MONARCH SPINE SYSTEM by DEPUY ACROMED

The MONARCH Spine System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

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.

Device Description

Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MONARCH Spine System, an addition of 5.5mm diameter rod, screws, hooks, and various connectors. It is a medical device submission, and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics against an AI algorithm.

Regarding your numbered requests, based only on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness substantially equivalent to predicate devices	Performance data were submitted to characterize the MONARCH Spine System. (Specific results not detailed in the provided text.)
Manufactured from ASTM F-136 implant grade titanium alloy	Manufactured from ASTM F-136 implant grade titanium alloy.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states "Performance data were submitted to characterize the MONARCH Spine System." However, it does not provide details on the sample size used for the test set, the provenance of the data (e.g., country of origin), or whether the data was retrospective or prospective. This information would typically be found in the detailed performance data report, which is not included in this summary.
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):
As this is a mechanical medical device (spinal implant), the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The "performance data" would likely refer to mechanical testing, biocompatibility testing, and potentially animal or clinical performance data if submitted, but not expert consensus on images. The document does not mention experts establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and performance data. The document does not mention any adjudication method.
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:
This device is a spinal implant, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a spinal implant, not an algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a spinal implant, "ground truth" would generally refer to established engineering standards for mechanical strength, fatigue, biocompatibility, and potentially clinical outcomes if a clinical study was performed. The document vaguely states "Performance data were submitted to characterize the MONARCH Spine System." It does not specify the type of ground truth used beyond the implicit requirement of meeting established regulatory and engineering standards for similar devices.
The sample size for the training set:
This device is a physical implant, not a machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" is not applicable.
How the ground truth for the training set was established:
As there is no training set for this type of device, this question is not applicable.

Summary

{0}------------------------------------------------

JAN 2 8 2003

510(k) Summary -- K024348

510(k) Summary – K024348 THE SUBMITTER: DePuy AcroMed, Inc. 325 Paramount Drive Raynham, MA 02767 CONTACT PERSON: Lisa A. Gilman DATE PREPARED: December 16, 2002 CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: MONARCH Spine System PREDICATE DEVICES: MONARCH Spine System (K021335, K010576) DEVICE DESCRIPTION: Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. INTENDED USE: The MONARCH Spine System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

{1}------------------------------------------------

510(k) Summary (cont)– K024348

	The MONARCH Spine System is also a hook andsacral/iliac screw fixation system of the noncervicalspine indicated for degenerative disc disease (definedas discogenic back pain with degeneration of the discconfirmed by history and radiographic studies),spondylolisthesis, trauma (fracture and/or dislocation),spinal stenosis, deformities (scoliosis, lordosis and/orkyphosis), tumor, and previous failed fusion(pseudarthrosis).
	The MONARCH Spine System when used with pediclescrews is indicated for degenerative disc disease(defined as discogenic back pain with degeneration ofthe disc confirmed by history and radiographic studies).Levels of fixation are for the thoracic, lumbar andsacral spine.
MATERIALS:	Manufactured from ASTM F-136 implant gradetitanium alloy.
PERFORMANCEDATA:	Performance data were submitted to characterize theMONARCH Spine System.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

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

Re: K024348

Trade Name: MONARCH Spine System - Addition of 5.5 mm Components Regulation Number: 21 CFR 888.3070 (b)(1) and 888.3050 Regulation Name: Pedicle screw spinal system, and spinal Interlaminal fixation orthosis Regulatory Class: III Product Code: MNH, MNI, KWP Dated: December 26, 2002 Received: December 30, 2002

Dear Mr. Maas:

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. Iisting 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,

{3}------------------------------------------------

Page 2 – Mr. Frank Maas

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 marketed 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 contact the Office of Compliance at (301) 594-4659. 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 vours.

Sincerely yours,

Mark N Milliman

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

K024348

Device Name:

MONARCH Spine System

Indications For Use:

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

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

Division Sign-Off

Restorative

and Devices

DePuy AcroMed, Inc. Special 510K
510(k) Number	K024398 4

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.