The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

Indications for use include:

Posttraumatic and primary Arthrosis
Neuromuscular deformity
Revision of Failed Ankle Arthrodesis
Failed Total Ankle Replacement
Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
A Neuroarthropathy (Charcot)
Rheumatoid Arthritis with severe deformity
Osteoarthritis
Pseudarthrosis

Device Description

The Force Medical IM Nail System is an angled (left & right) and straight (left & right due to hole orientation), cannulated, intramedullary nail in multiple diameters(8) and in multiple lengths(3) manufactured from High Strength 6-4 Titanium Alloy to ASTM F136. The nail features proximal, distal, and midshaft angled hole(s) to receive Alloyed Titanium transverse locking 4.5mm Cortical and 4.5/6.5 Transition Cortical - Cancellous Bone Screws (in various lengths). Endcaps (in 0+ and 6 lengths in 4 diameters) in the Titanium Alloy are available for nail end bottom screw locking and IM Nail length extension. A Titanium Alloy Compression Washer and Screw (in 5 lengths) is also available for joint compression(s) if distal talocalcaneal fusion is required. All alloyed titanium components have a Type II anodize surface treatment and are anodize color coded for left/right versions. A full set of guide/placement instrumentation is available for accurate placement and alignment of the bone screws within the nail when used in conjuction with x-ray fluoroscopy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Force Medical IM Nail System:

Based on the provided 510(k) summary, the device is an intramedullary nail for orthopedic use, not an AI/ML powered medical device. Therefore, typical performance metrics such as sensitivity, specificity, or AUC, and ground truth establishment methods relevant to AI/ML algorithms, are not applicable.

Instead, the acceptance criteria and the study proving it meets the criteria for this type of medical device revolve around substantial equivalence to predicate devices. This means demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance/Characteristics
Intended Use: Device is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle.	Intended Use: Consistent with predicate devices. The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
Indications for Use: Device addresses conditions similar to predicate devices.	Indications for Use: Consistent with predicate devices. Includes: Posttraumatic and primary Arthrosis, Neuromuscular deformity, Revision of Failed Ankle Arthrodesis, Failed Total Ankle Replacement, Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy (Charcot), Rheumatoid Arthritis with severe deformity, Osteoarthritis, Pseudarthrosis.
Technological Characteristics: Device is manufactured from similar materials and has similar design/markings as predicate devices.	Technological Characteristics: "The Force Medical IM Nail System is substantially equivalent in Material, Geometry Design/Markings, and Indications to the many predicate systems marketed and sold in the U.S." Specifically, it's an angled/straight, cannulated, intramedullary nail in multiple diameters and lengths, manufactured from High Strength 6-4 Titanium Alloy to ASTM F136. It features proximal, distal, and midshaft angled holes for locking screws, endcaps, and a compression washer/screw. All alloyed titanium components have a Type II anodize surface treatment and are color-coded.
Safety and Effectiveness: Device is safe and effective for its intended use.	Safety and Effectiveness: "The Force Medical IM Nail System is shown to be safe and effective for use in IM Nail ankle fusion procedures where stability and precision placement is required." (This statement is a conclusion based on the demonstration of substantial equivalence, not a direct measurement of performance from a clinical trial detailed here).

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

For this type of device (intramedullary nail), there isn't a "test set" in the sense of a dataset for an AI/ML algorithm. Instead, the "testing" involves demonstrating that the device's design, materials, and manufacturing processes lead to a product that is substantially equivalent to already cleared devices. This often involves:
- Mechanical testing: To ensure the device meets required strength, fatigue, and other biomechanical properties.
- Biocompatibility testing: To ensure the materials are safe for implantation.
- Sterilization validation: To ensure the device can be properly sterilized.
The provided document does not specify sample sizes for such tests or data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full 510(k) submission, but is summarized here. The summary focuses on the conclusion of substantial equivalence rather than the raw data or detailed methodologies of the tests performed.

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

This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI/ML algorithm evaluation. The "ground truth" for a mechanical device is established through engineering standards, material specifications, and regulatory requirements (e.g., ASTM standards for titanium alloy, biocompatibility guidelines).
The evaluation involves engineers and scientists performing the specified tests, and regulatory bodies (like the FDA) reviewing the results against established standards and predicate device data.

4. Adjudication method for the test set:

This question is not applicable as there is no "test set adjudication" process for this type of medical device in the way it applies to AI/ML output interpretation. The "adjudication" is essentially the FDA's review process of the submitted technical data and comparison to predicate devices, ensuring compliance with regulatory requirements.

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:

This question is not applicable as this is an orthopedic implant, not an AI-assisted diagnostic tool. No human "readers" are involved in interpreting output from this device in a clinical diagnostic setting where MRMC studies would be relevant.

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

This question is not applicable as this is not an AI/ML algorithm. The device functions as a standalone mechanical implant.

7. The type of ground truth used:

As mentioned, the concept of "ground truth" for an AI/ML algorithm does not apply directly. For this device, the "ground truth" for demonstrating safety and effectiveness refers to:
- Engineering standards: e.g., ASTM F136 for titanium alloy, various mechanical testing standards.
- Biocompatibility standards: ISO 10993 for biological evaluation of medical devices.
- Sterilization standards: ISO 11135 or ISO 11137 for sterilization of health care products.
- Performance criteria based on predicate devices: The established safety and effectiveness profile of the T2 Ankle Arthrodesis Nail, Phoenix Nail Systems, and Valor Ankle Fusion Nail serve as a benchmark for substantial equivalence.

8. The sample size for the training set:

This question is not applicable as this is not an AI/ML device that requires a training set.

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

This question is not applicable as this is not an AI/ML device that requires a training set and associated ground truth.

Summary

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Section XII: 510(k) Summary of Safety and Effectiveness

MAY - 3 2012

SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

NAME OF FIRM:	Force Medical, Inc.13566 Freeport RoadSan Diego, CA 92129
510(k) FIRM CONTACT:	Al LippincottBioMedical EngineerEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372allippincott@msn.com
DATE:	August 20, 2010
TRADE NAME:	Force Medical IM Nail System
COMMON NAME:	Intramedullary Nail
CLASSIFICATION:	Intramedullary fixation rod (see 21CFR, Sec. 888.3020)Single/Multiple component metallic bone fixation appliances andaccesories. (See 21CFR, Sec. 888.3030)
DEVICE PRODUCT CODE:	HSB
SUBSEQUENT PRODUCT CODE:	JDS
SUBSTANTIALLYEQUIVALENT DEVICES:	Stryker - T2 Ankle Arthrodesis Nail (K051590, K020384)Biomet - Phoenix Nail Systems (K091976, K081243)Wright Medical - Valor Ankle Fusion Nail (K110552)
DEVICE DESCRIPTION:	The Force Medical IM Nail System is an angled (left & right) andstraight (left & right due to hole orientation), cannulated,intramedullary nail in multiple diameters(8) and in multiple lengths(3)manufactured from High Strength 6-4 Titanium Alloy to ASTM F136.The nail features proximal, distal, and midshaft angled hole(s) toreceive Alloyed Titanium transverse locking 4.5mm Cortical and4.5/6.5 Transition Cortical - Cancellous Bone Screws (in variouslengths). Endcaps (in 0+ and 6 lengths in 4 diameters) in the TitaniumAlloy are available for nail end bottom screw locking and IM Naillength extension. A Titanium Alloy Compression Washer and Screw(in 5 lengths) is also available for joint compression(s) if distaltalocalcaneal fusion is required. All alloyed titanium components havea Type II anodize surface treatment and are anodize color coded forleft/right versions. A full set of guide/placement instrumentation isavailable for accurate placement and alignment of the bone screwswithin the nail when used in conjuction with x-ray fluoroscopy. The

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INTENDED USE:

Indications for use include:

Posttraumatic and primary Arthrosis a
Neuromuscular deformity A
Revision of Failed Ankle Arthrodesis A
Failed Total Ankle Replacement a
Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) A
A Neuroarthropathy (Charcot)
Rheumatoid Arthritis with severe deformity A
Osteoarthritis A
Pseudarthrosis A

BASIS OF SUBSTANTIAL EQUIVALENCY:

The Force Medical IM Nail System is substantially equivalent to predicate devices from Stryker, Biomet, and Wright Medical.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The Force Medical IM Nail System is substantially equivalent in Material, Geometry Design/Markings, and Indications to the many predicate systems marketed and sold in the U.S..

SUMMARY OF SAFETY AND EFFECTIVENESS:

The Force Medical IM Nail System is shown to be safe and effective for use in IM Nail ankle fusion procedures where stability and precision placement is required.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

Force Medical, Incorporated % Engineering Consulting Services, Incorporated Mr. Al Lippincott Biomedical Engineer 3150 East 200th Street Prior Lake, Minnesota 55372

MAY - 3 2012

Re: K102577

Trade/Device Name: Force Medical IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: April 10, 2012 Received: April 27, 2012

Dear Mr. Lippincott:

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 or uny I vith 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Al Lippincott

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 yours,

For Peter Der Dr.

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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Indications for Use

510(k) NUMBER: K102577

DEVICE NAME: Force Medcial IM Nail System

Indications for use include:

Posttraumatic and primary Arthrosis A
Neuromuscular deformity A
Revision of Failed Ankle Arthrodesis A
Failed Total Ankle Replacement A
Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) A
A Neuroarthropathy (Charcot)
Rheumatoid Arthritis with severe deformity >
Osteoarthritis A
Pseudarthrosis A

Ast

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

KID2577 510(k) Number __

× Prescription Use

AND/OR

Over-The-Counter-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)

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.