When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment 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

This product is an addition to the existing MOSS Miami Spinal System and consists of: a sacral extender available in multiple lengths from 2cm to 20cm manufactured from Ti-6Al-4V alloy. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared in K955348 for use with the Titanium MOSS Miami Spinal System.

The sacral extender consists of a body and a longitudinal extension "arm". The body is intended to be attached to a 5.5mm MOSS Miami Titanium rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami Tranium screws or hooks. The attachment mechanism between the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami Spinal System cleared for use in K955348.

AI/ML Overview

The provided text K974573 is a 510(k) summary for a medical device (DePuy Motech MOSS Miami Spinal System - Titanium Sacral Extender). This document focuses on demonstrating substantial equivalence to a predicate device and DOES NOT contain information about acceptance criteria or a study proving the device meets said criteria in the way a clinical performance study would.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled from this document alone:

This document is a marketing clearance application (510(k)), not a clinical study report. Its primary goal is to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving a specific performance metric against pre-defined acceptance criteria through a clinical trial.

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

Not applicable in this document. The 510(k) process for a device like this does not typically involve setting numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and then reporting device performance against those in the same way a diagnostic AI device would.
Instead, the "performance" demonstrated here is the device's substantial equivalence to an existing device, primarily based on material, design, and intended use similarities, often supported by non-clinical (e.g., mechanical or biocompatibility) testing, which is not detailed in this summary.

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

Not applicable in this document. There is no "test set" in the context of a clinical performance study described here. The evaluation is based on a comparison to a predicate device, not on analyzing patient data.

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)

Not applicable in this document. No ground truth for a test set is established or discussed, as this is not a diagnostic device undergoing such a validation.

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

Not applicable in this document. No adjudication method is described as there is no clinical test set being evaluated for diagnostic or predictive performance.

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 in this document. This device is a surgical implant (spinal system), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not described.

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

Not applicable in this document. This is a physical medical device, not an algorithm, so "standalone performance" in this context is not relevant.

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

Not applicable in this document. No ground truth in the sense of clinical diagnostic validation is used. The "ground truth" for this 510(k) is the existing, legally marketed predicate device (MOSS Miami Sacral Extender - K972568) to which the new device is compared. Its "truth" is its established safety and effectiveness.

8. The sample size for the training set

Not applicable in this document. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable in this document. See point 8.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The document describes the Basis of Substantial Equivalence, which acts as the "study" or justification for clearance in a 510(k). The "acceptance criteria" can be inferred as successfully demonstrating that:

Similar design: The Titanium Sacral Extender has a similar design to the predicate.
Same intended use: The new extender has the same intended use (spinal stabilization).
Material Change Analysis: The material change from stainless steel to titanium alloy is addressed (implying material compatibility and performance were considered through other means, though not detailed here).
Slight Dimensional Changes: Minor dimensional changes (extender arm diameter, slot width) are assessed for impact on compatibility with the MOSS Miami Titanium system.

The "study" that proves the device meets these (implied) acceptance criteria is the comparison to the predicate device (MOSS Miami Sacral Extender - K972568), arguing that the differences (material change, slight dimensional changes) do not raise new questions of safety or effectiveness. This comparison is the core of a 510(k) submission. Mechanical testing, biocompatibility testing, and perhaps other non-clinical tests would have been performed and submitted to the FDA to support these claims, but the details of those specific tests (e.g., specific acceptance values for fatigue or pull-out strength) are not included in this high-level summary.

Summary

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K974573

5100k) SUMMARY OF SAFETY AND ENTECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988
	FEB 18 19
510(K) CONTACT:	Cheryl K. HastingsManager, Regulatory Submissions
TRADE NAME:	DePuy MotechMOSS Miami Spinal System
COMMON NAME:	Hook, rod and screw spinal instrumentation
CLASSIFICATIONS:	888.3050 Spinal interlaminal fixation orthosis888.3060 Spinal intervertebral body fixation orthosisUnclassified
DEVICE PRODUCT CODE:	Product codes: 87 KWP, 87 KWQ, 87 MNH
SUBSTANTIALLYEQUIVALENT DEVICES:	MOSS Miami Sacral Extenders - K972568

DEVICE DESCRIPTION AND INTENDED USE:

The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior serew fixation or posterior hook, non-podicic scrow fixation the MOSS Miami Spiral System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turns. spinal stenosis, spondylolisthesis, a previously failed back surgery or degencrative disc discase (i.e. discogenic back pain with degeneration of the disc confirmed by patient listory and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in parients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusious with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw attachment are LS and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS Mami Spinal System is available in either Stainless Stccl or Titanium. The following components are currently available in Stainless Steel: 4 and 5mm diamotor longjudinal rods, 5-7mm diameter moroaxial screws, 5-7mm dismeter polymal scrows, hooks, trausverse comectors, axial comectors, staple washers, and sacral extenders. The following components are currently available in Tranium: 5.5mm diameter longfudinal rods, 5-8mm diameter monoaxial screws, 5-1mm diameter polyanal screws, hooks, transverse connectors, axial connectors, washers and staple washers.

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BASIS OF SUBSTANTIAL EQUIVALENCE:

The MOSS Miami Titanium Sacral Extender is substantially equivalent to the MOSS Miami Sacral Extender previously cleared in K972568 in that they have similar designs and the same intended use. The only differences between the MOSS Miami Titanium Sacral Extenders described in this submission, and the predicate MOSS Miami Sacral Extenders are: 1) a change in material from stainless steel to titanium alloy and 2) slight dimensional changes (increases in the extender ann diameter and the slot width from 5.0mm to accomodate use with the MOSS Miami Titanium system).

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

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

K974573 Re : Titanium Sacral Extender to be used as part of the MOSS-Miami Spinal System Requlatory Class: II Product Codes: MNH, KWP, and KWQ Dated: December 5, 1997 Received: December 8, 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 This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and intended for 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; and (d) who are having the device removed after the development of a solid You may, therefore, market your device system fusion mass. subject 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 for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.

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Page 2 - Ms. Cheryl K. Hastings

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III Class III devices are device under Section 513 (f) of the Act. required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for Ditients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using vercebrar joine, (b) mio are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS :

When used as a pedicle screw system, this device ● system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
The screws of this device system are not intended ● for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
Benefit of spinal fusions utilizing any pedicle ● screw fixation system has not been adequately established in patients with stable spines.
Potential risks identified with the use of this ● device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and ..................................................................................................................................................... vascular or visceral injury.

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Page 3 - Ms. Cheryl K. Hastings

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption All users of (IDE) regulations under 21 CFR, Part 812. the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investiqation.
Any previous warning statements identified as part of 4. previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above .

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 requlations 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 requirement, 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 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.

FDA advises that the use of your device system 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 those of other manufacturers, may also be required.

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Page 4 - Ms. Cheryl K. Hastings

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,

Celia M. Witten, Ph.D., M

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)K974573

DePuy Motech MOSS Miami Titanium Sacral Extender Device Name

Indications for Use:

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

Concurrence of CDRH, Office of Device Evaluation

signature

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

Prescription Use

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

000003

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.