The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Device Description

The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only. The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading. All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138. The devices will range in diameter from 0.028 inches to 0.1875 inches. The devices range in length from 4 inches to 12 inches. The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point. The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round. The devices will be provided in fully threaded, partially threaded and nonthreaded versions.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the OrthoPro Steinman Pins and Kirschner Wires, focusing on the acceptance criteria and supporting studies as requested:

Summary of Acceptance Criteria and Device Performance:

The 510(k) submission for the OrthoPro Steinman Pins and Kirschner Wires does not present specific quantitative acceptance criteria or a detailed "study" in the traditional sense (e.g., performance metrics with benchmarks). Instead, it relies on the concept of substantial equivalence to predicate devices. The primary "acceptance criteria" and "device performance" are centered around meeting the general characteristics of existing, legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance (OrthoPro Steinman Pins and Kirschner Wires)	Supporting Evidence/Commentary
Materials of Construction	Biocompatible, implant-grade stainless steel	Implant grade 316LVM stainless steel conformant to ASTM F138	Explicitly stated. Identical to predicate device material.
Physical Characteristics	Range of lengths, diameters, tip styles, and threading	Variety of lengths (4-12 inches), diameters (0.028-0.1875 inches), tip styles (trocar, diamond, cove), and threading (fully, partially, non-threaded)	Descriptions provided. Stated as "equivalent in physical dimensions" to predicate.
Intended Use	Fixation of bone fractures, bone reconstructions, guide pins, traction	Identical intended use	Explicitly stated. Identical to predicate device indications.
Sterility	Non-sterile	Non-sterile	Explicitly stated.
Usage	Single-use only	Single-use only	Explicitly stated.

Study Details:

The provided 510(k) summary does not describe a clinical study or a non-clinical performance study with quantitative results to establish specific acceptance criteria and then demonstrate the device meets those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices through a comparison of technological characteristics.

Here's why many of your detailed questions are not directly applicable or cannot be answered from this specific document:

Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The device's characteristics are compared directly to the specifications of predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment process is described as there isn't a performance test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This device (Steinman Pins and Kirschner Wires) is a mechanical orthopedic fixation device, not an AI or imaging diagnostic tool. MRMC studies are irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component in this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense of a performance study. The "ground truth" for substantial equivalence is the established characteristics and performance of the legally marketed predicate devices.
The sample size for the training set: Not applicable. No AI/machine learning component to train.
How the ground truth for the training set was established: Not applicable.

Explanation of the "Study" and Approach:

The document explicitly states:

"Summary of Non-Clinical Tests: The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification."
"The OrthoPro Steinman Pins and Kirschner Wires are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the "study" for this 510(k) submission primarily involved:

Engineering Analysis and Documentation: Verification of the device's material composition (316LVM stainless steel per ASTM F138) and its physical dimensions (lengths, diameters, tip styles, threading options) against its own specifications and in comparison to the publicly available characteristics of predicate devices (DePuy Steinman Pins and Kirschner Wires K960385, Smith and Nephew Pins and Wires K994143, and a pre-amendment Smith and Nephew device).
Predicate Comparison: The core of the submission is a detailed comparison demonstrating that the new device shares the same intended use, materials, and fundamental technological characteristics as already cleared devices, thus establishing substantial equivalence.

In essence, for this type of medical device (a well-understood mechanical component), "substantial equivalence" allows manufacturers to leverage the regulatory history and safety/effectiveness profile of existing predicate devices rather than conducting new, extensive clinical or performance studies, provided the new device does not raise new questions of safety or effectiveness. The "acceptance criteria" are implicitly met by being demonstrably equivalent to devices that have already met regulatory requirements.

Summary

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K07055

JUL 1 3 2007

510(k) Summary

July 12th, 2007

This safety and effectiveness summary for the OrthoPro Steinman Pins and Kirschner Wires is provided as required per section 513(i)(3) of the Food, Drug, and Cosmetic Act.

510(k) Owner:

OrthoPro LLC. 3450 S. Highland Dr. #303 Salt Lake City, UT 84106 Telephone: 801-746-0208

Authorized Contact Person: Christopher L. Cook Straits Orthopaedics Inc. 13115 NE 4th St. Suite 130 Vancouver, WA 98684 Telephone: 360-253-9761

Trade Name:	OrthoPro Steinman Pins and Kirschner Wires
Common Name:	Steinman PinsKirschner Wires
Classification Name:	Smooth or threaded metallic bone fixation fastener
Classification:	888.3040
Product Class:	II
Product Code:	HTY pin, fixation, smoothIDW pin, fixation, threaded

Predicate or legally marketed devices which are substantially equivalent:

Product	510k Number
DePuy Steinman Pins and Kirshner Wires	K960385
Smith and Nephew Pins and Wires	K994143
Smith and Nephew Pins and Wires	Pre-amendment

Device Description

OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission

Page 5 of 11

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Intended Use

Comparison of the technological characteristics of the device to predicate and legally marketed devices

The proposed devices are substantially equivalent to the identified predicate device in materials of construction, physical characteristics, and intended use.

Summary of Non-Clinical Tests

The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification.

The OrthoPro Steinman Pins and Kirschner Wires are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices.

Contact:

CTCK

Christopher L. Cook Authorized Contact Person Vice President Regulatory Affairs Straits Orthopaedics Inc.

OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission

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2.7 Classification:	888.3040
2.8 Panel	Orthopedic
2.9 Product Class:	II
Product Code	HTY pin, fixation, smoothJDW pin, fixation, threaded

2.1.1 Predicate Devices

Product	510k Number
DePuy Steinman Pins and Kirschner Wires	K960385
Smith and Nephew Pins and Wires	K994143
Smith and Nephew Pins and Wires	Pre-amendment

3.0 Device Description

2.1.0

The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading.

3.1 Materials of Construction
All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138.
3.2 Diameter
The devices will range in diameter from 0.028 inches to 0.1875 inches.
3.2 Length
The devices range in length from 4 inches to 12 inches.
3.3 Distal Tip Style
The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point.
3.4 Proximal Tip Style
The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round.
3.5 Threading
The devices will be provided in fully threaded, partially threaded and nonthreaded versions.
3.6 Device Specifications
Please refer to Appendix B for detailed device specifications.

OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 13 2007

OrthoPro LLC c/o Straits Orthopaedics Inc. Mr. Christopher L. Cook Vice President Regulatory Affairs 13115 NE 4th Street, Suite 130 Vancouver, WA 98684

Re: K070555

Trade/Device Name: OrthoPro Steinman Pins and Kirschner Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTY Dated: June 1. 2007 Received: June 11, 2007

Dear Mr. Cook:

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 (OS) 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. Christopher L. Cook

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, nlease contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Mark A. Milburn

Mark N. 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

4070555 510(k) Number (If Known)

OrthoPro Steinman Pins and Kirschner Wires Device Name:

Indications for Use:

OrthoPro Steinman Pins and Kirschner Wires Indications for Use

Prescription Use X (Part 21 CFR 801 Subpart D Over the Counter Use (21 CFR 807 Subpart C)

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

Mark A. Milham

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

510(k) Number _

OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.