The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Device Description

The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts:

Cannulated screws of various lengths, which are positioned through bony fragments to provide stability to the fracture site during healing.
A washer which provides a bearing surface for the cannulated screw head against the bone. The washer also prohibits migration of the screw head into the cortex.
ODi will manufacture the implants from implant grade titanium alloys.

AI/ML Overview

The provided text is a 510(k) Summary for the ODi 7.0mm Cannulated Screw System, which is a medical device. This type of document is a premarket notification to the FDA and primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than conducting a detailed performance study with acceptance criteria in the way a diagnostic AI device would.

Therefore, the information required to fill out the table and answer all questions for an AI device's acceptance criteria and study proving its performance is not present in this document.

Here's why and what information is available:

This is a medical device clearance, not an AI/diagnostic software clearance. The ODi 7.0mm Cannulated Screw System is a physical orthopedic implant (screws and washers for bone fixation). Its "performance" is assessed through manufacturing specifications, material testing, and comparison to predicate devices, not through algorithmic accuracy metrics like sensitivity, specificity, or AUC as an AI diagnostic would be.
The concept of "acceptance criteria" for this device is related to its physical properties, biocompatibility, and functional equivalence to predicate devices, not a statistical performance threshold.
There is no "test set," "training set," "ground truth," "experts for ground truth," or "MRMC study" in the context of an AI device. These terms are specific to the validation of AI algorithms.

Therefore, it is not possible to complete the requested table and answer the questions based on the provided text.

However, I can extract the information that is relevant to the document's purpose:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit - from substantial equivalence): The device must be equivalent to predicate devices in Indications for Use, Device Design, Materials, Method of Manufacture, and Method of Sterilization.
Reported Device Performance: The document states the device "is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable; this is not a study assessing diagnostic performance against a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable.

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.

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.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of available information from the document:

Device Name: ODi 7.0mm Cannulated Screw System
Indications for Use: Fixation/stabilization of stable fractures of the proximal femur (pertrochanteric, basilar femoral neck, subcapital, and combinations), intercondylar femoral fractures, and tibial plateau fractures until bony union occurs.
Predicate Devices: Examples include products from aaP Implants, Inc, Advanced Orthopaedic Solutions, DePuy/ACE, Inc., Magly Orthopedics, LLC, and Synthes, Inc. (K990776, K014185, K893512, K021662, K021932, K962011).
Basis for Clearance: Substantial equivalence to legally marketed predicate devices.

Summary

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APR 0 1 2003

SECTION 12: 510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo for ODI Orthopedic Designs, Inc. The logo features a stylized "i" inside a circle, followed by the letters "ODI" in a bold, sans-serif font. Below the letters, the words "ORTHOPEDIC DESIGNS, INC." are printed in a smaller font size.

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

For Release Upon Request Only

Date of Preparation: February 17, 2003

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name / Contact:

Company:	Orthopedic Designs, Inc. (ODi)6965 1st Ave. NorthSt. Petersburg, FL 33710
	A ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Contact: Patrick Cosgrove (888) 635-8535

Establishment Registration Number: 1064129

Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener -and- Single/multiple Component Metallic Bone Fixation Appliances and Accessories. 21 CFR § 888.3040 -- Smooth or Threaded Metallic Classification Reference: Bone Fixation Fastener 21 CFR § 888.3030 – Single/multiple Component Metallic Bone Fixation Appliances and Accessories.

Common Used Name:	Cannulated Screw
Device Product Code:	HWC and HTN
Classification Panel:	87- Orthopedic Devices
Trade Proprietary Name:	ODi 7.0mm Cannulated Screw System
Proposed Regulatory Class:	Class II

30619

page 1 of 2

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K030619
page 2 of 2

Device Description:

The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts:

Cannulated screws of various lengths, which are positioned through bony ● fragments to provide stability to the fracture site during healing.
A washer which provides a bearing surface for the cannulated screw head against . the bone. The washer also prohibits migration of the screw head into the cortex.

ODi will manufacture the implants from implant grade titanium alloys.

Indications for Use:

Contra-indications for Use:

The ODi 7.0mm Cannulated Screw System is not intended for use in patients with the following conditions:

1. Active local Infection.
1. Metal sensitivity or allergic reaction to foreign bodies.
1. Loss of bone stock or insufficient bone quality to support the device.
1. Obliterated femoral head, neck or trochanteric region.
1. Use in the spine

Substantial Equivalent Devices:

Orthopedic Designs, Inc. believes the ODi 7.0mm Cannulated Screw System is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison:

aaP Implants, Inc	K990776
Alphatec Mfg., Inc	-NA-
Advanced Orthopaedic Solutions	K014185
DePuy/ACE, Inc.	K893512
Magly Orthopedics, LLC	K021662
Smith and Nephew	-NA-
Stryker, Inc.-HowmedicaOsteonics	-NA-
Synthes, Inc.	K021932
	K962011

Each of these products are commercially available and marketed Class II devices indicated for similar use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 emblem featuring three stylized human profiles merging into a single form, often interpreted as representing the interconnectedness of health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 1 2003

Mr. Patrick J. Cosgrove Vice President Engineering and Product Support Orthopedic Designs, Inc. 6965 1st Avenue North St. Petersburg, FL 33710

Re: K030619 Trade/Device Name: ODi 7.0mm Cannulated Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: February 24, 2003 Received: February 27, 2003

Dear Mr. Cosgrove:

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. Patrick J. Cosgrove

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

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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DEVICE INDICATIONS FOR USE SECTION 5:

Page 1 of 1

510(k) Number:

ODi 7.0mm Cannulated Screw System Device Name:

Indications For Use:

Contra-Indications:

The ODi 7.0mm Cannulated Screw System is not intended for use in patients with the following conditions:

1. Active local Infection.
1. Metal sensitivity or allergic reaction to foreign bodies.
1. Loss of bone stock or insufficient bone quality to support the device.
1. Obliterated femoral head, neck or trochanteric region.
1. Use in the spine

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number -

Mark A. Millerson

is General, Restorative and Neurologica

5-1

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.