The OrthoHelix Calcaneal Trauma System is a set of metallic (titanium alloy), implantable, bone fixation plates and screws. Its' intended function use is to stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.

The System includes four (4) fixation plates and forty five (45) screws. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the "Calcaneal Trauma System," a set of metallic bone fixation plates and screws. This notification focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study related to artificial intelligence (AI) performance. Therefore, many of the requested categories related to AI devices, such as acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies for AI performance, are not applicable to this document.

Here's an attempt to extract relevant information and address the non-applicable aspects:

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

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices for intended use (stabilize fractures of the calcaneus)	FEA's and hand calculations confirm that the Calcaneal Trauma System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
Materials: implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136	All screws and plates are made from implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136.

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

Sample Size for Test Set: This document does not describe a "test set" in the context of an AI study. The performance assessment relied on engineering analysis and comparison to a predicate device.
Data Provenance: Not applicable in the context of an AI performance study. The performance data is derived from Finite Element Analysis (FEA) and hand calculations, which are engineering methods, not patient data trials.

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. This is not an AI device, and no ground truth was established by medical experts in this context. The "ground truth" for this device's performance would be engineering specifications and the established performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" requiring expert adjudication as this is not an AI device.

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

No. This is not an AI device, so an MRMC study comparing human readers with and without AI assistance was not performed.

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

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of an AI performance study. The "truth" for this device's regulatory pathway relies on engineering principles (FEA, hand calculations) and demonstrated equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI device, and thus no training set was used.

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

Not applicable. This is not an AI device.

Summary

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510(k) Premarket Notification

Calcaneal Trauma System

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 1815 West Market St. Suite #205 Akron, Ohio 44313 Phone: (330) 869-9563 Fax: (330) 869-9583

Contact Person:

Lee A. Strad Director of Operations & Development OrthoHelix Surgical Designs, Inc.

Date Prepared:

May 4, 2006

Name of Device

Calcaneal Trauma System

Common or Usual Name

Fixation Plates and Screws

Classification Name

Single/Multiple Component Metallic Fixation Appliances and Accessories

Predicate Devices

DePuy Ace Calcaneal Peri-articular Plate

Intended Use

To stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.

Device Description

The OrthoHelix Calcaneal Trauma System is a set of metallic (titanium alloy), implantable, bone fixation plates and screws. Its' intended function use is to stabilize

JUN 2 9 2006

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KC0614000
Pg 2 of 2

510(k) Premarket Notification

Calcaneal Trauma System

fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.

Performance Data

FEA's and hand calculations confirm that the Calcaneal Trauma System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

Orthohelix Surgical Designs, Inc. c/o Lee A. Strnad Director of Operations & Development 1815 West Market Street, Suite 205 Akron, Ohio 44313

Re: K061400

Trade/Device Name: Calcaneal Trauma System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HRS, HWC Dated: May 15. 2006 Received: May 25, 2006

Dear Mr. Strnad:

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

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Page 2 - Mr. Strnad

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. 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 ent thed, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bartare Bruckum

Mark Melkerson 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 (if known): TBD

Device Name: Calcancal Trauma System

Indications for Use:

The Calcaneal Trauma System is indicated for the repair of intra and extra articular fractures of the calcaneus

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Martina Buchwald for Men

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

510(k) Number K061406

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.