SUMMIT STAIRWAY LIFT by SUMMIT LIFTS, INC.

This product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. This design offers easy installation. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down stairs. The unit may be recommended by doctors or physical therapists for those who are recuperating, but a large number of users acquire a stairway elevator just because it eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.

Device Description

The Summit™Stairway Lift is a stairway chairlift designed to carry a rated load of 300 lbs. directly up and down a set of stairs in a residence. The Summit™Stairway Lift is designed to travel a maximum 20 feet at a rated speed of 22 feet per minute. Foot rest safety sensors stop the lift in either direction should it strike anything on the stairs. The chair can be swivelled at the top and bottom landing for easy and safe access to the seat. A swivel safety switch makes sure the seat is in the proper position before allowing the unit to run. The Summit™Stainway Lift can be transformed from a left hand to a right hand side on the site of installation within minutes. The chairlift can also be folded in the up position as to facilitate access to the staircase. Seat belt is standard. The lifting system is aircraft grade lifting cable on a grooved aluminum drum. The lifting system has safeties to stop the lift if the cable is not properly tensioned. Limit switches shut the unit off in the same place at the top and bottom of the stairs automatically. Constant pressure controls are designed to stop the lift immediately if and when controls are released. Features include: Cable driven, 180 degree swivel at both landings, Adjustable seat height, Seat belt, Padded seat folds up when not in use, Fold up footrest adjusts to two different heights, Obstacle sensor, Swivel seat actuator, Arm control switch, 110 VAC grounded outlet, Magazine rack.

AI/ML Overview

The provided document is a 510(k) summary for the "Summit™ Stairway Lift," a medical device. However, this type of document, particularly from 2003, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria and specific performance metrics in the way modern AI-device submissions would.

Therefore, much of the requested information (like specific acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, and detailed ground truth establishment) is not present in this document.

The document primarily describes the device, its intended use, and compares its features to a predicate device (Silver-Glide®-HD) to establish substantial equivalence. It does not contain information about a study designed to prove the device meets specific performance acceptance criteria for an AI algorithm.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

This 510(k) summary does not provide a table of acceptance criteria or reported device performance in the context of an AI/algorithm-driven device. The "performance" discussed relates to mechanical specifications and safety features, which are implicitly accepted if found substantially equivalent to a legally marketed predicate.

Information NOT available in the document regarding acceptance criteria and performance:

Specific quantitative acceptance criteria: There are no defined numerical targets for sensitivity, specificity, accuracy, or other performance metrics as would be expected for an AI device.
Reported Device Performance: No specific numerical results from a performance study are presented. The document states features like "rated load of 300 lbs.," "maximum 20 feet," "rated speed of 22 feet per minute," and lists safety features, implying these are the performance characteristics.

Study Details

This document describes a submission for a stairway lift, which is a mechanical device, not an AI or algorithm-driven medical device in the modern sense that would require the types of studies outlined in your request. Therefore, the detailed information about study design, ground truth, experts, and sample sizes for AI algorithm validation is not applicable and not present in this 510(k) summary.

Here's a breakdown of the requested information in the context of this document:

A table of acceptance criteria and the reported device performance:
- Not Applicable/Not Present. This type of table is not part of a 510(k) for a mechanical device like a stairway lift. The "acceptance" would be that the device met safety standards and was substantially equivalent to the predicate.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Present. No "test set" in the context of algorithm validation is described.
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 Present. No ground truth establishment for a test set is described. Device safety and function are likely assessed through engineering tests and adherence to standards, not expert consensus on data interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Present.
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 Present. This type of study is entirely irrelevant to a stairway lift.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable/Not Present. There is no "algorithm only" performance to evaluate for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Not Present for algorithm validation. The "ground truth" for the device's function would be its ability to perform its stated mechanical tasks safely (e.g., carrying 300 lbs, travelling at 22 fpm, safety sensors engaging). This is typically verified through engineering testing and compliance with safety standards, not through clinical ground truth data collection.
The sample size for the training set:
- Not Applicable/Not Present. No training set for an algorithm is described.
How the ground truth for the training set was established:
- Not Applicable/Not Present.

Summary of available information:

Device: Summit™ Stairway Lift
Intended Use: To assist patients with limited function of knees, hips, or ankles, or conditions like MS, arthritis, heart disease, or stroke, in navigating stairs. Also for general ease of climbing stairs.
Key Features (implicitly "performance characteristics" for this type of device):
- Rated load: 300 lbs.
- Maximum travel: 20 feet
- Rated speed: 22 feet per minute
- Safety sensors (footrest, swivel safety switch, cable tension, limit switches)
- Constant pressure controls
- Cable driven
- 180-degree swivel at both landings
- Adjustable seat height, padded seat, fold-up footrest
- Seat belt
Predicate Device: Silver-Glide®-HD
Basis for Acceptance: Substantial equivalence to the predicate device, implying that its design, materials, and safety features are comparable and satisfy relevant standards for patient transport devices. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than meeting novel performance acceptance criteria from a clinical trial.

Summary

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K032880 1/2

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Summit Lifts, Inc.

23615 S. 291 Highway Harrisonville, Mo 64701 PH: 816-887-9919 Fax: 816-380-5759 "TAKING YOU TO NEW HEIGHTS"

NOV 1 0 2003

510(k) SUMMARY

Submitted by: Summit Lifts, Inc. 23615 South 291 Highway Harrisonville, MO 64701
Contact:
- Telephone: (913) 498-1700 Facsimile (913) 498-8488

Kent T. Perry

Date Prepared: August 29, 2003
Summit™Stairway Lift Subject Device:
Predicate Devices: Silver-Glide®
Subject Product

Description:

Cable driven
. 180 degree swivel at both landings
Adjustable seat height .
. Seat belt

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Padded seat folds up when not in use
Fold up footrest adjusts to two different heights
Obstacle sensor
. Swivel seat actuator
. Arm control switch
. 110 VAC grounded outlet
. Magazine rack

Intended Use:

This product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. This design offers easy installation. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stainway elevator just because it eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.

Product Comparison:

The Summit™Stairway Lift is substantially equivalent to the the Silver-Glide ®-HD Both products are used by the patient to assist in navigating a specific set of stairs.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 three human profiles facing to the right, with flowing lines representing hair or a sense of movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Summit Lifts, Inc. C/o Mr. Kent T. Perry Kent T. Perry & Co., LC 7300 W. 110th St. Overland Park. Kansas 66210

Re: K032880

Trade/Device Name: Summit™ Stairway Lift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 11, 2003 Received: September 15, 2003

Dear Mr. Perry:

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.

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.

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); 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.

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Page 2 - Mr. Kent T. Perry

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

6 Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS OF USE STATEMENT

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032880

Regulation Number and Section

§ 890.5150 Powered patient transport.

(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair 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 American Society of Mechanical Engineers (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 chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(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; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.