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The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Device Description

The ELAN 4 Electro motor system is an electrical motor system consisting of a control unit with different sizes and types of handpieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc. The system allows for high-speed dissection at up to 80,000 RPM while also allowing low speed cutting between 1,000 and 20,000 RPM. System settings are controlled with the touch screen panel of the control unit, while all functions of the handpieces can be controlled from the sterile field by the foot control.

AI/ML Overview

The provided document details the acceptance criteria and study results for the ELAN 4 Electro Motor System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents several tables detailing acceptance criteria and results for different handpieces of the ELAN 4 Electro Motor System. Below is a consolidated representation of these, focusing on the general themes rather than repeating every specific test if the acceptance criteria and results are similar across different components.

Requirement / Test Category	Acceptance Criteria	Reported Device Performance (Results)
Handpieces (GA)
Material change (Titanium alloy to Stainless steel)	No new risk to patient. (Verified by testing and biocompatibility testing per ISO 10993-1)	Pass. Does not raise new questions of safety and effectiveness.
Material change (PEEK (blue) to PEEK (black))	No new risk to patient. (Verified by testing)	Pass. Does not raise new questions of safety and effectiveness.
Motor and handpiece has no coupling (one piece)	No new risk to patient. (Verified by testing)	Pass. Does not raise new questions of safety and effectiveness.
Tool adaptation at distal end of handpiece	No new risk to patient. (Verified by testing)	Pass. Does not raise new questions of safety and effectiveness.
Burr release only in off position mechanism	No new risk to patient. (Verified by testing)	Pass. Does not raise new questions of safety and effectiveness.
Bench Testing of ELAN 4 Attachments (General)
Contour milling performance (Drill hand pieces GA861 and GA864)	As representative of the standard tool portfolio "XS", contour milling is per application and processing cycle with the test pattern to be milled in bone replacement material (ash hardwood). Definition of the tools used.	The 120 application cycles, i.e., a contour milling, could be performed without affecting by the test pattern itself. Pass.
Coupling Toolfunctions	Tool is manually decoupled (with actuator).	120 times "OK", i.e., at 120 cycles of use, the tool was automatically coupled and uncoupled manually. There were no problems with tool coupling. PASS.
Function/Safety after Cleaning, Disinfection, Sterilization	No impairment of function and safety by cleaning, disinfection and steam sterilization.	During the preparation and application of 120 cycles, there were no function and safety impairments caused by cleaning, disinfection and steam sterilization. PASS. (Weight remained constant before/after processing cycle).
Overall Functional and Safety Impairments during/after cycles	No impairment of function and safety during and after at least 100 applications and processing cycles.	Since all other 20 acceptance criteria were "satisfied" rated, this also applies to requirement (5). After and during 120 application and processing cycles, there was no functional and safety impairments. PASS.
Label Readability	Labels are still readable after min. 100 application and processing cycles.	After 120 cycles all relevant information are still identifiable/readable. PASS.
Motor Cable Coupling/Uncoupling Ease	Motor cable can be coupled and uncoupled.	120 times "OK", i.e. at 120 cycles of use, the motor cables could be easily coupled and uncoupled. PASS.
No Operation Interruption from Cable Release	No interruption of operation by releasing the cable.	120 times "no", i.e. at 120 cycles of use, there was no interruption of operation through the cable. PASS.
No Operation Interruption from Electrical Component Failure	No interruption of operation due to failure of electrical components.	120 times "no", i.e. at 120 cycles of use, there was no operation interruption due to failure of electrical components. PASS.
No Operation Interruption from Mechanical Component Failure	No interruption of operation due to failure of mechanical components.	120 times "no", i.e. at 120 cycles of use, there was no interruption due to failure of mechanical components. PASS.
Tool Securely Locked During Use	Tool is securely locked during the function test and the use.	120 times "no", i.e. at 120 cycles of use the tool during application was securely locked and there was thus no interruption. PASS.
Elan 4 Bench Testing Craniotome Handpiece Summary Table
Tool coupling/uncoupling	Tool can be consistently coupled and uncoupled.	After 123 cycles the tool was automatically coupled and manually decoupled with no problems. PASS.
Reprocessing Procedure (Cleaning, Disinfecting, Steam Sterilization)	Reprocessing procedure does not cause any functional or safety impairments.	No performance or safety impairments caused by cleaning, disinfecting or sterilization. Weight remained constant. PASS.
Overall Functional and Safety Impairments	All other testing requirements must be passed.	Since all other acceptance criteria were satisfied this requirement can be determined to have met acceptance criteria. PASS.
Label Readability	Labels and other identifying information remains readable after set amount of reprocessing cycles.	After 123 cycles all relevant information are still identifiable/readable. PASS.
Motor Cable Consistency	Motor cable consistently couples and uncouples.	After 123 cycles motor cables are easily coupled/uncoupled. PASS.
No Cable Release Safety/Function Impairment	No safety or function impairments due to cable release.	After 123 cycles there was no interruption of operation due to cable release. PASS.
No Electrical Component Failure	No safety or function impairments due to failure of electrical components.	After 123 cycles there was no interruption of operation due to failure of electrical components. PASS.
No Mechanical Component Failure	No safety or function impairments due to failure of mechanical components.	After 123 cycles there was no interruption of operation due to failure of mechanical components. PASS.
Tool Lock Mechanism Integrity	No safety or function impairments due to failure or tool lock mechanism.	After 123 cycles the tool was securely locked and there was no interruption. PASS.
Temperature Measurement (Hand-piece)	Temperature remains in acceptable range throughout testing.	10th, 51st, and 101st cycle are all PASS.
Elan 4 Bench Testing Perforator Summary Table
Sterilization Test	Reprocessing does not result in any functional or safety issues.	PASS.
Bracket System Test	Motors held securely during processing.	PASS.
Function Test	Tool securely locked and could be safely removed.	PASS.
Plug Testing	Motor cable was safe, easy and error-free coupling and uncoupling.	PASS.
Lubrication Testing	Lack of lubrication did not cause impairment of function or safety.	PASS.
Perforation Test	Perforator broke through material and turned off automatically after breaking through.	PASS.
Weight and Temperature Test	Perforator hand piece maintained a consistent weight and temperature range throughout testing.	PASS.
Elan 4 Bench Testing Reciprocating Saw Handpiece Summary Table
Cleaning and Disinfection Test	No functional or safety issues caused by cleaning and disinfection procedures.	PASS.
Sterilization Test	No functional or safety issues caused by sterilization procedure.	PASS.
Bracket Test (for saw)	Saw held securely during reprocessing, transport and storage.	PASS.
Lubrication Test (for saw)	No impairment of safety or function due to lack of lubrication.	PASS.
Function Test (for saw)	Tool is static and locked securely. Tool can be safely removed. Oscillation of tool functions. No functional or safety issues as a result of material changes.	PASS.
Motor Cable Test (for saw)	Motor cable can be coupled and uncoupled safely, easily, and without error.	PASS.
Performance Test (Sawing motion)	Sawing motion (oscillation) is consistent and cut is at least 6cm.	PASS.
Temperature Measurement Test (for saw)	Temperature remains in acceptable range throughout testing.	PASS.
Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table
Cleaning Test	No function or safety issues as a result of the cleaning and disinfection procedure.	PASS.
Sterilization Test	No function or safety issues as a result of the sterilization procedure.	PASS.
Bracket Test (for saw)	Saw remained secure during reprocessing, transport and storage.	PASS.
Lubrication Test (for saw)	No safety or function issues due to lack of lubrication.	PASS.
Motor Cable Test (for saw)	No impairment of the connection and disconnection process.	PASS.
Performance Test (Sawing motion)	Sawing motion and cut is constant and consistent.	PASS.
Temperature Test (for saw)	Temperature remains in acceptable range throughout testing.	PASS.

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

Sample Size:
- For the "ELAN 4 Bench Testing Handpieces Summary Table" and "ELAN 4 Bench Testing Craniotome Handpiece Summary Table," the sample size for most tests was 120-123 cycles.
- For the "ELAN 4 Bench Testing Perforator Summary Table," "ELAN 4 Bench Testing Reciprocating Saw Handpiece Summary Table," and "Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table," the sample size for most tests was 100 cycles.
Data Provenance: The studies described are bench tests, meaning they were conducted in a controlled laboratory environment rather than on human or animal subjects. The document does not specify the country of origin of the data, but the context implies it was conducted by Aesculap, Inc., whose address is in Center Valley, PA, USA. These are prospective tests designed to demonstrate device performance against predefined criteria.

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

This information is not provided in the document. The studies are bench tests, and the "ground truth" implicitly refers to engineering specifications and performance criteria that the device is expected to meet. It's not a clinical study requiring human experts to establish diagnostic ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are bench tests with clearly defined pass/fail criteria based on engineering specifications. There is no mention of human adjudication for these technical performance tests.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench testing comparing the ELAN 4 Electro Motor System to its predicate device based on technological characteristics and performance in a controlled environment. It does not involve human readers or AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the loop performance):

Yes, the studies described are analogous to standalone performance studies for mechanical devices. The ELAN 4 Electro Motor System was tested in a standalone capacity (i.e., the device itself, without human intervention in the evaluation of the test results beyond operating the equipment and recording data) against predefined performance criteria. There is no "algorithm" in the sense of AI; it's the mechanical/electrical device's performance that is being evaluated.

7. Type of Ground Truth Used:

The ground truth used is primarily engineering specifications and predefined performance criteria. For example, a burr should not release during use, labels should remain readable after a certain number of cycles, and temperature should remain within an acceptable range. These are objective, measurable parameters.

8. Sample Size for the Training Set:

This concept is not applicable to the described studies. The document describes verification and validation bench testing for a physical medical device, not a machine learning or AI model that requires a training set.

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

This information is not applicable as it is not a study involving a training set for an AI/machine learning model. The ground truth for the verification and validation (bench testing) was established through engineering specifications and safety requirements relevant to the device's function.

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