POGO SCREW by FXDEVICES | FDA 510(k) Summary

The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.

AI/ML Overview

The POGO Screw is a medical device designed for the fixation of bone fractures and reconstructive surgery.

Here's an analysis of its acceptance criteria and the study conducted to prove it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Accomplish the same function of providing compression fixation between bone segments.	"The POGO Screw and the predicate device accomplish the same function of providing compression fixation between a base bone and a bone fragment."
Design Characteristics	Accommodate a similar range of total lengths within each product design.	"Both devices accommodate a range of total lengths within each product design."
Materials	Be manufactured from comparable materials (316 surgical stainless steel).	"The components are manufactured from 316 surgical stainless steel." (Also applies to the predicate devices).
Intended Use	Indicated for use in the general management of fractures and reconstructive surgery.	"The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery." (Identical to predicate).
Safety and Efficacy	Not raise any new safety and efficacy concerns compared to legally marketed predicate devices.	"The POGO Screw does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."
Substantial Equivalence	Demonstrably substantially equivalent to predicate devices to allow market clearance.	"The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate."

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

The documentation provided does not describe a test set with explicit sample sizes for clinical data, patient cases, or imaging. The evaluation of the POGO Screw for 510(k) clearance was based on bench testing and a comparison of its technological characteristics to predicate devices. Therefore, the concept of "data provenance" related to human data (e.g., country of origin, retrospective/prospective) is not applicable in this context.

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

This information is not applicable as the clearance was based on bench testing and comparison to predicate devices, not on the evaluation of a test set with human-labeled ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there was no test set involving human-labeled ground truth or adjudication.

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

An MRMC comparative effectiveness study was not performed. This device is a bone fixation screw, not an AI-powered diagnostic or assistive technology.

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

This information is not applicable. The POGO Screw is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the POGO Screw's performance was established through:

Bench Testing Data: This involved engineering tests to evaluate mechanical properties, strength, and other physical characteristics of the screw. While specific test types and results are not detailed in the summary, "Bench testing was conducted to support equivalency."
Comparison to Predicate Device Specifications: The key "ground truth" was that the POGO Screw's design, materials, and intended use were demonstrably the same or highly similar to legally marketed predicate devices (Smith and Nephew Cannulated Screws and Stryker Medical Asnis III). This effectively meant the established safety and efficacy of the predicate devices served as a benchmark for the POGO Screw.

8. The Sample Size for the Training Set

This information is not applicable. There was no "training set" in the context of machine learning or AI for this device. The development process would have involved engineering design, material selection, and manufacturing, followed by bench testing and comparison to established standards and predicate devices.

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

This information is not applicable as there was no "training set." The understanding of "ground truth" for a device like the POGO Screw is developed through engineering principles, material science, biomechanical testing, and clinical experience with similar devices (the predicate devices).

Summary

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10/9/2008

510K Summary of Safety and Effectiveness Fx Devices POGO Screw Oct 10. 2008

1. Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
  NOV 2 5 2008

2.	Device Name:	POGO Screw
Panel	Orthopaedic
Classification Name	Smooth or Threaded Metallic Bone Fixation Fastener
CFR Number	Class II (per 21 CFR 888.3040)
Product Code	HWC

1. Identification of Predicate or Legally Marketed Device The POGO Screw is substantially equivalent to the Smith and Nephew Cannulated Screws cleared under K060736 and the Stryker Medical Asnis III cleared under K071092.
1. Device Description

1. Intended Use The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
1. Comparison of Technological Characteristics The POGO Screw and the predicate device accomplish the same function of providing compression fixation between a base bone and a bone fragment. Both devices accommodate a range of total lengths within each product design.
7 Performance Testing Bench testing was conducted to support equivalency
8 Statement of Equivalency The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate. Since the POGO Screw is the same in intended use and technological characteristics as the predicate devices, the POGO Screw does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

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FxDevices Premarket Notification -- POGO Screw 10/9/2008

The test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FxDevices, Inc. % Mr. Rich Lipschutz Operations Manager One South Ocean Blvd., Suite 324 Boca Raton, Florida 33432

NOV 2 5 2008

Re: K080649

Trade/Device Name: POGO Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 10, 2008 Received: October 16, 2008

Dear Mr. Lipschutz:

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. Rich Lipschutz

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, please 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 M. Millman

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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FxDevices Premarket Notification - POGO Screw

Indications for Use

510(k) Number (if known): Ko80649

Device Name:

Indications For Use:

The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.

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)

Mark A. McKerss

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

510(k) Number

Page 1 of

Kool

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.