The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.

AI/ML Overview

The provided document is a 510(k) summary for the "Blue Topaz Sacroiliac Screw System" which is a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI-assistance. Therefore, I cannot provide details on most of the requested points, as they are specific to AI/ML device evaluations.

However, I can extract information related to the device's performance data based on non-clinical testing.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that the device was tested to demonstrate its strength for its intended use and substantial equivalence to predicate devices. However, specific numerical acceptance criteria and reported performance values are not explicitly stated in the provided text. It only lists the types of tests performed.

Acceptance Criteria	Reported Device Performance
Not explicitly stated (implied: sufficient strength for intended use and substantial equivalence to predicates)	"The results of this non-clinical testing show that the strength of the Blue Topaz Sacroiliac Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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 non-clinical mechanical testing of a physical medical device, not a study involving a test set of data or human subjects.

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 information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Ground truth, in the context of expert review, is not relevant for this type of evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Adjudication methods are typically used in clinical studies or expert reviews.

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 information is not applicable as the document describes a physical medical device (sacroiliac screw system) and its non-clinical mechanical testing. There is no mention of AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the document describes a physical medical device and its mechanical performance, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as the document describes non-clinical mechanical testing. The "ground truth" for mechanical performance would be the direct measurement outcomes from the specified ASTM standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set involved.

9. How the ground truth for the training set was established

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set or ground truth in that context.

Summary of available information regarding the device itself (not AI/ML related):

The Blue Topaz Sacroiliac Screw System underwent the following non-clinical (mechanical) tests:

Static and Dynamic Cantilever Bending per ASTM F2193
Driving Torque per ASTM F543
Static Torsion per ASTM F543
Pullout per ASTM F543

The conclusion from this testing was that the device's strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

Summary

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March 1, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osseus Fusion Systems, LLC % Mr. Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K213590

Trade/Device Name: Blue Topaz Sacroiliac Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 28, 2022 Received: January 31, 2022

Dear Mr. 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 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

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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,

for

Colin O'Neill, M.B.E. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement on last page.
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Indications for Use

510(k) Number ( if known )	K213590
Device Name
Blue Topaz Sacroiliac Screw System
Indications for Use ( Describe )
The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion forconditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)

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Submitter's Name:	Osseus Fusion Systems, LLC
Submitter's Address:	1931 Greenville Ave, Suite 200Dallas, Texas 75206
Submitter's Telephone:	888-330-5960
Contact Person:	Nathan Wright MSEmpirical Testing Corp.1-719-351-0248nwright@empiricaltech.com
	Image: Empirical Testing Corp. Logo
Date Summary was Prepared:	November 11, 2021
Trade or Proprietary Name:	Blue Topaz Sacroiliac Screw System
Common or Usual Name:	Sacroiliac Joint Fixation
Classification:	Class II per 21 CFR §888.3040
Product Code:	OUR
Classification Panel:	Orthopedic Devices – Spinal Devices (DHT6B)

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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
Materials of manufacture .
Structural support mechanism ●
Size ●

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Predicate Devices

510k #	Trade or Proprietary or Model Name	Manufacturer	Product Code	Type
K152237	Entasis™ Dual-Lead Sacroiliac Implant	CoreLink, LLC	OUR	Primary
K181881	Outlet Sacroiliac Joint Fusion System	SIJ Surgical	OUR	Additional
K121148	SAMBA™ Screw System	Medical Designs LLC	HWC, OUR	Additional

Performance Data

The Blue Topaz Sacroiliac Screw System has been tested in the following test modes:

Static and Dynamic Cantilever Bending per ASTM F2193 ●
Driving Torque per ASTM F543 .
Static Torsion per ASTM F543 ●
Pullout per ASTM F543 .

The results of this non-clinical testing show that the strength of the Blue Topaz Sacroiliac Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Blue Topaz Sacroiliac Screw System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.