K Number

Device Name

Manufacturer

SIGNUS MEDICAL

Date Cleared

2009-09-18

(154 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The DIANA™ Fusion Cage is intended for interbody fusion procedures and 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 device is intended to 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.

Device Description

The DIANA™ Fusion Cage is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIANA™ Fusion Cage.

Unfortunately, the provided document does not contain the detailed clinical study data or acceptance criteria that would typically be found in a performance study report for a medical device submitted for 510(k) clearance. The information provided is a 510(k) summary and the FDA's clearance letter.

A 510(k) relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring new clinical trials that establish specific performance metrics against pre-defined acceptance criteria. Therefore, the information you're asking for regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is generally not present in a 510(k) submission of this nature.

Based on the provided text, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Acceptance Criteria Category	Specific Metric/Description (Expected/Inferred)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Mechanical Performance	- Static Compression Strength: Ability to withstand axial loads without failure. - Dynamic/Fatigue Compression: Ability to withstand cyclic loading over time without failure or significant deformation. - Subsidence Resistance: Ability to resist sinking into the vertebral endplates.	"The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use." This implies that mechanical testing results met or exceeded the performance of the predicate devices based on established ASTM/ISO standards for interbody fusion devices.
Material Biocompatibility	- Cytotoxicity: Non-toxic to cells. - Sensitization/Irritation: No adverse skin reactions. - Systemic Toxicity: No harmful systemic effects.	Implied to be equivalent due to using "medical grade titanium alloy (Ti6Al4V-ELI)," which is a well-established and biocompatible material for implants.
Anatomical Fit/Design	- Range of sizes to accommodate various anatomies. - Design features for stability and insertion.	"comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation." Implied to be comparable to predicate devices in terms of its design for anatomical fit and surgical technique.

Study Details (Based on Provided Text)

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document states "pre-clinical testing." This typically refers to benchtop mechanical and material testing, not clinical studies with patient test sets. Therefore, there's no patient sample size, data provenance, or retrospective/prospective information mentioned.
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):
- N/A. For pre-clinical, benchtop testing, ground truth is established by engineering standards and validated testing protocols, not typically by medical experts in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept is relevant for clinical studies involving expert reviews or assessments, which were not conducted or reported in this 510(k) summary.
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:
- No. This device is an interbody fusion cage, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is completely irrelevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As above, this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For pre-clinical mechanical testing, the "ground truth" would be established by validated engineering standards (e.g., ASTM F2077 for intervertebral body fusion devices) and material specifications. The performance is judged against these quantifiable structural integrity and material properties.
The sample size for the training set:
- N/A. There is no "training set" in the context of an interbody fusion cage's pre-clinical testing. This term applies to machine learning or AI models.
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary of Device Performance Claim:

The core of the K091122 submission relies on demonstrating substantial equivalence to four previously cleared predicate devices:

BAK Interbody Fusion Device (P950002)
Inter Fix Threaded Fusion Device (P970015)
Ray Threaded Fusion Cage (P950019)
Brantigan Cage (P960025)

The document explicitly states: "The DIANA™ Fusion Cage was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." It further mentions: "The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use."

This means that the testing performed (primarily mechanical and material characterization) indicated that the DIANA™ Fusion Cage performs similarly to or better than the predicate devices, meeting the necessary safety and performance requirements for its intended use, without requiring new clinical efficacy data.

Summary

{0}------------------------------------------------

K091122

SEP 1 8 2009

4. 510(k) Summary according to 807.92(c)

Contact:

Thomas Hoghaug Signus Medical 18888 Lake Drive East Chanhassen, MN 55317 952-294-8700

Trade Name: Product Class: Classification: Product Codes: Panel Code:

DIANATM Fusion Cage Class II 21 CFR §888.3080 Orthosis, intervertebral fusion MAX 87

Indications for Use:

Device Description:

Predicate Device(s):

The DIANA™ Fusion Cage was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. . The four formerly Class III predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025).

Performance Testing:

The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The symbol is positioned to the right of the text.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 1 8 2009

Signus Medical % MCRAPPD Medical Device Rich Jansen, Pharm.D. 1331 H Street Northwest, Suite 1200 Washington, District of Columbia 20005

Re: K091122

Trade/Device Name: The DIANA™ Fusion Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 27, 2009 Received: August 5, 2009

Dear Mr. Jansen:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{2}------------------------------------------------

Page 2 - Rich Jansen, Pharm.D.

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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Harbare Buckins

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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3. Statement of Indications for Use

510(k) Number (if known): _KO91122

Indications for Use:

The DIANA™ Fusion Cage is intended for interbody fusion procedures and 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 is intended to 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.

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Kareem S. Roney for MXM
(Division Sign-Off)

Division of Stagical, Orthopedic, and Restorative Devices

510(k) Number K091122

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A