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The Garaventa X3 inclined platform lift is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.

The Garaventa X3 inclined platform lift is intended to mechanically transport one person in a wheelchair or in a fold down seat equipped with a seat belt, up and down stairs in a private or public facility either indoors or outdoors, on straight stairways.
The Garaventa X3 inclined platform lift uses two custom-cut extruded aluminum guide rails to guide and support the platform. An upper rail houses the drive rack that is engaged by the pinion gear providing platform movement as well as acting as the raceway for the control wiring. A lower rail stabilizes the platform keeping it in a level traveling position. The Garaventa X3 inclined platform lift has steel guide rails and haul ropes or cables are used for those products instead of extruded aluminum.
The Garaventa X3 inclined platform lift does not require a special cabinet to house the drive system. The drive system of the Garaventa X3 inclined platform lift is an on-board rack and pinion drive system. The drive system is protected from accidental contact by the user by a conveyance "hard" cover.
The Garaventa X3 inclined platform lift is a computer-controlled device equipped with a microprocessor and the software resides inside the conveyance controller.
The safety network monitors several switches, landing cam, the battery voltage and motor current limits. These are independent of the microprocessor system and provide a positive electromechanical means to reliably and safely stop the lift in any possible hazardous situation.
The controller is located in the conveyance unit. It receives the operating commands from the call station or from the conveyance controller. The conveyance control module always has a priority over the call stations.
The conveyance controller is powered by 24V DC batteries that are attached to the conveyance. The conveyance controller also controls the "barrier arms" motor, platform side-load motor and the platform motor in either of the landings.
The status of the safety switches and the emergency stop button are monitored by the conveyance controller.
There is a call station located at each landing. The call station transmits commands using a wireless simplex channel while the conveyance continuously scans all RF signals (decoded) from both call stations.
Call stations allow the user to call and send the unit into the desired landing and also fold and unfold the platform. The call stations are linked with the conveyance through the wireless link. The system uses a 2.4 GHz ISM band using encoded pulse for each call station does not process the button / command but simply transfers the state of each button to the conveyance.
The Garaventa X3 inclined platform lift is provided in four models: one fully automatic, two semi automatic, and one fully manual.

The provided text describes a 510(k) summary for the Garaventa X3 inclined platform lift, a device for transporting individuals in wheelchairs up and down stairs. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

Unfortunately, the provided text does not contain the level of detail typically found in a scientific study designed to establish acceptance criteria and prove device performance in the context of advanced AI/ML systems. This document is a regulatory submission for a physical medical device (a wheelchair elevator).

Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document. The document focuses on demonstrating that the new device (Garaventa X3) is substantially equivalent in safety and effectiveness to a previously cleared predicate device (Garaventa STAIR-LIFT K981486) by highlighting design changes and testing against applicable standards for physical lifts, not AI/ML performance metrics.

I will, however, extract the relevant information where available and explicitly state when information is not present or applicable.

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

The document frames "acceptance criteria" and "reported device performance" in terms of compliance with established safety standards and functionality relative to a predicate device, rather than specific quantitative performance metrics common in AI/ML validation (e.g., sensitivity, specificity, AUC).

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 in the context of this device. The testing described is for the physical components and safety circuits of a single device or a small number of prototypes, not a data-driven test set for an algorithm.
• Data Provenance: Not applicable. The "testing" refers to physical compliance testing, not data collection for algorithms. The manufacturer is Garaventa (Canada) LTD, suggesting testing likely occurred in Canada or under Canadian/US 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)

• Number of Experts & Qualifications: Not applicable. Ground truth, in this context, would be the adherence to engineering standards and proper mechanical function, validated by engineers or certified testing bodies, rather than medical experts interpreting data.

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

• Adjudication Method: Not applicable. This concept applies to human review of ambiguous cases in data interpretation, which is not relevant for the physical testing of an inclined platform lift. Testing involves pass/fail criteria 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

• MRMC Study: Not applicable. This type of study is used for diagnostic AI systems where human readers interpret patient data. The Garaventa X3 is a physical transport device.

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

• Standalone Performance: While the device is "computer-controlled" with a "microprocessor," the context is mechanical safety and operation, not an AI algorithm performing diagnostic tasks. The "safety network" and "conveyance controller" monitor switches and parameters to ensure safe mechanical operation. Therefore, this concept is not applicable as described for an AI application.

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

• Type of Ground Truth: The "ground truth" for this device's performance is adherence to recognized engineering and safety standards for inclined platform lifts, specifically ASME 18.1-2008 and CSA B335-09. This is a standards-based ground truth or engineering compliance ground truth.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML system that requires a "training set" of data in the conventional sense. The "training" in this context refers to the engineering design, development, and testing processes.

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

• How Ground Truth for Training Set was Established: Not applicable. As there’s no training set for an AI/ML model, there’s no ground truth established in that manner. The "ground truth" (i.e., correct design and functionality) for the device's development would be based on established mechanical engineering principles, safety regulations, and the performance characteristics of the predicate device.

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The Bella Elevator, LLC vertical Platform lift models RL, UL, SL, EL, EPL are designed to transport persons with a mobility disability either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The Bella Elevator, LLC vertical platform lift models RL, UL, SL, EPL are designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. The model EL and EPL are located within with their own integrated enclosure. The model SL is located within a hoistway. The UL model is unenclosed, other than guarding around the platform area. The RL model is unenclosed and intended for applications found in a residence. These models are designed for both indoor and outdoor applications. Each referenced model has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifts are available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low voltage, constant pressure. Use may be restricted to authorized persons with key switch located on control panels.

The provided text is a 510(k) summary for a medical device (Vertical Platform Lifts) and related FDA correspondence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/software medical device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

The documentation focuses on the device description, intended use, and its compliance with established national safety standards for physical devices. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment as per your prompt's structure, which is designed for AI/software-based devices.

The "Performance Data" section in the document states: "The Bella Elevator, LLC Vertical Platform Lift models RL, UL, SL, EL, and ELP fully comply with the applicable sections of the following National Safety Standards:

• ASME A18.1- Safety Standard for Platform Lifts and Stairway Chairlifts
• ASME 17.5- Electrical Code for Elevating Devices"

This indicates that the "acceptance criteria" for this physical device are the requirements of these safety standards, and the "study" proving compliance is likely a series of engineering tests and demonstrations showing the device adheres to these standards. However, the document does not elaborate on specific metrics, sample sizes, ground truth, or expert involvement as requested for AI/software evaluation.

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The intended use of the LIFTKAR PT™ is to transport a wheelchair user or a person needing assistance up or down stairs by means of a battery powered, mobile lifting device. LIFTKAR PT is operated by an attendant and is used in residential and public facilities indoors and outside.

The LIFTKAR PT™ Is a wheelchair, elevator commonly known as an easy method of transporting wheelchair users of uisabled persons, ap and as a mobile stair-climber. This is done with alitting - LIFT AD PT. LIFTKAR PT™ can be used on any stairs indoors or outside.

The LIFTKAR PT™ ADAPT is an attendant operated, battery powered lifting device that transports manual wheelchairs up or down stairs. The LIFTKAR PT is designed for indoor and outdoor use allowing mobility for the person needing assistance.

A portable stair-climber LIFTKAR PT can be dismantled into three parts, the climber unit, the battery pack and the handle. All parts are lightweight and easy to stow away.

Acceptance Criteria and Device Performance for SANO Transportgeraete GmbH LIFTKAR PT™ Elevator Wheelchair

This document outlines the acceptance criteria and reported device performance for the LIFTKAR PT™ ADAPT, an attendant-operated, battery-powered lifting device for transporting manual wheelchairs up or down stairs, as presented in the 510(k) Summary K110495.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™ ADAPT are primarily based on conformity to established international standards for wheelchairs and stair-climbing devices, as well as demonstrating substantial equivalence to a predicate device. The performance data section indicates that the device meets specifications for performance criteria and intended functions, thereby satisfying the acceptance criteria.

The "Reported Device Performance" for the LIFTKAR PT™ ADAPT, as stated in the submission, is that it "conforms with the following standards" and that "The performance Data results of the testing confirm that the device meets specifications for the performance criteria and the functions it was intended for." This implies successful demonstration against the requirements within each standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided document. The testing reports are referenced as "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32". These reports would contain the detailed sample sizes for the various tests carried out to confirm compliance with the listed ISO and EN standards.
• Data Provenance: The testing was performed by "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin". This indicates the testing was conducted in Germany (Berlin). The nature of the tests (compliance with standards for mechanical devices) suggests prospective testing specifically designed to evaluate the device against these criteria, rather than retrospective analysis of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For performance testing of a mechanical device against international standards, the "ground truth" is typically established by the specified test methods within the standards themselves and evaluated by qualified testing engineers at the certification body (BERLIN CERT). There is no indication of "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic or interpretative task.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/experts in diagnostic studies. For objective performance testing of a mechanical device against established engineering standards, an adjudication method for the "test set" as described is not applicable or typically used. The testing is based on objective measurements and predefined acceptance criteria outlined in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for medical imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The LIFTKAR PT™ is a mechanical mobility device; its evaluation focuses on engineering performance, safety, and substantial equivalence, not the interpretive accuracy of human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The concept of a "standalone" algorithm performance is not applicable to this device. The LIFTKAR PT™ is an attendant-operated mechanical device. Its performance is intrinsically linked to its mechanical function and its interaction with an attendant, not an independent algorithm making decisions or interpretations. The performance evaluation focuses on the mechanical and electrical integrity and functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation is based on objective engineering and safety standards (ISO and EN standards). This includes:

• Predefined thresholds and specifications: e.g., maximum load capacity, battery life (number of steps), static stability, dimensions.
• Standardized test methods: Procedures outlined in the ISO and EN standards for measuring these parameters.
• Substantial equivalence to a predicate device: Comparisons of design, components, and performance specifications to an already legally marketed device (Scalamobil K920105).

8. The Sample Size for the Training Set

This question is not applicable to the LIFTKAR PT™ ADAPT submission. "Training set" refers to data used to train machine learning algorithms. The LIFTKAR PT™ is a mechanical device, not an AI or machine learning product. Its development and approval process do not involve training sets for algorithms.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for an AI algorithm involved in the LIFTKAR PT™ ADAPT.

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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 Inclined Platform Lifts "JOURNEY" and "SUPRA" are intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility.

The Thyssenkrupp Ceteco's JOURNEY and SUPRA are unenclosed Inclined Platform Lifts (IPLs) designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. They are composed of two main parts the rail and the carriage. The rail is the part where the carriage is attached to and where it will move along. The carriage is the part where the person to be transported is positioned on.

The provided text is a 510(k) summary for an Inclined Platform Lift. It details the device, its predicate, and declares substantial equivalence. However, it does not include information about specific acceptance criteria or a study proving the device meets them in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

The document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, as opposed to a clinical or performance study with quantitative acceptance criteria. Therefore, I cannot extract the detailed information you requested as it is not present in the provided text.

Here is what can be inferred and what is explicitly stated concerning "acceptance criteria" in a regulatory context, but it doesn't align with the quantitative performance study you're asking for:

Implicit "Acceptance Criteria" (Regulatory Intent)

In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device. This means the new device (SUPRA) is considered to meet the safety and effectiveness requirements if it has:

• The same intended use as the predicate device (JOURNEY).
• The same technological characteristics as the predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.
• Performance data (if necessary, though not explicitly detailed as quantitative performance metrics in this summary) that demonstrates the device is as safe and effective as the predicate.

"Study" (Regulatory Declaration of Equivalence)

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence. The key evidence presented for "meeting acceptance criteria" (i.e., substantial equivalence) is the Product Comparison Table and the subsequent declaration.

Here's a breakdown of why each of your requested points cannot be filled from the provided text, or how they relate to the document's purpose:

1. A table of acceptance criteria and the reported device performance: Not present. The "Product comparison Table" lists features and compliance with standards (ASME A17.5, ASME A18.1), but not quantitative performance criteria with reported values against those criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no traditional "test set" in the sense of a data set for evaluation. The submission relies on design, performance specifications, and third-party certification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic or performance test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an Inclined Platform 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.
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.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission (510(k) summary) for an Inclined Platform Lift, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed quantitative performance studies, acceptance criteria, or expert review processes typically found for devices like AI algorithms or diagnostic tools.

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The intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.

The provided text is a 510(k) Premarket Notification for the Harmar Summit RPL/CPL Vertical Platform Lifts. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than presenting a clinical study with detailed acceptance criteria and performance data for a new medical device.

Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. The device in question is a wheelchair elevator, which is more of a mechanical and electrical safety device than a diagnostic or therapeutic medical device requiring extensive clinical trials with human subjects for efficacy.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, based on the provided text, the following apply:

• 2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on conformance to engineering standards, not on a clinical test set from human subjects.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is defined by the technical specifications and safety standards.
• 4. Adjudication method for the test set: Not applicable.
• 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 not an AI-enabled diagnostic or analytical device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical transport device.
• 7. The type of ground truth used: Conformance to established engineering and safety standards (ASME A18.1, CSA B44.1 / ASME 17.5) and the stated load capacities for the RPL and CPL models.
• 8. The sample size for the training set: Not applicable. There is no "training set" in the context of machine learning for this device. The design and validation are based on engineering principles and standard compliance.
• 9. How the ground truth for the training set was established: Not applicable.

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The Inclined Platform-Lift "JOURNEY" is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either in indoors or outdoors.

The JOURNEY consists of a motorized main-frame with a platform, moving on a public of The JOURNET Consists of a motorized man interest man and on the discussion fixed floors in a public of piritor of a fack placed at the bottom of the blood garror, it The JOURNEY is designed to carry a private dwelling; it is an unenclosed Inclined Platformlift. The JOURNEY of wheelchair and its occupant or a person with impaired mobility seated on a folding seat. There are currently two different models designed to address different kind of staircase. - The JOURNEY (technically called RPSP) designed strictly for straight stairways. ■ - The JOURNEY (technically called TP or ) docigned for straight and turning stairways. Starways. Each of the two models is accessible via four types of platform (special size are available under Each of the two models is accessible via four types of plations (promps are raided automatically (manually in emergency cases). (fridaliy in emergency casos). The JOURNEY, as rail, uses one guide, dimensions roughly 400 mm x 65 mm, the guide is made in extruded aluminium profile (TK Ceteco drawing) and anodised. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according to the stainway. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according T The JOUNCT GODIO, as Tail, acco two paralier garabel on extruded aluminium profile (TK Ceteco drawing) and powder coated painted. The guide follows the average of staircase and is supported by specific stanchions, anchors on the steps and/or to the wall. steps and/or to the wall. The JOURNEY is equipped with an "Over-speed Governor and Safety Gear" that it is directly and THE JOURNET is equipped with an "Over operated directly by a speed limiter device with mechanically liked on the 'system of the traction system, the insettion system, the insertion of the mput menta due to the merceased specu, in caso of failers of the armanical arrest" of the platform lift. the JOURNEY is equipped with "Hold to run Buttons" and with an emergency stop button. The JOURNEY is also provided the following safety devices: - onNice is also provided the following eactly in motion towards' high on both the body and the platform; 포 - anti-scissor system in motion down under the bottom of the platform and on the bottom of the . bodv: - body, I

The provided text describes a 510(k) premarket notification for a medical device, which typically focuses on establishing substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel, high-risk device might.

The document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a clinical or performance study of the "JOURNEY" Inclined Platform-Lift.

Instead, the document is a regulatory communication from the FDA stating that the device is "substantially equivalent" to a legally marketed predicate device (K981486). This determination is based on the device conforming to general controls and having similar indications for use and technological characteristics to the predicate device. For devices like this, the "study" is often an engineering and safety assessment against recognized standards for inclined platform lifts, demonstrating that it meets safety requirements and performs its intended function comparably to existing, approved devices.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The submission focuses on regulatory clearance, not on presenting performance data from a specific study with defined acceptance criteria.

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The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.

The Merits E700 Porch Lift basically consists of a platform assembly and a driving machine case assembly. The platform assembly vertically moves along a guide rail welded to the driving machine case assembly. The sides of the platform assembly are guarded by sheet steel plates. The lower landing side of the platform is equipped with an automatic folding ramp to not only offer easy access to the platform but also to prevent the mobility device rolling off the edges. The ramp will be automatically folded up as the lift begins to move upward and remain in elevated position until the platform returns to the lower landing. The underside of the platform is equipped with a safety plate to stop the motion when the platform is obstructed in the downward direction. The driving machine case assembly contains all necessary operation systems in the case. The operation of the lift is controlled by the platform operating panel and the call/send controls. These control devices are designed by means of continuous pressure type, which stop the lift immediately when the switch is released. The Merits E700 Porch Lift is using AC power as its power source.

The provided text concerns a 510(k) submission for a Merits E700 Porch Lift, which is a vertical platform lift. This document is a regulatory submission for a medical device that assists with mobility. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and statistical analysis typical for diagnostic AI/ML devices.

Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of device and submission.

Here's the information that can be extracted or deduced based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document focuses on demonstrating substantial equivalence rather than explicit, quantifiable performance metrics for a novel technology.

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

• Not applicable. This submission is for a mechanical device; it does not involve a test set of data in the context of an AI/ML diagnostic algorithm. The "testing" likely refers to engineering verification and validation tests common for mechanical devices (e.g., load testing, cycle testing, safety mechanism verification). The document does not specify the nature or sample size of these engineering tests, nor does it refer to data provenance in the context of patient data.

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

• Not applicable. Ground truth in the context of expert consensus on medical images or diagnostic data is not relevant for this mechanical device. The "ground truth" here would be established by engineering specifications, safety standards, and functional requirements.

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

• Not applicable. An adjudication method for a test set is not relevant for a mechanical device submission.

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 device, not an AI/ML diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This device does not have an AI algorithm.

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

• Not applicable in the context of diagnostic AI/ML. The "ground truth" for this device would be adherence to established engineering standards, safety regulations (e.g., related to lifts, general mechanical safety), and functional specifications. The performance is assessed against these technical and safety requirements, and by comparison to the established predicate device's performance characteristics.

8. The sample size for the training set:

• Not applicable. This submission does not involve a training set for an AI/ML model.

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

• Not applicable. This submission does not involve a training set for an AI/ML model.

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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.

Not Found

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 Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The Genesis Vertical Platform Lift is designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. It can be located within with its own integrated shaftway enclosure, located within a building shaftway or be unenclosed other than guarding around the platform area. It is designed for both indoor and outdoor locations. The Genesis has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifting height is up to 14 feet. It is available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low-voltage constant pressure. Use may be restricted to authorized persons with key switches located on the control panels. The Genesis is built in accordance with ASME A17.5 Electrical Code for Elevating Devices and the ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts.

This is a premarket notification for a Class II medical device, specifically a "Wheelchair elevator" or "Vertical Platform Lift." The submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria based on performance studies in the way one might for diagnostic or AI-driven devices.

Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable to this type of submission. This document describes the device's function and its adherence to established safety standards, which serves as the basis for its equivalence.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are compliance with relevant safety standards and technical specifications, and the "reported device performance" is its adherence to these.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a mechanical device, and a "test set" in the context of diagnostic or AI performance studies is not relevant here. The "testing" refers to the device's design and manufacturing to meet the specified engineering and safety standards. There is no mention of a specific clinical or performance test set with human subjects or data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" as defined for diagnostic or AI studies (e.g., expert consensus on medical images) does not apply to this device. The "truth" is whether the device meets the engineering and safety specifications, which would be verified through engineering tests, inspections, and adherence to codes, not expert consensus on performance data in the same way.

4. Adjudication Method for the Test Set

Not applicable. See reasoning for #2 and #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance, often with or without AI assistance, especially in diagnostic fields. It is not relevant for a mechanical device like a vertical platform lift.

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

No. This refers to the performance of an algorithm or AI system. This device is purely mechanical with electrical controls, not an AI or algorithm-driven system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is its compliance with established engineering and safety standards (ASME A17.5 and ASME A18.1) and its technical specifications (e.g., capacity, lifting height, control types, drive systems). This is verified through engineering design, manufacturing processes, and potentially physical testing against those standards. It does not involve expert consensus, pathology, or outcomes data in the typical medical device sense.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an algorithm or AI-driven system that requires data for machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. See reasoning for #8.

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