5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) by DEPUY ACROMED

When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, 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 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 Miami 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 Miami 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 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

Device Description

5.0mm Diameter Polyaxial Screws for the Moss Miami 6.35mm System. Manufactured from ASTM F-136 implant grade titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel.

AI/ML Overview

This 510(k) summary provides minimal information regarding the performance data, primarily stating that "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm System.)." It does not detail specific acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document is primarily a regulatory filing for substantial equivalence based on predicate devices, rather than a detailed scientific study report with performance metrics.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified (The document only states "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws")

2. Sample size used for the test set and data provenance:

Not specified. The document mentions "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws," but gives no details about the nature of this data, its sample size, or its provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable / Not specified. This document is for a spinal fixation system, not an AI/diagnostic device that typically involves human expert ground truth for interpretation. The "performance data" would likely refer to mechanical testing, biocompatibility, and sterilization, rather than diagnostic accuracy.

4. Adjudication method for the test set:

Not applicable / Not specified. Similar to point 3, this is irrelevant for a mechanical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is for diagnostic or AI-assisted interpretation devices. The document concerns a physical spinal implant.

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

Not applicable. This relates to AI algorithms, not a physical implant.

7. The type of ground truth used:

N/A (likely mechanical testing standards). For a spinal fixation system, "ground truth" would typically refer to established engineering standards for mechanical strength, fatigue, corrosion resistance, and biocompatibility. The document notes the materials are "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel," implying adherence to these material standards. However, specific performance metrics are not provided.

8. The sample size for the training set:

Not applicable. This question pertains to machine learning models, not a physical medical device like a spinal screw system.

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

Not applicable. Same as point 8.

Summary

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IX. 510(k) Summary

SUBMITTER:	DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02767
CONTACT PERSON:	Lisa A. Gilman
DATE PREPARED:	August 2, 2002
CLASSIFICATION NAME:	Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation
PROPRIETARY NAME:	5.0mm Diameter Polyaxial Screws for the Moss Miami6.35mm System
PREDICATE DEVICES:	Moss Miami Spinal System (K983583, K992168 &K002607)
INTENDED USE:	When used as a posterior, noncervical hook, and/orsacral/iliac screw fixation system, or as an anterior,thoracic/lumbar screw fixation system, the MossMiami Spinal system is intended to treat scoliosis,kyphosis and lordosis, fracture, loss of stability due totumor, spinal stenosis, spondylolisthesis, a previouslyfailed fusion surgery or degenerative disc disease(i.e., discogenic back pain with degeneration of thedisc confirmed by patient history and radiographicstudies).When used as a pedicle screw fixation system of thenoncervical spine in skeletally mature patients, theMoss Miami Spinal System is indicated fordegenerative spondylolisthesis with objectiveevidence of neurologic impairment, fracture,dislocation, scoliosis, kyphosis, spinal tumor, and

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K (12262

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel.

PERFORMANCE DATA:

Data were submitted to characterize the 5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm System.)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line, creating a sense of unity and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2002

Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc.

325 Paramount Drive

Raynham, Massachusetts 02767

K022623 Re:

Trade/Device Name: 5.0mm Diameter Polyaxial Screws (Moss Miami 6.35mm System) Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: August 2, 2002 Received: August 7, 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, 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 (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.

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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 and additionally 21 CFR Part 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained 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 yours.

L. Mark N. Millhussen

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

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Indications for Use III.

510(k) Number (if known): _ KO22623___________________________________________________________________________________________________________________________________________

5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm Device Name: System)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

for Mark N Millanzo

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number	K022623
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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.