Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. 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 provided text describes a 510(k) premarket notification for a medical device called the "POGO Screw." This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K080649), rather than proving the device meets specific acceptance criteria through clinical or even extensive bench performance studies with stated numerical targets.

Therefore, the requested information regarding acceptance criteria, study details like sample sizes, expert involvement, ground truth establishment, and comparative effectiveness with AI assistance is largely not applicable or not present in the provided document.

Here's an explanation of why and what information is available:

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

Not applicable/Not provided. The document states "Bench testing was conducted to support equivalency" but does not detail specific acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or the numerical results of this testing. The focus is on demonstrating "substantial equivalence" to a predicate device, meaning it performs similarly, not necessarily meeting a predefined set of numerical performance targets.

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

Not applicable/Not provided. This type of information is typically associated with clinical studies or extensive performance testing with defined test sets. For a 510(k) demonstrating substantial equivalence based on bench testing (as implied), these details are not usually required or disclosed in the summary.

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. There is no mention of human expert involvement in establishing a "ground truth" for the testing in this submission, as it focuses on material and design equivalency, not diagnostic or clinical interpretation.

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

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 bone fixation screw, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

Not applicable. As a physical medical device (bone screw), there is no "algorithm only" performance to evaluate.

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

Not applicable/Not provided. Since no specific "test set" and outcome evaluation in the clinical sense is detailed, there's no ground truth type mentioned. The "truth" in this context is the performance of the predicate device, to which the new device is compared.

8. The sample size for the training set

Not applicable. The concept of a "training set" applies to machine learning models. This device is a mechanical implant, not an AI system.

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

Not applicable. See point 8.

Summary of available information from the document that is tangentially related to "performance":

Study type: Bench testing was conducted to support equivalency with a predicate device.
Predicate Device: POGO Screw cleared under K080649.
Equivalency Statement: "The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate."
Safety and Efficacy: The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
Device Description (relevant to equivalency): The device consists of various size cannulated screws for bone fracture fixation, made of 316LVM Stainless Steel conforming to ASTM F138. Available in 55mm to 130mm lengths, provided sterile or non-sterile.
Intended Use: General management of fractures and reconstructive surgery.

In essence, the entire document serves as evidence of substantial equivalence to a device already on the market, not as a detailed report of a study proving a device meets specific, pre-defined quantitative acceptance criteria with associated ground truth from experts or large datasets.

Summary

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Modification to the POGO Screw

FxDEVICES

SEP 1 8 2009

Special Premarket Notification

K092489p.10亿2

510(k) Summary of Safety and Effectiveness FxDEVICES POGO Screw July 20, 2009

1. Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
- Device Name POGO Screw Orthopaedic Panel Smooth or Threaded Metallic Bone Fixation Classification Name Fastener Class II (per 21 CFR 888.3040) CFR Number HWC Product Code
Identification of Predicate or Legally Marketed Device 3. The POGO Screw is substantially equivalent to the POGO Screw cleared under K080649.

Device Description 4.

Intended Use 5. The ROGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Comparison of Technological Characteristics 6. 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.

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FxDEVICES

Modification to the POGO Screw

K092189 p. Z of 2

Performance Testing

Bench testing was conducted to support equivalency

Statement of Equivalency 8.

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.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings, symbolizing health and service.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 1 8 2009

FxDEVICES c/o Mr. Rich Lipschutz President, FxDEVICES One South Ocean Boulevard, Suite 324 Boca Raton, Florida 33432

K092189 Re:

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: August 19, 2009 Received: August 21, 2009

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

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Page 2 - Mr. Rich Lipschutz

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.

If you desire specific advice for your device on our labeling regulation (21 CFR-Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Barbara Buchner

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092189

POGO Screw Device Name:

Indications For Use:

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

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Somitu fer mym
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K092189

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.