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The NanoHive Medical Lumbar Interbody System, with a microscopic roughened surface and micro and nano-scale features, is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone (hereafter bone graft).

The NanoHive Medical Lumbar Interbody System, including the Hive™ PL Interbody System, the Hive™ TL Interbody System, and the Hive™ AL Interbody System, consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. The interbody cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure. The NanoHive Medical Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the NanoHive Medical Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided pre-sterile, in validated sterile packaging, and are one-time use only.

The purpose of this submission is to additional implant size options and sterile packaging configurations to the system.

The provided text does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) premarket notification summary for the NanoHive Medical Lumbar Interbody System, which is a medical device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristics and mechanical performance testing.

Here's what can be extracted from the document regarding "performance data":

1. A table of acceptance criteria and the reported device performance

The document states:
"The NanoHive Medical Lumbar Interbody System has been tested in the following test modes:

• Static & Dynamic Axial Compression per ASTM F2077
• Static & Dynamic Compression Shear per ASTM F2077
• Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the NanoHive Medical Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

However, specific numerical acceptance criteria (e.g., minimum load resistance in Newtons) and the corresponding numerical performance values of the device are not provided. The document only states that the device's strength is "sufficient" and "substantially equivalent."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes mechanical performance testing, not typical clinical or AI performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of mechanical performance testing described and is therefore not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and is not provided.

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

An MRMC study was not conducted as this is a mechanical interbody fusion device, not an AI or imaging-based diagnostic/assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as there is no algorithm or AI component mentioned for the device. The "standalone" performance refers to the mechanical properties of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" would be the engineering specifications and test standards (ASTM F2077, ASTM F2267). The device's performance is compared against the requirements within these standards.

8. The sample size for the training set

This is not applicable as there is no mention of a "training set" for this mechanical device.

9. How the ground truth for the training set was established

This is not applicable.

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The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion 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). These patients should be skeletally mature and have six months of non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: bi-laterally in pairs via a posterior (PLIF) approach; as a single device via a transverse (T-PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach.

All Blustone Synergy Interbody Fusion System implant components are made of polyether-ether-ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.

The provided text is a 510(k) summary for the Blustone Synergy Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with statistical data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on demonstrating substantial equivalence to previously cleared devices through:

• Comparison of Indications for Use, Materials, and Geometry: Stating that these aspects are "all-inclusive of the subject device" compared to predicates.
• Performance Testing: Mentioning that mechanical testing (expulsion, dynamic compression per ASTM F2077, and wear debris analysis per ASTM F1877) has been performed and "the results have shown them to be substantially equivalent to the predicate interbody devices." It also notes an "engineering rationale" for new MAGMA small IBDs.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth details, adjudication methods, MRMC study information, or standalone algorithm performance, as this information is not present in the provided text.

The document concludes that "Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices," which is the central finding of a 510(k) submission. However, the specifics of these "test results" in terms of statistical metrics against predefined acceptance criteria are not detailed.

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