EXTERNAL FIXATION by GEXFIX USA INC.

Analysis of the provided document (K052605, External Fixation) reveals that it is a 510(k) premarket notification for an external fixation system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for a device performance study is not typically found in these types of documents.

Here's a breakdown of why the requested information is not present and what is available:

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

Not Applicable: 510(k) submissions for devices like external fixation systems (which are typically Class II, as indicated by the regulation number 21 CFR 888.3030) do not usually include a table of quantitative acceptance criteria and reported device performance derived from a study designed to prove these criteria. The approval is based on demonstrating substantial equivalence to a predicate device. This often involves comparing design features, materials, and intended use, and sometimes non-clinical (e.g., mechanical) testing to ensure the device meets safety and performance standards equivalent to the predicate. However, these are typically engineering specifications rather than clinical performance metrics relative to a specific efficacy target.

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: Since no human clinical study demonstrating performance against specific acceptance criteria is described, there's no "test set" in the context of clinical data. If non-clinical bench testing was performed, details about the "sample size" would refer to the number of devices tested, and provenance would relate to the testing facility and methodology, but this document does not provide such details.

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: "Ground truth" established by experts is relevant for studies involving diagnostic or interpretive tasks (e.g., image analysis). An external fixation system is a therapeutic device, and its performance is typically assessed through mechanical properties, biocompatibility, and clinical outcomes (e.g., fracture healing rates). The 510(k) summary provided does not detail any such clinical study or expert consensus for ground truth.

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

Not Applicable: Adjudication methods are relevant when there are subjective assessments or disagreements among experts, such as in clinical trials with multiple reviewers. This information is not relevant to the type of submission or device described.

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: An MRMC study is specific to diagnostic imaging devices, often involving AI assistance. This device is an external fixation system, not a diagnostic imaging device with AI components.

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

Not Applicable: This question pertains to AI/algorithm performance studies. The device is a physical medical implant/device, not an algorithm.

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

Not Applicable: As established earlier, the concept of "ground truth" as requested is not applicable to a 510(k) submission for an external fixation device. Performance is typically gauged by successful mechanical function and clinical outcomes which, if studied in detail, would involve patient follow-up and clinical assessments, but this level of detail for a performance study is not in a 510(k) summary.

8. The sample size for the training set:

Not Applicable: There is no "training set" in the context of an external fixation device being submitted via a 510(k). This term applies to machine learning algorithms.

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

Not Applicable: Similar to point 8, this is not relevant to an external fixation device.

In summary, the provided document K052605 is a 510(k) premarket notification for an External Fixation system. The approval is based on demonstrating substantial equivalence to a predicate device, as confirmed by the FDA letter. It does not contain information about clinical performance studies with specific quantitative acceptance criteria, test sets, ground truth establishment, or AI-related metrics like those requested.

The core of a 510(k) for such a device is typically focused on:

Indications for Use: Clearly stated as Bone Fracture Fixation, Osteotomy, Arthodesis, Correction of deformity, Revision procedures where other treatments/devices have been unsuccessful, and Bone reconstruction procedures.
Technological Characteristics: Comparison of materials (metallic fasteners), design, and performance with a predicate device.
Substantial Equivalence: A conclusion by the FDA that the new device is as safe and effective as a legally marketed predicate device.

Summary

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K 05260

NOV 1 0 2005

Image /page/0/Picture/2 description: This image shows a document titled "PREMARKET NOTIFICATION SUBMISSION - 510 (k)". The document includes the date 09-15-2005 and page number 1 di 28. It provides a 510 (k) summary, including the applicant GexFix USA Inc. located at 1200 Clint Moore Rd. Suite # 1, Boca Raton, FL 33487, the contact person Mr. Lucio Improta, and the submission date May 15th, 2005.

Trade Name : External Fixation
Common Name : External Fixation System
Classification Name : Smooth or threaded metallic bone fixation fastener
Reg. # 888-3040 -..
Panel Code : Orthopedic
Prod. Code : KTT

Indication for use :

The indication for use of this device are:

1. Bone fracture fixation;
1. Osteotomy
1. Arthodesis
1. Correction of deformity
1. Revision procedures where other treatments oe devices have been unsuccessful Bone reconstruction procedures

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

NOV 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lucio Improta GexFix USA, Inc. 1200 Clint Moore Road, Suite # 1 Boca Raton, Florida 33487

Re: K052605 Trade/Device Name: EXTERNAL FIXATION Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 15, 2005 Received: September 23, 2005

Dear Mr. Improta:

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 -Lucio Improta

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 entitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkonian

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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J.S. Food and Drug Admini

CENTER FOR DEVICES AND RADIOT OCCIC

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Indications for Use

510(k) Number (if known): K052605

Device Name: EXTERNAL FIXATION

Indications for Use:

1. BONE FRACTURE FIXATION
1. OSTEOTOMY
1. ARTHODESIS
1. CORRECTION OF DEFORMITY
1. REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE UNSUCCESSFUL
1. BONE RECONSTRUCTION PROCEDURES

signature

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

510(k) Number_Kos2pos

AND/OR

Prescription Use _X (Part 21 CFR 801 Subpart D) Over-The-Counter Use

(21 CFR 801 Subpart C)

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

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.