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 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

The MOSS Miami Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.

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. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared for use with the 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 5mm MOSS Miami rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami 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 system originally cleared for use in K933881.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (DePuy Motech Stainless Steel MOSS Miami Spinal System, specifically an addition: sacral extender) and a clearance letter from the FDA. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way this request typically implies (e.g., performance metrics for a diagnostic algorithm, clinical trial outcomes for a drug, or specific engineering verification/validation tests with pass/fail criteria for a device).

This document demonstrates substantial equivalence to predicate devices, which is the regulatory pathway for many Class II medical devices in the US. Substantial equivalence is based on similar designs, materials, performance (e.g., fatigue strength), and indications for use, rather than meeting pre-defined performance acceptance criteria from a specific study as would be seen for a novel device or diagnostic.

Therefore, I cannot fulfill the request as phrased. However, I can extract information related to the basis of substantial equivalence, which serves as the "proof" for this type of device submission.

Here's a breakdown of what can be extracted and why other parts of your request cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The regulatory acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device.
Reported Device Performance: Instead of specific performance numbers against criteria, the basis for substantial equivalence is provided.

Feature / Performance Aspect	Stated Relationship to Predicate Devices (Basis for Substantial Equivalence)
Designs	Similar to MOSS Miami 5mm longitudinal rod, Harrington Rods, Acromed ISOLA Spinal System
Interconnection Mechanisms	Similar to MOSS Miami 5mm longitudinal rod
Materials	Similar to MOSS Miami 5mm longitudinal rod (Stainless Steel)
Fatigue Strength	Comparable to MOSS Miami 5mm longitudinal rod
Indications for Use	Similar to MOSS Miami 5mm longitudinal rod, Harrington Rods, Acromed ISOLA Spinal System

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study that uses a test set of data. It's a regulatory submission demonstrating equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for regulatory clearance is the existing predicate device and its established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not a machine learning or diagnostic algorithm.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "proof" of device performance/safety:

The "proof" for this device's acceptance (clearance) is articulated as Substantial Equivalence to existing, legally marketed predicate devices. The document explicitly states:

"The MOSS Miami Sacral Extender is substantially equivalent to the MOSS Miami 5mm longitudinal rod that has been previously cleared for posterior non-pedicle use and limited posterior pedicle fixation. This substantial equivalence is based on similar designs, similar interconnection mechanisms, similar materials, comparable fatigue strength and similar indications for use."
It also draws comparisons to the "intended technique" for Harrington Rods (pre-amendment devices) and the "L" shaped longitudinal rod/sacral screw construct marketed by Acromed in the ISOLA spinal system for similarity in application.

The FDA's clearance letter confirms this by stating: "we have determined the device system is substantially equivalent... 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."

In essence, the acceptance criteria for this device were met by demonstrating its fundamental similarity to devices already on the market, implying a similar safety and effectiveness profile without requiring new clinical trials or performance studies against novel endpoints.

Summary

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SEP 1 9 1997 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988
510(K) CONTACT:	Vickie ArfordSr. Clinical Research Associate
TRADE NAME:	DePuy Motech Stainless SteelMOSS Miami Spinal System
COMMON NAME:	Hook, rod and screw spinal instrumentation
CLASSIFICATION:	888.3050 Spinal interlaminal fixation orthosis
DEVICE PRODUCT CODE:	Product code: 87 KWP
SUBSTANTIALLYEQUIVALENT DEVICES:	• DePuy Motech MOSS Miami Spinal System• Harrington Rods• Acromed ISOLA Spinal System

DEVICE DESCRIPTION AND INTENDED USE:

The MOSS Miami Spinal System is intended for non-cervical use in the spine. 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 turnor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

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. This product uses the same inner

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screw and outer locking nut as the hooks and screws previously cleared for use with the MOSS Miami Spinal System.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The MOSS Miami Sacral Extender is substantially equivalent to the MOSS Miami 5mm longitudinal rod that has been previously cleared for posterior non-pedicle use and limited posterior pedicle fixation. This substantial equivalence is based on similar designs, similar interconnection mechanisms, similar materials, comparable fatigue strength and similar indications for use.

The intended technique for the sacral extender is similar to that of the Harrington Rod technique Harrington rods are pre-amendment devices marketed by Zimmer prior to 1976. The sacral extender / longitudinal rod/ sacral screw construct is also similar to the "L" shaped longitudinal rod/ sacral screw construct which is marketed by Acromed in the ISOLA spinal system.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and two curved lines representing its tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vickie E. Arford, R.N. ·Senior Clinical Research Associate DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

SEP | 9 1997

K972568 Re: MOSS-Miami Sacral Extender to be used with the DePuy Motech MOSS Miami Spinal System Requlatory Class: II Product Codes: MNH, KWP, and KWQ Dated: July 9, 1997 Received: July 10, 1997

Dear Ms. Arford:

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 fusion mass. You may, therefore, market your device system 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 - Vickie E. Arford, R.N.

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 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:

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 usinq pedicle screws is intended only 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 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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See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

1. Any pedicular screw fixation/attachment for intended uses 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 (IDE) regulations under 21 CFR, Part 812. All users of 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 investigation.
এ . Any previous warning statements identified as part of 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation 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.

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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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.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) K97.256 8

DePuy Motech MOSS Miami Spinal System 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

Acolla

(Division Sign-Off) Division of General Restorative Devices K972563 510(k) Number_

Prescription Use

OR (Per 21 CFR 801.109)

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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.