(60 days)
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous 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 standalone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation.
When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screw.
The Hive™ Standalone Cervical System consists of additively manufactured interbody fusion cages made from Ti-6Al-4V per ASTM F3001 and screws and plates made from Ti-6Al-4V per ASTM F136. The titanium cages take 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. Implants incorporate features for fixating the device to the vertebral body in a 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 outer-fixation allow adjustable placement of fixation components.
The implant components of the Hive™ Standalone Cervical System are offered in a variety of sizes to accommodate patient anatomy and surgical approach. The implants 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 single-use only.
The provided document is a 510(k) summary for the NanoHive Medical LLC Hive™ Standalone Cervical System. It describes the device, its indications for use, and a summary of performance data comparing it to predicate devices. However, it does not contain a detailed study proving acceptance criteria are met for AI/ML device performance. The "Performance Data" section specifically mentions non-clinical testing (mechanical tests) to demonstrate substantial equivalence to predicate devices, focusing on the physical strength and stability of the implant.
Therefore, many of the requested sections regarding AI/ML device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, cannot be extracted from this document because it describes a medical implant (an intervertebral body fusion device), not an AI/ML-driven diagnostic or therapeutic device.
Here's an attempt to answer the questions based on the available information regarding the medical device itself (the physical implant), while noting what is not applicable for AI/ML:
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are implicitly demonstrating substantial equivalence to predicate devices through various mechanical tests, as outlined in the "Performance Data" section. There are no explicit quantitative acceptance criteria thresholds provided in this summary, but the conclusion states that the device's strength is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in mechanical strength and stability sufficient for intended use. | Tested in the following modes, showing sufficient strength for intended use and substantial equivalence to legally marketed predicate devices: |
- Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Compression Shear per ASTM F2077
- Static and Dynamic Torsion per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion |
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 applicable as the document describes mechanical testing of a physical implant, not a study involving human or image data for AI/ML performance. The "sample size" would refer to the number of devices tested in the cited ASTM standards, which is not detailed here.
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 is not applicable. Ground truth, in the context of mechanical testing, would be defined by the physical properties and performance parameters measured according to the specified ASTM standards, not by expert consensus in a clinical or diagnostic setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document refers to mechanical testing of a physical implant.
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 as the document does not describe an AI/ML device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document does not describe an AI/ML algorithm. The term "Standalone" in the device name refers to the implant's ability to be used without supplemental fixation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the measured physical properties and performance characteristics as determined by standardized laboratory tests adhering to ASTM specifications (e.g., F2077, F2267). This is an objective, quantitative measure rather than an expert opinion, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable as the document does not describe an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the document does not describe an AI/ML device requiring a training set.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.