The EBI® XFIX® DFS® System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The System consists of external fixation components and implantable bone screws. The EBI XFIX DFS System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of an Angulating Screw Clamp to the System.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance. Based on the provided text, there is no acceptance criteria or detailed study proving device performance in the way you've described.

Here's why and what the document does include, addressing your points:

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

Not Applicable. The document explicitly states that the submission is "only for the addition of an Angulating Screw Clamp to the System" and that "The intended use and fundamental scientific technology have not changed from the previously cleared submission." It relies on substantial equivalence to a predicate device (EBI® XFIX® DFS® System K953406) rather than new performance testing against specific acceptance criteria.
The comparison focuses on:
- Same materials (aluminum, stainless steel, titanium alloy).
- Same indications for use (leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to external fixation).
- Similar design principle for bone screw clamps.
- Provided non-sterile.
The conclusion is: "There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."

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

Not Available. No new clinical or performance test set data is presented for the modified device. The submission relies on the existing clearance of the predicate device.

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. No new ground truth establishment is described as there's no new performance study data presented.

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

Not Applicable. No new test set and adjudication method is 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. This is a hardware modification for an external fixation device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

Not Applicable. As above, this is not an algorithm or AI device.

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

Not Applicable. No new ground truth is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not Applicable. There is no mention of a training set as this is not a learning algorithm or AI device.

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

Not Applicable. As there is no training set, there is no corresponding ground truth establishment described.

In summary: This 510(k) submission seeks clearance for a modification to an existing device (the addition of an Angulating Screw Clamp). The primary "study" proving it meets "acceptance criteria" is the demonstration of substantial equivalence to a previously cleared predicate device. This is achieved by comparing the materials, intended use, function, and manufacturing process of the modified device to the predicate, and asserting that there are no significant differences. New extensive performance studies, as one might find for novel devices or AI systems, are not typically required or presented for such substantial equivalence claims.

Summary

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NOV 0 82001

510(k) Summary

K013378

This 510(k) Summary for the modified EBI® XFIX® DFS® System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

Contact Person: Patricia Flood 1. Sponsor: EBI, L.P. Telephone: (973) 299-9300,ext.3318 100 Interpace Parkway Parsippany, NJ 07054 October 11, 2001 Date prepared: EBI® XFIX® DFS® System 2. Proprietary Name: External Fixation Device Common Name: Classification Names:
Single/Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030
1. Predicate or Legally Marketed Device:
- EBI® XFIX® DFS® System EBI, L.P. (K953406) ●

4. Description of the device:

5. Intended Use:

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6. Materials:

The components of the System may be manufactured from materials such as aluminum, stainless steel, and titanium alloy.

7. Comparison of the technological characteristics of the device to predicate devices:

The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:

EBI XFIX DFS System (K953406)

The modified EBI XFIX DFS System is fabricated from . the same materials as the components of the currently marketed EBI XFIX DFS Fixation System.
The modified EBI XFIX DFS System and the currently marketed EBI . XFIX DFS System are both indicated for the treatment of bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The bone screw clamps of the modified EBI XFIX DFS System, like the ● bone screw clamps currently marketed in the EBI XFIX DFS System, are designed for attachment to the bone screws.
The additional component of the EBI XFIX DFS System, like the ● components of the currently marketed EBI XFIX DFS System, is provided non-sterile.
There are no significant differences between the modified EBI XFIX DFS ● System and the currently marketed EBI XFIX DFS System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2001

Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K013378 Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 11, 2001 Received: October 12, 2001

Dear Ms. Flood:

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 -- Ms. Patricia Flood, RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susa Walker, us

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

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Page 1 of

510(k) Number (if known): K013378

Device Name: EBI® XFIX® DFS® System

Indications For Use:

The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Lisa Walk

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

510(k) Number

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.