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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 HD LifeSciences HiveTM Stand-alone Anterior Lumbar Interbody System 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as stand-alone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation.

Hyperlordotic implants (20° and greater lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine.

The Hive™ Lumbar Interbody Fusion System is FDA cleared under K170676. This submission describes an addition to the Anterior IBFD configurations in which the device in combination with the provided screws would serve as a stand-alone interbody fusion device. This submission adds the Hive™ Stand-alone Anterior Lumbar Interbody System to the previously cleared system, which consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium conforming to ASTM F3001 using additive manufacturing technology. The implants of the Hive™ Stand-alone Anterior 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 Hive™ Stand-alone Anterior Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. Implants incorporate features for fixating the device to the vertebral body in a modular stand-alone manner using either interfixated features within the intervertebral space or outer plate fixation on the anterior surface of the vertebral bodies. Inter-fixation and outerfixation allow adjustable placement of fixation components utilizing screws and screw cover plates made from Ti-6A1-4V conforming to ASTM F136.

This document is a 510(k) premarket notification decision letter from the FDA regarding the "Hive™ Stand-alone Anterior Lumbar Interbody System." It is not a document detailing an AI/machine learning device. The core of this submission is about a mechanical interbody fusion device for spine surgery and its substantial equivalence to previously cleared predicate devices based on mechanical and biocompatibility testing.

Therefore, the requested information regarding acceptance criteria, study design for AI devices (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.

The document discusses:

• Device Name: Hive™ Stand-alone Anterior Lumbar Interbody System
• Regulation: 21 CFR 888.3080, Intervertebral Body Fusion Device, Class II
• Indications for Use: Degenerative Disc Disease (DDD) at L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, used with autograft/allograft bone and accompanying screws. Hyperlordotic implants require supplemental fixation.
• Predicate Devices: K170676 (HDLS Lumbar Interbody System), K180814 (M3 Stand-alone Anterior Lumbar System), K180502 (S128 ALIF System), K182195 (Arco-SA Lumbar Cage System).
• Performance Data: This section does not refer to clinical or AI-related performance. Instead, it lists mechanical and biocompatibility tests performed according to ASTM and ISO standards:
  • Static axial compression (ASTM F2077-18)
  • Static compressive shear (ASTM F2077-18)
  • Dynamic axial compression (ASTM F2077-18)
  • Dynamic compressive shear (ASTM F2077-18)
  • Static expulsion (ASTM Draft F-04.25.02.02)
  • Static subsidence (ASTM F2267-04)
  • Screw Pullout (ASTM F543-17)
  • Cytotoxicity (MEM Elution) (ISO 10993-5)
  • Bacterial endotoxins test (ANSI/AAMI ST72:2019)
• Conclusion: The device is substantially equivalent based on overall technology characteristics and mechanical performance data, not clinical data or AI performance.

To answer your request, if this were an AI device, this document does not contain the specific information you are looking for.

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