The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Device Description

The StayFuse is a device consisting of two components. The male half possesses a protruding connection feature and the female half an internal connection feature. The bone-mating portion has a cancellous type thread with a self-drilling and tapping tip. Distal to the screw tip is an external hex that is engaged with a hex driver. The hex driver is dual purpose: one end shaped for pre-drilling the bone and the other end features an internal hex for inserting the implant. The hex driver is designed to interface with a chuck of a standard cannulated drill. The implant will be offered in a number of diameters, lengths and hex drives to accommodate the variability in bone sizes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called StayFuse and a letter from the FDA regarding its clearance. It does not contain information about specific acceptance criteria or a study with detailed performance data, sample sizes, expert qualifications, or ground truth establishment.

Instead, the document states: "The Pioneer StayFuse Implant was predicated on the use of K-Wires." This indicates that the device was deemed substantially equivalent to existing K-Wires based on its intended use and design, rather than being cleared through a study specifically demonstrating performance against detailed acceptance criteria in a clinical setting.

Therefore, most of the requested information cannot be extracted from this document as it describes a different type of regulatory submission.

However, I can provide what is available:

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

Acceptance Criteria: Not explicitly stated in the provided text. The clearance is based on substantial equivalence to predicate devices (K-Wires).
Reported Device Performance: Not explicitly reported in terms of quantitative metrics against acceptance criteria. The device is described as an "Intramedullary Bone Screw" for "small bone fusion and fractures," indicating its functional purpose.

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/Not provided. The 510(k) summary does not describe a performance study with 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/Not provided.

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

Not applicable/Not provided.

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. This device is a surgical implant, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable/Not provided.

8. The sample size for the training set

Not applicable/Not provided.

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

Not applicable/Not provided.

Summary

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Pioneer Surgical Technology

K990804

510(K) Notification Summary For StayFuse

Administrative Information

Manufacturer Identification and Sponsor:

Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855-1781 906-226-9909 Telephone: FAX: 906-226-4443

Official Contact:

Burns Severson Vice President, Regulatory Affairs/Quality Assurance

Date Prepared:March 4, 1999

Device Identification

Proprietary Name:

StayFuse

Common Name:

Intramedullary Bone Screw

Classification Name and Reference:

Fixation Screw Regulation Number: 888.3040, Class II Classification Number: 87HWC

Device on which substantial equivalence is claimed: K-Wire

Not intended for spinal use.

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Device Description

Intended Use

The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Performance Data

The Pioneer StayFuse Implant was predicated on the use of K-Wires.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles connected together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Burns Severson Vice President, Regulatory Affairs/Quality Assurance Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-1781

Re: K990804 Trade Name: StayFuse Regulatory Class: II Product Code: HWC Dated: March 5, 1999 Received: March 10, 1999

Dear Mr. Severson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Burns Severson

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pioneer Surgical Technology

StayFuse

Indications for Use

The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Páez

(Division an-Off Division o General Re 11990854 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.