indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, II, III, and IV trochanteric and subtrocianteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle

Device Description

The EZ-Fix™ Compression Hip/Supracondylar Screw system is manufactured from titanium (6Al-4V ELI) per ASTM F136. It is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), is available in 95°, 130°, 135°, 140°, 145° and 150° angles and is manufactured and tested per ASTM specifications F787 and F384 respectively. The bone screw hole pattern is offset and the most proximal hole accepts a large diameter cannulated screw. The plates shall be available in 3 hole, 4 hole, 5 hole, 6 hole, 10 hole, 12 hole and 14 hole lengths. The bone screws are self-tapping and the lag screws are available in 50-150 mm (5 mm increments) lengths. A compression screw threads into the lag screw to allow for optimal compression of the lag screw into the barrel during implantation.

AI/ML Overview

This document describes a 510(k) premarket notification for the EZ-Fix™ Compression Hip/Supracondylar Screw (CHS) System. The focus of this submission is on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct response to your request, which expects detailed performance metrics, sample sizes, and expert adjudication for a medical image analysis device, is not fully applicable.

However, I can extract the relevant information from the provided text that aligns with your request's spirit, particularly regarding the device's testing and the "acceptance criteria" through the lens of equivalence.

Here's an interpretation based on the document:

The "acceptance criteria" for this device are its ability to meet ASTM test standards for metallic nail-plate appliances (F384) and, crucially, to demonstrate equivalence in these test values to legally marketed predicate devices. The "study" proving this is the biomechanical testing performed, and the "reported device performance" is its successful comparison to predicate devices based on these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a mechanical implant, the "performance" is primarily defined by material properties, design features, and structural integrity under simulated conditions, benchmarked against predicate devices and established ASTM standards. The acceptance criteria are implicit in achieving comparable results to predicates under these standards.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Material Composition: Fabricated from suitable, biocompatible, and strong materials.	Titanium (6Al-4V ELI) per ASTM F136. This is equivalent to Alphatec, Ace, and Howmedica systems.
Mechanical Integrity/Design: Meets established ASTM standards for metallic nail-plate appliances (F384).	Tested per ASTM F787 (manufacturing) and F384 (testing). "Test results proved the device to be of sound design."
Functional Equivalence: Performance comparable to predicate devices in mechanical testing.	"These test values are comparable to those obtained from the referenced equivalent [predicate devices]." The document explicitly states the EZ-Fix™ CHS System is equivalent in materials, intended uses, design, testing, and manufacturing to multiple predicate devices (Alphatec, Ace, Richards, Howmedica, Zimmer). This includes features like self-tapping bone screws, large cannulated screw acceptance, non-modular design, and available barrel plate angles.
Sterilization Efficacy: Achieves a specified Sterilization Assurance Level (SAL) if supplied sterile.	SAL of 10⁻⁶ for gamma radiation sterilization (Cobalt 60), compliant with ANSVAAMVISO 11137-1994.
Non-Pyrogenic: Does not cause fever.	Non-pyrogenic, tested using LAL (Limulus Amebocyte Lysate) method.

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

Sample Size: Not explicitly stated for the biomechanical testing of the EZ-Fix™ device itself. However, for sterilization validation of sterile devices, 10% of each production lot is tested, broken down into 6% for bacteriostasis/fungistasis studies and 4% for bioburden recovery determination.
Data Provenance: The biomechanical testing was performed by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. It is a retrospective comparison in the sense that the test results of a new device are compared against known performance characteristics (or published data, or internal data) of already marketed predicate devices.

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

This type of information is not applicable to the biomechanical testing of a compression hip/supracondylar screw system. "Ground truth" in this context is established by objective engineering and material science standards (ASTM F384) and the measured mechanical properties of the device, compared against predicate devices. There wouldn't be "experts" in the sense of clinicians establishing a "diagnosis" or "interpretation." The expertise lies in the biomechanical engineers at the testing lab.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments or when reconciling differing expert opinions, common in medical imaging or clinical trials. For biomechanical testing, the results are objective measurements against a standard.

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. This device is a surgical implant, not an AI or diagnostic imaging tool. It does not involve "human readers" or "AI assistance" in its direct function.

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

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

7. The Type of Ground Truth Used

For the biomechanical testing, the "ground truth" equates to:

Objective Engineering Standards: Adherence to ASTM F384 for metallic nail-plate appliances.
Predicate Device Performance: The established and accepted mechanical performance characteristics of legally marketed, substantially equivalent devices. The EZ-Fix™ device's test values were compared for comparability.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no "training set" for this type of device.

Summary

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K96 2846

OCT 2 3 1996

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 TM Compression Hip/Supracondylar Screw (CHS) System
Common Name:	Compression Hip/Supracondylar Screw
Registration Number:	888.3030
Classification Name:	Appliance, Fixation, Nail/Blade/Plate Combination, MultipleComponent, Metal Composite
Product Code:	87LXT

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

Classification:

.. - - -

Device Class: Class II

Classification Panel: Orthopedic

Contact Person:

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

Special Controls:

Not applicable to this device.

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Device Description:

Substantially Equivalent Devices:

Alphatec Modular Hip Screw System
See Appendix III for promotional materials for the comparison device.

1. Ace Captured Hip Screw System See Appendix III for promotional materials for the comparison device.
1. Richards Classic and AMBI Compression Hip Screw Systems See Appendix III for promotional materials for the comparison device.
ব, Howmedica ALTA Modular Hip Screw System See Appendix III for promotional materials for the comparison device.
1. Zimmer Free-Lock Compression Hip Fixation System See Appendix III for promotional materials for the comparison device. .. .
1. Zimmer Versa-Fx Femoral Fixation System See Appendix III for promotional materials for the comparison device.

Comparison to Predicate Device:

The EZ-Fix™ Compression Hip Screw System is substantially equivalent to the Alphatec, Ace, Richards, Howmedica and Zimmer compression hip screw systems in that they are combination lag screw, bone screws, compression screw and plate fixation devices with indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, II, III, and IV trochanteric and subtrocianteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle, making it substantially equivalent to Alphatec, Richards, Howmedica and Zimmer. The EZ-FIX™ CHS is contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. It is fabricated and tested per ASTM standards.

The EZ-Fix™ CHS is substantially equivalent to the Alphatec, Richards, Howmedica and Zimmer systems in that it include self-tapping bone screws.

The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards' Classic, Howmedica and Zimmer in that it accepts a large cannulated screw in the most proximal plate hole.

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The EZ-Fix™ CHS is substantially equivalent to Alphatec, Ace, and Howmedica in that it is fabricated from titanium alloy (71-6Al-4V ELI). It is equivalent to the Richards, and Zimmer systems in that the barrel and plate are non-modular (solid) in design and the screw hole pattern along the length of the plate is offset.

The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards' AMBI, Howmedica, and Zimmer Free-Lock being available keyed or keyless with regard to the barrel and lag screw design.

The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards, Howmedica, and Zimmer Versa Fx in that the barrel plate angles include 95°, 130°, 135°, and 150°. Like Alphatec, the EZ-Fix™ lag screws are available in lengths ranging from 50 mm to 150 mm.

Packaging:

Sterlle

· The EZ-Fix™ Compression Hip Screw devices may be supplied sterile.

· The devices are packaged individually in a blister package consisting of a thermoformed inner tray that contains the EZ-Fix™ Rod. This tray is protected by an outer thermoformed tray that is sealed by TVVEK CR-27. The outer TYVEK cover is labeled and has affixed to it the Patient Chart Labels. Both the inner and outler 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™ Compression Hip Screw devices and all instrumentation may be supplied non-sterile.

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

Sterilization / Re-sterilization:

Sterlie

· The EZ-Fix™ Compression Hip Screw devices may be supplied sterlie.

· Sterilization is achieved by means of gamma radiation.
· Sterilization complies with ANSVAAMVISO 11137-1994 practices.

· 10% of each production lot of EZ-Fix™ devices are tested (6% for bacteriostasis -

fungistasis studies and 4% for bloburden recovery determination)

· The devices are packaged individually in a blister package consisting of a thermoformed inner tray that contains the EZ-Fix™ 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 Patient Chart Labels. Both the inner and outler 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 ANSVAAMI/ISO 11137.1994 dose setting.
· Sterilization Assurance Level (SAL) is 10°.

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· Sterilization process used is Cobalt 60.

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

Non-Sterile

· The EZ-Fix™ Compression Hip Screw devices and all instrumentation may be supplied non-sterile.

· Steam autoclavable sterilization travs have been designed to contain the EZ-Fix™ CHS 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™ devices are non-pyrogenic. Pyrogenicity testing of the devices to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.

Testing:

The EZ-Fix™ Compression Hip/Supracondylar Screw (CHS) system has been tested by the University of Miami Biomechanics Laboratory at Mount Sinal in Miami Beach. Florida. based upon ASTM test standards for metallic nail-plate appliances (F384). Test results proved the device to be of sound design.

Equivalence :

These test values are comparable to those obtained from the referenced equivalent.

Conclusion:

Based on the materials, intended uses, design, testing, and manufacturing, the EZ Fix™ Compression Hip/Supracondylar Screw System is equivalent to the referenced legally marketed comparison devices. The feature comparison chart below graphically demonstrates equivalence.

Comparison Table:

EZ-Fix™CHS	AlphatecMHS	Ace®CHS	RichardsAMBI / Classic	HowmedicaAlta	ZimmerFree Lock / Versa
Materials
Titanium Alloy	Titanium Alloy	Titanium Alloy	Stainless SteelStainless Steel	Titanium Alloy	Stainless SteelStainless Steel
Keyed / Keyless
Both	Both	Keyless	KeyableKeyed	Both	KeyableKeyed
Plate Design
Solid	Modular	Modular	SolidSolid	Modular	SolidSolid

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.