The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

Device Description

The Fixion Intramedullary Nailing System consist of the following main components:

The Nail Implant is an expandable, sealed, stainless steel, cylindrical, ribbed rod without interlocking holes. The proximal end has a one-way valve for expansion. The nail is cap protected.
The Insertion Handle is a device designed to be connected to the nail proximal end, and used for nail insertion. Its distal end has locking "teeth" to prevent relative rotation between the nail and the handle.
The Inflation Device is a pump, which rotation of its handle delivers saline into the nail. The pump pressure gauge indicates the expansion pressure. This action causes the nail expansion and abutment to the bone medullary cavity.
In addition the system consists of additional accessories including a removal adapter, a slide hammer and a slide hammer adapter and a screwdriver.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Fixion Intramedullary Nailing System:

This document is a 510(k) premarket notification for a medical device. FDA 510(k) clearances typically rely on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria and performance metrics against a robust ground truth, as would be common for AI/ML-based software. Therefore, many of the requested categories are not applicable to this type of submission.

The "acceptance criteria" here are primarily about meeting existing material and handling standards and demonstrating similarity to already-cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Standards:
1. Fixion IM Nail made from 316L stainless steel meeting ASTM F138.	The Fixion IM Nail is manufactured from 316L stainless steel, which meets the requirements of ASTM F138.
2. Accessories incorporate surgical grade stainless steel (ASTM 899, ASTM F1586) and Celeron (ISO 16061).	The Fixion IM Nailing System accessories incorporate surgical grade stainless steel (ASTM 899, ASTM F1586) and Celeron (ISO 16061).
Handling Standards:
3. Fixion IM Nail designed to meet ASTM F565 for care and handling of orthopedic implants and instruments.	The Fixion IM Nail is designed to meet the requirements of ASTM F565.
Substantial Equivalence (Functional/Design Similarity to Predicates):
1. Same intended use as predicate devices.	Stated as having the "same intended use" as predicate devices (e.g., K990717, K003212, K003215, K010901, K010988, K012967).
2. Same operating principles as predicate devices.	Stated as having the "same operating principles."
3. Nail and Instrumentation Set incorporate same design as predicate devices.	Stated as incorporating the "same design."
4. Nail and Instrumentation Set incorporate same materials as predicate devices.	Stated as incorporating the "same materials."
5. Nail and Instrumentation Set have same packaging and sterilization (materials and processes) as predicate devices.	Stated as having the "same packaging and sterilization, using the same materials and processes."
6. Components of Insertion Kit (now separate) are identical or similar in design, materials, packaging, and sterilization to other Fixion IM System components or Fixion IL and PF Nailing Systems components.	Stated as being "either identical or similar in design, materials, packaging, and sterilization" to predicate system components.

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

This information is not applicable to this 510(k) submission. There is no "test set" in the context of an algorithm or diagnostic performance evaluation described. The submission focuses on demonstrating compliance with material standards and substantial equivalence to existing devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. No ground truth for a test set (in the context of diagnostic accuracy or AI performance) was established or is relevant to this type of device submission.

4. Adjudication Method for the Test Set

This information is not applicable. No test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device (intramedullary nail), not a diagnostic algorithm or AI-assisted system where human reader performance would be a relevant metric.

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

No, a standalone performance evaluation (as would be done for an algorithm) was not done. This device is a surgical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The primary "ground truth" for this submission would be:

Engineering Standards: Conformance to established ASTM and ISO standards for materials (e.g., 316L stainless steel meeting F138).
Predicate Device Characteristics: The characteristics (intended use, operating principles, design, materials, packaging, sterilization) of the previously cleared Fixion IM Nailing System (K990717, K003212, K003215, K010901) and Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967). The new device's characteristics are compared against these known, legally marketed devices.

There is no "ground truth" related to disease pathology or patient outcomes in this particular 510(k) submission beyond the general safety and effectiveness implied by equivalence to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an algorithm or AI system for a physical medical device.

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

This information is not applicable. As there is no training set, there is no method for establishing its ground truth.

Summary

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MAY 2 3 2002

021324
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510(K) Summary

Disc-O-Tech Medical Technologies, Ltd. Fixion Intramedullary Nailing System

Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia Israel, 46728

Submitter's Name and Contact Person

Yael Rubin Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia Israel, 46728 Tel: +972 9 9511511 Fax: +972 9 9548939

Date Prepared

April 2002

Trade/Proprietary Name

Fixion™ Intramedullary Nailing System (Fixion IM Nailing System)

Classification Name

Intramedullary Fixation Rod 21 CFR § 888.3020 Class II

Predicate Devices

Fixion Intramedullary Nailing System (K990717, K003212, K003215, 1. K010901) by Disc-O-Tech.
Fixion Interlocking Proximal Femoral Intramedullary Nailing System 2. (K010988, K012967) by Disc-O-Tech.

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Performance Standards

The following standards were used:

The Fixion IM Nail is manufactured from 316L stainless steel, which 1. meets the requirements of ASTM F138 - Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
The Fixion IM Nailing System accessories incorporate surgical grade 2. stainless steel (ASTM 899, ASTM F1586) and Celeron (ISO 16061).
The Fixion IM Nail is designed to meet the requirements of ASTM F565 3. - Standard Practice for Care and Handling of Orthopedic Implants and Instruments.

Intended Use

System Description

The Fixion Intramedullary Nailing System consist of the following main components:

The Nail Implant is an expandable, sealed, stainless steel, cylindrical, 1. ribbed rod without interlocking holes. The proximal end has a one-way valve for expansion. The nail is cap protected.
1. The Insertion Handle is a device designed to be connected to the nail proximal end, and used for nail insertion. Its distal end has locking "teeth" to prevent relative rotation between the nail and the handle.
1. The Inflation Device is a pump, which rotation of its handle delivers saline into the nail. The pump pressure gauge indicates the expansion pressure. This action causes the nail expansion and abutment to the bone medullary cavity.

In addition the system consists of additional accessories including a removal adapter, a slide hammer and a slide hammer adapter and a screwdriver.

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K 021324
page 3 of 3

Once the nail is positioned within the medullary canal, rotation of the pump handle allows for nail diameter increase to its intended diameter under x-ray and controlled pressure.

Substantial Equivalence

The Fixion IM Nailing System is substantially equivalent to the Fixion IM Nailing System cleared for marketing under 510(k) K990717, K003212, K003215, K010901, and to the Fixion Interlocking Proximal Femoral Intramedullary Nailing System cleared for marketing under 510(k) K010988, K012967.

The modified Fixion IM Nail has the following similarities to that which previously received 510(k) concurrence:

A Have the same intended use
A Have the same operating principles
The Nail and the Instrumentation Set incorporate the same design ア
The Nail and the Instrumentation Set incorporate the same materials >
The Nail and the Instrumentation Set have the same packaging and > sterilization, using the same materials and processes.

The components of the Insertion Kit, which are now supplied separately, are either identical or similar in design, materials, packaging and sterilization to other components of the Fixion IM Nailing System or to components of the Fixion IL and PF Nailing Systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2002

Mr. Yael Rubin Director of Regulatory Affairs Disco-O-Tech Medical Technologies, Inc. 3 Hasadnaot St. Herzelia, Israel 46728

Re: K021324

Trade/Device Name: Fixion™ Intramedullary Nailing System (Fixion™ IM Nail) Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 24, 2002 Received: April 26, 2002

Dear Mr. Rubin:

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 - Dear Mr. Rubin:

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

D. Mark Millmann

Celia 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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Disc-O-Tech Medical Technologies, Ltd. Fixion Intramedullary Nailing. System

page 1 of 1

Indication for Use

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Fixion™ Intramedullary Nailing System (Fixion™ IM Nail)

Indication for Use: The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

for Mark N Millman

vision Sign-Off Division of General, Restorative and Neurological Devices

021324 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over the Counter Use _

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.