BEE HA Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

Device Description

The subject BEE HA Cage is an anterior cervical interbody fusion device. BEE HA Cage is manufactured from Hydroxyapetite (HA) Enhanced PEEK-OPTIMA™ HA Enhanced Optima. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. BEE HA implants are not to be used with any components from other manufacturers with the exception of use with autogenous and/or allogeneic bone graft.

AI/ML Overview

This document is a 510(k) premarket notification for the BEE HA Cage, an intervertebral body fusion device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader performance study. The provided text discusses mechanical and biocompatibility testing for a medical implant, not an AI or diagnostic software.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study involving human readers with AI assistance. The document refers to:

Mechanical testing according to ASTM F2077 and ASTM F2276.
Biocompatibility evaluation based on ISO 10993-1.

These tests are standard for a physical medical implant to ensure its safety and performance. The document states that "All tests confirmed that the product met the predetermined acceptance criteria." However, it does not specify what those criteria were (e.g., specific load capacities, displacement limits for mechanical tests) or detail the results of these tests in a table as requested for an AI device.

To answer your specific questions in the context of an AI/human reader performance study, the document:

Does not provide a table of acceptance criteria and reported device performance for an AI system.
Does not discuss sample sizes for test sets, data provenance, or training sets in the context of an AI system.
Does not mention experts or adjudication methods for ground truth because it's not an AI diagnostic device.
Does not include information on MRMC comparative effectiveness studies or effect sizes for human readers with and without AI.
Does not discuss standalone algorithm performance.
Does not mention the type of ground truth used for an AI system.
Does not specify training set size or how ground truth was established for a training set (as these concepts are not applicable to this physical device submission).

Summary

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March 18, 2021

NGMedical GmbH % Ms. Christine Scifert Partner MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112

Re: K203444

Trade/Device Name: BEE HA Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 15, 2021 Received: February 22, 2021

Dear Ms. Scifert:

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 medical devices and radiation-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,

for

Brent L. 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) K203444

Device Name BEE HA Cage

Indications for Use (Describe)

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

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510(k) Summary BEE HA Cage 15 February 2021

Company:	NGMedical GmbHTalsperrenblick 566620 NonnweilerGERMANY+49 6873 99997-100
Company Contact:	Stella Hahn – Head of Regulatory Affairs+49 6873 99997-100
Official Correspondent:	Christine Scifert – MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053
Trade Name:	BEE HA Cage
Common Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral body fusion device)
Panel:	Orthopedic
Product Code:	ODP

Device Description:

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Indications for Use:

Substantial Equivalence:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate: Meditech Spine, LLC – Talos®-C (HA) Cervical Intervertebral Body Fusion Devices – K142345

Secondary Predicates: Globus Medical Inc. - PATRIOT® COLONIAL® Spacer - K173722 Exactech, Inc. (Choice Spine) - Ascendant™ Cervical Spacer System - K150130 NG Medical - BEE Cervical Cage - K200429

The subject and predicate devices are similar in Intended Use, Technological Characteristics, Performance Specifications, and Material.

Therefore, it can be concluded that the subject BEE HA Cage does not raise new questions of safety and effectiveness when compared to the predicate devices.

Performance Testing:

In accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", a biocompatibility evaluation was performed.

Mechanical testing was performed according to ASTM F2077 and ASTM F2276. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical bench performance testing demonstrated that the BEE HA Cages is substantially equivalent to previously cleared devices.

Conclusion:

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.

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.