femoral head/neck fractures or non-unions;
aseptic necrosis of the femoral head/neck; and
osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

Femur:

fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
use in osteotomy, nonunions, bone reconstruction following turnor resection, grafting and pathological fractures, and revision procedures in the femur;
mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
comminuted shaft fractures:
fixation of short distal or proximal fragments

Tibia:

diaphyseal shaft fractures in the tibia:
comminuted shaft fractures;
fixation of short distal or proximal fragments

Humerus:

diaphyseal shaft fractures in the humerus;
comminuted shaft fractures;
fixation of short distal or proximal fragments

Device Description

The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems.

The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified Pump) has the following similarities to that which previously received 510(k) clearance;

Have the same intended use
Have the same operating principles
The Implants and the Instrumentation Set incorporate the same design
The Implants and the Instrumentation Set incorporate the same materials
The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Fixion Interlocking Proximal Femur Intramedullary Nailing System. This submission focuses on establishing substantially equivalent performance to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a novel clinical study with quantitative performance metrics.

Therefore, the requested information elements related to a study proving acceptance criteria (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable and not present in the provided document.

Instead, the document details the device's adherence to relevant performance standards for materials and care handling, and its similarities to legally marketed predicate devices.

Here's the breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Met)	Reported Device Performance
Material Composition: ASTM F 138 Standard Specification for Stainless Steel Bar and Wire for Surgical Implants (for 316L Stainless Steel)	The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F 138.
Component Materials: Surgical grade Stainless Steel, Silicone, and Celeron	The Fixion PF Nailing System accessories incorporate surgical grade Stainless Steel, Silicone and Celeron.
Care and Handling: ASTM F 565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments	The Fixion PF Nailing System is designed to meet the requirements of ASTM F 565.
Substantial Equivalence to Predicate Devices:	The modified Fixion PF Nailing System (modified Pump) has the following similarities to previously cleared Fixion Systems (K990717, K003212, K003215, K010901, K021324, K002783, K013449, K014072): - Have the same intended use. - Have the same operating principles. - The Implants and the Instrumentation Set incorporate the same design. - The Implants and the Instrumentation Set incorporate the same materials. - The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes. The Inflation Device (Nail Pump/Hip Peg Pump) operates similarly to the pump used with aforementioned Fixion Systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document describes a 510(k) submission based on compliance with existing standards and substantial equivalence to predicate devices, not a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. This information would be relevant for a clinical study assessing diagnostic or therapeutic effectiveness based on expert-adjudicated ground truth. This submission relies on engineering standards and design comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Similar to point 3, this is relevant for studies involving human interpretation or clinical outcomes.

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 / Not provided. This device is an intramedullary nailing system and a hemi-hip system, not an AI-powered diagnostic or assistive tool.

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

Not applicable / Not provided. This device is a physical implant, not an algorithm.

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

Not applicable / Not provided. The "ground truth" in this context is adherence to specified engineering material standards (ASTM F 138, ASTM F 565) and functional equivalence to known predicate devices based on design, materials, and intended use.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable / Not provided. As there is no training set, this question is not applicable.

Summary

{0}------------------------------------------------

NOV 1 4 2002

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

K023437

510(k) Summary

Disc-O-Tech Medical Technologies, Ltd. Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

Company Name

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

Submitter's Name and Contact Person

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

Date Prepared

October 2002

Trade/Proprietary Name

Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion Interlocking Intramedullary Nailing System; Fixion" Unipolar Modular Hemi-Hip System

Classification Name

21 CFR & 888.3020, Class II, Intramedullary fixation rod

21 CFR § 888.3390, Class II, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Predicate Devices

1. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-Tech Medical Technologies, Ltd.

Performance Standards

The following standards were used:

1. The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F 138 Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
1. The Fixion PF Nailing System accessories incorporate surgical grade Stainless Steel, Silicone

{1}------------------------------------------------

K023437

and Celeron. '

1. The Fixion PF Nailing System is designed to meet the requirements of ASTM F 565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments.

Intended Use

Hip:

femoral head/neck fractures or non-unions; . I
aseptic necrosis of the femoral head/neck; and
osteo-, theumatoid, and post-traumatic arthritis of the hip, with mimmal acetabular involvement

Femur:

ー fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures: proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
= use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
ー mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
comminuted shaft fractures; ー
fixation of short distal or proximal fragments -

Tibia:

diaphyseal shaft fractures in the tibia: -
comminuted shaft fractures: ー
fixation of short distal or proximal fragments

Humerus:

ー diaphyseal shaft fractures in the humerus:
comminuted shaft fractures:
fixation of short distal or proximal fragments -

Substantial Equivalence

{2}------------------------------------------------

Page 3 of 3

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

K023437

Pump) has the following similarities to that which previously received 510(k) clearance;

Have the same intended use -
Have the same operating principles l
The Implants and the Instrumentation Set incorporate the same design ー
The Implants and the Instrumentation Set incorporate the same materials -
The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

NOV 1 4 2002

9200 Corporate Bouleva Rockville MD 20850

Ms. Yael Rubin Director of Regulatory Affairs Disc-o-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya 46728 ISRAEL

Re: K023437

Trade/Device Name: Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System; Fixion™ Intramedullary Nailing System; Fixion™ Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

Regulation Number: 21 CFR 888.3020; 21 CFR 888.3390

Regulation Name: Intramedullary fixation rod; Hip joint (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: Class II

Product Code: HSB, JDS, KWY Dated: October 10, 2002

Received: October 15, 2002

Dear Ms. 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 enclosures) 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.

{4}------------------------------------------------

Page 2 - Ms. Yael Rubin

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. 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. 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" (21 CFR 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,

Mark N. Melkerson

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

Enclosures

{5}------------------------------------------------

510(k) Number (if known): K023437

Device Name: Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

Indications For Use: These devices are indicated for the following:

Hip:

femoral head/neck fractures or non-unions; -
aseptic necrosis of the femoral head/neck; and -
osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

Femur:

fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; l proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
use in osteotomy, nonunions, bone reconstruction following turnor resection, ー grafting and pathological fractures, and revision procedures in the femur;
mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
comminuted shaft fractures: -
fixation of short distal or proximal fragments -

Tibia:

diaphyseal shaft fractures in the tibia: -
comminuted shaft fractures; -
fixation of short distal or proximal fragments a

Humerus:

diaphyseal shaft fractures in the humerus; -
comminuted shaft fractures;
fixation of short distal or proximal fragments -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-the-Counter Use
(Per 21 CFR § 801.109)		(Optional Format 1-2-96)

Signature
(Division Sign-Off)

Division of General, Restorative

and No Rogical Devices

510(k) Number	K023437
---------------	---------

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.