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The product will be used by patients to assist in navigating a specific set of stairs. This is a selfcontained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. 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. Doctors or physical therapists may recommend the unit 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.

The Stairfriend is a curved stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence. The Stairfriend is designed to travel a maximum 30 feet at a rated speed of 16 feet per minute. Safety switches installed on the Stairfriend stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. Standard equipment includes: Rack and pinion drive, Dynamic motor braking and self-locking gearbox, 2" (51 mm) rigid double square tube rail construction, Inside and outside radius curve capabilities, Spiral and flat landing configurations, Support posts anchored to stair treads (no wall required), 300 lb (136 kg) capacity, Battery-powered 24 vdc motor, Pair of 12-volt, maintenance-free batteries, Charger to be plugged in at top or bottom landing 110 vac, 15 amp, 60 hz outlet, Electronic controller with soft start, Fused control circuit, Wireless call-send controls at both landings, Continuous pressure buttons, No rail overhang at top landing, Foldable footrest, seat and padded armrest, Seat that swivels and locks in 60° and 90° positions in both directions, Seatbelt, Seat swivel safety switch, Obstacle sensor.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) premarket notification for the "Stairfriend" Curved Stairway Chairlift, indicating a determination of substantial equivalence to a predicate device.

The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies against specific acceptance criteria like those outlined in your request. The document mentions that both the subject device and the predicate device "have been designed and engineered to meet and exceed the safety standards CSA-B355 -- 'Lifts for persons with physical disabilities' and ASME A17.1 part XX and part XXI 'Safety Code for Elevators and Escalators'." However, no specific performance data or a study demonstrating adherence to these standards is included.

Therefore, I cannot provide the requested information based on the given input.

To answer your specific points, based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This type of information is typically not included in a 510(k) for devices like a chairlift, which are evaluated against engineering standards rather than clinical performance data with human subjects.
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/Not provided. The ground truth concept, typically involving expert consensus or pathology for diagnostic devices, is not relevant to this type of mechanical aid.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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. This is a chairlift, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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The Multilift Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.

The Multilift is similar to other products in commercial distribution. These products, like the Multilift, utilize electrically driven, wall-mounted on self-standing platform units to enable individuals in wheelchairs to travel up and down between floors in a residential or public setting.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

The document is a 510(k) summary for a vertical platform lift (Multilift) and focuses on establishing substantial equivalence to a predicate device (Savaria V-1504 Vertical Platform Lift). It primarily discusses the device's description, intended use, and comparison to the predicate, as well as the FDA's regulatory decision. It does not contain details of a performance study or testing that would typically address the criteria you've outlined.

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The 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. A trained dealer will install the unit, test it and teach the end user how to operate it. 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.

The B.07 is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence or public setting. The B.07 is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the B.07 stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. The B.07's simple design allows for easy operation, quick installation and reliability. Its rail is made of extruded aluminum and hides the drive components and the traveling cable. It is a vertical mount rail that attaches to the tread so wear marks cannot develop on its outer surface due to the internal rolling system. The angle is fully adjustable for staircases of 25 to 45 degrees. The seat and footrest height are adjustable for both short and tall people. The chair can be swiveled at the top and bottom landing for easy and safe access to the seat. The stairlift can be transformed from a left hand to a right hand side on the site of installation within minutes. The device uses a roller chain drive system with an aluminum rail that allows for modifying the length of travel without having a weld. For safety, the B.07 is equipped with a safety brake, an obstruction sensor, a swiveled seat detector and a final limit switch. The chair lift can also be folded in the up position as to facilitate access to the staircase.

The provided 510(k) summary for the B.07 Stairway Chairlift does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance.

This document describes a stairway chairlift, which is a mechanical device for patient transport, not a diagnostic or AI-powered medical device that would have performance metrics like sensitivity, specificity, or agreement with expert readers. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device, primarily concerning its design, intended use, and safety features.

Therefore, I cannot provide answers to the requested points, as they are not applicable to the type of device and the information presented in this 510(k) summary. The document focuses on:

• Subject Device Description: Mechanical features, load capacity, speed, safety mechanisms (obstruction sensors, safety brake, limit switch).
• Intended Use: Assisting patients with limited mobility to navigate stairs.
• Product Comparison: Substantial equivalence to another stairway chairlift (Bruno Electra-Ride K921648).

There is no mention of an algorithm, AI, human readers, ground truth consensus, or effect sizes related to diagnostic improvement.

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The 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. A trained dealer will install the unit, test it and teach the end user how to operate it. 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 the 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 to 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.

The Stepsaver is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence. The Step-saver is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the Step-saver stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. Features include: Rack and pinion drive 60 and 90 degree swivel at top Adjustable seat height Seat belt with positive locking mechanism Flip-up padded armrests Constant pressure control switch on armrest (reversible side) Obstacle sensor Swivel seat actuator Electronic controller with soft start

This document is a 510(k) summary for the "Step-saver (B2002)" Stairway Chairlift. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device is not an AI/ML powered medical device, but rather a physical stairway chairlift. Therefore, the questions regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) are not applicable in the context of typical AI/ML device submissions.

The submission focuses on demonstrating substantial equivalence to a predicate device (Bruno Electra-Ride K921648) by meeting established safety standards for such equipment.

Here's an attempt to extract relevant information, acknowledging that many fields will be N/A due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. This is a physical device submission demonstrating compliance with engineering standards, not a data-driven AI/ML model for which a test set of data would be used. The "study" here refers to the engineering and design process to meet established safety 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)

• N/A. Ground truth in the context of an AI/ML model is not applicable here. Compliance with safety standards would be assessed by engineering experts, testing bodies, and regulatory agencies.

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

• N/A. Adjudication methods are specific to human review of data, typically for AI/ML or clinical trial endpoints.

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

• N/A. This device does not involve human readers interpreting medical images or data. It is a mechanical assistant.

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

• N/A. This device is a mechanical system, not an algorithm. Its "standalone" performance would be its functional operation in isolation, which is implicitly covered by its design specifications and compliance with safety standards.

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

• The "ground truth" for this device's safety and effectiveness lies in its compliance with established engineering and safety standards (CSA-B355 and ASME A17.1 parts XX and XXI), as well as its functional specifications (load capacity, speed, safety features).

8. The sample size for the training set

• N/A. There is no "training set" in the context of an AI/ML model. The design and engineering process for this mechanical device would involve iterative design, prototyping, and testing.

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

• N/A. There is no "training set" or "ground truth for training" as understood in AI/ML development. The "ground truth" for its design and manufacturing is adherence to engineering principles, materials science, and established safety regulations for medical/accessibility devices.

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The ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility.

The ES-125 Stair Platform Lift is an unenclosed stair platform lift designed to carry a wheelchair and its occupant between floors in a residential or public facility. It is accessible via automatic dual access ramps (straight or 90 degree entry) and is driven by a cable/drum unit that incorporates a 3/16" aircraft cable with a breaking load of 4,200 lbs, a deviator pulley, and winding drum. It can be controlled from either end at a key-controlled station or from an on- board, hand-held control panel. The entire carriage unit is designed with ASTM 30 tubular steel, and the fold-away platform contains a non-skid surface. The unit travels at a rated speed of approximately 14 ft/min and possesses a mechanical emergency brake in case of drive cable failure. The lift can be used with stairways at an incline of up to 45 degrees and has a rated carrying load of up to 450 lbs. The power supply is 110 VAC, 1Ph, 60 Hz, 15 amp. The lift complies with ANSI-A17.1 Code specifications regarding elevating devices for the handicapped

The provided text is a 510(k) Summary for a medical device called the "Savaria ES-125 Stair Platform Lift." This document is a pre-market submission to the FDA to demonstrate that the device is as safe and effective as (substantially equivalent to) a legally marketed predicate device.

Crucially, a 510(k) summary does not typically contain information about clinical studies, acceptance criteria, or performance data in the same way a clinical trial report or a performance study for an AI/ML medical device would.

The "acceptance criteria" and "device performance" in this context refer to the device's design specifications and its compliance with industry standards, rather than statistical performance metrics against a defined ground truth. The study that "proves" the device meets the acceptance criteria is generally a bench test and verification of these design specifications against standards like ANSI-A17.1.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, acknowledging its limitations for typical AI/ML device performance reporting:

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

Since this is a non-AI/ML device, the "acceptance criteria" are the design specifications and compliance with safety standards, and the "reported device performance" is the confirmation that the device meets these specifications.

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

This information is not provided in the 510(k) summary. For a mechanical device like this, testing would typically involve engineering validation and verification tests on prototypes or production units, not a "test set" or "data provenance" in the sense of clinical data.

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. The "ground truth" for a stair lift is its mechanical function and safety compliance, established through engineering specifications and adherence to standards like ANSI-A17.1, verified through testing, not expert consensus on medical images or patient outcomes.

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

Not applicable. This type of adjudication method is relevant for clinical studies, especially those involving human interpretation of medical images. For a mechanical device, performance is typically verified against design specifications and 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

Not applicable. This is a mechanical stair lift, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device is its adherence to engineering specifications, safety standards (e.g., ANSI-A17.1 Code), and functional requirements for transporting a wheelchair and occupant. This is established through design documents, material specifications, and performance testing against those predefined criteria.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved for this mechanical device.

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