The Trivergent Spinal Fixation System is intended to provide immobilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; and failed previous fusion.

Device Description

The Trivergent Spinal Fixation System is a pedicle screw system intended to stabilize and immobilize the L2-S1 spinal segments as an adjunct to fusion. The system includes a variety of screws and plates along with guides, guidewires, drills, drivers, handles, and tans.

The Trivergent Spinal Fixation System plates and screws are available in a variety of geometries to accommodate various patient anatomies. The Trivergent screws come in lengths from 45mm to 60mm, and the Trivergent plates come in angles from 60° to 75°.

The Trivergent Spinal Fixation System implants and instruments are provided non-sterile and are to be sterilized by the end user.

The Trivergent Spinal Fixation System implants are machined from Ti-6A1-4V ELI per ASTM F136.

AI/ML Overview

This document describes the Trivergent Spinal Fixation System, a medical device. Based on the provided text, it's a 510(k) Premarket Notification for a Class II medical device, specifically a pedicle screw system. These submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results for novel AI-powered diagnostics.

Therefore, the information typically found in an AI/ML medical device submission (such as acceptance criteria for AI performance, clinical study design for AI efficacy, expert adjudication, etc.) is not present in this document. The "Performance Testing Summary" section focuses on bench testing of the physical device (e.g., static compression, fatigue testing) and a cadaver usability study, which are standard for orthopedic implants, not AI/ML algorithms.

Based on the provided text, I cannot answer the questions directly as they pertain to an AI/ML device's acceptance criteria and proving its performance.

Here's why and what information is available:

Device Type: This is a physical orthopedic implant (spinal fixation system), not an AI/ML diagnostic or therapeutic device.
Regulatory Pathway: 510(k) demonstrates substantial equivalence, primarily through non-clinical (bench) testing and comparison to predicates, not typically extensive human clinical trials to establish efficacy akin to AI-driven diagnostics.
Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, or any other AI-related components.

Therefore, the questions regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance simply do not apply to the content of this particular document.

If this document were for an AI/ML device, the required information would be detailed under sections like "Clinical Performance Data," "Software Validation," or "Algorithm Performance Benchmarks." This document is focused on the mechanical and material properties of a physical implant.

Summary

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October 21, 2020

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Benvenue Medical, Inc. % Justin Eggleston Vice President, Spine Regulatory Affairs Mcra, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K201427

Trade/Device Name: Trivergent Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 25, 2020 Received: September 25, 2020

Dear Justin Eggleston:

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,

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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Indications for Use

510(k) Number (if known) K201427

Device Name Trivergent Spinal Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

Device Trade Name:	Trivergent Spinal Fixation System
Manufacturer:	Benvenue Medical, Inc.5403 Betsy Ross DriveSanta Clara, California 95054 USA
Contact:	Laurent SchallerCTO and FounderBenvenue Medical, Inc.4590 Patrick Henry DriveSanta Clara, California 95054 USAPhone: (408) 454 9300lschaller@benvenuemedical.com
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com
Date Prepared:	October 21, 2020
Classification Names:	21 CFR §888.3070Thoracolumbosacral pedicle screw system
Class:	II
Product Codes:	NKB
Primary Predicate:	Genesys Spine, TiLock2 Spinal System (K171838)
Reference Devices:	Spinal Simplicity, Spinous Process Fusion Plate (K140046)PMT Facet Screw, Providence Medical Technology, Inc. (K183589)

The Trivergent Spinal Fixation System is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

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Device Description:

The Trivergent Spinal Fixation System implants and instruments are provided non-sterile and are to be sterilized by the end user.

The Trivergent Spinal Fixation System implants are machined from Ti-6A1-4V ELI per ASTM F136.

Performance Testing Summary:

The following bench testing was performed on the Trivergent Spinal Fixation System:

Static Compression Testing	-	ASTM F1717-18
Static Torsion Testing	-	ASTM F1717-18
Compression Fatigue Testing	-	ASTM F1717-18
Cadaver Usability Study
Biocompatibility	-	ISO 10993-1

In summary, bench testing of the Trivergent Spinal Fixation System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

Substantial Equivalence Summary:

Comparative information presented in the 510(k) supports the substantial equivalence of the Trivergent Spinal Fixation System to its predicate devices. The subject device was shown to have the same technological characteristics through comparisons in indications, intended use, design, material composition, range of sizes, function, and performance as compared to its predicate devices.

Conclusion:

The information and performance data demonstrate that the device is as safe, as effective, and performs as well as or better than the primary predicate device. This 510(k) was submitted on behalf of the Trivergent Spinal Fixation System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.

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.