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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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The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.

The HD LifeSciences Cervical IBFD 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 provided text describes a medical device, the HD LifeSciences Cervical IBFD System, and its substantial equivalence to predicate devices, focusing on its mechanical performance. However, it does not include information on acceptance criteria for a study, reported device performance metrics in relation to those criteria, or details regarding study design, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence through technological characteristics and performance testing against industry standards for mechanical strength, rather than a clinical study evaluating diagnostic or treatment efficacy.

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The HD 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. The device must be used with supplemental fixation. 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.

The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD 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 HD 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 sterile.

The provided text describes a 510(k) premarket notification for the "HD Lumbar Interbody System," a medical device used in spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent effectiveness through clinical studies with acceptance criteria for device performance in terms of accuracy or efficacy in diagnosing/treating disease.

Therefore, many of the requested items related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software as a medical device (SaMD) are not applicable to this submission. This is a traditional hardware medical device.

However, I can extract information related to the performance testing that was done to demonstrate substantial equivalence.

Here's a breakdown of what is and is not applicable based on the provided text:

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

• Applicable, but not in the context of clinical accuracy: The acceptance criteria for this device relate to mechanical performance (strength, stability, etc.) rather than clinical outcomes or diagnostic accuracy.
• Reported Device Performance: The document states: "The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical results or direct comparisons to numerical acceptance criteria are not provided in this summary, but the conclusion of meeting these criteria is given.

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

• Not applicable for clinical data: This information is not provided as the submission relies on mechanical testing rather than clinical data from human subjects. The "sample size" would refer to the number of devices tested in the lab, which is not specified in this summary.

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)

• Not applicable: Ground truth in the context of expert review is relevant for diagnostic or AI-based devices. This device is an implant, and its "ground truth" for performance is based on standardized mechanical testing rather than expert clinical assessment of patient data.

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

• Not applicable: Adjudication methods are used to resolve discrepancies in expert labeling or diagnoses. This is not relevant for the mechanical testing performed on this device.

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

• Not applicable: This type of study is specific to AI-assisted diagnostic devices. The HD Lumbar Interbody System is a physical implant.

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

• Not applicable: This refers to the standalone performance of an AI algorithm, which is not relevant for this device.

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

• Applicable, but different context: The "ground truth" for this device's performance is defined by adherence to established ASTM (American Society for Testing and Materials) and other recognized standards for mechanical and biocompatibility testing. These standards define the acceptable range for forces, loads, and biological responses.

8. The sample size for the training set

• Not applicable: There is no "training set" in the context of an implant device relying on mechanical testing for 510(k) clearance based on substantial equivalence. This concept is relevant for machine learning/AI models.

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

• Not applicable: As there's no training set, this question is not relevant.

In summary: The provided document is for a traditional medical device (an interbody fusion cage) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. The primary evidence presented relates to non-clinical (mechanical and biological) performance testing against recognized industry standards, rather than clinical efficacy studies, diagnostic accuracy, or AI model performance benchmarks. Therefore, most of the questions relating to AI/SaMD acceptance criteria and study design are not applicable.

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