullet nose design and an axial void designed to hold autograft material. The subject device is made in various lengths and are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 16mm in height and footprints of 11 x 28 up to 13 x 37 mm. All the cages incorporate an A/P lordotic angle of 5 degrees.

The Bluefin™ Anteriar Lumbar Interbody Fusion (ALIF).Cage was developed as an implant for the anterior stabilization of the lumbar spinal column. The cages footprint is oval in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and resist expulsion. The devices range from 8mm to 22mm in height and footprints of 30 x 24 up to 47 x 30 mm. All the cages incorporate an A/P lordotic angle of 6 or 12 degrees.

The Bluefin™ Lateral Lumbar Interbody Fusion (LLIF).Cage was developed as an implant for a lateral approach to the lumbar spine. The cages footprint are rectangular in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and resist expulsion. The devices range from 8mm to 16mm in height and footprints of 18 x 50 up to 22 x 60 mm All the cages incorporate an A/P lordotic angle of 0 or 6 degrees.

The Bluefin" devices are manufactured from Medical Grade PEEK (Polyetheretherketone) Zeniva Polymer Solvay™ per ISO 10993-1 USP Class VI and ASTM F2026. The tantalum rods are manufactured from Grade UNS R05200 material according to ASTM F560.

"The provided document is a 510(k) premarket notification for the Bluefin™ Interbody System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

However, I can extract the acceptance criteria (performance tests) that were performed and confirm that the reported device performance, in this context, refers to the device being found ""substantially equivalent"" based on these tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This document describes a premarket notification for medical devices (510(k)), which typically relies on bench testing and comparisons to predicate devices for substantial equivalence, rather than clinical studies with test sets in the context of AI/software performance. Therefore, information regarding human test set sample sizes and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this document. The tests performed are mechanical and material tests in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. Ground truth in the context of device performance described here refers to meeting established engineering and material standards through laboratory testing, not medical expert consensus on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not the focus of this 510(k) submission.

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 information is not applicable or provided. The Bluefin™ Interbody System is a physical intervertebral fusion device, not an AI or software device that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. The Bluefin™ Interbody System is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on established engineering and material standards (e.g., ASTM standards F2077, F1839-08, F2267, ISO 10993-1, USP Class VI, ASTM F560) through laboratory testing. The objective is to demonstrate that the physical device's mechanical properties and material composition meet the requirements for its intended use and are comparable to predicate devices.

8. The sample size for the training set
This information is not applicable or provided. The device is a physical implant, not an AI model that requires a training set.

9. How the ground truth for the training set was established
This information is not applicable or provided. As mentioned, this is a physical medical device, not an AI model."

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