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The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.

The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.

My deepest apologies, but the document provided is a 510(k) clearance letter for a Bruno Élan Stairway Elevator System. This document type does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device's performance, as it pertains to medical AI or diagnostic devices.

The letter simply states that the device (a stairlift) has been found substantially equivalent to a predicate device. It does not include:

• A table of acceptance criteria and reported device performance
• Sample sizes or data provenance for a test set
• Details about experts establishing ground truth
• Adjudication methods
• Multi-reader multi-case studies
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size or how its ground truth was established

Therefore, I cannot fulfill your request based on the provided input.

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The VPL-3100 is intended to mechanically transport an individual with a mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.

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This document is a 510(k) premarket notification from the FDA, specifically concerning the Bruno Vertical Platform Lift, VPL-3100. This type of document is for medical device clearance, not for AI/software device performance studies. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI device is not available in this text.

The document discusses substantial equivalence to predicate devices, general controls, and regulations for market access of the physical elevator device, not the performance of an AI algorithm.

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The Bruno Electra-Ride™ III Stairway Elevator System, Model CRE-2100, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a Powered Patient Transport, and is intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

Bruno Electra-Ride™ III Stairway Elevator System

This document is a 510(k) clearance letter from the FDA for a medical device called the "Bruno Electra-Ride III Stairway Elevator System". It does not contain information about acceptance criteria or specific study data to prove the device meets performance criteria.

Therefore, I cannot extract the requested information. This type of FDA clearance letter focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from a specific study against predefined acceptance criteria.

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The Bruno Electra-Ride™, Model Sre-1540 and Electra-Ride™ II, Model SRE-1550, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairliff. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

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The provided text is a 510(k) premarket notification approval letter for the Bruno Electra-Ride™ Models SRE-1540 and SRE-1550, which are powered patient transport devices (stairlifts). This document focuses on regulatory approval rather than a detailed study evaluating specific acceptance criteria for device performance. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and a study proving those criteria were met.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. The type of ground truth used.
5. Sample size for the training set or how ground truth for the training set was established.

This document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness profiles to existing products on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence.

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The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, 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.

The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, 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.

The provided documents pertain to the FDA 510(k) premarket notification for the Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000. This is a medical device clearance letter, not a study evaluating a diagnostic or AI-powered device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not present in these documents. The letter confirms substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the product.

The document describes the device as 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."

Since this is a simple medical device clearance, and not a study with performance metrics, I cannot fill out the requested table or answer the specific questions related to AI/diagnostic device evaluation.

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The Bruno Electra-Ride Stairway Elevator System, Model SRE-2700, 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.

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The provided text is a 510(k) clearance letter from the FDA for the Bruno Electra-Ride, Model SRE-2700, a Powered Patient Transport device. This letter does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the device is "substantially equivalent to legally marketed predicate devices." This means the FDA determined the new device is as safe and effective as another legally marketed device, often without requiring new clinical trials that would generate the kind of detailed performance data you're asking for.

Therefore, I cannot provide a response to your numbered questions based on the input text. The document is solely a regulatory clearance letter, not a study report.

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The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair. The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.

Power Wheelchair Model 2200

The provided document is a 510(k) clearance letter from the FDA for a power wheelchair, Model PSB-2200 (also referred to as Model 2200). It focuses on the substantial equivalence of the device to a predicate device and its indications for use. The document does not contain any information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for testing or training, ground truth establishment, or details of specific studies proving the device meets acceptance criteria.

Therefore, I cannot answer the questions directly from the provided text. The output of the desired information would be:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample sized used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided as there's no mention of a ground truth for a test set.
4. Adjudication method for the test set: Not provided in the document.
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, as this is a physical medical device (power wheelchair), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable/provided.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not applicable/provided.

The document is a regulatory clearance letter, not a clinical study report or technical specification detailing performance metrics.

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This Product will be used by the patient to assist themselves 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 can not 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 it eases the burden of climbing the 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.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called the "Bruno Electra-Ride™ III Stairway Elevator System". This document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested.

The letter primarily focuses on:

• Confirming the device is substantially equivalent to legally marketed predicate devices.
• Outlining general controls provisions (annual registration, listing, good manufacturing practices, labeling, etc.).
• Indicating that the manufacturer can begin marketing the device.
• Providing contact information for regulatory questions.
• Stating the intended use of the device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study to prove the device meets them based solely on the provided text. The document is a regulatory clearance letter, not a technical report detailing performance studies.

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