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The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.

The proposed device is an update to the previously cleared iBOT® PMD (K210920). The device retains all the following from the original device including:

The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.

The device still includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.

The device still utilizes the primary components of a stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger. It can also be produced without the stair climbing function.

The device still allows occupied transportation while an individual is seated in through both a 4-point tie down system and a docking system.

In addition, the device incorporates the following updates to the iBOT® PMD design:

• · Modified the device to add the Motion Concepts Modular Power Positioning Seating System (K150574) as an option / accessory which includes greater degrees of posterior tilt, power recline with shear reduction, and power elevating legrests
• · Adds anterior tilt to the power positioning options available on the product
• · Adds the existing power seat elevation to the Standard Mode of the device
• · Updates that operator of the chair can be the occupant or an attendant to increase clarity
• · Updates contraindications to increase clarity
• · Adds optional seat interface brackets that include seat height and static tilt angle adjustments
• · Minor redesign of front casters and changes of materials / processes in support of design for manufacturing efforts
• · Software revisions / changes
• · Removes the contraindication for a mechanical ventilator mount can be added to the device, when the device is modified to remove stair and balance modes.

This document is an FDA 510(k) summary for a medical device called the "iBOT® PMD," a stair-climbing wheelchair. It describes an updated version of a previously cleared device. The purpose of this 510(k) is to demonstrate that the updated device is substantially equivalent to the predicate device, meaning it is as safe and effective.

Based on the provided text, the device in question is a Stair-Climbing Wheelchair (iBOT® PMD). The context of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to the regulatory requirement that the updated device must demonstrate substantial equivalence to its predicate device through performance testing and compliance with recognized standards.

Here's the breakdown of the information requested:

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

The document doesn't explicitly list "acceptance criteria" in a quantitative sense as might be seen for a diagnostic AI device (e.g., target specificity/sensitivity). Instead, the acceptance criteria are implicitly satisfied by demonstrating compliance with a long list of recognized performance standards for wheelchairs and related components. The "reported device performance" is essentially a comparison of the updated iBOT® PMD's specifications against those of its predicate device, as well as the results of compliance testing to the listed standards.

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 lists performance standard compliance (e.g., ISO 7176 series, IEC 62133-2) and general statements like "The following performance testing was conducted to demonstrate that the proposed device complies..." and "A summary of the testing performed is provided below."

• Sample Size: The document does not specify the sample size for object testing (e.g., number of wheelchairs tested). This type of testing typically involves a small number of production units (e.g., 1-3 devices) to demonstrate compliance with engineering standards.
• Data Provenance: Not specified, but generally, such regulatory testing is performed in controlled lab environments as part of the device manufacturer's design verification and validation activities. It is inherently prospective testing against predefined specifications and standards. Country of origin for testing is not mentioned but would typically be where the manufacturer or their chosen test labs are located.

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 product is a physical medical device (stair-climbing wheelchair), not an AI/ML-based diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts (like radiologists for imaging) is not applicable in the same way. The "ground truth" for this device's performance is established by engineering standards and direct physical testing against those standards. The expertise comes from the engineers and technicians performing the tests and validating the design against the requirements of the standards (e.g., ISO, IEC).

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

Not applicable for a physical device's performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging AI where human readers might disagree. For device performance testing, results are typically objective measurements against a standard.

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-assisted diagnostic device. The study described is an engineering performance validation and comparison to a predicate device, not a human reader study.

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

Not applicable. This is not an algorithm-only device. Its performance is demonstrated through its physical functions and safety features.

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

The "ground truth" for this device lies in its compliance with internationally recognized performance and safety standards (e.g., ISO 7176 series for wheelchairs, IEC 62133-2 for batteries) and its demonstrated substantial equivalence to the previously cleared predicate device. This is primarily a technical and objective "ground truth" established through physical testing and measurement.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for physical device performance validation.

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The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc.

The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position.

The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.

The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°.

The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.

The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.

Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.

The Modula Power Standing System (MPSS) aims to add standing (and other features) to a power wheelchair. The relevant information from the provided text has been extracted for your request. It should be noted that this is a 510(k) summary, and as such, detailed study information like sample sizes for test sets, the number and qualifications of experts, adjudication methods, and explicit effect sizes for human improvement with AI assistance are typically not part of such submissions, particularly for mechanical devices without AI components.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria (Performance Data) and Reported Device Performance

The acceptance criteria for the Modular Power Standing System (MPSS) are demonstrated by adherence to various ISO standards and by exhibiting similar technological characteristics to the predicate device (Levo C3) and a reference device (Motion Concepts Modular Power Positioning System). The 'Reported Device Performance' columns below reflect the characteristics of the Subject Device (MPSS) as provided in the comparison table.

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

• Sample Size: The document does not specify a "sample size" in terms of subject count for clinical testing. Instead, the performance data refers to various engineering and materials testing (biocompatibility, software, electrical, mechanical). For mechanical and electrical tests, it's typically performed on a limited number of device units rather than a "sample size" of users.
• Data Provenance: The testing appears to be internal verification and validation testing performed by Motion Concepts. There is no mention of country of origin for data or whether it was retrospective or prospective in the context of user studies.

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

• This information is not provided in the document. The testing described is primarily engineering-based, not clinical trials requiring human expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as the testing is not based on expert review or adjudication of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." The device is a mechanical system, not an AI or imaging device that would typically undergo such a study.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a mechanical device and does not involve AI assistance for human readers.

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

• Not applicable, as this is a mechanical device; there is no "algorithm only" performance study in the context of AI or diagnostic interpretation. The device's performance is its direct mechanical functionality.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized international technical standards (ISO). For example, static stability (ISO 7176-1) is a directly measurable property against a standard, not subject to expert consensus or pathology. Biocompatibility is verified against ISO 10993 standards using laboratory tests.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical product; there is no "training set" in the context of machine learning or AI algorithms.

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

• Not applicable, as there is no training set for this type of device.

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The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.

The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K141783) with the MK6i™ control system and Formula™ CG Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:

• . The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface,
• The Ultra-Low Maxx™ Seating System, and ●
• Minor changes to mechanical components such as rim inserts and new colours. .

The TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with centre-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

This document describes acceptance criteria and testing for the Invacare® TDX® SP2 Power Wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance:

The document highlights conformity to various ISO, IEC, ANSI, CAL, and EN standards for different aspects of the wheelchair's hardware, software, and materials. Due to the nature of the device (a configurable power wheelchair) and the submission type (510(k) for substantial equivalence), the acceptance criteria are primarily described as meeting the requirements and passing the tests of these recognized standards. The reported device performance is generally stated as meeting these requirements and demonstrating substantial equivalence.

Here's a summary derived from the document, focusing on categories rather than specific numerical values where not explicitly provided for the subject device in comparison tables:

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

The document states: "Because the subject Invacare® TDX® SP2 Power Wheelchair is highly configurable Power Wheelchair (PWC), intended to serve a diverse population with unique individual needs, a wide variety of options and accessories have been designed. However, due to the highly customizable nature of the subject device, testing to every possible combination would not be practical. However, every design feature of the subject device was verified. This was accomplished by identifying the specific wheelchair configurations that represent the full range of product permutations."

• Sample Size: The exact numerical sample size for "test sets" (e.g., number of individual wheelchairs or components tested) is not explicitly provided. Instead, it indicates that "specific wheelchair configurations that represent the full range of product permutations" were identified and tested for each design feature. This implies a comprehensive, representative testing approach rather than a fixed "sample size" in the sense of clinical trials.
• Data Provenance: The testing was "Non-clinical Test" and "Software Verification Testing" performed on the "subject Invacare® TDX® SP2 Power Wheelchair." This indicates that the data was generated through laboratory testing by the manufacturer (Invacare Corporation) as part of their design verification process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as it was non-clinical laboratory testing.

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

This information is not applicable to this submission. The device is a physical product (power wheelchair) and the testing performed is non-clinical laboratory testing against established engineering and safety standards (ISO, IEC, etc.). The "ground truth" is defined by the technical specifications and performance limits set by these international standards, not by expert consensus on clinical diagnoses or interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing is non-clinical laboratory testing against defined standards, there is no ambiguity or subjective interpretation requiring adjudication by multiple parties or a specific method like 2+1 or 3+1. The tests yield objective results (e.g., pass/fail for a specified load, speed, or range).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation (e.g., radiologists reading images) is involved, and the AI's assistance to human readers is being evaluated. This submission is for a physical medical device (power wheelchair) and involves non-clinical performance and safety testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

While not an "algorithm only" in the sense of an AI diagnostic tool, the non-clinical tests performed on the physical wheelchair and its software are effectively "standalone" tests in that they evaluate the device's performance against defined criteria without active human intervention in the loop of the specific test itself (beyond setting up and observing the test). For example, stability tests, braking tests, and energy consumption tests are direct measurements of the device's inherent capabilities. The "Software Verification Testing" also falls into this category, assessing the software's functionality independently.

7. The Type of Ground Truth Used:

The ground truth used for these tests is objective performance specifications and safety requirements defined by internationally recognized standards (e.g., ISO 7176 series for wheelchairs, IEC 62304 for software, ISO 10993 for biocompatibility, flammability standards). The device's performance characteristics are measured and compared against the limits and criteria set forth in these standards.

8. The Sample Size for the Training Set:

This information is not applicable. This is a 510(k) submission for a physical medical device based on engineering and safety testing, not a machine learning or AI-driven diagnostic device that would typically involve a "training set" of data.

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

This information is not applicable for the same reason as point 8.

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