DEPUY ACROMED MOSS SPINAL SYSTEM by DEPUY, INC.

When used as an anterior, thoracic/lumbar screw fixation system, the MOSS Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

Device Description

The MOS'S Spinal System is available in Stainless Steel. The following components are included in the system: threaded rods, monoaxial and polyaxial screws, hexnut, washers, and transverse rod stabilizers. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

AI/ML Overview

The provided text describes a 510(k) submission for the DePuy AcroMed MOSS Spinal System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than conducting a de novo study with acceptance criteria and direct performance evaluation. Therefore, the device meets acceptance criteria by demonstrating it is as safe and effective as legally marketed predicate devices, not through a study proving specific performance metrics against a predefined set of criteria.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically applied to a de novo study (e.g., sensitivity, specificity, accuracy) is not directly applicable here because this is a 510(k) submission based on substantial equivalence. The "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a predicate device.

Acceptance Criteria (for 510(k) Substantial Equivalence): The device is substantially equivalent to legally marketed predicate devices in terms of:

Intended use
Technological characteristics (materials, design, performance)
Safety and effectiveness

Reported Device Performance: The submission states:

Characteristic	DePuy AcroMed MOSS Spinal System	Predicate Device (DePuy Motech MOSS Spinal System - Pedicle Fixation, DePuy Motech Universal Spinal System and Transverse Rod Stabilizer)
Components	Threaded rods, monoaxial and polyaxial screws, hexnut, washers, and transverse rod stabilizers	Components as described for MOSS Spinal Systems (implied to be similar or identical)
Material	Stainless Steel	Not explicitly stated, but implied to be similar for substantial equivalence (e.g., Stainless Steel)
Design	Cleared in previous 510(k) submissions	Cleared in previous 510(k) submissions
Intended Use	Anterior, thoracic/lumbar screw fixation for scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, failed fusion, degenerative disc disease. Pedicle screw fixation for degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion. Pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1.	Similar or identical intended uses as extensively described for MOSS Spinal Systems, including pedicle fixation use indications.

The basis of substantial equivalence is explicitly stated as: "The components of the MOSS Spinal System are identical to the components of the other MOSS Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications."

This means the "performance" demonstrated is that its components and functionality are equivalent to previously cleared devices.

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

Not applicable. This 510(k) relies on demonstrating substantial equivalence to existing predicate devices rather than a new study with a "test set" of patients or data. The "data provenance" would refer to the regulatory history and technical specifications of the predicate devices.

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

Not applicable. No "test set" requiring expert ground truth establishment for performance metrics was used in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication was used.

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 device is a spinal implant system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a spinal implant system, not an algorithm.

7. The Type of Ground Truth Used

For a 510(k) based on substantial equivalence, the "ground truth" is effectively the regulatory history and established safety and effectiveness of the predicate devices. The ground truth is that the predicate devices have been deemed safe and effective for their indicated uses by the FDA. The new device is then compared against this established "ground truth" of the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission for a spinal implant. This is not an AI/machine learning device.

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

Not applicable. No "training set" was used.

Summary

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K984378

Image /page/0/Picture/5 description: The image shows the logo for DePuy AcroMed. The logo consists of a solid black circle to the left of the text "DePuyAcroMed". The text is in a stylized font, with the "D" in "DePuy" being larger than the other letters. The "A" in "AcroMed" is also larger than the other letters. There is a small "TM" symbol in the upper right corner of the "d" in "AcroMed".

510(k) SUMMARY OF SAFETY AND EFFECTIVEN

Cleveland, Ohio 4 USA

Fax: +1 (216) 432 6999

NAME OF FIRM:	DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988
510(K) CONTACT:	Lynnette WhitakerManager, Clinical and Regulatory Affairs
TRADE NAME:	DePuy AcroMed MOSS Spinal System
COMMON NAME:	Rod and screw spinal instrumentation
CLASSIFICATION:	888.3050 Spinal interlaminal fixation orthosis888.3070 Pedicle screw spinal system
DEVICE PRODUCT CODE:	Product code: 87MNH87MNI87KWQ
SUBSTANTIALLYEQUIVALENT DEVICES:	DePuy Motech MOSS Spinal System - PedicleFixationDePuy Motech Universal Spinal System and

and Transverse Rod Stabilizer

DEVICE DESCRIPTION AND INTENDED USE:

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The MOS'S Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the MOSS Spinal System are identical to the components of the other MOSS Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Motech AcroMed, Inc. 3303 Carnegie Avenue Cleveland, Ohio 44115

Re: K984378

MOSS Spinal System - expanded uses Regulatory Class: II Product Codes: MNI, KWQ, and MNH Dated: December 4, 1998 Received: December 7, 1998

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Lynnette Whitaker

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 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 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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Russell T. Kayan

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

Enclosure

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510(k) Number (if known) $984378

Device Name DePuy AcroMed MOSS Spinal System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K984378

Prescription Use	X
------------------	---

OR
(Per 21 CFR 801.109)

Over-The Counter Use
----------------------	--

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.