The IFS is a hollow fenestrated cylinder fabricated from nitinol with a section that increases the implants diameter to lock into the medullary compartment of bone while shortening its length. The nitinol's transition temperatures are set so that the material is in the austenitic state when released at room temperature. Features on the cylinder's surface, such as bulges and prongs, lock into bone.

The IFS is pre-loaded onto an insertion instrument and held elongated in position by a lock plate. During insertion, the IFS is released by turning a knob on its instrument while the lock plate both releases the IFS and limits the depth of implant insertion.

The IFS implants range in diameter from 2.5 to 4.5 mm and up to 9.3 mm when expanded and range in length from 21 to 27 mm depending on size and extent of contraction.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Intramedullary Fixation Scaffold (IFS) System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be done for a software or AI/ML-driven device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not relevant or available in this type of submission.

However, I can extract the relevant performance data that serves as the "acceptance criteria" and the "study" demonstrating the device meets these in the context of a 510(k) submission, which focuses on comparison to predicate devices.

Here's the breakdown based on the provided text:

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

In a 510(k), "acceptance criteria" are often implicitly defined by the performance of the predicate device, with the new device needing to perform "equivalently or better."

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (IFS Fixation Scaffold)
Corrosion Susceptibility (equivalent or better than predicate per ASTM F2129)	"The corrosion behavior of the IFS was equivalent or better than the predicate device to which it was compared and presented high corrosion breakdown potentials for all IFS devices tested."
Contraction Force (equivalent to or less than predicate bone staple implants K123363 9x9 mm and 11x10 mm)	"Contraction tests showed that the IFS contraction force causing bone segments to be put into compression was equivalent to or less than the 9x9 mm and 11x10 mm bone staple implants of K123363."
Expansion Force (equivalent or superior to predicate K133520)	"...the expansion force causing retention in the medullary canal was equivalent or superior to the K133520 predicate device."
Ultimate Strength in Bending (equivalent or superior to predicates K133520 and K863734)	"Ultimate strength in bending was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior in strength to the predicate devices tested."
Bone Fixation Strength (equivalent or superior to predicates K133520 and K863734)	"Bone fixation strength was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior to the predicate device."

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

Sample Size: Not explicitly stated as a number of devices or "test set" size. The document refers to "all IFS devices tested" for corrosion and "the IFS" (implying a set of IFS devices) for mechanical tests. For the predicates, it refers to specific models (e.g., "9x9 mm and 11x10 mm bone staple implants of K123363"). The exact number of units tested for each metric is not disclosed.
Data Provenance: The studies are described as "Corrosion testing per ASTM F2129" and various mechanical tests conducted on the IFS and predicate devices. No information on country of origin of data or retrospective/prospective nature is provided, as these are in vitro engineering tests of the device itself, not clinical trial data.

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

Not applicable. This relates to clinical data interpretation or ground truth establishment for AI/ML algorithms, which is not the subject of this 510(k) for a physical medical device. The "ground truth" here is the physical measurement of the device's mechanical and material properties.

4. Adjudication method for the test set

Not applicable. This is for clinical data review or AI/ML ground truth, not for in vitro material and mechanical testing. The results are from direct physical measurements.

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 physical scaffold, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is a physical scaffold, not an AI/ML algorithm.

7. The type of ground truth used

For the performance data mentioned (corrosion, contraction/expansion force, ultimate strength, bone fixation strength), the "ground truth" is established through objective, standardized engineering and material science measurements according to recognized ASTM standards (e.g., ASTM F2129 for corrosion) or similar biomechanical testing protocols. These are direct physical properties of the device and its interaction with simulated bone.

8. The sample size for the training set

Not applicable. This refers to AI/ML algorithms. The IFS System is a physical device.

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

Not applicable. This refers to AI/ML algorithms.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

January 13, 2016

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

Metric Medical Devices, Incorporated W.Casey Fox, Ph.D., P.E. President 846 Silver Springs Helotes, Texas 78023

Re: K152627

Trade/Device Name: IFS Fixation Scaffold System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: December 8, 2015 Received: December 14, 2015

Dear Dr. Fox:

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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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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Indications For Use

K152627 510(k) Number (if Known):

Device Name: Intramedullary Fixation Scaffold (IFS) System

Indications for use: The IFS Fixation Scaffold is indicated for small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes.

Prescription Use X Over-The-Counter AND/OR Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Appendix I: 510(k) Summary of Safety and Effectiveness

510(k) Summary As required by 21 CFR 807.92: Name of Sponsor: Metric Medical Devices, Inc., 846 Silver Springs, Helotes, TX, 78023 Contact: W. Casey Fox, Ph.D., P.E., President 12/3/2015 Date Prepared: Proprietary Name: IFS Fixation Scaffold System Classification Name: Pin, Fixation, Bone Device classification: Class II per 21 CFR 888.3040 Product Device Code: HTY

Substantial Equivalence: The IFS is substantially equivalent to legally marketed intramedullary implants (K133520), k-wires (K863734) and bone staple (K123363) in indications for use, material, design and function. Any minor differences between these devices or their performance do not raise any questions of safety and effectiveness.

The IFS Fixation Scaffold is indicated for small bone fixation, Indications for use: reconstruction and fusion such as inter-digital fusion of fingers and toes.

Performance Data: Corrosion susceptibility, implant contraction and expansion forces, ultimate strength, amount of shape change and bone fixation strength was measured and compared between the IFS and three predicate devices.

Corrosion testing per ASTM F2129 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices" was performed. The corrosion behavior of the IFS was equivalent or better than the predicate device to which it was compared and presented high corrosion breakdown potentials for all IFS devices tested.

IFS contraction and expansion forces, ultimate strength and bone fixation strength were measured for the IFS and predicate devices. Contraction tests showed that the IFS contraction force causing bone segments to be put into compression was equivalent to or less than the 9x9 mm and 11x10 mm bone staple implants of K123363 and the expansion force causing retention in the medullary canal was equivalent or superior to the K133520 predicate device. Ultimate strength in bending was measured for the IFS. K133520 and K863734 and the IFS was found equivalent or superior in strength to the predicate devices tested. Bone fixation strength was measured for the IFS, K 133520 and K863734 and the IFS was found equivalent or superior to the predicate device.

Device Description: The IFS is a hollow fenestrated cylinder fabricated from nitinol with a section that increases the implants diameter to lock into the medullary compartment of bone while shortening its length. The nitinol's transition temperatures are set so that the material is in the austenitic state when released at room temperature. Features on the cylinder's surface, such as bulges and prongs, lock into bone.

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The IFS implants range in diameter from 2.5 to 4.5 mm and up to 9.3 mm when expanded and range in length from 21 to 27 mm depending on size and extent of contraction.

Comparison of Technical Characteristics with the Predicate Device:

The IFS and predicates K123363 and K133520 are fabricated from nitinol. The IFS and K123363 change shape at room temperature and K133420 changes at body temperature. The IFS and predicate K123363 have essentially the same manufacturing thermal history and surface treatment. The K863734 predicate is fabricated from stainless steel.

The IFS and K123363 both change shape to pull bone together. The IFS shortens its cylindrical length and the K123363 brings its legs together and shortens its bridge to pull bone segments together and apply fixation forces to bone during healing. The fixation force of the IFS is in the same range as a small K123363 implant.

The IFS and K133520 both have sections that expand to lock into the medullary canal of bone. Features on the surface of these devices include barbs or prongs for locking into bone. The expansion force of the IFS is within the range of expansion forces of the predicate K133520.

The IFS and predicate K123363 and K133520 implants are held with an instrument during insertion. The IFS and K123363 instruments are fabricated from the same material. The instruments hold these implants from changing shape. When released from the instrument the shape changing features of the implants are enabled and the bone locking features engage bone. The IFS and K133520 instruments also act as a depth stop.

The K863734 predicate device is implanted with a drill motor, locks due to surface friction and interference, is round in cross section, solid, and has a trocar tip for cutting bone.

The IFS, K133520, K123363 and K863734 are small devices and similar in size: the IFS is 2.5 to 4.5 mm in diameter and up to 9.3 mm when expanded and its length ranges from 21 to 27 mm; the K 133520 device ranges in width from 4 mm to 7 mm when expanded and its length ranges12 to 25 mm; the K123363 device ranges in bridge and leg length from 9 mm to 20 mm; and the K863734 ranges in diameters of 1 mm to 2 mm and lengths exceeding several inches.

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.