The Merits E600 Series Stair Lift System is a powered patient transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

Device Description

The Merits E600 Series Stair Lift basically consists of an upholstered chair assembly, a truck assembly, and a maximum 16 feet track. The chair and truck assemblies constitute the platform moving up and down along the inclined track. The entire lift is installed in either side of the indoor stairway in a private residence. All models share the same specifications such as driving means and safeties other than the power source. The Model E600 uses the AC power as its power source while the Model E601 employs the batteries and chargers. The operation of the lift is controlled by a momentary rocker control under one armrest and two infrared remote controls. The move of the lift will stop immediately when the button or switch of the controls is released.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Merits E600 Series Stair Lift, which is a medical device. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a study designed to establish new performance criteria or clinical efficacy with detailed statistical analysis as might be expected for an AI/ML medical device.

Therefore, many of the requested elements pertaining to acceptance criteria and performance studies (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not applicable to this type of document or device submission.

However, I can extract information related to the device's comparison to its predicate and the general nature of its "performance data" as mentioned.

Here's an analysis based on the provided text, addressing the applicable points and explaining the non-applicability of others:

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity) against which the device's performance is measured. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a legally marketed predicate device (Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550, K033752).

Implied Acceptance Criteria: The device must demonstrate similar technological characteristics and intended use, and show that its "performance data" confirms it meets specifications and is substantially equivalent to the predicate. This is a qualitative comparison rather than a quantitative one against predefined thresholds.
Reported Device Performance: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." The document explicitly states the testing confirmed this, without providing specific numerical performance data.

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

Not applicable. This is a premarket notification for a physical medical device (stair lift), not an AI/ML algorithm. The "testing" referred to likely involves engineering verification and validation testing (e.g., load bearing, safety mechanisms, durability) rather than a clinical trial with a "test set" of patients or data. The document does not specify details about these engineering tests, such as sample sizes or data provenance.

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. Ground truth establishment by experts is relevant for diagnostic or AI/ML devices where a "correct answer" needs to be determined for comparison. For a stair lift, the "ground truth" would be the engineering specifications and safety standards, confirmed through physical testing.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth when there is disagreement among experts about diagnostic labels or outcomes. This concept does not apply to the regulatory submission for a mechanical stair lift.

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. MRMC studies are used to evaluate the performance of diagnostic devices or AI algorithms often in the context of human-in-the-loop scenarios. This is not relevant for a stair lift.

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

Not applicable. There is no algorithm or AI component mentioned in the description of the Merits E600 Series Stair Lift.

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

As discussed in point 3, the concept of "ground truth" in the context of an AI/ML device is not applicable here. For this device, the "ground truth" implicitly refers to adherence to engineering design specifications, safety standards, and functional equivalence to the predicate device, which would be verified through mechanical and electrical testing.

8. The sample size for the training set

Not applicable. This device does not involve machine learning, so there is no "training set."

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

Not applicable for the same reason as point 8.

Summary

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K073/10

510(k) SUMMARY

9 1 Trade/Proprietary Name: Merits E600 Series Stair Lift
9.2 Common/Usual Name: Stairway Chairlift

FEB - 6
CUN

9.3 Classification Name: Powered patient transport
9.4 Comparison to Currently Marketed Devices

The Merits E600 Series Stair Lift is substantially equivalent to the Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550 (K033752)

તે રે Device Description

તે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ Intended use

The Merits E600 Series Stair Lift System is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobilityimpaired persons, up and down flights of stairs.

9.7 Technological Characteristics

Merits E600 Series Stair Lift is equivalent in functions to the legally marketed predicate device. They all use rack and pinion as its driving and support means. This kind of means offers self-locking mechanism to prevent uncontrolled movement. The application of rack and pinion is well-established and has been extensively used by other legally marketed products. There is no technology difference between the two. For the remote control, Merits E600 Series Stair Lift adopts infrared light to achieve the controlling needs. Unlike radio signals used by the predicate, the infrared technology eliminates the possible interference or damage to the environment. The technology is not only safer than the radio frequency technology but also widely used by other products.

9.8 Performance Data

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

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9.9 Conclusion

Based on the design, performance specifications, testing, and intended use, the Merits E600 Series Stair Lift is substantially equivalent to the legally marketed device, Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550 (K033752)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merits Health Products Co., LTD. c/o Mr. Steve Chao No. 9, Rd. 36, Taichung Industrial Park Taichung City China (Taiwan) 40768

Re: K073110 Trade/Device Name: Merits E600 Series Stair Lift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: January 4, 2008 Received: January 4, 2008

Dear Mr. Chao:

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. Steve Chao

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millhussen

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

Enclosure

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Indications For Use

510(k) Number:

Device Name: Merits E600 Series Stair Lift

Indications For Use:

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)	✓
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Division of General, Restorative, and Neurological Devices

510(k) Number	11073
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11-15-2019

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.