The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus.

Device Description

The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of Midshaft Humeral fractures. The EZ-Fix™ Midshaft Humeral IM Rod System is substantially equivalent to the Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, the Applied Osteo Systems True/Flex™ Fixation Device, the Howmedica Seidel™ Humeral Locking Nail System, and the Howmedica Alta@Humeral Rod. The EZ-Fix™ Midshaft Humeral Rod is cylindrical and available in 9mm, 11mm and 13mm diameters. The 9mm rod reduces to 7mm distally and is available in 200mm and 250mm lengths. The 11mm rod reduces to 9mm distally and is available in 200mm and 250mm lengths. The 13mm rod reduces to 11mm distally and is available in 200mm and 250mm lengths. Three screw holes proximally accept 5mm bone screws. Tuberosity fragments can be stabilized by transfixing screws. Two holes distally accept 3.5mm screws to capture and secure distal fragments or to enhance rotational stability. The EZ-Fix™ Midshaft Humeral Rod has shallow grooves situated from the beginning of the taper and extending lengthwise for ease of implantation, enhanced flexibility and rotational stability. An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is profected by a titanlum allov (T1-6AL-4V) capscrew, disallowing soft tissue ingrowth post implantation. The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.

AI/ML Overview

This K962553 document describes a premarket notification for the "EZ-Fix™ Midshaft Humeral Intramedullary Rod System." It is a medical device application for an intramedullary rod used to stabilize midshaft humeral fractures.

It's important to note that this is a medical device submission, not a submission for an AI/CAD (Computer-Aided Diagnosis) device. Therefore, many of the requested categories in your prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case study," and "standalone algorithm performance," are not applicable to this type of traditional medical device.

The "study" referenced in this document is a biomechanical performance test on the physical device itself, not a clinical study involving human patients or an AI algorithm's diagnostic performance. The acceptance criteria are based on established engineering standards for medical implants.

Here's the information parsed from the provided text, addressing your questions where applicable and indicating "Not Applicable" (N/A) for those that do not fit this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for an intramedullary rod are typically related to mechanical strength, fatigue life, material compatibility, and sterilization efficacy, per relevant ASTM standards. The document states that the device "proved the rods to be of sound design" based on ASTM F383. Specific quantitative acceptance values are not provided in this summary, but the general criteria are adherence to ASTM standards.

Acceptance Criteria Category	Specific Criteria (Inferred from ASTM F383)	Reported Device Performance (as stated in the document)
Mechanical Strength	e.g., Bending strength, torsional stability	"Test results proved the rods to be of sound design."
Material Properties	Compatibility, strength of Titanium Alloy (Ti-6AL-4V)	"The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength."
Biocompatibility	Non-toxic, non-allergenic with body tissues	"The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility..."
Sterilization Efficacy	10⁻⁶ Sterility Assurance Level (SAL) per ANSI/AAMI/ISO 11137-1994	"Sterilization Assurance Level (SAL) is 10⁻⁶." "Sterilization complies with ANSI/AAMVISO 11137-1994 practices."
Non-pyrogenicity	Absence of endotoxins	"The EZ-Fix™ is non-pyrogenic. Pyrogenicity testing... performed using LAL method."
Equivalence to Predicates	Performance values identical to referenced equivalent devices	"These test values are identical to those obtained on the referenced equivalent."

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

Sample Size for Test Set: The document states for sterilization testing: "10% of each production lot of EZ-Fix™ kits are tested (6% for bacteriostasis fungistasis studies and 4% for bioburden recovery determination)." For the biomechanical testing, a specific sample size (N) for the intramedullary rods themselves is not explicitly stated in this summary. It refers to "the rods" in general.
Data Provenance: The biomechanical testing was performed by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. This is a prospective test on newly manufactured devices, not retrospective data analysis from patients.

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

N/A. This is a hardware device. "Ground truth" in this context refers to the physical and mechanical properties of the rod, established by engineering tests according to ASTM standards, not by expert medical opinion on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As above, no medical judgment or diagnostic adjudication was performed. The "adjudication" is essentially whether the device's measured performance met the specified ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This is not an AI/CAD system, so an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an AI algorithm. The device's performance is standalone in the sense that it is a physical object that performs its function without human intervention after surgical implantation (though human surgeons obviously implant it).

7. The Type of Ground Truth Used

Engineering Standards / Biomechanical Performance Data. The "ground truth" for this device's performance is derived from its physical and mechanical properties measured against established industry standards (ASTM F383) and material specifications (Titanium Alloy Ti-6AL-4V). For sterility, it's defined by achieving a 10⁻⁶ SAL.

8. The Sample Size for the Training Set

N/A. There is no "training set" as this is a physical medical device, not a machine learning model.

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

N/A. As there is no training set, this question is not applicable.

Summary

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K962553

AUG 2 8 1998

Section 510(k) Premarket Notification

Summary of Safety and Effectiveness Information

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Device Trade Name:	EZ-Fix™ Midshaft Humeral Intramedullary Rod System
Common Name:	Intramedullary Rods
Registration Number:	888.3020
Classification Name:	Rod, Fixation, Intramedullary and Accessories

Establishment Name & Registration Number:

Name:	Biodynamic Technologies, Inc.
	East Newport Center Drive
	Deerfield Beach, Florida 33442
	(305) 421-3166 (305) 570-6368 FAX

Number: 1035157

Contact Person:

Danny Hodgeman Biodynamic Technologies, Inc. East Newport Center Drive Deerfield Beach, Florida 33442 (305) 421-3166 (305) 570-6368 FAX

Classification:

Device Class: Class II

Classification Panel: Orthopedic

Special Controls:

Not applicable to this device.

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Device Description:

The EZ-Fix™ Midshaft Humeral IM Rod System is substantially equivalent to the Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, the Applied Osteo Systems True/Flex™ Fixation Device, the Howmedica Seidel™ Humeral Locking Nail System, and the Howmedica Alta@Humeral Rod.

The EZ-Fix™ Midshaft Humeral Rod is cylindrical and available in 9mm, 11mm and 13mm diameters. The 9mm rod reduces to 7mm distally and is available in 200mm and 250mm lengths. The 11mm rod reduces to 9mm distally and is available in 200mm and 250mm lengths. The 13mm rod reduces to 11mm distally and is available in 200mm and 250mm lengths. Three screw holes proximally accept 5mm bone screws. Tuberosity fragments can be stabilized by transfixing screws. Two holes distally accept 3.5mm screws to capture and secure distal fragments or to enhance rotational stability.

The EZ-Fix™ Midshaft Humeral Rod has shallow grooves situated from the beginning of the taper and extending lengthwise for ease of implantation, enhanced flexibility and rotational stability.

An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is profected by a titanlum allov (T1-6AL-4V) capscrew, disallowing soft tissue ingrowth post implantation.

The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.

Substantially Equivalent Devices:

Orthologic® OrthoNail® Humeral Intramedullary Fixation Device See Appendix III for promotional materials for the comparison device.

Applied Osteo Systems True/Flex™

See Appendix III for promotional materials for the comparison device.

Howmedica Seidel™ Humeral Locking Nail System See Appendix III for promotional materials for the comparison device.

Howmedica Alta®Humeral Rod See Appendix III for promotional materials for the comparison device.

Comparison to Predicate Device:

The EZ-Fix™ Humeral Rod is substantially equivalent to the OrthoNail®, the True/Flex™ and the Alta®, in that it is manufactured from titanium or titanium alloy. Like the OrthoNail®, the Seidel™, and the Alta®, the EZ-Fix™ is of a cvlindrical configuration proximally.

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The EZ-Fix™ is indicated for Midshaft Humeral fractures as is the OrthoNail®, the True/Flex™, the Seider™, and the Alta®. Like the OrthoNail®, the Seidel™, and the Alta®, the EZ-Fix™ has screw holes for fixation.

The EZ-Fix™ is equivalent to OrthoNail®, the Alta™, and the Seidel in that it is cannulated. Like the OrthoNail®, the EZ-Fix™ threaded insertion/extraction hole is protected by a titanium alloy capscrew, disallowing soft tissue ingrowth post implantation.

Packaging:

Sterlie

The EZ-Fix™ Midshaft Humeral Intramedullary Rods are packaged in a blister package consisting of a thermoformed inner tray that contains the EZ-Flx™ Rod. This tray is protected by an outer thermoformed tray that is sealed by TYVEK CR-27. The outer TYVEK cover is labeled and has affixed to it the Patlent Chart Labels. Both the inner and outer trays when sealed with the TYVEK cover are enclosed in a box that is sealed and indicates the sterility of the contents. Packaging material consists of .025 BT/CTD PETG, WEB#1:CTD 1073B TYVEK CR-27.

Non-Sterile

The EZ-Fix™ Midshaft Humeral Intramedullary Rod System includes EZ-Fix™ midshafts humeral rods and instrumentation and is made available non-sterile. Steam autoclavable sterlization trays have been designed to contain the EZ-Fix™ Rod System and maintain adequate separation of the implants and instruments. Sterillzation cvcles should be followed appropriately to achieve a 10ª sterility assurance level (SAL).

Sterilization / Re-sterilization:

Sterile

· The EZ-Fix™ Midshaft Humeral Intramedullary Rod may be supplied sterile.
· Sterilization is achieved by means of gamma radiation.
· Sterilization complies with ANSI/AAMVISO 11137-1994 practices.

· 10% of each production lot of EZ-Fix™ kits are tested (6% for bacteriostasis fungistasis studies and 4% for bioburden recovery determination)

· The EZ-Fix™ is packaged in a blister package consisting of a thermoformed inner tray that contains the EZ-FIX™ Rod. This trav is protected by an outer thermoformed tray that is sealed by TYVEK CR-27. The outer TYVEK cover is labeled and has affixed to it the Patient Chart Labels. Both the inner and outer trays when sealed with the TYVEK cover are enclosed in a box that is sealed and indicates the sterility of the contents. Packaging material consists of .025 BT/CTD PETG, WEB#1:CTD 1073B TYVEK CR-27.

· The radiation dose is based on the ANSVAAMVISO 11137.1994 dose setting.
· Sterilization Assurance Level (SAL) is 10°.
· Sterilization process used is Cobalt 60.

· The EZ-Fix™ is non-pyrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.

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Non-Sterile

· The EZ-Fix™ Humeral Intramedullary Rods and all instrumentation may be supplied non-sterile.

· Steam autoclavable sterilization trays have been designed to contain the EZ-Fix™ Rod System and maintain adequate separation of the implants and instruments.

· Sterilization cycles should be followed appropriately to achieve a 10 sterility assurance level (SAL).

· See Appendix I for Sterilization Procedure
· The EZ-Fix™ is non-pvrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.

Testing:

The EZ-Fix™ Midshaft Humeral IM Rod has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida, based upon ASTM test standards for intermedullary rods (F383). Test results proved the rods to be of sound design.

Equivalence :

These test values are identical to those obtained on the referenced equivalent.

Conclusion:

Based on the materials, intended uses, design, testing, and manufacturing, the EZ Fix™ Proximal Humeral Intramedullary Rod System is equivalent to the referenced legally marketed comparison devices. The feature comparison chart below graphically demonstrates equivalence.

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Comparison Table:

EZ-Fix™	OrthoNall®	Alta™	True/Flex™	Seidel™	SubstantialEquivalence
Materials	Titanium Alloy	Titanium Alloy	Titanium Alloy	Stainless Steel	Yes
Geometry	Cylindrical/Flat	Cylindrical	Star Shaped	Cylindrical	Yes
Intended Use	Single UseProx/DistalHumeralFractures	Single UseMidshaftHumeralFractures	Single UseMid/DistalHumeralFractures	Single UseProx/Mid ShaftHumeralFractures	Yes
Performance Standards	ASTM	ASTM	ASTM	ASTM	Yes
Fixation	InterferenceOptionalScrew Holes	InterferenceOptionalScrew Holes	InterferenceMechanism	InterferenceMechanism	Yes
Preparation (Reaming)	Optional	Optional	No	Yes	Yes
Cannulated	Yes	Yes/No	No	Yes	Yes
Sterile	Non-Sterile	Sterile	Sterile	Sterile	Yes

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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.