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The intended use of the Model DX Micro-Computer Control is to activate and control power wheelchair motion.

The Model Dx Controller is a series of electronic, microcomputer based, motion control devices for use with power wheelchairs. Their intended function and use is to activate and control power wheelchair motion. Additionally, they provide a method of adjusting, selecting and programming the type of power wheelchair performance characteristics which best suit the specific control needs of the wheelchair user. The Dx product line includes a motor controller power module with microprocessor, and a variety of joystick options and accessories which are used to perform various functions. The power module, which contains the system microprocessor, is housed in a pressure die cast aluminum enclosure. The power module stores preprogrammed operating functions, processes user inputs and issues commands to the wheelchair motors. The joystick options are used to engage wheelchair motion and to steer the chair. The options and accessories are used to program the wheelchair performance parameters and to perform additional functions as needed by the wheelchair user.

This submission does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a diagnostic or AI-driven device would. The Invacare Model Dx Micro-Computer Controls for Power Wheelchairs is a control system for mobility, and the provided document focuses on its substantial equivalence to previously cleared predicate devices and its compliance with a relevant ISO standard for safety and performance in its operational context.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when the information is not present:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: The primary acceptance criterion mentioned is compliance with ISO 7176:1993(E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." Specific quantitative criteria within this standard are not listed in the provided text (e.g., maximum speed deviation, response time, etc.).
   • Reported Device Performance: The document states: "Results indicate that the Dx Controller meets the requirements of this standard." No specific performance metrics or values are reported beyond this general statement of compliance.

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 text. The document mentions "tested for compliance," but does not detail the nature of the test set (e.g., how many wheelchairs, how many controllers, data 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 question is more applicable to diagnostic devices or those requiring expert interpretation of results. For a power wheelchair control system tested against an ISO standard, "ground truth" would typically refer to objective measurements of the device's performance against the standard's specifications, not human expert consensus on interpretations. Therefore, this information is not applicable/not provided in the context of this device and study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Similar to point 3, adjudication methods are typically used for expert review and consensus in studies involving subjective interpretation (e.g., medical image assessment). For compliance testing against a technical standard, objective measurement and verification are expected, not expert adjudication. This information is not applicable/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 device is not an AI-assisted diagnostic tool. An MRMC study is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   • This concept is typically relevant for AI algorithms. While the Dx Controller is a "microcomputer-based" system, its function is inherently "human-in-the-loop" as it takes user input (joystick) to control wheelchair motion. The compliance testing would assess the system's performance as a control system, which inherently involves its interaction with the wheelchair and a user's input, even if testing is automated to simulate user input. A "standalone" performance without the concept of user interaction or the wheelchair it controls is not applicable in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • For this device, the "ground truth" is defined by the specifications and test methods outlined in ISO 7176:1993(E). Performance measurements were taken and compared against the defined thresholds and requirements of this international standard.

8. The sample size for the training set
   • This question pertains to machine learning models. The Dx Micro-Computer Control is a deterministic, pre-programmed control system, not a device that learns from a training set. Therefore, a "training set" is not applicable.

9. How the ground truth for the training set was established
   • As there is no training set for this type of device, this information is not applicable.

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The Action Cat Scooter with DS60 Controller is intended to be used to provide mobility to persons restricted to a seated position.

As indicated above, the Action Cat Scooter with DS60 Controller is intended for use to provide mobility to persons restricted to a seated position. The scooter has a total weight of 160 pounds (including batteries), and its overall width, track, and wheelbase are 24", 34", and 46", respectively. All upholstery on the device is flame rated to FMVSS302 and CMVSS302. The maximum grade is 9 degrees with a 300 pound load, and the leakage current is less than 100 amperes. The maximum load is 300 pounds, and the maximum speed for the scooter is 5 (±1) mph. The scooter does not have separate "slow," "normal," and "fast" speed control modes; instead, the speed of the vehicle simply is determined on a continuous range by how far the user pushes the speed control bar/tiller.

The braking system for the scooter is electromechanical. Activation of the throttle speed control (either forward or reverse), causes the engagement of an electromagnet which overcomes spring pressure and releases the brake. Releasing the throttle causes the motor control board to induce dynamic braking and reduce speed. Once motor revolution reaches zero, the electromagnet will release, allowing the spring pressure to apply the brake. As an additional feature, the scooter will not operate if the brake is disconnected. The brake is designed to hold a 400 pound load on a 15 degree incline. On level ground with dry conditions and a 300 pound load, braking time from a top speed of 6 mph to zero is 1 second and requires a distance of 5 feet.

The Action Cat Scooter with DS60 Controller uses two 12 volt gel cell batteries. The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 25 miles. The front approach angle for the Action Cat Scooter with DS60 Controller is 71 degrees, and the rear departure angle is 13 degrees. At the scooter's center, the ground clearance from the chassis is 3.0". Likewise, the maximum curb clearance is 3.0". The breakover angle is 10 degrees, and the minimum radius at which the Action Cat Scooter with DS60 Controller will not tip (at maximum speed) is 6 feet.

The controller for the scooter is a Model DS60 system for DC motor control applications. The DS60 Controller is designed to operate with a nominal 24 volt battery input and to yield a maximum output current of 60 amperes. It also is designed to control a single conventional permanent magnet DC motor with a solenoid-controlled motor brake. The controller incorporates motor load compensation which provides precise motor control over a wide range of driving conditions, thereby maintaining the selected speed of the scooter at a constant level, regardless of the surface type or grade on which the vehicle is driven. This feature ensures less roll-back when stopping the Action Cat Scooter on a slope. The correct level of load compensation depends on the type of motor used and the length of the wiring, and is easily set using the separate handheld DS Programmer.

The programmable features of the DS60 Controller include forward/reverse acceleration, forward/reverse deceleration, motor resistance, etc. It should be noted, however, that although the DS60 Controller for the modified Cat Scooter is programmable, all parameters for the controller will be set only by the factory (i.e., Invacare) prior to sale, and no modifications will be made by either the retailer or the user of the scooter. The DS100 Programmer will not be available for purchase.

The DS60 Controller is a single printed circuit board fixed to an aluminum base. A plastic vacuum-molded case protects the electronics of the DS60 Controller. The DS60 Controller also is protected against accidental reverse battery connection.

Several accessories are available through Invacare for the modified Action Cat Scooter. These options are: a basket, antitipper components, a flat-free insert, an extended throttle lever, a safety flag, a crutch/cane carrier, and a spare key set. The Action Cat Scooter with DS60 Controller also is available in a compact style which measures 43½ inches in length (versus 50" for the regular size scooter).

This 510(k) summary describes a powered scooter, the "Action Cat Scooter with DS60 Controller," and compares it to a predicate device, the "Invacare Cat Scooter (K941966)." The document focuses on demonstrating substantial equivalence rather than presenting a performance study with specific acceptance criteria in the way a medical device utilizing AI/ML might.

Here's an analysis based on your request, with the understanding that the provided text is for a mechanical device and not an AI/ML powered medical device, thus many of your requested fields are not applicable:

Analysis of Acceptance Criteria and Study for the Invacare Action Cat Scooter with DS60 Controller

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are largely defined by regulatory standards met and direct comparison to a predicate device's established performance and specifications. The document highlights the device meeting an ISO draft standard for electromagnetic compatibility and various performance tests.

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

• Sample Size: Not explicitly stated as a numerical sample size of devices tested. The language indicates "the Action Cat Scooter with DS60 Controller was tested," implying at least one unit was subjected to the described tests.
• Data Provenance: The tests were conducted internally by Invacare Corporation ("Invacare... was tested," "tests performed voluntarily by Invacare"). There is no mention of country of origin for the data or if it was retrospective or prospective, as this is a new device being qualified against standards for market entry.

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

• Experts/Ground Truth: Not applicable in the context of this mechanical device. The "ground truth" here is compliance with engineering specifications, safety standards, and functional performance, which would be assessed through objective measurements and standard test protocols, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance is measured against physical specifications and regulatory standards, not subjective interpretations 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

• MRMC Study: Not applicable. This is a mechanical mobility device, not a diagnostic medical device involving human interpretation of data (e.g., medical images) with or without AI assistance.

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

• Standalone Performance: Not applicable. While the device contains a "digital controller," it is not an AI/ML algorithm acting in a standalone diagnostic or decision-making capacity. It's a control system for a mechanical device, inherently designed for human operation (human-in-the-loop).

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 established engineering specifications, safety standards (e.g., flame rating, leakage current), and functional requirements (e.g., maximum speed, braking distance, grade capability). These are objectively measurable physical properties and performance metrics. Substantial equivalence is also a key "ground truth" metric, relying on direct comparison of specifications to a predicate device.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the controller involves factory programming of parameters, not machine learning from a dataset.

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

• Training Set Ground Truth: Not applicable. As there is no AI/ML training set, there is no ground truth established for one. The programmable features of the DS60 controller are "set only by the factory (i.e., Invacare) prior to sale," based on engineering design and performance optimization, rather than a data-driven ground truth.

Summary of the Study:

The "study" described in the 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device (Invacare Cat Scooter K941966) and compliance with regulatory standards for powered wheelchairs and motorized scooters.

• The key test explicitly mentioned is compliance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibiliity Addition" And Dated April 3, 1995). The device "met the required performance criteria and functioned as intended" in all instances of this test.
• Additionally, the document states the device "passed a number of performance tests performed voluntarily by Invacare." While specifics of these voluntary tests are not detailed, they would likely cover the various specifications listed (e.g., maximum speed, braking, grade capability, anti-tipping, range, etc.).
• The primary method of demonstrating acceptance is through direct comparison of specifications and features to the predicate device, highlighting that "The predicate motorized three-wheeled vehicle is nearly identical to the Action Cat Scooter with DS60 Controller and has the same intended use." The differences (digital vs. analog controller, increased weight limit, onboard charger, compact model, adjustable seat) are deemed "minor and raise no new questions of safety and effectiveness."

In essence, the "study" is a combination of direct specification comparison and compliance testing against relevant engineering and regulatory standards, rather than a clinical or AI/ML performance study.

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