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The LEVO MAX power wheelchair is intended to provide indoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
The LEVO MAX power wheelchair is intended to provide indoor and outdoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.

The LEVO MAX powered wheelchair with optional seating and function is center wheel motor driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "R-net" or "VR2". The joystick user interface is integrated in the controller. The wheelchair is powered by two 12V/55Ah, 12V/73Ah or two 12V/75Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah); with fully charged batteries.
Components:The LEVO MAX power wheelchair consists of three basic sub-sections. These are: the base with drive units, the PG Drives Technology's R-NET or VR-2 Control System, and the body supporting system.
The base of the LEVO MAX includes: the frame, two direct-drive units with integrated parking brakes, two 12V/55Ah, two 12V/73Ah, or two 12V/75Ah batteries, two straight front and two center driving wheels as well as two twin rear caster wheels.
PG Drives Technology's VR2-Control System includes the power module, the integrated lighting module and the controller with integrated joystick. PG Drives Technology's R-NET Control System includes the power module, the intelligent seating/lighting module and the controller with integrated joystick.
The body supporting system includes the seat support, armrests and leg rests.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LEVO MAX power wheelchair:

The document is a 510(k) summary, which concerns medical device clearance in the US based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data. Therefore, the "study" described here is primarily a series of engineering and performance tests based on recognized standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the listed standards being "met," meaning the device passed the performance requirements specified in each standard. The document doesn't provide specific quantitative acceptance thresholds for each test, but rather states that the "Levo MAX functioned as intended" in all instances of the performed tests.

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

• Sample Size: The document does not specify a "sample size" in the conventional sense for clinical studies. It refers to a single device (the LEVO MAX) undergoing various engineering performance tests.
• Data Provenance: The tests were performed to international and national standards (ISO, RESNA, EN), which implies the testing environment would adhere to the specified protocols of these standards. The device manufacturer, LEVO AG, is based in Wohlen, Switzerland. The nature of these tests (e.g., static stability, dynamic stability, brake efficiency) indicates an engineering/benchtop testing environment, not human subject data. The testing is prospective in the sense that the device was actively tested against these standards for the purpose of seeking clearance.

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

• This is not applicable as the "ground truth" for these engineering performance tests is defined by the objective physical and mechanical properties and performance of the device against the criteria outlined in the referenced standards. There is no subjective interpretation by human experts being adjudicated to establish ground truth in the way it would be for, e.g., image interpretation in an AI study. The tests are machine-measured or involve objective physical events.

4. Adjudication Method for the Test Set

• This is not applicable. The tests performed are objective engineering measurements and evaluations against predefined standard parameters. They do not involve subjective assessments requiring adjudication.

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 is not applicable. The device is a powered wheelchair, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). This document does not describe any MRMC study or AI component.

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

• This is not applicable. There is no "algorithm" or AI component described in the context of this device that would undergo standalone performance testing. The "performance data" refers to the physical performance of the mechanical and electrical system of the wheelchair.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for these tests is the quantitative and qualitative performance requirements specified within each referenced engineering standard (RESNA, ISO, EN). For example, a stability test would define the angle at which a wheelchair must remain stable, and the "ground truth" is whether the tested wheelchair meets or exceeds that angle. For speed, the ground truth is the measured speed compared to a specified maximum.
  • Examples:
    • Static Stability: The ground truth is the specified tilt angle(s) the wheelchair must withstand without tipping, as defined by the RESNA/ISO standard.
    • Brake Effectiveness: The ground truth is the required stopping distance or holding capability on an incline, as specified by the standard.
    • Dimensions/Weight: The ground truth is the actual measured dimensions and weight of the device.

8. The Sample Size for the Training Set

• This is not applicable. There is no AI or machine learning component described that would require a "training set."

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

• This is not applicable as there is no training set for an AI model.

Summary of the Study:

The "study" presented here is a series of engineering performance tests conducted on the LEVO MAX power wheelchair. These tests evaluated the device's physical and mechanical characteristics and performance against internationally recognized standards (RESNA, ISO, and EN) for wheelchairs. The purpose was to demonstrate that the LEVO MAX is safe and effective and substantially equivalent to its predicate device, the Permobil M400, by showing it meets or exceeds the performance requirements outlined in these standards. The document explicitly states that "In all instances of the above mentioned test criteria, the Levo MAX functioned as intended," meaning it passed all conducted tests. Additional tests for climatic conditions and electromagnetic compatibility are planned before the device is marketed.

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The LEVO C3 power wheelchair with optional seating and standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.. The LEVO C3 power wheelchair is a product which changes people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility.

The LEVO C with optional seating and standing position function is center wheel driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "VR2". The joystick is integrated in the controller. The wheelchair is powered by two 12V/55Ah or two 12V/72Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah). The electrical positioning change is integrated in an electrical center wheel drive power wheelchair that performs high indoor and outdoor mobility in any optional possible position. For security, the speed is reduced to half speed as soon as the patient is not in the sitting position.

This document primarily describes a 510(k) submission for a medical device, the LEVO C3 power wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of algorithm or diagnostic device evaluation.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in this type of regulatory document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't provide a table of quantitative acceptance criteria and reported device performance in terms of accuracy, sensitivity, specificity, etc., as one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are compliance with established safety and performance standards for power wheelchairs, and the "reported performance" is that the device meets these standards and is substantially equivalent to predicate devices.

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. The document describes compliance with standards and equivalence to predicate devices, which typically involves engineering testing and comparative analysis, not a clinical "test set" in the sense of human subject data for an AI algorithm.

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. "Ground truth" in this context would likely refer to the established specifications and performance expectations outlined in the relevant ISO, EN, and ANSI/RESNA standards, rather than expert consensus on medical images or patient outcomes.

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

Not applicable. The "test set" described is a regulatory and engineering compliance process, not a clinical study requiring adjudication of expert interpretations.

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 physical medical device (power wheelchair), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study is not relevant.

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

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

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

The "ground truth" for this device's performance is implicit in the international and national standards (ISO, EN, ANSI/RESNA) that govern the safety and performance of power wheelchairs. These standards define the acceptable range of physical, mechanical, and electrical characteristics, as well as safety features.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set. The design of the LEVO C3 is based on "experience from the past" and previous models (LEVO combi, LEVO comfort II), which can be considered an analogous "training" or experience base for the engineering design, but not a data set in the AI sense.

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

Not applicable in the AI sense. The "ground truth" for the engineering design and development came from "Experience from the past has shown" and "Experience from the past has shown that the centre wheel driven power wheel chair has the most compact and efficient manoeuvrability capability with some limitations...". This refers to empirical knowledge gained from previous product development and market use of their own and competitor's wheelchairs.

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The LEVO comfort II stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.

The LEVO comfort II power wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the PG Drives Technology's power wheelchair controller "VSI" The Joystick is integrated in the Controller. The wheelchair is powered by: two 12V/26Ah, two 12V/40Ah or four 12V/26Ah batteries with a theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries.

The wheelchair consists of the following basic sub-sections:

• Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
• PG Drives Technology's power wheelchair controller . "VSI"
• Seating System including stand-up mechanisms and actuator.

The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.

The LEVO comfort II is a stand-up power wheelchair. The provided text indicates that the device's safety and effectiveness were established primarily through substantial equivalence to predicate devices, namely the LEVO mobil LCM (K 963817) and Quickie Freestyle (K 031289). No specific acceptance criteria with quantifiable metrics or a detailed study evaluating the device against such criteria are explicitly provided in the furnished document.

The document states: "The LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness." This implies that the device is considered safe and effective because its core design and performance are substantially similar to previously cleared devices, with only minor aesthetic and functional improvements that do not introduce new safety or effectiveness concerns.

Therefore, many of the specific details requested in the prompt, such as

• a table of acceptance criteria and reported device performance,
• sample sizes for test sets,
• details of experts and adjudication methods,
• MRMC studies,
• standalone performance studies,
• ground truth types,
• training set sample sizes, and
• ground truth establishment for training sets,
  are not present in the provided 510(k) summary. These types of detailed studies are typical for novel devices or those with significant changes that might impact safety or effectiveness. For devices demonstrating substantial equivalence to existing products with minor modifications, such extensive testing might not be required or documented in the summary.

The only performance-related detail mentioned is a "theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries," which describes a characteristic rather than a performance target against a predefined criterion.

Acceptance Criteria and Reported Device Performance:

Study Information (Based on provided text):

1. Sample size used for the test set and the data provenance: Not explicitly stated. The determination of safety and effectiveness appears to be based on a comparison to predicate devices, rather than a new standalone test set for empirical performance evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical efficacy or safety studies with expert ground truth establishment are not mentioned for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the predicate devices.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as detailed testing requiring adjudication is not described.
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: Not applicable. This device is a physical medical device (power wheelchair), not an AI/software-based diagnostic or assistive system that would involve human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
6. The type of ground truth used: Substantial equivalence to predicate devices (LEVO mobil LCM and Quickie Freestyle). The safety and effectiveness of these predicate devices serve as the "ground truth."
7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.
8. How the ground truth for the training set was established: Not applicable.

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The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

The LEVO combi powered wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact power wheelchair controller Pilot+. The joystick is integrated in the controller. The wheelchair is powered by two 12V55Ah batteries with a theoretical driving range of 35km on the fully charged batteries. The wheelchair consists of the following basic sub-sections:

• Base with two direct-drive units with integrated parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
• Penny & Giles power electronics Pilot+.
• Seating system including mechanisms for all possible positions, stand-up actuator and optional lift and/or backrest actuator.
  The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs.

The provided 510(k) summary for the LEVO combi device does not contain acceptance criteria or detailed study results to prove the device meets specific performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LEVO mobil LCM) based on intended use, materials, and a comparison of technological characteristics. The manufacturer asserts that the LEVO combi's design is "basically developed on experience of the LEVO mobil LCM" and that "the minor changes declared in the submission do not raise new questions of safety and effectiveness."

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as this information is not present in the provided text. The document does not describe a clinical study, an MRMC study, or a standalone algorithm performance study.

Here's what can be extracted from the document based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not applicable/Not provided. No dedicated test set for performance evaluation is described.
• Data provenance: Not applicable. The document refers to "experience of the LEVO mobil LCM" but does not detail any data, its origin (country), or whether it was retrospective or prospective.

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

• Not applicable/Not provided. No test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable/Not provided. No test set requiring an 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

• No MRMC comparative effectiveness study was done. This device is a physical medical device (stand-up electrical power wheelchair), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant in this context.

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

• No standalone algorithm performance study was done. This device is a physical medical device and does not involve a standalone algorithm in the sense of AI or software performance evaluation.

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

• Not applicable/Not provided. No ground truth is described as part of a performance evaluation. The substantial equivalence argument relies on comparing the new device's features and safety profile to an existing, legally marketed device.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" in the context of device development or testing as would be seen for an AI/ML device. The device's development leveraged "experience of the LEVO mobil LCM."

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

• Not applicable/Not provided. As no training set or ground truth in that context is mentioned, this information is not available.

Summary of what the document does state (related to safety and effectiveness):

The LEVO combi's safety and effectiveness claim is based on its substantial equivalence to the predicate device, LEVO mobil LCM (K963817). The core argument is:

• Intended Use: The LEVO combi has the same intended use as the predicate (position changes from sitting to standing and vice-versa, reclining, seat/back lift, indoor and outdoor mobility).
• Materials: Substantially equivalent materials.
• Technological Characteristics: The LEVO combi was "basically developed on experience of the LEVO mobil LCM" and has "in substantial the same technological characteristics" as the predicate.
• Changes: Minor changes (rear suspension, outdoor mobility, different controller - Pilot+ vs. PG8, and additional position capabilities like reclining to lying/relax) are highlighted.
• Conclusion: The manufacturer asserts that these minor changes "do not raise new questions of safety and effectiveness" and that the device therefore has "the same safety and effectiveness as the predicate device(s)."

This type of 510(k) submission relies on a comparative analysis rather than new, extensive performance studies for the device itself, assuming the predicate device has already established its safety and effectiveness.

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