This 510(k) summary (K051181) describes a modification to an existing device, the Custom-Hip Tool™. As such, the submission primarily focuses on demonstrating substantial equivalence to the predicate device (Hip Tool™ Implant, K022139) rather than presenting a new clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not explicitly detailed in this document.

However, based on the provided text, we can infer some aspects and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Goal: To demonstrate substantial equivalence to the predicate device (Hip Tool™ Implant, K022139).	The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This implies that the Custom-Hip Tool™ performs comparably to the predicate for stabilizing bone grafts within the femoral head and neck to assist healing of an intraosseous fracture.
Functional Equivalence: The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture, consistent with the predicate device.	The FDA concurrence on "Indications For Use" confirms that the Custom-Hip Tool™ meets this intended use.
Safety and Effectiveness Equivalence: The modified device should not raise new questions of safety or effectiveness compared to the predicate.	The FDA's finding of substantial equivalence implicitly means that the device's safety and effectiveness profiles are considered equivalent to the predicate, as no new safety or effectiveness concerns were raised that would prevent clearance.

Missing Information:

Specific quantitative acceptance criteria: The document does not specify quantitative performance metrics (e.g., tensile strength, fatigue life, stability under certain loads, specific healing rates, or accuracy of placement) for the Custom-Hip Tool™ or the predicate device that were used to establish substantial equivalence.
Specific comparative performance data: No explicit data comparing the performance of the Custom-Hip Tool™ to the Hip Tool™ Implant (K022139) is presented in this summary. The substantial equivalence determination is a regulatory finding, not a disclosure of a full performance study report.

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) summary does not describe a de novo study with a test set. The submission is for a device modification, relying on the substantial equivalence to a predicate device. Therefore, information on a "test set" in the context of an original clinical or performance study is not provided.

If there were any in vitro or in vivo bench testing performed to support the modification, the details (sample size, data provenance) are not included in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or provided. Since no clinical or performance study with a test set (requiring ground truth) is described in this 510(k) summary, there is no mention of experts or their qualifications for establishing ground truth. The FDA's review for substantial equivalence is based on the information provided by the manufacturer, which typically includes device specifications, design comparisons, and potentially bench testing, rather than a new clinical study.

4. Adjudication Method for the Test Set

This information is not applicable or provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable or provided. The Custom-Hip Tool™ is a medical implant intended to stabilize bone grafts. It is not an imaging device or AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable or provided. The Custom-Hip Tool™ is an implantable device, not a software algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

This information is not applicable or provided. As there is no de novo study with a test set generating new "ground truth," this concept is not discussed in the summary. The substantial equivalence determination relies on the existing knowledge and regulatory history of the predicate device.

8. Sample Size for the Training Set

This information is not applicable or provided. The Custom-Hip Tool™ is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI model development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided for the same reasons as point 8.

Summary

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Special 510(k): Device Modification

K051181

Custom-Hip Tool™

MAY 2 3 2005

510(k) SUMMARY

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Orthopedic Sciences,Inc. 6080 Center Drive,Sixth Floor LosAngeles, CA 90045
Official Contact:	James K. Brannon. M.D. President/CEO

Telephone (310) 242-6643 FAX (310) 242-6603

DEVICE NAME

Classification Name:	Plate, fixation, bone
Trade/Proprietary Name:	Custom-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 Custom-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 is a black and white logo for the Department of Health and Human Services, USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2005

James K. Brannon, M.D. President/CEO Orthopedic Sciences Incorporated 6080 Center Drive 6th Floor Los Angeles, California 90045

Re: K051181 Trade/Device Name: Custom-Hip Tool™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 27, 2005 Received: May 9, 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 the endobate) to regulty management date of the Medical Device Amendments, or to devices that have been reasy 12, 1978, 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 do not require approvisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 If your device to such addition (seconders). Existing major regulations affecting your device can be found in be subject to such additions, 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 I lease be advised that in that your device complies with other requirements of the Act or any I Drivias made a acterninations administered by other Federal agencies. You must comply with all the I cated statues and regulating, 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) (21 Crical 007), good no); 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 -James K. Brannon, M.D.

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,

Miriam C. Provost

Miriam C. Provost, Ph.D. 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

K051181 510(k) Number:

Device Name: Custom-Hip Tool™

Indications For Use:

The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing 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)

Miriam C. Provost

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

510(k) Number K051181

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.