When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.

When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA II anterior cervical plate systems if desired.

When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.

When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.

Device Description

The basic shape of the NUBIC device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the Signus TOSCA II anterior cervical plate if the surgeon so chooses.

The basic shape of the RABEA device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

AI/ML Overview

This is a medical device submission (510(k)) for the NUBIC™ and RABEA™ devices, which are spinal vertebral body replacement and intervertebral fusion devices. The FDA has determined the devices are substantially equivalent to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the typical sense of a performance study with metrics like sensitivity, specificity, or accuracy. This document is a 510(k) summary for a medical device. For devices like these (implants), "acceptance criteria" and "studies" usually refer to biocompatibility, mechanical testing (e.g., fatigue, compression, expulsion), sterilization validation, and often a demonstration of substantial equivalence to a predicate device. The provided text primarily focuses on the latter.

Here's an analysis of what information is available, formatted to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific quantitative acceptance criteria and performance data from a clinical trial or a machine learning model.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study testing a diagnostic algorithm or a similar device that would have a "test set" in the context of machine learning. The "testing" for these devices would be mechanical and biocompatibility testing, which are referenced indirectly through adherence to ASTM standards and substantial equivalence claims.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no mention of experts establishing a ground truth as would be relevant for a diagnostic or AI-driven device.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not applicable to an implantable medical device like a spinal cage.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of typical AI/diagnostic device evaluation. For this type of device, ground truth would be related to biocompatibility (e.g., validated materials), mechanical integrity (e.g., strength, durability against specified loads), and clinical outcomes (e.g., fusion rates, adverse events), none of which are detailed in this summary. The "ground truth" for substantial equivalence is that the device's design, materials, and intended use are equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device Acceptance and "Study" Information from the Provided Text:

The "study" or justification for acceptance of the NUBIC™ and RABEA™ devices is based on demonstrating "Substantial Equivalence" to previously cleared predicate devices.

The key points from the provided text regarding this:

Substantial Equivalence Basis: "Documentation was provided which demonstrated the NUBIC to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance." (Identical text is provided for both NUBIC and RABEA devices).
Material Standards: The devices are made of materials conforming to ASTM standards (PEEK-OPTIMA® LT1, Invibio™ as described by ASTM F2026; titanium alloy (Ti-6Al-4V) as described by ASTM F136). Adherence to these standards implies certain material performance characteristics have been met, often acting as "acceptance criteria" for material properties.
FDA Determination: The FDA reviewed the 510(k) submission and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Therefore, the acceptance criteria primarily revolved around demonstrating that the new devices (NUBIC and RABEA) are as safe and effective as existing legally marketed devices, by showing equivalence in:

Basic design
Intended use
Indications for use
Anatomic sites
Performance (implied through design, materials, and comparison to predicates)

The "study" proving this is the submission of documentation for substantial equivalence, which would include detailed comparisons to predicate devices and evidence of material conformity to relevant ASTM standards. These documents are not fully provided here, but their successful review by the FDA constitutes the acceptance.

Summary

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K0 82848 page 1 of Z

510(k) Summary
Sponsor:	JUL 2 4 2009SIGNUS Medizintechnik GmbHCarl-Zeiss-Strasse 2D-63755 Alzenau, GERMANY
	Tel + 49 (0) 6023 9166-136Fax + 49 (0) 6023 9166-161Url: http://www.signus-med.de
Contact Person:	Jörg Degen, Regulatory Affairs, QM
Proposed Trade Name:	NUBIC™ device
Device Classification	Class II
Classification Name:	Spinal vertebral body replacement device; Intervertebral fusion device withbone graft, cervical
Regulation:	888.3060; 888.3080
Device Product Code:	MQP; ODP
Device Description:	The basic shape of the NUBIC device is a rectangular frame. The upper andlower aspects of the implant are open with surface spikes which assist in thepositive anchorage and seating of the implant between the superior andinferior vertebral bodies. The device is available in a variety of sizesenabling the surgeon to choose the size best suited to the individualpathology and anatomical condition. A connecting screw is available whichpermits attachment of the NUBIC (without strut) to the Signus TOSCA IIanterior cervical plate if the surgeon so chooses.
Intended Use:	When used as a vertebral body replacement, the NUBIC devices areindicated for use in skeletally mature patients to replace a vertebral bodythat has been resected or excised due to tumor or trauma/fracture. Thedevice is intended for use in the thoracolumbar spine (from T1 to L5) and isintended for use with supplemental internal fixation. The NUBIC devicemay be implanted singularly or in pairs and may be used with allograft orautograft.
	When used as an intervertebral fusion device, the NUBIC devices areintended for use in skeletally mature patients at one level in the cervicalspine, from C3 to T1, for the treatment of cervical disc disease (defined asneck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies). The cervical device is to be used inpatients who have had six weeks of non-operative treatment. The devicesare designed for use with autograft to facilitate fusion and intended for usewith supplemental internal fixation. One NUBIC device is used perintervertebral space. A connecting screw is available which allows theNUBIC device (without strut) to be physically attached to the SIGNUSTOSCA or TOSCA II anterior cervical plate systems if desired.
Materials:	The NUBIC device is manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral markerpins in the implants and the connecting screw are manufactured fromtitanium alloy (Ti-6Al-4V) as described by ASTM F136.
SubstantialEquivalence:	Documentation was provided which demonstrated the NUBIC to besubstantially equivalent to previously cleared devices. The substantialequivalence is based upon equivalence in basic design, intended use,indications, anatomic sites and performance.

()

and the state of the state of the states and

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K082848 Page 2 of Z

510(k) Summary
Sponsor:	SIGNUS Medizintechnik GmbHCarl-Zeiss-Strasse 2D-63755 Alzenau, GERMANYTel. + 49 (0) 6023 9166-136Fax + 49 (0) 6023 9166-161Url: http://www.signus-med.de
Contact Person:	Jörg Degen, Regulatory Affairs, QM
Proposed Trade Name:	RABEA™ device
Device Classification	Class II
Classification Name:	Spinal vertebral body replacement device; Intervertebral fusion device withbone graft, cervical
Regulation:	888.3060; 888.3080
Device Product Code:	MQP; ODP
Device Description:	The basic shape of the RABEA device is a rectangular frame. The upperand lower aspects of the implant are open with surface spikes which assistin the positive anchorage and seating of the implant between the superiorand inferior vertebral bodies. The device is available in a variety of sizesenabling the surgeon to choose the size best suited to the individualpathology and anatomical condition.
Intended Use:	When used as a vertebral body replacement, the RABEA devices areindicated for use in skeletally mature patients to replace a vertebral bodythat has been resected or excised due to tumor or trauma/fracture. Thedevice is intended for use in the thoracolumbar spine (from T1 to L5) and isintended for use with supplemental internal fixation. The RABEA device isintended to be implanted in pairs and may be used with allograft orautograft.When used as an intervertebral fusion device, the RABEA devices areintended for use in skeletally mature patients at one level in the cervicalspine, from C3 to T1, for the treatment of cervical disc disease (defined asneck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies). The cervical device is to be used inpatients who have had six weeks of non-operative treatment. The devicesare designed for use with autograft to facilitate fusion and intended for usewith supplemental internal fixation. One RABEA device is used perintervertebral space.
Materials:	The RABEA device is manufactured from either titanium alloy (Ti-6Al-4V)as described by ASTM F136 or polyetheretherketone (PEEK-OPTIMA®LT1, Invibio™) as described by ASTM F2026. Integral marker pins in thePEEK implants are manufactured from titanium alloy (Ti-6Al-4V) asdescribed by ASTM F136.
SubstantialEquivalence:	Documentation was provided which demonstrated the RABEA to besubstantially equivalent to previously cleared devices. The substantialequivalence is based upon equivalence in basic design, intended use,indications, anatomic sites and performance.

. . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIGNUS Medizintechnik GmbH % Dr. Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, OH 44026-2141

Re: K082848

Trade/Device Name: NUBIC™ and RABEA™ Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: July 22, 2009 Received: July 23, 2009

JUL 2 4 2009

Dear Dr. Warden:

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. 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.

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 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 (reporting of medical of it rate of your may (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Karen E. Warden

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Harbare frels

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K08 2848 Page 1 of 2

Indications for Use Statement

510(k) Number:

Device Name: NUBIC device

Indications for Use:

When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ea
(EXT for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082848

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K082848 page 2 of

Over-the-Counter Use

Indications for Use Statement

510(k) Number:

Device Name: RABEA device

Indications for Use:

When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.

Prescription Use X (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

En (Ext for Mux)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_に08ことよ48

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.