The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

Device Description

The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Summary)
Similar intended use	"similar intended uses"
Same materials	"fabricated from the same material as the predicate devices"
Similar design features/functions	"share similar basic design features and functions"
Dimensionally similar	"dimensionally similar to cited predicate devices"
Sterilization method (non-sterile)	"supplied non-sterile and cited predicate devices are non-sterile"
Non-inferior mechanical performance	"Showed as good or better performance to the cited predicate devices under the same test conditions."

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

Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.

4. Adjudication Method:

Not applicable.

5. MRMC Comparative Effectiveness Study:

Not applicable. No clinical studies involving human readers or AI assistance were performed.

6. Standalone Performance Study:

Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.

7. Type of Ground Truth Used:

Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.

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

Not applicable.

Summary

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October 29, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osseus Fusion Systems % J.D.Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K192121

Trade/Device Name: Black Diamond Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 31, 2019 Received: August 6, 2019

Dear Mr. Webb:

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.

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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 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 (OS) 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

Ronald Jean, Ph.D. Acting 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) K192121

Device Name

Black Diamond Pedicle Screw System

Indications for Use (Describe)

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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K192121 510(k) Summary: Black Diamond Pedicle Screw System

Date Prepared	July 31, 2019
Submitted By	Osseus Fusion Systems, LLC2703 W. Mockingbird Ln., Ste. #102Dallas, TX 75204
Primary Contact	J.D. Webb4313 W. 3800 S.West Haven, UT 84401512-590-5810 Telee-mail: jdwebb@orthomedix.net
Trade Name	Black Diamond Pedicle Screw System
Common Name	pedicle screw system
Classification Name	Thoracolumbosacral Pedicle Screw SystemPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Class	ll
Product Code	NKB
CFR Section	21 CFR section 888.3070
Device Panel	Orthopedic
Primary PredicateDevice	INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/K153453)
Secondary PredicateDevices	Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810)Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007)Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381)Savannah-T Dual Fix, Amendia (K132925)
Reference PredicateDevices	Synergy VLS - open, Cross Medical Products (K940631 / K950099)Moss Miami SS, DePuy Spine (K950697)Rogozinski, Smith & Nephew Richards (K954696)
Device Description	The Black Diamond Pedicle Screw System is a top loading, multiple component,posterior spinal fixation system which consists of pedicle screws, rods, and cross links.All the components are available in a variety of sizes to match more closely the patient'sanatomy
Materials	Ti-6Al-4V per ASTM F136CoCr per ASTM F1537
Intended Use	Black Diamond Pedicle Screw System is intended to provide immobilization andstabilization of spinal segments until fusion is accomplished
SubstantialEquivalence Claimedto Predicate Devices	The Black Diamond Pedicle Screw System is equivalent to the predicate devices interms of intended use, design, materials used, mechanical safety and performances.
Indications for Use	The Black Diamond Pedicle Screw System, with or without MIS instrumentation, isintended to provide immobilization and stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of the following acute and chronicinstabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies), degenerative spondylolisthesis with objective evidenceof neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis,kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the BlackDiamond Pedicle Screw System implants are indicated as an adjunct to fusion to treat
	progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathicscoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the BlackDiamond Pedicle Screw System is intended to treat pediatric patients diagnosed withspondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis,and/or failed previous fusion. This system is intended to be used with autograft and/orallograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseThe Black Diamond Pedicle Screw System and all the predicates have similar intendeduses.
	MaterialsThe Black Diamond Pedicle Screw System is fabricated from the same material as thepredicate devices.
	Design Features/FunctionsThe Black Diamond Pedicle Screw System and cited predicate devices share similar basicdesign features and functions.
	DimensionsThe Black Diamond Pedicle Screw System is dimensionally similar to cited predicatedevices.
	SterilizationThe Black Diamond Pedicle Screw System is supplied non-sterile and cited predicatedevices are non-sterile.
	Performance SpecificationMechanical testing confirmed the Black Diamond Pedicle Screw System showed as goodor better performance to the cited predicate devices under the same test conditions.
Non-clinical TestSummary	The following analyses were conducted:
	● Static and dynamic compression per ASTM F1717
	● Static torsion per ASTM F1717The results of these evaluations show that the Black Diamond Pedicle Screw System isequivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Osseus Fusion Systems considers the Black Diamond Pedicle Screw System to beequivalent to the predicate devices listed above. This conclusion is based upon thedevices' similarities in principles of operation, technology, materials, and indications foruse.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.