The Garaventa X3 inclined platform lift is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.

Device Description

The Garaventa X3 inclined platform lift is intended to mechanically transport one person in a wheelchair or in a fold down seat equipped with a seat belt, up and down stairs in a private or public facility either indoors or outdoors, on straight stairways.
The Garaventa X3 inclined platform lift uses two custom-cut extruded aluminum guide rails to guide and support the platform. An upper rail houses the drive rack that is engaged by the pinion gear providing platform movement as well as acting as the raceway for the control wiring. A lower rail stabilizes the platform keeping it in a level traveling position. The Garaventa X3 inclined platform lift has steel guide rails and haul ropes or cables are used for those products instead of extruded aluminum.
The Garaventa X3 inclined platform lift does not require a special cabinet to house the drive system. The drive system of the Garaventa X3 inclined platform lift is an on-board rack and pinion drive system. The drive system is protected from accidental contact by the user by a conveyance "hard" cover.
The Garaventa X3 inclined platform lift is a computer-controlled device equipped with a microprocessor and the software resides inside the conveyance controller.
The safety network monitors several switches, landing cam, the battery voltage and motor current limits. These are independent of the microprocessor system and provide a positive electromechanical means to reliably and safely stop the lift in any possible hazardous situation.
The controller is located in the conveyance unit. It receives the operating commands from the call station or from the conveyance controller. The conveyance control module always has a priority over the call stations.
The conveyance controller is powered by 24V DC batteries that are attached to the conveyance. The conveyance controller also controls the "barrier arms" motor, platform side-load motor and the platform motor in either of the landings.
The status of the safety switches and the emergency stop button are monitored by the conveyance controller.
There is a call station located at each landing. The call station transmits commands using a wireless simplex channel while the conveyance continuously scans all RF signals (decoded) from both call stations.
Call stations allow the user to call and send the unit into the desired landing and also fold and unfold the platform. The call stations are linked with the conveyance through the wireless link. The system uses a 2.4 GHz ISM band using encoded pulse for each call station does not process the button / command but simply transfers the state of each button to the conveyance.
The Garaventa X3 inclined platform lift is provided in four models: one fully automatic, two semi automatic, and one fully manual.

AI/ML Overview

The provided text describes a 510(k) summary for the Garaventa X3 inclined platform lift, a device for transporting individuals in wheelchairs up and down stairs. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

Unfortunately, the provided text does not contain the level of detail typically found in a scientific study designed to establish acceptance criteria and prove device performance in the context of advanced AI/ML systems. This document is a regulatory submission for a physical medical device (a wheelchair elevator).

Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document. The document focuses on demonstrating that the new device (Garaventa X3) is substantially equivalent in safety and effectiveness to a previously cleared predicate device (Garaventa STAIR-LIFT K981486) by highlighting design changes and testing against applicable standards for physical lifts, not AI/ML performance metrics.

I will, however, extract the relevant information where available and explicitly state when information is not present or applicable.

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

The document frames "acceptance criteria" and "reported device performance" in terms of compliance with established safety standards and functionality relative to a predicate device, rather than specific quantitative performance metrics common in AI/ML validation (e.g., sensitivity, specificity, AUC).

Category	Acceptance Criteria (Implied)	Reported Device Performance
Rail System (X3 uses GSL2 rail)	Compliance with ASME 18.1-2008 and CSA B335-09.	"Tested with 'X3 Safety Circuit Test' attached in this report in tab J Item 26 to comply with ASME 18.1-2008 and CSA B335-09."
Hanger System (X3 uses GSL 1/3 hanger)	Compliance with ASME 18.1-2008 and CSA B335-09.	"Safety tests done and documented in 'X3 Safety Circuit Test' attached in this report in Tab J Item 26 to comply with ASME 18.1-2008 and CSA B335-09."
Platform System (X3 uses GSL 1/3 platform)	Compliance with ASME 18.1-2008 and CSA B335-09.	"Safety tests done and documented in 'X3 Safety Circuit Test' attached in this report in Tab J Item 26 to comply with ASME 18.1-2008 and CSA B335-09."
Call Station (Remote Control)	Design compliance to ASME 18.1 - 2008 and CSA B 335-09. Allocated band frequency has no conflict with outside radio frequencies.	"Remote control Call station designed for wireless operation...Allocated band frequency has no conflict with outside radio frequencies. Design compliance to ASME 18.1 - 2008 and CSA B 335-09."
Power Source (Battery only)	Design compliance to ASME 18.1 - 2008 and CSA B 335-09.	"Design compliance to ASME 18.1 - 2008 and CSA B 335-09."
Overall Safety & Functionality	As safe and effective as, and performs as well as or better than the predicate device(s).	"As shown in the safety tests and functionality of the equipment, X3 performs effectively as the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of this device. The testing described is for the physical components and safety circuits of a single device or a small number of prototypes, not a data-driven test set for an algorithm.
Data Provenance: Not applicable. The "testing" refers to physical compliance testing, not data collection for algorithms. The manufacturer is Garaventa (Canada) LTD, suggesting testing likely occurred in Canada or under Canadian/US standards.

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)

Number of Experts & Qualifications: Not applicable. Ground truth, in this context, would be the adherence to engineering standards and proper mechanical function, validated by engineers or certified testing bodies, rather than medical experts interpreting data.

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

Adjudication Method: Not applicable. This concept applies to human review of ambiguous cases in data interpretation, which is not relevant for the physical testing of an inclined platform lift. Testing involves pass/fail criteria against engineering standards.

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

MRMC Study: Not applicable. This type of study is used for diagnostic AI systems where human readers interpret patient data. The Garaventa X3 is a physical transport device.

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

Standalone Performance: While the device is "computer-controlled" with a "microprocessor," the context is mechanical safety and operation, not an AI algorithm performing diagnostic tasks. The "safety network" and "conveyance controller" monitor switches and parameters to ensure safe mechanical operation. Therefore, this concept is not applicable as described for an AI application.

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

Type of Ground Truth: The "ground truth" for this device's performance is adherence to recognized engineering and safety standards for inclined platform lifts, specifically ASME 18.1-2008 and CSA B335-09. This is a standards-based ground truth or engineering compliance ground truth.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/ML system that requires a "training set" of data in the conventional sense. The "training" in this context refers to the engineering design, development, and testing processes.

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

How Ground Truth for Training Set was Established: Not applicable. As there’s no training set for an AI/ML model, there’s no ground truth established in that manner. The "ground truth" (i.e., correct design and functionality) for the device's development would be based on established mechanical engineering principles, safety regulations, and the performance characteristics of the predicate device.

Summary

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510k Summary

As required by 21 CFR 807.92 (c)

MAR 2 1 2013

1- Date summary prepared: March 19, 2013

2 - Owner/submitter/applicant/sponsor information:

GARAVENTA (CANADA) LTD 7505 134A Street, Surrey BC, Canada V3W 7B3 1-604-594-0422 / 1-800-663-6556 Fax 1-604-594-9915

3- Submission official correspondent:

Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court. Roswell, GA 30075 USA 678-908-8180 Fax 678-623-3765

4- Device information:

Common/usual/classification name: ELEVATOR, WHEELCHAIR

Device name: Garaventa X3 inclined platform lift.

Device classification:

FDA 3 letter code	PCE
FDA regulation number: 21 CFR:	890.3930
Regulation medical specialty	Physical Medicine
Review panel	Physical Medicine
Class	2

5- Substantial equivalency is claimed against the following predicate device(s):

510k number	Trade or Proprietary or Model Name	Manufacturer
K981486	STAIR-LIFT (Models GSL-1, GSL-2 & GSL-3)	GARAVENTA (CANADA) LTD

6- Description of the device:

Page F-1

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The Garaventa X3 inclined platform lift uses two custom-cut extruded aluminum guide rails to guide and support the platform. An upper rail houses the drive rack that is engaged by the pinion gear providing platform movement as well as acting as the raceway for the control wiring. A lower rail stabilizes the platform keeping it in a level traveling position. The Garaventa X3 inclined platform lift has steel guide rails and haul ropes or cables are used for those products instead of extruded aluminum.

The Garaventa X3 inclined platform lift does not require a special cabinet to house the drive system. The drive system of the Garaventa X3 inclined platform lift is an on-board rack and pinion drive system. The drive system is protected from accidental contact by the user by a conveyance "hard" cover.

The Garaventa X3 inclined platform lift is a computer-controlled device equipped with a microprocessor and the software resides inside the conveyance controller.

The safety network monitors several switches, landing cam, the battery voltage and motor current limits. These are independent of the microprocessor system and provide a positive electromechanical means to reliably and safely stop the lift in any possible hazardous situation.

The controller is located in the conveyance unit. It receives the operating commands from the call station or from the conveyance controller. The conveyance control module always has a priority over the call stations.

The conveyance controller is powered by 24V DC batteries that are attached to the conveyance. The conveyance controller also controls the "barrier arms" motor, platform side-load motor and the platform motor in either of the landings.

The status of the safety switches and the emergency stop button are monitored by the conveyance controller.

There is a call station located at each landing. The call station transmits commands using a wireless simplex channel while the conveyance continuously scans all RF signals (decoded) from both call stations.

Call stations allow the user to call and send the unit into the desired landing and also fold and unfold the platform. The call stations are linked with the conveyance through the wireless link. The system uses a 2.4 GHz ISM band using encoded pulse for each call station does not process the button / command but simply transfers the state of each button to the conveyance.

The Garaventa X3 inclined platform lift is provided in four models: one fully automatic, two semi automatic, and one fully manual.

7- Intended use:

The Garaventa X3 inclined platform lift is a motorized lift device intended for medical purposes to provide a means for a disabled person to move a wheelchair from one level to another

8- Indications for use:

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The Garaventa X3 inclined platform lift is indicated to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.

9- Basis for a determination of substantial equivalency:

(a) Indications for use:
The indications for use are the same as the predicate device(s).
(b) Technological characteristics:
The main differences between this device and predicate device are:
i. X3 uses battery only in the control system.
ii. X3 uses remote control call station using specified frequency.
The table below reflects how the change in design is controlled and tested against, providing the basis of the determination of substantial equivalency in a summarized format.

#	Subject	Main design	Reason of change	Test conducted
		item/feature change
1	Rail	X3 Uses the Rail	Ease in production	Use existing GSL 2 Rail System for straight lifts applications. Tested with "X3
	System	System of GSL2, not	and installation of	Safety Circuit Test" attached in this report in tab J Item 26 to comply with
		the tube system of	the product.	ASME 18.1-2008 and CSA B335-09.
		GSL 1/3.
2	Hanger	X3 uses the Hanger of	Ease in production	Use the existing hanger of GSL 1 & 3 for complete control system. Safety
	System	GSL 1/3, not the bulky	and installation of	tests done and documented in "X3 Safety Circuit Test" attached in this
		Hanger of GSL 2.	the product.	report in Tab J Item 26 to comply with ASME 18.1-2008 and CSA B335-09.
3	Platform	X3 uses the Platform	Align control	Use the existing platform of GSL 1 & 3 for conveyance system. Safety tests
	System	of GSL 1/3, not the	system with the	done and documented in "X3 Safety Circuit Test" attached in this report in
		GSL 2 Platform.	hanger system	Tab J Item 26 to comply with ASME 18.1-2008 and CSA B335-09.
4	Call	Remote Control Call	Ease in control and	Remote control Call station designed for wireless operation to improve the
	Station	Station with specified	portability of call	wired operations of GSL 2 and GSL 1 & 3 for portability and ease of
		frequency.	station. Cost-	operation. Allocated band frequency has no conflict with outside radio
			effective.	frequencies. Design compliance to ASME 18.1 - 2008 and CSA 8 335-09.
ട്	Power	The whole control	Cost-effectiveness	Instead of using the Main AC power of 120 V, X3 uses battery only to
	Source	system is by battery	and ease in	minimize power consumption and ease in installations. Design compliance
		only.	installation.	to ASME 18.1 - 2008 and CSA B 335-09.

(c) Non clinical tests- brief discussion: Tests on functionality and safeties has been done in the design phase in accordance to applicable standards. See Tab J3 Item 26 : Test Report X3 Safety Circuit.
(d) Clinical tests- brief discussion: Not applicable

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(e) Non clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as or better than the predicate device(s): As shown in the safety tests and functionality of the equipment, X3 performs effectively as the predicate devices. , .
:

the submit the state of the subject of the states of the states

and and the comments of the country

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped by a pair of wings.

March 21, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Garaventa (Canada) Ltd. % Jay Mansour, MSQA, BE, RAC, LA Mansour Consulting 845 Aronson Lake Court Roswell, GA 30075

Re: K122206

Trade/Device Name: Garaventa X3 Inclined Platform Lift Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: Class II Product Code: PCE Dated: February 11, 2013 Received: February 22, 2013

Dear Mr. Jay Mansour:

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. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 890.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 890.9, will be exempt from the premarket notification requirements of the Act.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 – Dear Mr. Jay Mansour

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting 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): K122206

Device Name: Garaventa X3 inclined platform lift

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brian D. Pullin - S

(Division Sign-off) Division of Neurological and Physical Medicine Device 510(k) Number K122206

Page 1 of

Regulation Number and Section

§ 890.3930 Wheelchair elevator.

(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.