The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.

The eG1 Wireless Hand Control System consists of two articles:

The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.
The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.

The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.

AI/ML Overview

This looks like an FDA 510(k) summary for a medical device called the "eG1 Wireless Hand Control System." The document aims to demonstrate that this new device is substantially equivalent to a previously cleared predicate device ("Foot control pedals used with eG1 High Speed System K133604").

However, the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way you've outlined for diagnostic aids or AI products (e.g., sensitivity, specificity, clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence based on:

Identical intended use and indications for use.
Similar technological characteristics where applicable, and where there are differences (e.g., wireless technology, power source, sterilization), verifying that these differences do not raise new questions of safety or effectiveness through specific engineering and regulatory testing.

The "studies" and "acceptance criteria" discussed here are primarily engineering verification and validation tests and compliance with recognized standards.

Let's break down what is available in the provided text in relation to your request, and explicitly state what is not present:

1. A table of acceptance criteria and the reported device performance

What's available: The document lists several tests performed to assess the device's safety, effectiveness, and compliance with standards. It generally states that "All acceptance criteria are met." However, it does not provide a specific table with quantitative acceptance criteria (e.g., a specific speed range, latency, signal reliability percentage) paired with reported performance metrics from a clinical study or a performance study with human subjects operating the device for diagnostic or therapeutic outcomes.
Example of what is present as "performance" in this context:
- Test Category: Design verification analysis
- Purpose: Verify physical characteristics meet design inputs related to interfaces.
- Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
- Test Category: Design verification testing
- Purpose: Verify functional aspects of the proposed device.
- Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
- Test Category: Software Validation
- Purpose: Developed applying IEC 62304:2015.
- Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
- Test Category: Electrical Safety (IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012)
- Purpose: Basic Safety and Essential Performance.
- Reported Performance/Conclusion: Certified compliant.
- Test Category: Electromagnetic Compatibility (IEC 60601-1-2:2014)
- Purpose: Electromagnetic disturbances.
- Reported Performance/Conclusion: Certified compliant.
- Test Category: Radio Emissions (IEC 62311:2007)
- Purpose: Human exposure restrictions for electromagnetic fields.
- Reported Performance/Conclusion: Tested according to standard. (Implies compliance, though "compliant" isn't explicitly stated here).
- Test Category: Sterilization Validation (ISO 11135:2014)
- Purpose: Ethylene Oxide sterilization for WIRELESS-HC.
- Reported Performance/Conclusion: Validated according to standard.

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 in this document. This device is a surgical tool control, not a diagnostic device relying on patient data. The "test set" here refers to the physical devices and software being tested. There's no mention of patient data, retrospective/prospective studies, or country of origin for such 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 type of information is relevant for studies involving expert interpretation of medical images or other clinical data to establish a "ground truth." This document describes engineering and regulatory compliance testing for a physical device. Ground truth, in this context, would be defined by engineering standards and specifications.

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

Not applicable/Not provided. Similar to point 3, this refers to methods for resolving discrepancies among expert interpretations, which is not relevant for the type of testing described here.

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 is explicitly for AI-enabled diagnostic aids. The eG1 Wireless Hand Control System is a physical surgical control device, not an AI system or diagnostic aid.

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

Not applicable/Not provided. Again, this is for AI algorithms. The device performs its function as designed; there's no "algorithm only" performance separate from the device's operation.

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

N/A in the context of your question. For this device, "ground truth" equates to adherence to engineering specifications, performance standards (e.g., motor speed control accuracy, signal latency, electromagnetic compatibility limits), and recognized regulatory standards (IEC, ISO, FCC). It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

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

Not applicable/Not provided. As above, no training set for this device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a new surgical control device to an existing one by confirming adherence to engineering specifications, recognized safety and performance standards (like IEC and ISO), and regulatory compliance (FCC). It does not present clinical study data with acceptance criteria for diagnostic performance or AI model evaluation as implied by your detailed questions.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 19, 2022

The Anspach Effort, Inc. % Marie Ferrier Senior Regulatory Affairs Program Lead Synthes GmbH Eimattstrasse 3 Oberdorf, 4436, Switzerland

Re: K220485

Trade/Device Name: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, ERL Dated: April 20, 2022 Received: April 21, 2022

Dear Marie Ferrier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220485

Device Name

Wireless Hand Control, EG1A (WIRELESS-HC); Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)

Indications for Use (Describe)

The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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The Anspach Effort, Inc. eG1 Wireless Hand Control System: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)

510(k) Summary

A. Device Information:

Category	Comments
Sponsor:	The Anspach Effort, Inc.4500 Riverside DrivePalm Beach Gardens FL 33410, United StatesTel: 1-561-627-1080
Correspondent ContactInformation:	Mrs. Marie FerrierSynthes GmbHEimattstrasse 3Oberdorf 4436, SwitzerlandTel: +33(0)675765048
Device Common Name:	Wireless Hand Control System
Device Regulation & Name:	882.4360 – Electrical cranial drill motor874.4250 – Ear, nose, and throat electric or pneumaticsurgical drill
Classification & Product Code:	HBC (Class 2) – Motor, Drill, ElectricERL (Class 2) – Drill, Surgical, Ent (Electric orPneumatic) Including Handpiece
510(k) Number:	K220485
Device Proprietary Name:	eG1 Wireless Hand Control System

Predicate Device Information:

Predicate Device:	Foot control pedals used with eG1 HighSpeed System
Predicate Device Manufacturer:	The Anspach Effort, Inc.
Predicate Device Common Name:	eG1 High Speed System
Predicate Device Premarket Notification #	K133604
Predicate Device Regulation & Name:	882.4360 - Electrical cranial drill motor874.4250 - Ear, nose, and throat electric orpneumatic surgical drill
Predicate Device Classification& Product Code:	HBC (Class 2) – Motor, Drill, ElectricERL (Class 2) – Drill, Surgical, Ent(Electric or Pneumatic) IncludingHandpiece

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B. Date Summary Prepared

May 19th, 2022

C. Description of Device

The eG1 Wireless Hand Control System consists of two articles:

The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.
The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.

D. Indications for Use

The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

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Characteristic	Application Device:eG1 Wireless HandControl SystemK220485	Predicate Device:Foot control pedals usedwith eG1 High SpeedSystem K133604	Impact on SubstantialEquivalence
Company	The Anspach Effort, Inc.	The Anspach Effort, Inc.	-
RegulationNumber	882.4360 – Electricalcranial drill motor874.4250 – Ear, nose, andthroat electric orpneumatic surgical drill	882.4360 – Electricalcranial drill motor874.4250 – Ear, nose, andthroat electric orpneumatic surgical drill	Identical
FDA ProductCode	HBC (Class 2) – Motor,Drill, ElectricERL (Class 2) – Drill,Surgical, Ent (Electric orPneumatic) IncludingHandpiece	HBC (Class 2) – Motor,Drill, ElectricERL (Class 2) – Drill,Surgical, Ent (Electric orPneumatic) IncludingHandpiece	Identical
Intended Use& Indicationsfor Use	Cutting and shaping boneincluding spine andcranium	Cutting and shaping boneincluding spine andcranium	Identical
The devicecontrols/function	Speed (increase/decrease) of thehandpiece motor	Speed (increase/ decrease)of the handpiece motorDepending on model:-rotation-irrigation pump	Identical (the predicatehas additional functions)
Principle ofoperation/Technology	The pressure on thebutton is transferred fromthe WIRELESS-HC toRECEIVER-HCwirelessly (radio signal)and transformed into anelectric signal	The pressure on the pedalis transformed into anelectric signal	The predicate devicedoes not contain anywireless technology.The device WirelessFoot control used withELAN 4 Electro MotorSystem (K203739) isused as a referencedevice for thisapplication as it sharesthe same indications foruse, function and usageof the wirelesstechnology to transmit asignal in order toregulate the speed of thehandpiece motor. Theproposed device and thereference device operatein the same frequencyband (2.4 GHz).Software, Wireless andElectromagneticCompatibility testing are
			provided in thisapplication todemonstrate theSubstantial Equivalence.
Power toolcompatibility	eG1 High Speed System	eG1 High Speed System	Identical
Interface withthe user (useraction)	Increase/ decrease thepressure on the button toincrease/ decrease thespeed	Increase/ decrease thepressure on the pedal toincrease/ decrease thespeedDepending on model:-Press the dedicated buttonto change rotation-Press the dedicated buttonto activate irrigation pump	Identical (the predicatehas additional functions)
Interface withthe console	Receiver plugs into theeG1 consoles (foot pedalconnector port)	Cord plugs into the eG1consoles (foot pedalconnector port)	Identical
Power source	RECEIVER-HC: mainpower through theconsoleWIRELESS-HC: containsa lithium coin battery	Main power through theconsole	Electrical Safety testingis provided in thisapplication todemonstrate theSubstantial Equivalence.
Patientcontact	No direct or indirectpatient contact	No direct or indirectpatient contact	Identical
Sterilization/Reprocessing	RECEIVER-HC: nonsterile, reusable (cleaningonly)WIRELESS-HC: sterile,single-use	Non sterile, reusable(cleaning only)	The predicate device isnon sterile. SterilizationValidation is providedin this application todemonstrate theSubstantial Equivalence.

E. Comparison of the Technological Characteristics

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F. Summary of Supporting Data

The proposed device eG1 Wireless Hand Control System has the same intended use, function, interface with the eG1 console and patient contact as the predicate device Foot control pedals used with eG1 High Speed System (K133604). The proposed device shows some differences regarding the power source, the technology (wireless) and sterilization.

A design verification analysis was conducted to verify that the physical characteristics of the eG1 Wireless Hand Control System meet the design inputs related to the interfaces with the user, eG1 Handpiece and Console.

Design verification testing was conducted to verify the functional aspects of the proposed device.

The software of the proposed device was developed applying IEC 62304:2015 Medical device software - Software life cycle processes. Design verification analysis, Design verification testing and Software Validation were conducted on the proposed device firmware.

The proposed device was developed, tested and certified according to IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment – General Requirements for

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Basic Safety and Essential Performance.

The proposed device was developed, tested and certified according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The proposed device was found compliant with applicable US FCC regulations and standards 47 CFR Part 15 Subpart B and 47 CFR § 15.247.

The radio emissions were tested according to IEC 62311:2007 Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz).

The WIRELESS-HC is sterilized by Ethylene Oxide. The sterilization cycle was validated according to ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.

G. Discussion of Performance Testing

All acceptance criteria are met. The differences in technological characteristics do not raise new questions of safety or effectiveness based on results of risk-based verification and validation testing.

H. Conclusion

Following the 510(k) Decision-Making Flowchart, it is determined that the eG1 Wireless Hand Control System is substantially equivalent to the predicate Foot control pedals used with eG1 High Speed System (K133604) as there is no difference in the intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness.

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).