The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.

Device Description

The Espire Elbow is an advanced upper extremity prosthetic component that when paired with other manufacturers' devices can create a complete upper extremity prosthetic system. Control means of the Espire Elbow include cutaneous electrodes, linear transducers, touchpads and/or switches. The manual control methods (linear transducer, touchpads, and switches) only require that the patient can press/touch the buttons as well as provide a pull type activation. The cutaneous electrodes offer an advanced method of control that uses the patient's muscle signals to govern the movement of the upper extremity prosthetic system. Depending on patient preferences the Espire Elbow comes in two configurations, Pro and Hybrid. The Espire Elbow (Pro) is designed to provide natural flexion and extension through a powered elbow joint which is activated by the input signals from the user. The Espire Elbow (Hybrid) contains an auto-forearm balance mechanism that assists the user with manually moving the elbow into different positions. use the same battery, electronics, inputs, and outputs.

At the time of the fitting a certified prosthetist uses the set-up application to program the device with custom criteria specific for each patient's needs. The setup is completed over a secure Bluetooth connection, no patient information is kept within the application. The Espire Elbow is designed to work seamlessly with most major manufacturers' wrist and hand devices. The Espire Elbow provides the control signals and battery power to these terminal devices.

The Espire Elbow is suitable for adult patients that are unilateral above elbow upper limb amputees. The device can be administered via prescription by a licensed and certified prosthetist only. For the prosthetist fitting the arm, CPI does not require any specific training related to the technology. The prosthetist will determine the combination of control means to be used with the Espire Elbow. The Espire Elbow is to be used for assistance in daily living; this includes normal daily routine type activities, as well as returning to work. The Espire Elbow is not indicated for use while driving any motorized vehicle or operation of heavy machinery. The device is also not to be used in any extremely warm or cold environments; this is primarily determined by the battery pack requirements. The battery pack must be removed in order to charge the device, using the supplied wall charger. Use in very wet environments, showering or swimming with the device is also outside the system capabilities.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Espire Elbow prosthetic device. It outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen in AI/ML medical device submissions.

The Espire Elbow is a physical medical device (an elbow prosthetic), not a software-driven AI/ML diagnostic or prognostic system. Therefore, the types of acceptance criteria and performance studies requested in the prompt (e.g., related to AI performance metrics like sensitivity, specificity, types of data, expert ground truth, MRMC studies) are not applicable to this device.

The "Non-Clinical Performance Data" section mentions various testing performed (biocompatibility, electrical safety, EMC, usability, battery safety, software verification, mechanical testing), all of which are standard validations for physical medical devices to ensure they meet their design inputs and safety standards. The "Clinical Performance Data" section explicitly states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

Therefore, I cannot fulfill the request for a table of acceptance criteria and AI/ML-specific study details because the provided text is for a physical medical device, not an AI/ML-driven one.

To answer your prompt, I would need a document describing an AI/ML medical device submission.

Summary

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November 29, 2018

College Park Industries, Inc. % Ken Pilgrim Senior RA/QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K182757

Trade/Device Name: Espire Elbow Pro, Espire Elbow Hybrid Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IRE Dated: September 21, 2018 Received: September 28, 2018

Dear Ken Pilgrim:

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 avare 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.

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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182757

Device Name ESPIRE ELBOW

Indications for Use (Describe)

The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

ESPIRE DIGITAL ELBOW

K182757

1. Submission Sponsor

College Park Industries, Inc.

27955 College Park Dr.

Warren, MI 48088 USA

Contact: Deborah Mackmin, Regulatory Specialist

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746 USA

Office Phone: (512) 327.9997

Contact: Ken Pilgrim, Senior Consultant, RA&QA

3. Date Prepared

21 September 2018

4. Device Identification

Trade/Proprietary Name:	Espire Elbow
Classification Name:	Cutaneous Electrode
Regulation Number:	882.1320
Product Code:	Primary: GXY (Electrode, Cutaneous)Secondary: IRE (Joint, Elbow, External Limb Component, Powered)
Device Class:	Class II
Classification Panel:	Neurology

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5. Legally Marketed Predicate Device

510[k] Number:	K123795
Device Name:	Axon-Bus Prosthetic System
Manufacturer:	Otto Bock Healthcare Product GmbH
Product Code:	Primary: GXY (Electrode, Cutaneous)Secondary: IQZ (Hand, External Limb Component, Powered)

6. Indications for Use Statement

The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.

7. Device Description

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The CPI Elbow unit contains the following components:

Espire Elbow 1.
1. Pro Powered Elbow Joint or Hybrid Elbow Joint
ന് Removeable Battery - 2 included
1. Battery Wall Charger
ഗ് Selected Input Device Cables
1. Set-up application on tablet
1. Dome electrodes (provided separately)

8. Substantial Equivalence Discussion

The following table compares the Espire Elbow to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	College Park Industries, Inc.	Otto Bock Health CareProduct GmbH	DeviceComparison
Trade Name	Espire Elbow	Axon-Bus Prosthetic System
510(k) Number	TBD	K123795	N/A
Product Code	Primary: GXY (Electrode,Cutaneous)	Primary: GXY (Electrode,Cutaneous)	Same PrimaryProduct Code
Secondary ProductCode	Secondary: IRE (Joint, Elbow,External Limb Component,Powered)	Secondary: IQZ (Hand,External Limb Component,Powered)	Differs
Regulation No.	21 CFR 890.3450	21 CFR 890.3450	Same
Regulation Name	Cutaneous electrode	Cutaneous electrode	Same
Indications for Use	The Espire Elbow is to beused exclusively for externalprosthetic fittings of theupper limbs. The EspireElbow processes user's inputsignals to activate andcontrol elbow movement.	The Axon-Bus ProstheticSystem is to be usedexclusively for exoprostheticfittings of the upper limbs.	Similar. Subjectdevice has addeddescription ofapplication areaand use of inputs.
Manufacturer	College Park Industries, Inc.	Otto Bock Health CareProduct GmbH	DeviceComparison
Trade Name	Espire Elbow	Axon-Bus Prosthetic System
Use/Field ofApplication	The Espire Elbow System issuitable for unilateral orbilateral amputations startingwith transhumeralamputation level.	The Axon-Bus ProstheticSystem is suitable forunilateral or bilateralamputations starting with thetransradial / transhumeralamputation level or, in case ofdysmelia, for forearm orupper arm fittings.	Similar
Conditions for Use	The Espire Elbow is to beused for normal daily routinetype activities, as well asreturning to work. The EspireElbow is not indicated for usewhile driving any motorizedvehicle, operation of heavymachinery, or use in anyextreme sport. The device isalso not to be used in anyextremely warm or coldenvironments.	The Axon-Bus ProstheticSystem was developed foreveryday use and must not beused for unusual activities.These activities include, forexample, sports withexcessive strain and/or shocksto the wrist unit (pushups,downhill, mountain biking) orextreme sports (free climbing,paragliding, etc.) Furthermore,the Axon-Bus ProstheticSystem should not be used forthe operation of motorvehicles or motor drivenequipment.	Similar
Mechanism ofAction	The components of theEspire Elbow system areassembled by a prosthetistaccording to the individualneeds of the patient.	The components of the Axon-Bus Prosthetic System areassembled by a prosthetistaccording to the individualneeds of the amputee.	Similar
Myo ControlOptions	5	4	Similar
Power Source
Battery Pack	Li-Ion, 3 cell	Li-Ion, 3 cell	Same
Battery Capacity	3000 mAh	1150/1500 mAh	Differs
Nominal Voltage	10.8 V	11.1 V	Similar
Manufacturer	College Park Industries, Inc.	Otto Bock Health CareProduct GmbH	DeviceComparison
Trade Name	Espire Elbow	Axon-Bus Prosthetic System
Charge Time	3.5 hours	3.5 hours	Same
Weight	174 g	142 g	Differs
Rechargeable	Yes	Yes	Same
Electrode
Contact Material	316L Stainless Steel	Titanium	Differs withregard to Hybridmodel
Adjustment	Within Setup Software,	Potentiometer 1-7	Differs withregard to Hybridmodel
Testing	ISO-10993	ISO-10993	Same
Elbow
Powered	Pro — yes, Hybrid — no	No	Differs
Product Code IREApplicable	Yes	No - elbow joint is notpowered	Differs
AutomaticForearm Balance	Pro - no, Hybrid - Yes	No	Differs
Lock	Electric	Mechanical, electric	Similar
Right and LeftConfigurations	Yes	No	Differs
Wrist size	45 mm / 50 mm	45 mm / 50 mm	Same
Maximum forearmlength	12 in	12 in	Same
Flexion Angle	-5-135°	15-145°	Differs
Maximum Lifting	10 lbs	10 lbs	Same
Maximum Holding	25 lbs	50 lbs	Differs
Manufacturer	College Park Industries, Inc.	Otto Bock Health CareProduct GmbH	DeviceComparison
Trade Name	Espire Elbow	Axon-Bus Prosthetic System
Hand
ManufacturesHand	No, uses othermanufacturers' terminaldevices. Only supplies 1degree of freedom.	Yes, multiarticulating hand.	Differs
Setup
DeviceProgramming	Espire Hub Tablet Application	Axon Bus ComputerApplication	Similar

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Espire Elbow and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, College Park Industries, Inc. completed a number of non-clinical performance tests. The Espire Elbow meets all the requirements for overall design, biocompatibility and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The Espire Elbow passed all the testing in accordance with internal requirements, national standards, and international standards, including those shown below to support substantial equivalence of the subject device:

. Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
Electrical safety (including home healthcare) testing per AAMI IEC ES60601-1 and IEC 60601-1-11
. Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2
Usability testing per IEC 60601-1-6 and IEC 62366-1
Battery safety testing per IEC 62133-2
Software verification and validation testing per IEC 62304/FDA Guidance
Mechanical Testing per ISO 22523

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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11. Statement of Substantial Equivalence

The Espire Elbow, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).