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SOLO+, SOLO and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

The subject devices SOLO, SOLO+ and SERVO are power-wheelchair-conversion-kits that add powered propulsion to a manual wheelchair, thereby, turning a manual wheelchair into a powered wheelchair. They consist of two powered wheels (each incorporating an electrical motor) a control unit with its bracket and a battery pack. A battery charger and a bag for the battery pack are included in the delivery as well. The powered wheels substitute the conventional manual wheels from selected wheelchairs. The battery-pack and the controller-unit can easily be attached to the wheelchair. Speed, acceleration and deceleration are microprocessor-controlled. A preselection of the maximum speed can be done with buttons on the control unit. The wheelchair will accelerate or drive with steady speed when the joystick (SOLO and SOLO+) or the hand-rims (SERVO) are pushed into the travel-direction. The motors will steadily reduce the driving force until the wheelchair stops if no driving-signal (deflection of the joystick or the rim) is provided. The safety-brakes lock automatically when the wheelchair stopped (SOLO, SOLO+). The manual parking brakes can also be used to prevent unintended movement. After ten minutes of non-use the device turns off automatically. The powered wheels can be disengaged if the user wants to drive with manual propulsion, only.

The provided document describes the Food and Drug Administration's (FDA) substantial equivalence determination for the AAT Alber Antriebstechnik GmbH's SOLO+, SOLO, and SERVO powered wheelchair conversion kits (K142770). It specifies the devices, their intended use, and a comparison to a predicate device. The document details the non-clinical tests performed to demonstrate substantial equivalence to legally marketed predicate devices, focusing on various ISO standards.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it refers to performing non-clinical tests according to recognized standards. The "reported device performance" is generally stated as meeting these standards or being similar to the predicate device, implying compliance with the standards' requirements.

However, a comparison table and a discussion of differences between the subject device (SOLO / SOLO+ / SERVO) and the predicate device (e-motion, K003449) are provided, which indirectly indicate performance attributes.

Acceptance Criteria (Implied by Standards Met):

The device is deemed to meet acceptance criteria by conforming to the following recognized standards:

• Static stability: ISO 7176-1: Determination of static stability.
• Dynamic stability: ISO 7176-2: Determination of dynamic stability.
• Brake effectiveness: ISO 7176-3: Determination of effectiveness of brakes.
• Power system effectiveness (range): ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance.
• Speed, acceleration, deceleration: ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
• Measurement comparability: ISO 7176-7 and ANSI / RESNA WC-1:2009 section 7: method of measurement of seating and wheel dimensions.
• Mechanical strength and durability: ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
• Climatic tests: ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs.
• Load tests comparability: ISO 7176-11 Wheelchairs - Part 11: Test Dummies.
• Driving and braking tests comparability: ISO 7176-13 Wheelchairs – Part 13 Determination Of Coefficient Of Friction Of Test Surfaces.
• Electrical safety, software-validation and performance: ISO 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods.
• Electromagnetic compatibility: ANSI/RESNA wc/ vol.2 and ISO 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
• Biocompatibility: ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.

The document states that the devices are "as safe, as effective and perform as well as the predicate device" based on these non-clinical tests, implying that the performance meets the necessary standards for substantial equivalence.

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

The document explicitly states that non-clinical tests were performed. These types of tests typically involve testing the physical devices themselves (e.g., a sample of the SOLO, SOLO+, and SERVO models) under controlled laboratory conditions, rather than a "test set" of patient data as might be relevant for AI or diagnostic devices.

The document does not specify the sample size for the devices tested (e.g., number of units of each model).

The data provenance is not explicitly stated as country of origin or retrospective/prospective. However, given that it's a submission to the U.S. FDA by AAT Alber Antriebstechnik GmbH (Germany-based company), the tests were likely performed either in Germany or by a certified testing facility relevant to international standards (ISO). The testing is prospective in the sense that the tests were conducted for the purpose of this submission to demonstrate compliance and substantial equivalence before commercial distribution. It is not retrospective data from real-world usage.

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

This information is not applicable to this type of device and submission. The tests performed are non-clinical, mechanical, electrical, and materials-based assessments against recognized engineering and medical device standards (ISO). There is no "ground truth" derived from expert interpretation of clinical data in the way one would for an AI diagnostic device. The "ground truth" here is the physical performance of the device measured against the established parameters and limits of the ISO standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. "Adjudication" typically refers to resolving discrepancies in expert interpretations or clinical outcomes. In non-clinical engineering tests, the results are quantitative measurements against predefined criteria in the 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

This information is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where AI assistance might improve their performance. The SOLO+, SOLO, and SERVO are powered mobility devices, not diagnostic or AI-powered devices, and therefore an MRMC study would be irrelevant.

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

This information is not applicable. These devices are not AI algorithms. They are electromechanical devices with microprocessors controlling speed, acceleration, and deceleration, but this is embedded control logic, not a "standalone algorithm" in the context of an AI device. The phrase "algorithm only without human-in-the-loop performance" specifically refers to AI models making decisions independently, which is not what these devices do. They assist a human user in propelling a wheelchair.

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

As discussed in point 3, for these non-clinical tests, the "ground truth" is established by the definitions and quantitative limits within the referenced ISO and ANSI/RESNA standards. For example:

• For static stability (ISO 7176-1), the ground truth is whether the device remains stable at specified angles.
• For brake effectiveness (ISO 7176-3), the ground truth is whether the brakes can stop the device within specified distances or hold it on a specified incline.
• For biocompatibility (ISO 10993-5), the ground truth is the chemical and biological response of materials.

There is no expert consensus on clinical findings, pathology, or outcomes data involved in these specific tests for this device.

8. The sample size for the training set

This information is not applicable. These are not machine learning or AI devices that require a "training set" of data.

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

This information is not applicable as there is no training set.

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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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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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