The Inclined Platform Lifts "JOURNEY" and "SUPRA" are 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.

Device Description

The Thyssenkrupp Ceteco's JOURNEY and SUPRA are unenclosed Inclined Platform Lifts (IPLs) designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. They are composed of two main parts the rail and the carriage. The rail is the part where the carriage is attached to and where it will move along. The carriage is the part where the person to be transported is positioned on.

AI/ML Overview

The provided text is a 510(k) summary for an Inclined Platform Lift. It details the device, its predicate, and declares substantial equivalence. However, it does not include information about specific acceptance criteria or a study proving the device meets them in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

The document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, as opposed to a clinical or performance study with quantitative acceptance criteria. Therefore, I cannot extract the detailed information you requested as it is not present in the provided text.

Here is what can be inferred and what is explicitly stated concerning "acceptance criteria" in a regulatory context, but it doesn't align with the quantitative performance study you're asking for:

Implicit "Acceptance Criteria" (Regulatory Intent)

In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device. This means the new device (SUPRA) is considered to meet the safety and effectiveness requirements if it has:

The same intended use as the predicate device (JOURNEY).
The same technological characteristics as the predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.
Performance data (if necessary, though not explicitly detailed as quantitative performance metrics in this summary) that demonstrates the device is as safe and effective as the predicate.

"Study" (Regulatory Declaration of Equivalence)

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence. The key evidence presented for "meeting acceptance criteria" (i.e., substantial equivalence) is the Product Comparison Table and the subsequent declaration.

Here's a breakdown of why each of your requested points cannot be filled from the provided text, or how they relate to the document's purpose:

A table of acceptance criteria and the reported device performance: Not present. The "Product comparison Table" lists features and compliance with standards (ASME A17.5, ASME A18.1), but not quantitative performance criteria with reported values against those criteria.
Sample sizes used for the test set and the data provenance: Not applicable. There is no traditional "test set" in the sense of a data set for evaluation. The submission relies on design, performance specifications, and third-party certification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic or performance test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an Inclined Platform Lift, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission (510(k) summary) for an Inclined Platform Lift, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed quantitative performance studies, acceptance criteria, or expert review processes typically found for devices like AI algorithms or diagnostic tools.

Summary

{0}------------------------------------------------

K102088
OCT. 2 2010

: .

510 (K) SUMMARY

(In accordance with 21 CFR 807.92)

Submitted by:

ThyssenKrupp Ceteco S.r.I. Via S. Cannizzaro nº 2 56121 PISA (PI) - ITALY

Contact: Fabrizio Fedele or (Fabio Sbrana, Fabio Neri) E-mail: f.fedele@ceteco.it or (f.sbrana@ceteco.it, f.neri@ceteco.it ) Tel. 0039 050 955111 Fax 0039 050 982255

Date prepared:

July 22nd, 2010

Trade Name: JOURNEY TH: SUPRATM

Common Device Name: Inclined Platform Lift (IPL)

Predicate device: ThyssenKrupp Ceteco Inclined Platform Lift "Journey" K090856

Product description:

They are composed of two main parts the rail and the carriage. The rail is the part where the cariage is attached to and where it will move along. The carriage the carriage the carriage the carriage
transported is nositioned on transported is positioned on.

There are currently two different models designed to address different kind of staircases. 내

The JOURNEY (technically called RPSP) is designed strictly for straight stainly for straight stainways. .
The SUPRA, formerly JOURNEY CUBIC (technically called TP) is designed for straight and turning stairways.

Both mouels were included in the previous 510K submission from our Company (K090856) and were determined substantially equivalent to legally marketed predicate devices.

We are hereby providing Additional and Expanded indications, with specific reference to the Supra model.

What Supra differs from Journey in?

The two versions of the platform lift are equal for principles of operation, performances and safety devices; they differs mainly in the rail are open for principies of operation, performances and sarely

Rail Assembly

The SUPRA rail is made of two aluminum tubes vertically spaced, while the JOURNEY rail is made of a one-piece aluminum extruded profile.

Drive System

The carriage is inserted into the rail and it moves by means of a set of wheels. The drive system consists of an electric motor and a worm gearbox that moves a pinion. The union engages a rack converting his rotary motion into a linear one, moving the platform up and down along the stainway. The drive system assembly is different in that the rail assembly differs itself.

The SUPRA main cariage is composed of two cast iron trolleys with six wheels for each trolley, which support the whole load of the platform. The two trolleys with six wheels in each tonley, which the stairway's angle.

The JOURNEY main carriage is composed of one carbon steel trolley, with six which support the whole load of the platform.

{1}------------------------------------------------

In both the models, the gearbox (worm gearbox), the motor, the safety brake and the limit switch are connected to the trolley. The more goalson, the motor, the saley unale and the limit switch are
assembly assembly.

12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

ついては、いつではなくなると、そのため、そして、そして、

Power source of the carriage

Both the platform-lifts are powered by alternating current (AC). Both the machine could be equipped with an auxiliary emergency batteries system (optional), as a back-up in case of a power outage. This optional batteries system is placed inside a cabinet in a dry and covered place, separated from the carriage and the rail.

The SUPRA is equipped by a 24V Vdc drive motor and the rail's aluminum profile contains a bus-bar that is electrically permanent connected to the main electrical box (24Vdc). The back-up batteries (option) are directly connected to the two bus-bars and provide the low voltage current to the motor.

The JOURNEY is equipped by an AC three-phase drive motors that is feed by an altemating current. The main aluminum profile contains a cable chain with its electric wire, one end is attached to the drive unit's carriage and the other end to the main switch (permanently connected). The back-up batteries (option) are connected to an inverter which increases the tension and provide a three-phase alternet current to the motor.

	JOURNEY	SUPRA
Intended Use	To mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility.	To mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility.
Standards compliance	ASME A17.5 Electrical Code for Elevating DevicesASME A18.1 Safety Standard for Platform Lift and Stairway Chairlift	ASME A17.5 Electrical Code for Elevating DevicesASME A18.1 Safety Standard for Platform Lift and Stairway Chairlift
Type of drive unit	Rack and Pinion	Rack and Pinion
Main Power	208-240 volts AC	208-240 volts AC
Electric Motor	Yes, onboard	Yes, onboard
Drive unit power	550 W or 750 W Vac	350 W or 700 W, 24Vdc
Electric control board	Yes	Yes
Optional manual operation	Yes	Yes
Key-operated Station controls	Yes	Yes
On-Board control with Key-Switch	Yes	Yes
Continuous pressure directional controls	Yes	Yes
Under platform sensing to stop lift upon contact with obstacle	Under hanger sensing to stop movement upon contact with obstacle upon being called to/from landing areas. Multi directional ramp sensing to detect pressure from inside the platform ramps to ensure passengers positioned safely before lift begins movement. Overspeed safety device.	Under hanger sensing to stop movement upon contact with obstacle upon being called to/from landing areas. Multi directional ramp sensing to detect pressure from inside the platform ramps to ensure passengers positioned safely before lift begins movement. Overspeed safety device.
Optional fold-down seat for non-wheelchair passengers	Yes	Yes
Automatic foldable platform	Yes	Yes
Automatic access ramp	Yes	Yes
Optional Battery Back-up	Yes	Yes

Product comparison Table:

Substantial Equivalence

Based on the design, performance specifications, testing, third part certification and intended use the SUPRA is substantially equivalent to the legally marketed device JOURNEY.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three tail feathers.

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

Thyssenkrupp Ceteco Srl % Mr. Fabrizio Fedele Via S. Cannizzaro, nº 2 56121 PISA (PI) - Italy

OCT 2 0 2010

Re: K102088

Trade/Device Name: Inclined Platform-Lifts "JOURNEY" and "SUPRA" Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: Class II Product Code: ING Dated: September 13, 2010 Received: September 16, 2010

Dear Mr. Fedele:

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, 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 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.

{3}------------------------------------------------

Page 2 - Mr. Fabrizio Fedele

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Statement of Indications for Use

K102088

OCT 2 0 2010

510(k) Number (if known):

Inclined Platform-Lifts "JOURNEY" and "SUPRA"

Indications for Use:

Device Name:

The Inclined Platform Lifts "JOURNEY" and "SUPRA" are 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Only) Only DIVIsion of Swices

510(k) Number

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.