The provided document is a 510(k) summary for a medical device called the "TSY™ Shoulder Plate Implant," which is a bone fixation appliance. It details the administrative information, predicate device, and intended use. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary serves to establish substantial equivalence to a legally marketed predicate device, not to present performance study results against specific acceptance criteria in the manner you've described. The content provided is typical of a premarket notification where the focus is on device description, intended use, and comparison to a predicate, rather than detailed performance data from clinical or non-clinical studies.

Therefore, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication, or ground truth, as none of this information is present in the provided text.

Summary

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Special 510(k): Device Modification

TSY" Shoulder Plate Implant

JUN 2 4 2004

ge 1 of

510(k) SUMMARY

K040850

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Orthopedic Sciences, Inc.6080 Center Drive, 6th FloorLos Angeles, CA 90045
Official Contact:	James K. Brannon, M.D.
Representative/Consultant:	Floyd G. LarsonPaxMed International4329 Graydon RoadSan Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236flarson@paxmed.com
DEVICE NAME
Classification Name:	Plate, fixation, bone
Trade/Proprietary Name:	TSY™ Shoulder Plate Implant
Common Name:	Bone plate

PREDICATE DEVICE INFORMATION

The predicate device for this modification is the Hip Tool™ Implant, a component of the Hip Tool " Bone Graft Stabilization System, cleared by FDA on September 23, 2002 under K022139.

INTENDED USE

The TSY" Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

Orthopedic Sciences, Inc. C/o Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K040850 K040850
Trade/Device Name: TSY™ Shoulder Plate Implant Regulation Number: 21 CFR 888.3030 Regulation Number: 21 CFR 886.5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 31, 2004 Received: March 31, 2004

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed previoe Amendments for use stated in the enclosure) to regary mance.ca producal Device Amendments, or to commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been recults in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approvisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, merelore, market the devreet, see in and of general controls provisions of the Fields required or qualibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mo existing major regulations affecting your device can
may be subject to such additional controls. This Control Control of Class of may be subject to such additional controllar Existing in the 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to be found in the Code of Peacharing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualities with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA nas made a dectorimiation administered by other Federal agencies. You must or any Federal statutes and regulations annualing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good frant 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1900-1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Floyd G. Larson

This letter will allow you to begin marketing your device as described in your becine in 10(k) I his letter will anow you to oegin maketing of substantial equivalence of your device to a legally premaired notheation: "The PDF Intellig of easification 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), please If you desire specific advice for your as 1 (301) 594-4659. Also, please note the regulation entitled, comact the Office of Comphalled as (SS = 7, 21 CFR Part 807.97). You may obtain Misolaliums by telefonee to premainter to premainter the Act from the Division of Small other geleral information on your respended to 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,

Made A. Milburn

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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K040850/A1

Indications for Use

510(k) Number (if known): K040850

Device Name: TSY™ Shoulder Plate Implant:

Indications For Use:

The TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the The 131 - "Onoulder Plato implant. Should of an intraosseous fracture.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millkern

f General, Restorative, and Neurological Devices

510(k) Number K040850

Page 1 of 1_

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.