The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.

AI/ML Overview

This 510(k) summary is for the STØRM™ Operating Kit, which is an external fixation system. This medical device submission does not involve AI/ML technology or image analysis, but rather describes a physical surgical kit. Therefore, many of the requested categories related to AI/ML device performance, such as acceptance criteria based on accuracy metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device based on similarities in intended use, materials, design, and mechanical performance.

Below is an attempt to address the request based on the provided document, highlighting where information is not applicable due to the nature of the device.

Acceptance Criteria and Study for the STØRM™ Operating Kit

As this submission is for a physical surgical kit (external fixation system components) and not an AI/ML-driven device, the acceptance criteria and study focus on substantial equivalence through material properties, design, intended use, and mechanical performance rather than diagnostic accuracy or algorithmic performance metrics.

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Summary)
Intended Use	Same as predicate device (K061607).	"Used in conjunction with the STØRM™ in the reduction and fixation of fractures of the lower leg or distal femur." — Matches predicate.
Technological Characteristics	Similar materials and design to predicate device.	"Components are made from stainless steel and are presented sterile." — Similar to predicate.
Material/Design	Components (Kirschner wires, bone screws, drill bit) should match the specifications and design of the predicate kit.	The device consists of "two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit." — Implied to be equivalent to predicate components.
Mechanical Performance	Mechanical performance demonstrating equivalence to the predicate device.	"Mechanical performance demonstrating substantial equivalence to the predicate devices." — No specific values or tests reported in this summary, but this statement indicates conformance.
Sterility	Components are sterile.	"Components are ... presented sterile." — Confirmed.

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable in the context of a "test set" for an AI/ML algorithm. This submission relies on a comparison of device specifications and, presumably, mechanical testing of a representative sample of components, though specific sample sizes for such tests are not detailed in this 510(k) summary.
Data Provenance: Not applicable in the AI/ML sense. The information provided is from the manufacturer, Intelligent Orthopaedics Limited, based in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and the qualfications of those experts

Not applicable. There is no "ground truth" establishment in the context of AI/ML or diagnostic accuracy for this type of device. The evaluation is against the specifications and performance of a predicate device.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" as would be used to resolve discrepancies in expert readings for an AI/ML device. The assessment is made by the FDA's Office of Device Evaluation based on the submission documents proving substantial equivalence.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. For this type of device, "ground truth" would relate to accepted engineering standards, material properties, and established predicate device performance rather than clinical outcomes or pathology. The "truth" is established by showing the device meets its own specifications and is equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Device Acceptance (FDA's Determination):

The FDA granted substantial equivalence (K111001) for the STØRM™ Operating Kit. This determination was based on the similarities in intended use, materials, and design to the predicate device (K061607), and the assertion that "mechanical performance demonstrating substantial equivalence to the predicate devices" was provided. The specific details of the mechanical testing that supported this claim are not present in the provided 510(k) summary, but such data would have been part of the full submission package reviewed by the FDA.

Summary

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K 111001 (1/2)

MAY 17 2011

FDA CDRH DMC

APR 11 2011

Received

PO Box 2681 Stoke on Trent ST4 9BE

T: +44 (0) 17 82 84 78 40 F: +44 (0) 17 82 84 60 46 www.intelligent-orthopaedics.co.uk

E) 510(k) Summary

Submitted by

Peter Ogrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom

Date

25th March 2011

Contact person: Peter Ogrodnik

Sterile STORM®® Operating Kit

Proprietary Name Common Name Classification / Reference

External Fixation Systems Class II - 888.3040 Smooth or Threaded Bone Fixation fasteners HTY and HWC / Orthopedic

Product Code & Panel

Device Description

Intended Use

The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reductic and fixation of fractures of the lower leg or distal femur

Technological characteristics

The STΦRM™ Operating Kit components are made from stainless steel and are presented sterile.

Substantial Equivalence

The components of the Sterile STORM™ Operating Kit are substantially equivalent to K061607 STORM™ Operating Kit

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Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in a simple, abstract design. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002

Intelligent Orthopaedics Limited % Staffordshire University Mr. Peter Ogrodnik Managing Director Business Village, Leek Road Stoke On Trent, Staffordshire United Kingdom ST4 2AR

MAY 17 2011

Re: K111001

Trade/Device Name: STORMTM Operating Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: March 25, 2011 Received: April 22, 2011

Dear Mr. Ogrodnik:

We have reviewed your Section 51.0(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 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); medical device reporting (reporting of medical

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Page 2 - Mr. Peter Ogrodnik

device-related adverse events) (21 CFR 803); 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aig B. R. h
for

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): {{{| | 0 0

Device Name:

Indications for Use:

The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerson

(Division Sign-Off) (Division of Surgical, Orthopedic,
Division of Surgical, Orthopedic, Division Restorative Devices

Page 1 of 1

510(k) Number K111001

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.