This document is a 510(k) summary for a medical device called the "S-Bone Hip Tool™", a bone plate. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about performance studies with acceptance criteria or ground truth establishment typically associated with AI/ML devices. Therefore, I cannot provide the requested information.

The document does not contain the following information:

Acceptance criteria and reported device performance: This document is a regulatory submission for a bone fixation device, not an AI/ML algorithm. It doesn't present performance metrics like sensitivity, specificity, or F1-score with acceptance criteria, which are common for AI/ML device evaluations.
Sample size and data provenance for a test set: This information is not relevant to a 510(k) submission for a bone plate, where evaluation typically involves mechanical testing or clinical use data for the device itself rather than a test set for an algorithm.
Number and qualifications of experts for ground truth: Not applicable for this type of device submission.
Adjudication method: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: This device is a physical bone plate, not an algorithm.
Type of ground truth used: Not applicable as it's not an AI/ML device.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

Since the provided document is for a physical medical device (bone plate) and not an AI/ML powered device, the questions related to AI/ML evaluation metrics and study design are not applicable. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, which is typically done through comparison of indications for use, technological characteristics, and performance data from mechanical testing or clinical experience without the need for detailed ground truth establishment methods for an algorithm.

Summary

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OCT 7 - 2005

510(k) SUMMARY

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Orthopedic Sciences, Inc.3020 Old Ranch Parkway, Suite 325Los Angeles, CA 90045
Official Contact:	James K. Brannon. M.D. President/CEOTelephone (562) 799-5550 Fax (562) 799-5533

DEVICE NAME

Classification Name:	Plate, fixation, bone
Trade/Proprietary Name:	S-Bone Hip ToolTM
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 S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral 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 Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a bird-like shape.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

James K. Brannon, M.D. President/CEO Orthopedic Sciences, Inc. 3020 Old Ranch Parkway, Suite 325 Seal Beach, California 90740

Re: K052538 Trade/Device Name: S-Bone Hip Tool™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: September 6, 2005 Received: September 15, 2005

Dear Dr. Brannon:

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- Dr. James K. Brannon

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

8-64

Acting 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

510(k) Number: K052538

Device Name: S-Bone Hip Tool™

Indications For Use:

The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

Prescription Use × (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)

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

510(k) Number_KO52538

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.