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.

Device Description

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.

AI/ML Overview

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.

Summary

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December 12, 2022

NanoHive Medical LLC % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K223190

Trade/Device Name: Hive™ Standalone Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 12, 2022 Received: October 13, 2022

Dear Nathan Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223190

Device Name Hive™ Standalone Cervical System

Indications for Use (Describe)

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 pror to treatment with 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 screws.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Submitter's Name:	NanoHive Medical LLC
Submitter's Address:	12 Gill Street, Suite 4500Woburn, Massachusetts 01801
Submitter's Telephone:	844-943-5433
Contact Person:	Nathan Wright MSEmpirical Technologies1-719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	October 12, 2022
Trade or Proprietary Name:	Hive™ Standalone Cervical System
Classification Name:	Intervertebral Fusion Device with Integrated Fixation, CervicalIntervertebral Fusion Device with Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE, ODP
Classification Panel:	Orthopedic Devices – Spinal Devices (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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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.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

. Indications for Use
Principle of Operation ●
Structural Support Mechanism ●
Materials ●
. Sterility
. Sizes
Manufacturing and Biocompatibility ●

510kNumber	Trade or Proprietary or Model Name	Manufacturer	Product Code	PredicateType
K212904	SeaSpine WaveForm™ C Interbody System	SeaSpine OrthopedicsCorporation	OVE, ODP	Primary
K212853	Cervical Stand-Alone System	Eminent Spine, LLC	OVE	Additional
K190885	Elevation Spine Saber-C System	Elevation Spine	OVE, ODP, KWQ	Additional
K200541	Hive™ Stand-alone Anterior LumbarInterbody System	HD LifeSciences	OVD, MAX	Reference

Performance Data

The Hive™ Standalone Cervical System has been tested in the following test modes:

. Static and Dynamic Axial Compression per ASTM F2077
Static and Dynamic Compression Shear per ASTM F2077 ●
Static and Dynamic Torsion per ASTM 2077 ●
Subsidence per ASTM F2267 .
. Expulsion

The results of this non-clinical testing show that the strength of the Hive™ Standalone Cervical System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Hive™ Standalone Cervical System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.