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The intended use of the ELECTRO powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Electro series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

Electro Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VSI 70 amp controller. The user interface is a joystick. The Electro is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25 km (16 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (motor, gear, brake), batteries and back pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided document is a 510(k) summary for a powered wheelchair, the Permobil Electro. It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-enabled medical devices.

Here's why and what information is missing:

This 510(k) submission is for a traditional medical device (a powered wheelchair) and precedes the widespread adoption and specific regulatory requirements for AI/ML-enabled devices. Therefore, the performance data section is very brief and focuses on the device functioning as intended and its substantial equivalence to a predicate device, rather than quantitative performance metrics against specific acceptance criteria.

Missing Information:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or report detailed performance metrics for the Electro powered wheelchair in this format. The "Performance Data" section simply states, "In all instances, the Electro functioned as intended."
2. Sample size used for the test set and the data provenance: Not applicable. Performance for a powered wheelchair typically involves engineering testing for safety and functionality, not a "test set" of data in the AI/ML sense.
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 an AI/ML device, refers to a verified label or diagnosis. For a powered wheelchair, this is not relevant.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. MRMC studies are specific to image interpretation or diagnostic aid effectiveness, not powered wheelchairs.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Electro is a physical device, not an algorithm.
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. The Electro is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about performance and equivalence:

• Performance Data: "In all instances, the Electro functioned as intended." This is a qualitative statement indicating that engineering and functional tests showed no failures.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to a predicate device: the Chairman 2k (K991658).
  • The Electro has the "same intended uses and similar indications, technological characteristics and principles of operation" as the predicate device.
  • "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness."
  • "Performance data demonstrate that the Electro is as safe and effective as the Chairman 2K." This performance data would typically be in the form of engineering tests, bench testing, and potentially some limited user testing to confirm basic functionality, stability, braking, speed, etc., rather than clinical study data with specific quantitative metrics.

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The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided text describes a 510(k) submission for a powered wheelchair named "STREET" (K032765). This is a traditional medical device submission, focusing on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device through a study with acceptance criteria.

Therefore, many of the requested categories (such as acceptance criteria, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

The document primarily focuses on demonstrating that the STREET wheelchair is safe and effective by showing its substantial equivalence to a previously cleared predicate device, the Quantum Blast (K011993).

Here's a breakdown of the information that is available in the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. The 510(k) submission for this powered wheelchair does not detail specific acceptance criteria or performance metrics in a way that would be typical for an AI/ML device. Instead, it relies on demonstrating that its technological characteristics and intended use are substantially equivalent to a predicate device.

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

• Not Applicable. This is a hardware device (powered wheelchair). There is no "test set" in the context of an AI/ML algorithm. The performance is assessed through non-clinical testing and comparison to the predicate device. The information provided does not specify any particular sample size or data provenance related to a test set.

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

• Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this powered wheelchair submission. Safety and effectiveness are demonstrated via engineering design, compliance with relevant standards (not explicitly detailed in this summary but implied by the 510(k) process), and substantial equivalence to a predicate.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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/ML device, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

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

• Not Applicable. This is a powered wheelchair; it does not have a standalone algorithm in the sense of an AI/ML device.

7. The Type of Ground Truth Used

• Not Applicable. There is no "ground truth" as it would be understood for an AI/ML algorithm. The safety and effectiveness are established through engineering principles, adherence to manufacturing practices, and comparison to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device; there is no "training set" in the context of an AI/ML algorithm.

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

• Not Applicable. See point 8.

Summary of Relevant Information from the Provided Text:

• Device Name: STREET Powered Wheelchair
• Predicate Device: Quantum Blast (K011993) manufactured by Pride Mobility.
• Intended Use: To provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
• Safety and Effectiveness Justification: "The STREET has in substantially the same intended use and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device."

Conclusion:

The provided document describes a traditional 510(k) submission for a physical medical device (a powered wheelchair). The framework for acceptance criteria and study design requested in the prompt is specific to AI/ML-driven devices, which this product is not. The "study" described is the process of comparing the STREET wheelchair to its predicate device, the Quantum Blast, through non-clinical testing and characterization of its technological features to demonstrate substantial equivalence.

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The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position.

Powered wheelchair, battery-operated device with wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class II. The indoor use is depending of available space.

The Permobil powered wheelchair TRAX is rear wheel driven, battery powered, motor driven and is controlled by the Permobil wheelchair controller SAFEGATE. The user interface is a joystick manufactured by Sakai for proportional control of the speed and the steering.

The wheelchair is powered by two 12V 97 Ah gel batteries.

Theoretical driving range on the fully charged batteries is 30 - 50 km depending of the terrain the chair is driven on.

The wheelchair consists of the following basic sub-sections:

• · Base with two direct-drive units with integrated parking brakes, two 10"x3" rear wheels, suspension with stabilizer and two 12V 97Ah batteries.
• Extendable and pivoted front, length adjustable 0-200 mm (0-8"), teleflex . wire steering, suspension and two 8"x2,5" front wheels.
• SAFEGATE TRAX Power electronics. .
• · Seating system.

The base is of welded steel construction with laser cut sheet details. The direct-drive units consist of two 12V DC permanent magnet motors with gears and integrated parking brakes.

I am sorry, but based on the provided document, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not available.

The document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair TRAX. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance acceptance criteria and a study to prove they are met for the TRAX device itself.

Here's what the document does include:

• Intended Use: "to provide indoor and outdoor mobility to persons restricted to a sitting position."
• Description of the Device: Details on its components (base, drive units, batteries, steering, seating system).
• Substantial Equivalence Claim: States that the TRAX is substantially equivalent to predicate devices (Max90 (K870224) and Exterior (K870225)) with respect to intended use, energy source, and materials.
• Safety and Effectiveness Claim: States that the TRAX has "in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the design changes declared in this submission do not raise new questions of safety and effectiveness."

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document's purpose is to argue for substantial equivalence to already approved devices, implicitly relying on the predicate devices having met necessary performance and safety criteria. It does not detail specific acceptance criteria for the TRAX and then a study showing how the TRAX met those specific criteria.

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The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility to persons restricted to a sitting position.

The Permobil powered wheelchair 1280 is front wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact powered wheelchair controller Pilot +. The joystick is integrated in the controller. The wheelchair is powered by two 12V 73 Ah batteries. Theoretical driving range on the fully charged batteries is 35 km. The wheelchair consists of two basic sub-sections. These are the base with motor controller and the body supporting system. In this submission, only the design changes made to base is included. The base is of welded steel construction and includes the base frame, front drive wheels with drive unit (motor/gear/brakes), batteries and pivoting rear casters. The motor controller is mounted to the left or right armrest, depending on user needs. The motor controller, including the joystick, is housed in a pressure die cast aluminum enclosure.

This document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair 1280. It concludes that the device is substantially equivalent to predicate devices and does not raise new questions of safety and effectiveness due to minor design changes.

Based on the provided text, the Permobil Powered Wheelchair 1280 is not an AI/ML device and therefore the concept of "acceptance criteria" for AI performance, "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "MRMC study," or "standalone performance" do not apply in the context of this traditional medical device submission.

The document discusses the "substantial equivalence" of the Permobil Powered Wheelchair 1280 to existing predicate devices (Permobil Chairman L/CS 8 (K960951) and G-424 power wheelchair (K983677)). Substantial equivalence is the primary regulatory pathway for many devices, where the new device is compared to a legally marketed predicate device.

Here's an analysis of what is provided, framed in terms of a traditional medical device submission, and how it relates to the questions:

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

• Acceptance Criteria (Implied by Substantial Equivalence): The Permobil Powered Wheelchair 1280 must have "substantially the same technological characteristics and the same safety and effectiveness as the predicate device(s)." The "minor design changes declared in this submission do not raise new questions of safety and effectiveness."
• Reported Device Performance: The document does not provide a table of performance metrics in the way an AI/ML study would. Instead, it asserts its equivalence based on:
  • Intended Use: Identical to predicate device(s) ("to provide indoor and outdoor mobility to persons restricted to a sitting position").
  • Energy Source: Identical to predicate device(s).
  • Materials: Identical to predicate device(s).
  • Key Changes: Frame suspension and use of Penny & Giles Pilot + controller instead of PG8 controller. The document explicitly states these changes do not raise new questions of safety and effectiveness.
  • Theoretical Driving Range: 35 km on fully charged batteries (this is a performance spec, but not tied to a specific "acceptance limit" or comparison in a table within this document).

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

• Not Applicable. This is not an AI/ML study. Performance is asserted through comparison to predicate devices, and the inherent safety/effectiveness of its components (e.g., standard wheelchair frame, motor, battery, controller). There is no "test set" in the sense of a dataset for an algorithm.

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 in the context of AI/ML evaluation. Regulatory review is performed by FDA staff (e.g., Division of General and Restorative Devices).

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

• Not Applicable. No "test set" 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:

• Not Applicable. This is not an AI/ML device, so no MRMC study, human readers, or AI assistance is involved.

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

• Not Applicable. This is a hardware medical device (a powered wheelchair), not an algorithm.

7. The type of ground truth used:

• Not Applicable. No "ground truth" in the AI/ML sense. The "truth" for this submission revolved around demonstrating that the device's design, materials, and function align with established safe and effective powered wheelchairs (the predicate devices).

8. The sample size for the training set:

• Not Applicable. No training set for an algorithm.

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

• Not Applicable. No training set for an algorithm.

In summary: The provided document is a 510(k) submission for a non-AI powered wheelchair. The "acceptance criteria" are implicitly defined by the FDA's substantial equivalence requirements, which focus on comparing the device's intended use, technological characteristics, and safety/effectiveness to previously cleared predicate devices, rather than a quantifiable performance study against a ground truth dataset as would be seen for an AI/ML device.

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