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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.

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.

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:

1. 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.

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/Not Present. No "test set" in the context of algorithm validation is described.

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 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.

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

   • Not Applicable/Not Present.

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/Not Present. This type of study is entirely irrelevant to a stairway lift.

6. 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.

7. 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.

8. The sample size for the training set:

   • Not Applicable/Not Present. No training set for an algorithm is described.

9. 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.

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