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The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs. The Stairlift is capable of moving adult, adolescent occupants (12 years and up) who are able to remain seated while secured by the safety belt. The Mobile Stairlift is for residential use with proper training. This device can also be used routinely in a hospital environment or as a tool for all types of medical personnel. The target patient population are disabled seated persons i.e. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets the acceptance criteria. The text provided is an FDA 510(k) clearance letter for a "Powered Patient Transport" device named "Genesis (MS-P02-GEN)".

It discusses:

• The FDA's review and determination of substantial equivalence.
• General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
• Additional controls for Class II or III devices.
• FDA guidance documents for changes requiring new premarket notifications.
• Quality System (QS) regulation requirements.
• Compliance with other Act requirements (registration and listing, labeling, medical device reporting, good manufacturing practices, electronic product radiation control provisions, Unique Device Identification System rule).
• Misbranding by reference to premarket notification.
• Contact information for questions.
• Indications for Use for the "Mobile Stairlift" (which is actually the device name, not "Genesis (MS-P02-GEN)", despite being listed under "Device Name" as "Genesis (MS-P02-GEN)").

There is no mention of specific acceptance criteria (like accuracy, sensitivity, specificity, etc.) nor any details about a study conducted to prove the device meets such criteria, the sample size used, expert qualifications, ground truth establishment, or any comparative effectiveness studies with human readers.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Xpedition transports a patient with a mobility-limiting medical condition or injury, who is physically able to maintain a seated position while restrained, up or down a set of stairs. Xpedition is intended for use in residential and commercial environments, including pre-hospital environments, emergency, and non-emergency applications. All operators, including healthcare professionals such as emergency medical service personnel and medical first responders, must be trained by a qualified trainer before product use.

The Stryker Xpedition™ Powered Stair Chair is a seated patient transport device with handles and a powered belt and track system. The chair is designed to support and transport a maximum weight of 500 1b (227kg) up and down stairs. The chair is intended for patients who weigh 50 lb (23 kg) or more and can remain seated in the chair while secured by patient restraint straps. Handles at the head and foot ends allow operators to control the chair during powered or manual ascent or descent on stairs. Operators can push and maneuver the chair over various types of terrain expected in commercial and residential environments, as well as lift patients over obstacles. The chair has a removable patient containment system with attachment points for the chest and waist to secure a patient during transport. A fold-out footrest can be deployed for secure feet placement. A removable, rechargeable battery powers electrical functions including the motorized drive system for traversing stairs, speed selection, direction, ground lighting activation, battery capacity feedback, drive activation buttons, and LED visual feedback networks. User interfaces at the back of the chair and the top handle allow for drive system control. The chair has several mechanical activations including wheel locks to prevent unintended motion on ground, a latch to fold or unfold the chair, a track deployment mechanism to deploy the stair driving track system, and top and bottom handle length adjustment activations. Options include the footrest and head end flip-up carry handles.

The provided document describes the Stryker Xpedition™ Powered Stair Chair (K222818), a device intended for patient transport. However, it does not include specific quantitative acceptance criteria or a study that directly proves the device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (C-Max +, K130864) through non-clinical performance data, rather than establishing and meeting discrete performance acceptance criteria for a novel AI/software-driven medical device. The tests performed are in accordance with various ISO and IEC standards to demonstrate safety, effectiveness, and general functionality.

Therefore, many of the requested fields cannot be directly extracted from the provided text, as they pertain to specific types of studies (e.g., AI performance, multi-reader multi-case studies, ground truth establishment) that are not detailed for this device.

Here's an attempt to answer based on the available information, with many points noted as "Not Applicable" or "Not Provided" due to the nature of the submission (a 510(k) for a physical medical device, not an AI/software device with diagnostic or predictive capabilities).

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (powered stair chair) and not an AI or diagnostic software, explicit "acceptance criteria" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC) are not defined in the document. Instead, the "performance" is demonstrated by meeting various engineering and safety standards.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable in the context of clinical "test sets" for diagnostic or AI performance. The document describes non-clinical engineering and safety tests, which typically involve specific test units of the device under controlled conditions. The number of such units is not specified.
• Data provenance: Not applicable. The tests are lab-based engineering and safety assessments of the device itself, not data collected from patients or a specific population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "truth" in these tests is compliance with engineering standards and functional specifications, typically verified by test engineers.
• Qualifications of experts: Not provided, but implied to be qualified engineers and technicians for the various standards.

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

• Adjudication method: Not applicable. This concept is typically for resolving discrepancies in expert opinion for ground truth in medical imaging or diagnostic studies. The tests described are objective, pass/fail based on 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

• MRMC study: No. This type of study is for evaluating AI-assisted diagnostic performance. The Xpedition™ is a powered patient transport device, not a diagnostic tool.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This concept is for AI algorithms. The device's "performance" is its mechanical and electrical function, which is assessed during the non-clinical tests. While it has powered functions, it still requires human operators.

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

• Ground truth: For this type of device, the "ground truth" is defined by compliance with established engineering and safety standards (e.g., ISO, IEC, AAMI). The "truth" is whether the device performs as specified and meets the limits/requirements of these standards, which are based on extensive industry consensus for safety and performance.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is not an AI/machine learning model that requires a training set of data.

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

• Ground truth for training set: Not applicable.

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Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.

The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.

With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care.

On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution.

At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe.

Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.

The provided text describes a 510(k) summary for the "c-max+ (plus)" powered patient stairway chair lift and its substantial equivalence to a predicate device, the "c-max". The document focuses on regulatory compliance through non-clinical testing against recognized standards rather than a clinical study with human subjects or AI-assisted performance.

Therefore, many of the requested sections related to clinical studies, AI performance, ground truth establishment, expert adjudication, and associated sample sizes are not applicable to the information contained in this 510(k) summary.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria are established by various international standards for safety, function, and performance of patient transport devices. The "reported device performance" is essentially that the device performed in accordance with these standards, demonstrating its safety and effectiveness.

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

• Sample Size for Test Set: Not applicable as this document describes non-clinical engineering and performance testing of the device itself, not a clinical study with a "test set" of patients or data. The "sample" would be the device prototypes tested.
• Data Provenance: The tests were performed according to recognized international standards (EN, ISO). The manufacturer is AAT Alber Antriebstechnik GmbH, located in Germany. These would be considered prospective non-clinical tests.

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" in this context would refer to the successful execution and results of the non-clinical tests, which are objectively measured against the specified standards by qualified testing personnel and facilities.

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

Not applicable. This is a non-clinical testing report, not a clinical study requiring adjudication of expert opinions.

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 device is a powered patient stairway chair lift and does not involve AI or "human readers" in its intended use or in the described testing for regulatory clearance.

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

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

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

The "ground truth" for the device's performance is established by its adherence to the technical and safety requirements outlined in the cited international standards (EN 12182, ISO 7176 series, ISO 10993-5). This is a form of objective technical compliance and engineering performance data.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning model requiring a "training set."

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

Not applicable.

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ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.

Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs. It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options. The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel. The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.

The provided text is a 510(k) summary for a medical device called the "LEVANT/HOMEGLIDE" Battery Operated Stair Lift for Straight Stairs. This document does not describe a study to prove the device meets acceptance criteria, but rather a comparison to a predicate device to establish substantial equivalence.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert involvement, and statistical analyses) are not applicable to the information provided. The document outlines a product comparison rather than a performance study with specific acceptance criteria that would typically be described for software or AI-driven medical devices.

Here's how to address the questions based on the provided text, noting its limitations:

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

Since this is a 510(k) premarket notification focusing on substantial equivalence to a predicate device rather than a study with defined acceptance criteria and performance against those criteria, a direct "acceptance criteria" table as typically seen in performance studies is not present. Instead, the document compares the technical characteristics of the proposed device to a predicate device to demonstrate equivalence.

Here’s a summary of the comparative characteristics, which implicitly serve as the basis for "performance" from an equivalence standpoint:

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 document is a premarket notification for substantial equivalence, not a clinical or performance study involving a test set of data. The "comparison" is based on the technical specifications of the devices themselves, not on collected data from a test set.

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. There is no test set or ground truth established by experts described in this document. The assessment is based on a technical review by the manufacturer and subsequently the FDA.

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

Not applicable. No test set or related adjudication method is described.

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 device is a mechanical stair lift, not an AI or imaging device that would involve human readers or comparative effectiveness studies of this nature.

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)

Not applicable. There is no ground truth, as this document focuses on substantial equivalence based on technical specifications and adherence to standards (like ASME 18.1 and EN 81-40), rather than a diagnostic or analytical performance study.

8. The sample size for the training set

Not applicable. There is no training set mentioned or relevant for this type of mechanical device submission.

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

Not applicable. There is no training set or ground truth described.

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ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.

Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.

Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.

The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.

Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.

The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ThyssenKrupp Accessibility FLOW2 stair lift:

This 510(k) summary does not contain a traditional performance study comparing the device to acceptance criteria with detailed metrics like sensitivity, specificity, accuracy, or confidence intervals. Instead, it relies on a substantial equivalence approach by comparing the FLOW2 to a predicate device (Bruno CRE-2110 Electra-Ride) and demonstrating compliance with relevant international standards.

For medical devices, especially those that are electromechanical and not diagnostic in nature, "acceptance criteria" often refer to meeting established safety and performance standards, and demonstrating that the new device is as safe and effective as a legally marketed predicate.

Here's a breakdown of the requested information based on the provided document:

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

For devices like a stair lift, acceptance criteria often relate to meeting specific safety standards, load capacities, speed limits, and other functional aspects. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate.

Note on Acceptance Criteria: For this type of device and submission, the primary "acceptance criteria" are the successful demonstration of substantial equivalence to a predicate device and compliance with recognized consensus standards (ASME 18.1, IEC 60601-1-2:2007). The "reported device performance" is essentially that the device meets these standards and its characteristics are within an acceptable range compared to the predicate, even where there are non-equivalent technological characteristics. The non-equivalent characteristics were discussed to show they do not raise new questions of safety or effectiveness.

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

• Sample Size: Not applicable in the context of a clinical trial or performance study with a test set of data. The submission relies on engineering testing and comparison to standards and a predicate device.
• Data Provenance: Not applicable for clinical data. The data provenance is from engineering and safety standard testing conducted by organizations like ETL and Lift Institute. The country of origin of the manufacturer is The Netherlands.

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. This is not a diagnostic device requiring expert interpretation for ground truth establishment. Third-party testing and certification bodies (ETL, Lift Institute) verified compliance with safety and performance standards. Their "expertise" for this type of device lies in their accreditation to test against these specific standards.

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

• Not applicable. There was no "test set" of clinical cases requiring adjudication. Compliance was determined by accredited testing laboratories against 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

• No MRMC study was done. This device is a mechanical stair lift, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a mechanical device with human users, not an algorithm. Its operation involves human interaction (joystick control) for its intended function. The "standalone" performance would be its mechanical and electrical function independent of a specific user, verified by engineering tests.

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

• The "ground truth" for this submission is established by compliance with international consensus safety and performance standards (ASME 18.1, IEC 60601-1-2:2007) as verified by accredited testing bodies (ETL, Lift Institute). For mechanical devices, this often involves physical load testing, endurance testing, electrical safety testing, and functional assessments without human subjects.

8. The sample size for the training set

• Not applicable. There is no AI component or "training set" for this device.

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

• Not applicable, as there is no training set for this device.

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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 LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.

The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.

Here's an analysis of the provided text regarding the LIFTKAR PT™-S device, focusing on acceptance criteria and study details:

This submission is for a K111858, a 510(k) premarket notification. In a 510(k), manufacturers demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that their new device is as safe and effective as the predicate device, often through performance testing and comparison of technical specifications. It's important to understand that a 510(k) does not usually involve extensive clinical trials like a PMA (Premarket Approval) application, nor does it typically detail acceptance criteria in the same way one might for a novel, high-risk device. The "acceptance criteria" here are largely implied by demonstrating compliance with recognized standards and equivalence to the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™-S are not explicitly stated in a quantitative table with pass/fail thresholds. Instead, acceptance is demonstrated by conforming to relevant international standards and showing substantial equivalence in performance to its predicate device, the C-Max-U2 (K103122).

The following table summarizes the device performance of the LIFTKAR PT™-S and its comparison to the predicate, which implies the performance criteria were met if the LIFTKAR PT™-S's performance is similar to or better than the predicate and complies with the standards.

The "acceptance criteria" are intrinsically tied to demonstrating that the LIFTKAR PT™-S meets the requirements of the listed international standards (ISO 7176-23:2002 and DIN EN ISO 10993-5) and performs comparably to or better than the predicate device in key functional areas.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested for performance. It states that "The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin." This implies that the device (likely one or a few units representative of the production model) was subjected to performance tests. The testing focuses on mechanical, electrical, and safety aspects according to standards, rather than statistical sampling from a large test set.
   • Data Provenance: The testing was conducted by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin (a German testing and certification body). This is in Europe (Germany/Austria). The study is prospective in the sense that the device was manufactured and then tested according to defined protocols to assess its conformance to standards and specifications. It is not a retrospective analysis of existing data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of information (number and qualifications of experts for ground truth) is not applicable to this 510(k) submission. For a device like a powered patient transport, "ground truth" is established by direct physical measurement, engineering analysis, and evaluation against technical standards (e.g., measuring weight capacity, step height, battery life, and confirming compliance with ISO 7176-23). The "experts" involved would be the technical engineers and certifiers at BERLIN CERT, whose qualifications are implicit in the accreditation of the certification body, but not explicitly stated here (e.g., "radiologist with 10 years of experience" is for diagnostic devices).

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a role and consensus among experts is needed for ground truth. For a mechanical device tested against engineering standards, the results are objective measurements and pass/fail determinations based on those standards.

4. 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:

   • No. An MRMC study is not applicable to this device. This is a powered patient transport device, not a diagnostic imaging device with AI assistance for human readers.

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

   • Not applicable. This device is a physical mechanical/electrical apparatus, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the certified attendant).

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

   • The "ground truth" used for this device's performance evaluation is based on objective physical measurements and engineering assessments against recognized international standards (ISO 7176-23:2002 for requirements and test methods for attendant-operated stair climbing devices, and DIN EN ISO 10993-5 for biocompatibility/cytotoxicity testing). The device's specifications (e.g., weight capacity, maximum stair height, battery life) are the defined parameters that the tests verified.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI algorithm that requires a "training set." The training relates to the attendant who uses the device, not an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI algorithm training set, this question is irrelevant. Any "training" mentioned refers to the certification of the human attendant who operates the device.

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The products c-max and s-max offer motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.to move from one level to another with or without manual wheelchair adaption.

The products c-max and s-max offer motorized stair-climbing support for disabled seated persons to move from one level to another with or without manual wheelchair adaption.

The provided text describes two medical devices, c-max and s-max, which are motorized stair-climbing support systems for disabled individuals. The information focuses on a 510(k) premarket notification for substantial equivalence, rather than a clinical study evaluating the device against specific acceptance criteria for performance.

Therefore, much of the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication methods is not present in the provided document, as it outlines a regulatory submission for device clearance, not a performance study report.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but lists safety and performance standards that the devices are stated to meet and provides technical data. The "acceptance criteria" can be inferred from the "Performance Standards" section.

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 document. The document refers to meeting performance standards, but does not detail the testing methodology, sample sizes, or data provenance (e.g., specific test reports, countries of origin, or if the testing was retrospective or prospective).

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)
This information is not provided in the document. The document refers to meeting established performance standards (e.g., ISO, EN) but does not involve expert consensus on a test set for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As this is a regulatory submission based on technical standards, not a clinical study with subjective interpretations, an adjudication method for a "test set" as typically understood in AI/clinical studies would not apply.

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
This information is not provided in the document. The devices (c-max and s-max) are motorized assistance devices, not AI-driven diagnostic or interpretative tools that would involve human "readers" or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The devices are physical medical devices, and the submission is focused on their engineering and safety standards, not on the performance of a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as "ground truth" in the context of a clinical study. However, the "ground truth" for demonstrating compliance with performance standards would be the results of standardized tests and measurements carried out according to the specified EN and ISO standards (e.g., measurements of lifting capacity, noise levels, vibration, battery life, step climbing height, and resistance to ignition).

8. The sample size for the training set
This information is not provided in the document. This is not a machine learning or AI-driven device, so there is no concept of a "training set" in the context presented.

9. How the ground truth for the training set was established
This information is not provided in the document. See point 8.

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The intended use is to assist transfer of an individual up or down a straight, residential, indoor staircase while in a seated position.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the Hoveround HoverGlide Stairlift. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for any medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is a regulatory approval letter, not a scientific study report.

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The Pinnacle Stair Way Lift is intended to assist transfers of patients or mobility impaired persons up and down flights of stairs.

The Harmar Summit, LLC Pinnacle Stair Way Lift is a battery powered patient transport. It's intended function and use is to assist transfers of patients or mobility impaired persons up and down flights of stairs. It is intended for indoor use only. The system is designed to carry a single patient, up a single flight of stairs while seated, at angle of between 27-45 degrees. Maximum travel distance is 75' at the maximum patient weight is 350 lbs. Maximum travel speed at full rated load is 20' per minute.

The provided document describes the Harmar Summit Pinnacle Stair Way Lift, a battery-powered patient transport device. However, it does not contain information on the acceptance criteria and study design elements that would typically be found in a medical device clinical validation or performance study.

Here's a breakdown of what is available and what is missing based on your request:

Acceptance Criteria and Reported Device Performance (Missing/Not Applicable)

The document primarily focuses on regulatory approval (510(k)) and substantial equivalence to a predicate device, rather than detailed performance comparisons against quantitative acceptance criteria from a specific study.

• A table of acceptance criteria and the reported device performance: This information is not provided. The document states the device is "CSA and CUS listed under 226703" and "certified by CSA to the following standards; ASME A18.1 Safety Standards for Platform Lifts and Stairway Lifts, ASME A17.1 Safety Code for Elevators and Escalators." This implies the device meets the safety standards, but specific performance metrics and their corresponding acceptance criteria from a separate study are not detailed.

Study Details (Missing/Not Applicable for a medical device clinical validation)

The "Performance Data" section solely refers to certifications to standards, not a dedicated study to assess clinical performance or diagnostic accuracy. Therefore, most of the following information is not present:

• Sample size used for the test set and the data provenance: Not applicable. The document discusses regulatory certification to standards, not a test set of patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Available Information Related to Performance:

The document mentions some physical specifications and operational limits, which could be interpreted as inherent performance characteristics, but not as part of a formal study with acceptance criteria:

• Maximum patient weight: 350 lbs.
• Maximum travel speed at full rated load: 20' per minute.
• Angle of stairs: between 27-45 degrees.
• Maximum travel distance: 75'.
• Intended for indoor use only.

Conclusion:

The provided 510(k) Premarket Notification focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety standards (ASME A18.1 and A17.1) through CSA certification. It does not present a detailed study with acceptance criteria for device performance in the way one would expect for a diagnostic or AI-powered medical device. The "Performance Data" section simply states that the device is certified to existing safety standards, implying it meets the requirements of those standards rather than detailing a specific experimental validation study.

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