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 rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. The implants are made of medical grade titanium alloy, and are also offered in medical grade stainless steel. Stainless steel and titanium implant components must not be used together in a construct. The purpose of this submission is to include an additional 3.5mm rod and associated components to the system.

AI/ML Overview

Here's an analysis of the provided text regarding the Medtronic Sofamor Danek EQUATION™ Fixation System, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document is a 510(k) summary for a medical device (spinal fixation system) seeking clearance for an additional component. Crucially, 510(k) submissions for Class II devices generally do not involve clinical studies with human participants to establish performance against acceptance criteria in the way described in your request. Instead, the primary method for demonstrating safety and effectiveness in such cases is through substantial equivalence to a previously cleared predicate device. This is explicitly stated in the document: "The EQUATION™ Fixation System is substantially equivalent to itself (K013962, SE 06/20/02)." and "Mechanical testing was performed on the subject components. Results indicated that the subject components were substantially equivalent to the previously cleared EQUATION™ Fixation System device."

Therefore, the typical metrics, sample sizes, expert involvement, and statistical analyses relevant to clinical trials (as implied by your questions 1-9) are not applicable or not present in this type of regulatory submission and will not be found herein.

The "acceptance criteria" here relate to the mechanical properties of the new component compared to the previously cleared system, and the "study" is mechanical testing.

Here's a breakdown based on the information available and what can be inferred for a 510(k) for a spinal fixation system:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from 510(k) process)	Reported Device Performance
Mechanical Equivalence: The additional 3.5mm rod and associated components must demonstrate mechanical properties (e.g., strength, fatigue life, torsional stiffness, pull-out strength, bending strength) that are substantially equivalent to the corresponding components of the predicate EQUATION™ Fixation System (K013962).	"Results indicated that the subject components were substantially equivalent to the previously cleared EQUATION™ Fixation System device." (Based on mechanical testing.)
Risk Profile: The proposed changes (addition of 3.5mm rod) must not introduce any new or increased risks compared to the predicate device.	"A Risk Analysis was performed and determined that the proposed changes do not present any additional risks."
Biocompatibility: Materials (medical grade titanium alloy, medical grade stainless steel) must meet established biocompatibility standards for implantable devices.	(Implicit, as the predicate device already uses these materials, and no new materials are introduced. This is not explicitly stated as a new test in this submission but would have been part of the predicate's clearance.)
Sterilization: The device must be able to be sterilized to an appropriate Sterility Assurance Level (SAL).	(Implicit, as a standard requirement for implantable devices. Not explicitly stated as a new test for this submission but covered by the predicate's clearance.)

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

Sample Size: Not specified quantitatively in the summary. For mechanical testing of medical devices, "sample size" refers to the number of individual components tested for each specific mechanical property (e.g., 3-6 samples for static tests, 12+ for fatigue tests, per ISO/ASTM standards). This information is typically detailed in the full test report, not the 510(k) summary.
Data Provenance: The mechanical testing was performed on the "subject components" (the newly added 3.5mm rod and associated components). This would be prospective testing specifically conducted for this 510(k) modification. The country of origin of the data would be the testing laboratories, likely in the USA, given the submitter's location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the human clinical sense. For mechanical testing, the "ground truth" is established by validated testing methods and engineering standards (e.g., ASTM F1717 for spinal implant constructs, ISO 12189). The "experts" would be the biomedical engineers and technicians performing and interpreting these standardized tests, ensuring they follow protocols to generate reliable data. Their qualifications would be in mechanical engineering, materials science, or related fields, with experience in medical device testing.

4. Adjudication Method for the Test Set

Not applicable in the clinical sense. For mechanical testing, adjudication would involve standard peer review and verification of test results by other qualified engineers or a quality assurance department to ensure compliance with protocols and accurate reporting. There is no "adjudication method" in the sense of reconciling differing expert opinions on a patient case.

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

No such study was performed or is relevant. This device is a mechanical spinal implant, not an AI-powered diagnostic or assistive tool for human readers. MRMC studies are for evaluating AI's impact on human interpretation tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No such study was performed or is relevant. Again, this is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

Established mechanical testing standards and performance specifications. The "ground truth" for the mechanical testing is the expected performance (e.g., ultimate tensile strength, fatigue cycles to failure) as defined by relevant ISO and ASTM standards for spinal implant components, and crucially, the performance of the predicate device's components. The testing aims to demonstrate the newly added components meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning context.

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

Not applicable. As there is no training set for an AI algorithm.

In summary: The 510(k) process for this type of device (a modification to an existing mechanical implant) relies on demonstrating substantial equivalence through mechanical testing against established engineering standards and comparison to the predicate device's performance. It does not involve the clinical trial methodologies or AI evaluation metrics described in your comprehensive set of questions.

Summary

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OCT 7 - 2004

Medtronic Sofamor Danek EQUATION™ Fixation System 510(k) Summary - K042453 October 2004

Submitter:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132
Contact Person:	Richard TreharneSr. Vice President Regulatory Affairs(901) 396-3133
Trade Name:	EQUATION™ Fixation System
Classification Name:Regulation Number:Regulatory Class:Product Code:	Pedicle Screw Spinal System888.3070Class IIMNI, MNH
Predicate Device(s):	The EQUATION™ Fixation System is substantially equivalent to itself(K013962, SE 06/20/02).
Device Description:	The Medtronic Sofamor Danek EQUATION™ Fixation Systemconsists of a variety of shapes and sizes of screws, nuts, and rods andcross connectors. The implant components can be rigidly locked in avariety of configurations, with each construct being tailor-made for theindividual case. The implants are made of medical grade titaniumalloy, and are also offered in medical grade stainless steel. Stainlesssteel and titanium implant components must not be used together in aconstruct. The purpose of this submission is to include an additional3.5mm rod and associated components to the system.

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

Page 1 of 2

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K042453

objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

Functionality &

Mechanical testing was performed on the subject components. Results Safety Testing: indicated that the subject components were substantially equivalent to the previously cleared EQUATION™ Fixation System device. A Risk Analysis was performed and determined that the proposed changes do not present any additional risks.

The EQUATION™ Fixation System is substantially equivalent to Conclusion: components previously cleared for use in the EQUATION™ Fixation System (K013962, SE 06/20/02).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines extending from its body, representing human services.

OCT 7 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, PhD. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis. Tennessee 38132

Re: K042453

Trade/Device Name: EQUATION™ Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: September 9, 2004 Received: September 10, 2004

Dear Dr. Treharne:

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. 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 comply with all the Act's requirements, including, but not limited to: 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, PhD.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotes notification. The FDA finding of substantial equivalence of your device to a legally promatic notificated wice 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 contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, 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. Milken

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

Enclosure

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Kod Lucy 510(k) Number (if known):_

Device Name: EQUATION™ Fixation System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milken

Neurologica

510(k) Number

2953

OCCO21

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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.