The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.

Device Description

The Eminent Foot Plate System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features twenty four (24) types of plates (Evans, Metatarsal, Metatarsal Left, Metatarsal Right, Metatarsal Step Left, Metatarsal Step Right, PMO Right, PMO Right, PMO Wedge Left, PMO Wedge Right, Osteotomy Left, Osteotomy Right, Osteotomy Wedge Left, Osteotomy Wedge Right, Osteotomy L Left, Osteotomy L Right, Peanut Slotted, Utility, Utility Long, Lis' Franc, Calcaneus, Calcaneus Long, and Forefoot H), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade titanium (ASTM F136), and offered in various widths and lengths. Plates and screws are provided non-sterile.

AI/ML Overview

The provided text describes the 510(k) summary for the Eminent Foot Plate System, a medical device for internal bone fixation. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing.

Here's an analysis of the provided information, specifically addressing the requested points:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported device performance values. Instead, it describes mechanical tests performed and concludes that the "strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria were met by demonstrating non-inferiority to the predicate devices in these mechanical tests.

The information available for a table is limited to the types of tests performed:

Acceptance Criteria (Implied)	Reported Device Performance
Static Three-point Bending	Sufficient and substantially equivalent to predicate devices.
Dynamic Three-point Bending	Sufficient and substantially equivalent to predicate devices.
Torsion Testing	Sufficient and substantially equivalent to predicate devices.
Static Axial Pullout Test	Sufficient and substantially equivalent to predicate devices.

Missing Information: The actual quantitative results (e.g., bending strength values, fatigue life cycles, torque values, pullout forces) for both the subject device and the predicate devices are not provided in this document. This makes it impossible to create a more detailed table with specific numerical acceptance criteria and performance data.

Study Details for Demonstrating Acceptance Criteria:

The document does not describe a clinical study or a study involving human subjects or expert review. The "study" here refers to non-clinical mechanical testing.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The wording "The Eminent Foot Plate System has been tested in the following test modes" implies that samples of the device were subjected to these tests. Without further detail, specific numbers are unknown.
- Data Provenance: The tests are likely performed in a controlled laboratory environment by the manufacturer or a third-party testing facility (like Empirical Testing Corporation, mentioned in the letter's address). The data is non-clinical/bench testing data. Country of origin is not specified but presumed to be a regulated environment relevant to the US market. The data is prospective in the sense that the device was manufactured and then tested to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This section describes mechanical bench testing, not a study involving human experts or ground truth establishment in a diagnostic or clinical context. The "ground truth" for these tests would be the established ASTM standards themselves, and the measurement of physical properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved. This is mechanical testing against established standards.
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 system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical tests would be the physical properties and performance characteristics of the device measured against the requirements of the cited ASTM standards (ASTM F382 and ASTM F543) and compared to the performance of predicate devices. There is no expert consensus, pathology, or outcomes data involved in these specific tests.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device and testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.

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

March 30, 2015

Eminent Spine % Ms. Meredith May Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K143365

Trade/Device Name: Eminent Foot Plate Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 20, 2015 Received: February 25, 2015

Dear Ms. May:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Meredith May

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
Device Name
Eminent Foot Plate System
Indications for Use (Describe)
The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

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FORM FDA 3881 (9/13)

Page 2 of 2

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5.510(K) SUMMARY

Submitter's Name:	Eminent Spine
Submitter's Address:	7200 N. IH 35 Bldg. #1Georgetown, TX 78626
Submitter's Telephone:	512.868.5980
Contact Person:	Meredith L. May MS, RACEmpirical Consulting LLC719.337.7579
Date Summary was Prepared:	04-Nov-14
Trade or Proprietary Name:	Eminent Foot Plate System
Common or Usual Name:	Single/multiple component metallic bone fixationappliances and accessories (§888.3030)Smooth or threaded metallic bone fixation fastener(§888.3040)
Classification:	Class II per 21 CFR §888.3030Class II per 21 CFR §888.3040
Product Code:	HRS, HWC
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

CONTRAINDICATIONS

Active or latent infection. Osteoporosis, insufficient quantity or quality of bone/soft tissue. Material sensitivity. If suspected, tests should be performed prior to implantation. Sepsis. Patients who are unwilling or incapable of following postoperative care instructions. This device

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is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:

. Indications for Use
Materials of manufacture ●
Structural support mechanism ●
. Principles of Operation

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	Type
K131722	Extremity Fixation Systems	I.T.S.	Primary
K071105, K091614,K131445, K133437	FPS – Foot Plate System	Osteomed	Additional

Performance Data

The Eminent Foot Plate System has been tested in the following test modes:

. Static Three-point Bending Test per ASTM F382
Dynamic Three-point Bending Test per ASTM F382 ●
. Torsion Testing per ASTM F543
. Static Axial Pullout Test per ASTM F543

The results of this non-clinical testing show that the strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Eminent Foot Plate System is substantially equivalent to the predicate device.

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.