The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are:

Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.

The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine.

The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.

Device Description

The Inter-Os Limb Lengthener is an implantable device used to treat conditions where bone length is deficient. It is used for distraction osteogenesis techniques in the femur and is intended to be implanted by orthopedic surgeons. The device is removed after distraction is complete. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. Activation of the drive shaft is by means of a transcutaneous pin, which may be removed once the distraction phase is complete. The Activation Pin and the drive shaft are articulated using an internal gear.

All of the components of the Inter-Os Limb Lengthener are fabricated from stainless steel. The Inter-Os Limb Lengthener is intended to be sold non-sterile. It is a singleuse device. Sterilization instructions are included in the labeling.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device performance studies (e.g., sensitivity, specificity, AUC). This document is a 510(k) summary for a medical device (Inter-Os Limb Lengthener) which focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive characteristics, intended use, principle of operation, and mechanical testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No explicit numerical acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity).	"Performance has been substantiated by mechanical tests in conformity to standard testing guidelines for equivalent devices and literature review."
No specific performance metrics (e.g., accuracy, diagnostic yield, time savings) are defined.	"Our device is substantially equivalent based on the descriptive characteristics, same intended use, and same principle operation of distraction osteogenesis."
The primary "acceptance criterion" appears to be substantial equivalence to legally marketed predicate devices, with performance supported by mechanical testing and literature review.	The device is deemed "substantially equivalent" and "raises no new safety or effectiveness issues," indicating it meets the general safety and effectiveness standards of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/Not mentioned. The study is described as mechanical testing and literature review, not a clinical study with a patient "test set."
Data Provenance: Not applicable/Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device's performance demonstration does not involve establishing ground truth through expert review in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was one done? No.
Effect size of human readers with vs. without AI assistance: Not applicable, as this is not an AI/ML device.

6. Standalone (Algorithm Only) Performance Study

Was one done? No. This device is not an algorithm, but a physical implantable medical device.

7. Type of Ground Truth Used

Not applicable. The performance is assessed through mechanical tests against "standard testing guidelines for equivalent devices" and "literature review," implying a comparison to established benchmarks for physical device performance rather than clinical ground truth for diagnostic accuracy.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria, as described in the 510(k) summary, is primarily based on:

Mechanical Testing: The document states, "Performance has been substantiated by mechanical tests in conformity to standard testing guidelines for equivalent devices." This indicates that the physical properties and functionality of the Inter-Os Limb Lengthener were evaluated in a laboratory setting to ensure they met established engineering and safety standards applicable to similar bone fixation devices.
Literature Review: The submission also mentions "literature review" as a basis for substantiating performance. This typically involves reviewing published scientific and clinical data related to the predicate devices and the principles of distraction osteogenesis to support the safety and effectiveness claims.
Substantial Equivalence Argument: The core of the 510(k) involves demonstrating that the Inter-Os Limb Lengthener is "substantially equivalent" to legally marketed predicate devices in terms of design, materials, function, and intended use. The conclusion explicitly states, "Based on the design, materials, function, intended use, the Inter-Os Limb Lengthener is substantially equivalent to the devices currently marketed... The Inter-Os Limb Lengthener raises no new safety or effectiveness issues."

In essence, the "acceptance criteria" for this device's 510(k) clearance were met by proving that its physical performance through mechanical testing aligns with standards for similar devices and that its characteristics are substantially equivalent to already cleared devices, thereby assuring its safety and effectiveness. This is distinct from the type of performance evaluation required for AI/ML-based diagnostic devices.

Summary

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OCT 2 2 2003

1.3 [510(k) Summary]

K031875 Page 1 of 2

Inter-Os Technologies, Inc. 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124

Contact: Randolph C. Robinson, MD, DDS 303-708-8390 voice 303-790-7322 fax

Summary Prepared: May 15, 2003

Device Identification:

Trade Name:	Inter-Os Limb Lengthener
Common Name:	Internal Bone Plate Distractor
Classification Name:	Single/Multiple component metallic bone fixation appliance and accessories, 21 CFR 888.3030

Product Description:

Indications for Use

Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.

The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine.

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KO31875 Page 2 of 2

Predicate Devices

The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#K982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and K021031), the Orthofix/Orthodyne ISKD (#K010322) and others. We believe the Inter-Os device to be substantially equivalent based on the descriptive characteristics, same intended use, and same principle operation of distraction osteogenesis.

Performance has been substantiated by mechanical tests in conformity to standard testing guidelines for equivalent devices and literature review.

CONCLUSION

Based on the design, materials, function, intended use, the Inter-Os Limb Lengthener is substantially equivalent to the devices currently marketed under the Federal Food. Drug and Cosmetic Act. The Inter-Os Limb Lengthener raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randolph C. Robinson, M.D., D.D.S. President Inter-Os Technologies, Inc. 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124

Re: K031875

Trade/Device Name: Inter-Os Limb Lengthener Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 2, 2003 Received: September 3, 2003

Dear Dr. Robinson:

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 - Randolph C. Robinson, M.D., D.D.S.

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Melbernan

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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1.2 Indications Enclosure

Page 1 of 1

Pending K031875 510(k) Number:

Device Name:

Intended Uses/Indications

Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.

The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) x Over-The-Counter Use

Mark V. Milkerson

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

510(k) Number K03875

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.