The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

Device Description

The Medtronic Sofamor Danek EQUATION™ Fixation System consists of a variety of shapes and sizes of screws, nuts, and 3.6mm rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. The implants are made of medical grade titanium alloy. Stainless steel and titanium implant components must not be used together in a construct. The purpose of this submission is to provide the surgeon with an alternative minimally invasive surgical technique.

AI/ML Overview

This document is a 510(k) premarket notification for the Medtronic Sofamor Danek EQUATION™ Fixation System, a spinal implant. It describes the device, its intended use, and its substantial equivalence to itself (meaning a previous version of the same device).

Based on the provided text, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as typically understood for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth) is not applicable to this submission.

Here's why and what information is provided:

Device Type: The EQUATION™ Fixation System is a physical medical device (spinal implant components like screws, rods, and nuts), not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic/interpretive tool.
Regulatory Pathway: This is a 510(k) submission, specifically demonstrating "substantial equivalence" to a predicate device. For physical devices like this, substantial equivalence is typically demonstrated through engineering testing (e.g., mechanical strength, biocompatibility), materials testing, and sometimes benchtop or animal studies, rather than clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy.
"Study" Described: The only "study" mentioned is a "Risk Analysis." This is a regulatory requirement for medical devices to identify potential hazards and mitigate them, not a performance study in the context of diagnostic accuracy.

Therefore, the requested information elements related to diagnostic performance (acceptance criteria table, sample size for test set, ground truth, experts, adjudication, MRMC, standalone performance, training set) do not apply to this 510(k) submission as the device is not an AI/ML diagnostic or interpretive device.

Information applicable from the provided text:

A table of acceptance criteria and the reported device performance:
- N/A. This device is a physical implant. The "performance" assessment is based on demonstrating substantial equivalence to a predicate device, primarily through engineering and materials testing, and a risk analysis. No quantifiable diagnostic performance metrics (e.g., sensitivity, specificity) are relevant or provided.
- The "reported device performance" is essentially that a "Risk Analysis was performed... and it was determined that the proposed changes do not present any additional risks." This indicates safety.
Sample size used for the test set and the data provenance:
- N/A. No "test set" in the context of diagnostic performance testing is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No diagnostic ground truth establishment is described.
Adjudication method for the test set:
- N/A. No diagnostic test set or adjudication process is described.
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:
- N/A. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No diagnostic ground truth is used as this is a physical implant. The "ground truth" for a physical implant's safe and effective use is typically established through engineering standards, biocompatibility testing, and preclinical cadaveric or animal studies, none of which are detailed here beyond the mention of a risk analysis.
The sample size for the training set:
- N/A. No "training set" in the context of AI/ML is used.
How the ground truth for the training set was established:
- N/A. No AI/ML training set or ground truth establishment is mentioned.

In summary: The provided 510(k) submission pertains to a physical spinal implant system. The regulatory review focuses on demonstration of substantial equivalence to an existing (predicate) device, primarily through engineering and materials considerations, and a risk analysis. It does not involve performance studies typical for AI/ML diagnostic devices, and therefore, the requested information regarding acceptance criteria, ground truth, expert review, and training/test sets is not relevant to this specific submission.

Summary

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K053495 p'/2

DEC = 3 2003

Medtronic Sofamor Danek EQUATION™ Fixation System 510(k) Summary October 2003

Medtronic Sofamor Danek USA, Inc. Submitter: 1800 Pyramid Place Memphis, TN 38132 Richard Trehame Contact Person: Sr. Vice President Regulatory Affairs EQUATION™ Fixation System Trade Name: Spinal Intervertebral Body Fixation Orthosis, Class II Classification Name: The EQUATION™ Fixation System is substantially equivalent to Predicate Device(s): itself. The Medtronic Sofamor Danek EQUATION™ Fixation System Device Description: consists of a variety of shapes and sizes of screws, nuts, and 3.6mm rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. The implants are made of medical grade titanium alloy. Stainless steel and titanium implant components must not be used together in a construct. The purpose of this submission is to provide the surgeon with an alternative minimally invasive surgical technique. The EQUATION™ Fixation System is a temporary implant system Intended Use: used for correction and stabilization of the posterior spine for the

development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3)

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K033495r²/k

dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are recciving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

Functionality &

A Risk Analysis was performed on the EQUATION™ Fixation System Safety Testing: and it was determined that the proposed changes do not present any additional risks.

The EQUATION™ Fixation System is substantially equivalent to Conclusion: itself, the EQUATION™ Fixation System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized depiction of a bird or eagle with three wing-like shapes above a wavy line, representing the department's mission related to health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132

Re: K033495

Trade/Devicc Name: EQUATION™ Fixation System Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Il Product Code: MNI, MNH Dated: November 4, 2003 Received: November 5, 2003

Dear Dr. Treharne:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 such 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 or any I ederal battler and states and the best be registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

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Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at notially at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golders, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): (0334 95

Device Name: EQUATION™ Fixation System

Indications for Use:

The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skelctally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional)

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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.