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The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.

The purpose of this pre-market notification is to request marketing clearance from FDA to change the controller of certain power wheelchairs models, manufactured by Invacare Corporation, which have already been granted marketing clearance by FDA under separate submissions.

The controller change applies to the Invacare Pronto Powered Wheelchair Series (K012927, 9/19/2001), and the Nutron Powered Wheelchair Series (K900565, 2/15/1990). Each of these devices are battery powered, motorized mobility vehicles. Their intended function and use, which has not changed, is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.

The controller for the Nutron and Pronto Series of Wheelchairs is being modified from the Invacare MKIV-RII controller to the Invacare MKV-NX controller. The Invacare MKV-NX controller, which is the subject of this premarket notification, is an electronic, microcomputer based. motion control device designed for use with Invacare powered wheelchairs. The intended function of the controller is to activate and control powered wheelchair motions. Additionally, it provides a method of adjusting, selecting and programming certain powered wheelchair performance characteristics to better suit the specific control needs of the user.

Two versions of the controller will be available. These are the MKV-NX and the MKY-NX LP. The MKV NX version has full programming capability, while the MKV-NX LP version has limited programming capability. Programming capability for the LP version is limited to forward speed, turning speed, and reverse speed only. Otherwise the controllers are identical.

The Invacare MKV-NX and MKV-NX LP controllers are programmed using the Invacare MIV remote programmer, previously cleared with the Model MCC-MKIV Micro Computer Control (K940972, 6/2/1994). The controller software and electronics will not allow wheelchair operation during programming.

The provided text describes a 510(k) premarket notification for a modification to power wheelchairs, specifically a change in the controller. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data for the modified device.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not present in the provided text.

Here's a breakdown of what can be extracted:

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

The document states:
"The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), 'ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.'"

This indicates the types of standards against which performance was assessed. However, specific numerical acceptance criteria (e.g., maximum speed, minimum turning radius, battery life) and the actual reported performance values are not provided in this summary.

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 "the Invacare Elevating Seat" meeting standards, but doesn't specify if this refers to the new controller or a separate component, nor does it detail a specific test set, its size, or provenance.

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 and is not relevant to this type of device submission, which references engineering standards rather than diagnostic accuracy.

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

This information is not provided.

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 and is not applicable to a power wheelchair controller. This type of study is relevant for diagnostic AI devices, not mobility devices.

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

The device is a physical controller for a power wheelchair. The "performance data" refers to its ability to meet engineering safety and functional standards. The concept of "standalone" performance in the context of an algorithm's diagnostic accuracy is not applicable to this device. The controller functions as an integral part of the human-in-the-loop system (the user operating the wheelchair).

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

For this type of engineering device, "ground truth" would be established by objective measurements against the specified performance parameters in the ANSI/RESNA and ISO standards (e.g., speed measurements, control response times, stability tests). The specific method for establishing these ground truths (e.g., specific test equipment, calibrated sensors) is not detailed in this summary.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are typically relevant for machine learning algorithms. While the controller is "electronic, microcomputer based," the document does not describe it as an AI/ML device that requires a "training set" in the conventional sense. Therefore, this information is not provided and likely not applicable to this type of device submission.

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The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.

The Invacare Elevating Seat consists of a pedestal actuator, mounting weldments with mounting hardware, and a toggle control. The intended function and use of the elevating seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.

The bottom of the actuator assembly is mounted to the base of the wheelchair via the seat support weldment, which is specific to the particular wheelchair model. The top of the actuator assembly mounts to the wheelchair seat assembly via the seat mount bracket, which is specific to the seat assembly of the wheelchair. The ball drive pedestal actuator has a load capacity of 500 pounds and a maximum stroke of 8 inches. The elevating seat is available for select models of power wheelchair as a factory installed option.

The MIV Elevating Seat Toggle is standard with the elevating seat option. It is a DC brush type motor controller that is used to control the elevating actuator on power wheelchair systems with the elevating seat option installed. A double throw momentary position switch is used to drive the actuator. Current through the motor is limited and drive speed reduction occurs when the chair is in an elevated position.

The MIV Elevating Seat Toggle connects to the Power Take Off (PTO) connector of the wheelchair battery harness. Therefore, the power supply for the elevating seat toggle is taken directly from the wheelchair battery harness through a 15 amp fused power block, and the elevate function can be activated even when the wheelchair drive controls are turned off.

The MIV Elevating Seat Toggle also connects to a proximity switch, which senses when the seat is elevated. When the switch senses that the seat is elevated more than .75 inches, the speed of the wheelchair is reduced to 20% of the maximum possible speed of the chair. However, the reduced speed will not exceed the user-programmed speed.

For certain wheelchair models, the MIV TAC, a two-actuator control, is available as an option to the MIV Elevating Seat Toggle. The MIV TAC allows the elevating seat to be combined with the tilt feature of the wheelchair seating system and it allows the elevating seat to be controlled through the joystick of the wheelchair.

In addition to the features described under the MIV Elevating Seat Toggle, the MIV TAC has an additional tilt sensor that detects the overall back angle of the seating system. If the seat is tilted more than 20 degrees the elevating seat will not elevate. Also, if the seat is elevated more than .75 inches, the seat will not tilt.

The provided text describes the Invacare Elevating Seat Option, a powered wheelchair seat elevation system, seeking 510(k) clearance. However, the document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on establishing substantial equivalence to a predicate device and states that the device meets certain standards, rather than providing a detailed study proving it meets acceptance criteria with specific data.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and the Reported Device Performance

Missing Information:
The document states that the device "meets the applicable requirements" of the specified standards but does not provide specific numerical performance data against quantifiable acceptance criteria within those standards. For example, it doesn't say "the device was tested for stability according to RESNA WC/14 section X and passed with a value of Y," or "the device's power consumption was Z, meeting the requirement of

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To provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
To provide mobility to persons limited to a seated position.

The Invacare Models Ranger II and Power 9000 front wheel drive power wheelchairs are battery powered, motor driven devices with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. They are non rigid, or "folding" type, front wheel drive power wheelchairs.
The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and Joystick. They are powered by two Size 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chairs will travel approximately 17 to 22 miles between charges, depending on use.
The wheelchairs consist of two basic sub-sections. These are the base section of the wheelchair, and the seating section of the wheelchair. Both are of welded steel construction. The base section includes the base frame, front drive wheels and axles, rear pivoting casters, motor/gearbox drive mechanism and batteries. The motor/gearbox location is adjustable, relative to the upper seating frame. This adjustment is used to compensate for weight and balance shift, which are both user dependent.
The seating, or upper section of the wheelchair, includes the seating upholstery, front foot rests, side arm rests, and joystick operating control. Seating sizes range from 14" wide to 20" wide, depending on user needs. The wheelchair motor controller is mounted to the side arm and under the backrest of the seat. The upholstery material is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 117 and Boston Fire Department BFD-1 specifications for fire retardancy.

This is a medical device application for a power wheelchair, K982064, which is a physical device and not an AI/ML algorithm. Therefore, the questions related to AI/ML specific performance, ground truth, and study designs are not applicable.

However, I can extract information regarding its performance testing.

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

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

The document does not specify the sample size for the devices tested or the data provenance. It refers to a general test against a standard.

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, as this is a physical medical device (power wheelchair) and not an AI/ML algorithm requiring expert-established ground truth. Performance was assessed against an engineering standard.

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

Not applicable, as this is a physical medical device subject to engineering standard testing, not human-read assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is a physical medical device and not an AI/ML system.

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

Not applicable, as this is a physical medical device and not an AI/ML algorithm. The performance described is the standalone performance of the physical device.

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

The "ground truth" or reference for performance was compliance with the ISO EMC Draft Standard 7176-14.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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

Not applicable, as this is a physical medical device and not an AI/ML algorithm.

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