The DePuy Motech Profile Anterior Thoracolumbar Plate System is intended for use in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture, (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Description

The DePuy Motech Profile Anterior Thoracolumbar Plate System consists of 10 thoracolumbar and 12 high thoracic plates of various lengths (40-120mm); 9 cancellous screws in varying lengths (20-60mm); 8 cancellous bolts in progressive lengths (25-60mm) with locking nuts and screws; and four bone graft screws of different lengths (15, 20, 25, 30mm).

The anterior thoracolumbar plates are implanted using 2 cancellous bolts placed through the plate's bolt slots and fixed with locking nuts and screws, 2 cancellous screws placed through the plate's threaded screw holes, and an optional graft screw which can be placed through the plates's center slot to provide fixation between the plate and a strut graft if desired.

The high thoracic plates are implanted using 4-6 cancellous screws, placed through the plate's screw holes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Motech™ Profile™ Anterior Thoracolumbar Plate System.

It's important to note that the provided document is a 510(k) summary for a medical device (spinal plate system), not a software or AI/ML device. Therefore, the concepts of human readers, AI assistance, ground truth establishment through expert consensus or pathology for an algorithm, training sets, and test sets in the context of AI/ML performance are not directly applicable to this type of submission.

Instead, for a hardware medical device like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing and comparison of materials, design, and intended use.

Acceptance Criteria and Study for DePuy Motech™ Profile™ Anterior Thoracolumbar Plate System

Given that this is a 510(k) submission for a physical medical device (spinal plate system), the structure of the acceptance criteria and supporting study is different from a software/AI/ML device.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices)	Reported Device Performance (as stated in 510(k) summary)
Material Equivalence: Manufactured from a material substantially equivalent to predicate devices.	"Both the ATL plates and the MOSS Miami Titanium sub-system are manufactured from Ti-6A1-4V alloy." (Substantially equivalent to MOSS Miami Titanium sub-system). "The major difference between these systems [ATL and Amset ALPS] is that the Amset ALPS plates are manufactured from 316 LVM Stainless Steel." (Acknowledges material difference with Amset, but emphasizes similar design and anterior stabilization intent, likely deemed acceptable given other equivalences).
Design Equivalence: Similar design principles and components for their intended use.	"The DePuy Motech Profile Anterior Thoracolumbar Plate System consists of 10 thoracolumbar and 12 high thoracic plates of various lengths... 9 cancellous screws... 8 cancellous bolts... four bone graft screws." "The designs of the systems are similar" (referring to Amset ALPS).
Intended Use Equivalence: Same indications for use as predicate devices.	"intended for use in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture... tumor, degenerative disc disease... scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery." (Identical or very similar to predicate devices, as stated in the basis for substantial equivalence).
Mechanical Performance Equivalence: Fatigue strength and other mechanical properties are at least equivalent to predicate devices.	"Mechanical testing shows that the fatigue strength of the ATL plates is, at least, equivalent to that of both the MOSS Miami Titanium sub-system and the MOSS Miami 4.0mm sub-system." (This is the primary performance criterion for this type of device).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not applicable in the context of an "AI test set." For mechanical testing, the "sample size" would refer to the number of devices or components tested. This information is not detailed in the provided 510(k) summary. The summary only states that "Mechanical testing shows..." but does not provide specific sample quantities, test protocols, or raw data.
Data Provenance: Not applicable in the context of "data provenance" for AI. Mechanical testing is typically conducted in a laboratory setting by the manufacturer, following standardized testing methods (e.g., ASTM standards for orthopedic implants).

3. 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):

This concept is not applicable to the submission of this physical medical device. "Ground truth" for this device is established through objective mechanical testing against established industry standards and comparison to predicate devices, not subjective expert judgment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This concept is not applicable to this device. Adjudication methods are typically used for establishing ground truth in clinical studies or for evaluating human performance, not for mechanical device testing.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, where human readers interact with AI. This device is a surgical implant.

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

No. This refers to the performance of an AI algorithm alone. The DePuy Motech Profile Anterior Thoracolumbar Plate System is a physical device, not an algorithm. Its "standalone performance" is its mechanical integrity and ability to fulfill its intended function when implanted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this physical medical device, the "ground truth" (or basis for acceptance) is established by:
- Mechanical Test Results: Objective measurements of fatigue strength and other mechanical properties, compared against those of predicate devices (and likely against internal specifications or relevant ASTM/ISO standards).
- Material Specifications: Verification that the materials used (e.g., Ti-6A1-4V alloy) meet established standards and are equivalent to predicate devices.
- Design Specifications: Comparison of the physical design and components to predicate devices.
- Intended Use/Indications: Ensuring the proposed indications for use are consistent with those of predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" for a physical medical device in the context of an AI/ML workflow.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, there is no ground truth established for one.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The "study" presented here to prove the device meets acceptance criteria is primarily a comparison of the new device to legally marketed predicate devices (DePuy Motech MOSS Miami Titanium Spinal System, DePuy Motech MOSS Miami 4.0mm Spinal System, and Amset Anterior Locking Plate System) to establish substantial equivalence.

The key evidence provided is:

Material Comparison: Both the new ATL plates and the MOSS Miami Titanium sub-system are made from Ti-6A1-4V alloy.
Design Similarities: The ATL plates and Amset ALPS plates have similar designs for anterior stabilization.
Intended Use: All compared systems are intended for anterolateral fixation to the thoracic and thoracolumbar spine (T1-L5) for the same indications.
Mechanical Testing: Crucially, "Mechanical testing shows that the fatigue strength of the ATL plates is, at least, equivalent to that of both the MOSS Miami Titanium sub-system and the MOSS Miami 4.0mm sub-system." This mechanical testing is the primary "study" that directly addresses a performance "acceptance criterion" for a physical implant.

The submission successfully argued that the new device is substantially equivalent to the predicates, allowing it to be marketed under a 510(k) pathway without requiring a full Premarket Approval (PMA) process.

Summary

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

K973060 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988
	NOV - 3 199
510(K) CONTACT:	John D. Van VleetManager, Clinical and Regulatory ApplicationsDePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988
TRADE NAME:	DePuy Motech™ Profile™ Anterior ThoracolumbarPlate System
COMMON NAME:	Anterior Thoracic/Thoracolumbar Plate
CLASSIFICATION:	888.3060: Spinal intervertebral body fixationorthosis
DEVICE PRODUCT CODE:	87 KWO

SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy Motech MOSS Miami Titanium Spinal System DePuy Motech MOSS Miami Spinal System -4.0mm Amset Anterior Locking Plate System

DEVICE DESCRIPTION AND INTENDED USE:

The high thoracic plates are implanted using 4-6 cancellous screws, placed through the plate's screw holes.

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

The DePuy Motech Profile Anterior Thoracolumbar Plate System is intended for use in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Motech Profile Anterior Thoracolumbar (ATL) Plates are substantially equivalent to the DePuy Motech MOSS Miami Spinal System Titanium sub-system and 4.0mm sub-system in that all of these systems are intended for anterolateral fixation to the thoracic and thoracolumbar spine (T1-L5) for the same indications. Both the ATL plates and the MOSS Miami Titanium sub-system are manufactured from Ti-6A1-4V alloy. Mechanical testing shows that the fatigue strength of the ATL plates is, at least, equivalent to that of both the MOSS Miami Titanium sub-system and the MOSS Miami 4.0mm sub-system.

The DePuy Motech Profile ATL Plates are also substantially equivalent to the Amset ALPS plates in that both systems are intended for anterior stabilization of the spine and the designs of the systems are similar. The major difference between these systems is that the Amset ALPS plates are manufactured from 316 LVM Stainless Steel.

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

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a human figure embracing or protecting another, representing the department's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 1997

Ms. Cheryl K. Hastings
Manager, Regulatory Submissions
DePuy®, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

K973060 Re: Profile™ Anterior Thoracolumbar Plate System Requlatory Class: II Product Code: KWQ Dated: October 17, 1997 Received: October 20, 1997

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act) . to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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

Page 2 - Ms. Cheryl K. Hastings

You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";
All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

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. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical ( Devices: General requlation (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 In addition, FDA may publish further announcements action. 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.

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

Page 3 - Ms. Cheryl K. Hastings

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
As well as

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

{5}------------------------------------------------

INDICATIONS

510(k) Number (if known)

Device Name: DePuy Motech™ Profile™ Anterior Thoracolumbar Plate System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Aceda

Prescription Use X

Over-The Counter Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.