The Mercury® and Overwatch® Spinal Systems are intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

These systems are intended to be used with bone graft.

The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatic patients the Mercury and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, set screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6A1-4V (ASTM F136).

The Overwatch Spine System is a multiple component system comprised of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, pedicle screws, set screws, transverse crosslinks, rod connectors, and hooks. When assembled, the components create a rigid structure to provide stabilization and promote spinal fusion. The systems screws are self-tapping and are available with either a cancellous or cortical cancellous dualfix thread design. The tulips are offered in low top, extended tab and tower configurations. All implant components of the Overwatch Spine System are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use. The system is to be used with bone graft material to facilitate spinal fusion.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the Mercury® and Overwatch® Spinal Systems. It establishes the substantial equivalence of these devices to previously cleared predicate devices. The information provided outlines the device description, indications for use, and performance data, but it does not describe a study meant to prove the device meets specific acceptance criteria in the way one might for a diagnostic AI device.

Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The study described is a series of performance tests.

Here's the breakdown of the requested information based on the provided document:

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

Acceptance Criteria (Implied from FDA 510(k) process for substantial equivalence)	Reported Device Performance and Evidence in Document
Similar Indications for Use to predicate devices.	The Indications for Use for the Mercury® and Overwatch® Spinal Systems are stated to be substantially equivalent to the predicate devices.
Similar Technological Characteristics (design, intended use, operating principle, function) to predicate devices.	The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device.
Meets Performance Standards (mechanical and material properties) comparable to predicate devices.	Performance testing included: Static Axial Grip, Static Torsional Grip (both per ASTM F1798), Dynamic Compression Bending (per ASTM F 1717), Dynamic Flexion-Extension (per ASTM F1798), and Interconnection Strength (per ASTM F1798). All data indicates that the devices will perform as intended.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes performance testing for a medical implant (spinal system), not a diagnostic algorithm. Therefore, the concept of "test set" and "data provenance" for patient data is not directly applicable in the same way.

Sample Size: Not specified in terms of patient numbers. The "sample size" would refer to the number of devices or components tested in the mechanical performance tests. This information is typically detailed in the full test reports, which are not included here.
Data Provenance: Not applicable in the context of patient data. The performance tests are laboratory-based mechanical tests.

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 is not applicable. The "ground truth" for this type of device is established through engineering and biomechanical standards (e.g., ASTM standards) and laboratory testing, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, particularly for image-based diagnostics. This document is about mechanical performance testing.

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

Not applicable. MRMC studies are for evaluating diagnostic accuracy, particularly in imaging, with and without AI assistance. This document describes the mechanical performance of a spinal implant.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance claims for this device is based on accepted engineering standards (ASTM) for the mechanical and material properties of spinal implants. The device components are manufactured from materials conforming to specific ASTM and ISO standards (e.g., Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3). The performance tests (Static Axial Grip, Dynamic Compression Bending, etc.) are conducted according to these established standards.

8. The sample size for the training set

Not applicable. This device is not an AI model that requires a training set.

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

Not applicable. This device is not an AI model that requires a training set.

Summary

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September 16, 2019

Spinal Elements, Inc Julie Lamothe, Ph.D., MBA Vice President of Regulatory Affairs & Quality Assurance 3115 Melrose Drive, Suite 200 Carlsbad, California 92010

Re: K191576

Trade/Device Name: Mercury® Spinal System, Overwatch® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: June 12, 2019 Received: June 14, 2019

Dear Dr. Lamothe:

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

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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,

Ronald P. Jean, Ph.D. Director (Acting) 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) K191576

Device Name

Mercury® Spinal System; Overwatch® Spinal System

Indications for Use (Describe)

These systems are intended to be used with bone graft.

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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510(k) Summary Mercury® and Overwatch Spinal Systems

510(k) Number
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Manufacturer IdentificationSubmitted by:	Spinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-0121
Contact Information:	Julie LamotheVice President of RA & QASpinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-1816760-607-0125 (fax)jlamothe@spinalelements.com
Date Prepared:	June 12th, 2019
Device Identification
Proprietary Name	Mercury® Spinal System; Overwatch® Spinal System
Common Name	Pedicle Screw Spinal System
Device Regulation Name	Thoracolumbosacral Pedicle Screw System
Device Classification	21 CFR Section 888.3070
Proposed Regulatory Class	Class II
Device Product Code	NKB, KWP, KWQ

Device Description

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Indications for Use

The Mercury® and Overwatch® Spinal Systems are intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1 -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

These systems are intended to be used with bone graft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients the Mercury and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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Substantial Equivalence

The subject devices are substantially equivalent in indications for use, surgical technique, design features and instrumentation to the following predicate devices:

. Primary Predicate: Overwatch Spinal System K161842
Additional Predicates are for Mercury Spinal System (K083230, K091587, ● K141372, and K151215)

Technological Characteristics

The subject device was established as substantially equivalent to another predicate device cleared by the FDA for commercial distribution in the Untied States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, operating principle and function.

Performance Data

Performance testing included:

Static Axial Grip testing per ASTM F1798
Static Torsional Grip testing per ASTM F1798
Dynamic Compression Bending per ASTM F 1717
Dynamic Flexion-Extension testing per ASTM F1798
Interconnection Strength testing per ASTM F1798 ●

All data indicates that the devices will perform as intended.

Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.

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.