MONARCH SPINE SYSTEM by DEPUY ACROMED

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis and kyphosis), tumor, fracture and previous failed fusion.

Device Description

The MONARCH Spine System consists of pedicle screws, washers, spine plates, spinal rods, slotted connectors, dual rod connectors, J-hooks, polyaxial screws, open hooks, closed hooks, and spherical nuts.

AI/ML Overview

Here's an analysis of the provided text regarding the MONARCH Spine System, focusing on the acceptance criteria and study information:

Based on the provided text, the MONARCH Spine System is a spinal fixation device, and the "performance data" mentioned refers to engineering tests to characterize the device's mechanical properties, not clinical studies involving human or AI evaluation. Therefore, many of your requested points regarding clinical study design are not applicable.

Here's the information that can be extracted or deduced from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "Performance data were submitted to characterize the MONARCH Spine System." However, it does not detail the specific acceptance criteria or the reported performance outcomes of these tests. This information would typically be in a more detailed performance data section of the 510(k) submission, which is not fully included here. The 510(k) summary focuses on the substantial equivalence against predicate devices for its intended use, implying that the performance data demonstrated equivalence in mechanical characteristics.

Acceptance Criteria (Type of Test)	Reported Device Performance
Characterization of Mechanical Properties	Not explicitly detailed in this summary
(Likely included tests for strength, fatigue, torsional stability, etc., to ensure equivalence with predicate devices)	Performance data submitted and deemed sufficient for substantial equivalence.

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

This is not applicable as the "performance data" refers to device characterization tests (e.g., mechanical testing of components or assemblies), not a clinical test set with patient data.

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

Not applicable. Ground truth for clinical data is not relevant here as there's no clinical test set described. For device performance testing, the "ground truth" would be established by engineering standards and validated testing methodologies, not clinical experts.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set mentioned.

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. This is a spinal implant, not an AI-powered diagnostic device, and no MRMC study or AI-assistance is mentioned.

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

For the device's mechanical performance, the "ground truth" would be the established engineering standards and specifications to which the device was designed and tested (e.g., ASTM standards for implant materials and mechanical performance). It relies on physical measurements and adherence to specified limits rather than expert consensus or patient outcomes directly for the "performance data" section.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device does not involve machine learning.

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

Not applicable. No training set is mentioned.

Summary of Device Performance and 510(k) Process:

The provided document is a 510(k) summary for the MONARCH Spine System. The "performance data" mentioned refers to the engineering and mechanical testing required to demonstrate that the device is substantially equivalent to legally marketed predicate devices (ISOLA Spinal System, K993030; Tri-Fix Spinal Fixation System, K011830).

The key takeaway from this document is that the FDA reviewed these performance data and determined that the MONARCH Spine System, for its stated indications for use, is as safe and effective as the predicate devices. The focus of a 510(k) is typically on demonstrating this substantial equivalence through a comparison of technological characteristics and performance data, not through extensive clinical studies as required for a Class III device with a PMA.

Summary

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JUL 11 2002 510(k) Summary XIII. DePuy AcroMed, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780 Lisa A. Gilman CONTACT PERSON: DATE PREPARED: April 18, 2002 CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: MONARCH Spine System PREDICATE DEVICES: ISOLA Spinal System (K993030) Tri-Fix Spinal Fixation System (K011830) The MONARCH Spine System consists of pedicle DESCRIPTION: screws, washers, spine plates, spinal rods, slotted connectors, dual rod connectors, J-hooks, polyaxial screws, open hooks, closed hooks, and spherical nuts. The MONARCH Spine System when used with INTENDED USE: pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis,

spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

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The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire. and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor. fracture and previous failed fusion.

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy or ASTM F-76 commercially pure titanium.

PERFORMANCE DATA:

Performance data were submitted to characterize the MONARCH Spine System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 11 2002

Mr. Frank Maas Director, Regulatory Affairs Depuv AcroMed 325 Paramount Drive Raynham, MA 02767-0350

Re: K021335

Trade Name: MONARCH Spine System Regulation Number: 21 CFR 888.3050 and 888.3070 Regulation Name: Pedicle Screw Spinal System, and Spinal Interlaminal Fixation Orthosis Regulatory Class: III, II Product Code: MNH, MNI, KWP Dated: April 19, 2002 Received: April 26, 2002

Dear Mr. Maas:

We have reviewed vour 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.

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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Page 2 – Mr. Frank Maas –

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed needicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stupt Rlwdus

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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Indications for Use IV. :

:510(k) Number (if known): __ 上 ○ 乙 : 3 3 S

MONARCH Spine System Device Name:

Indications For Use:

(Please do not write below this line - continue on another page if needed)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:(Per 21 CFR 801.109)	OR Over-The-Counter Use:
DePuy AcroMed, Inc.510K	Division of General, Restorativeand Neurological Devices	Page 6
	KOZI335510(k) Number_

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.