Search Results

The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.

F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 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 to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.

This document (K191874) is a 510(k) premarket notification for a powered wheelchair, the F5 Corpus VS. It compares the device to two predicates: the Quickie® Q700-UP M (K172384) and the F5 (K143014).

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with various ISO and RESNA standards for wheelchairs. The document does not present a single table explicitly listing "acceptance criteria" against "reported device performance" in a quantitative manner for all aspects. Instead, it states compliance with standards and provides some performance specifications when comparing the device to its predicates.

Here's an attempt to compile relevant information, though a direct "acceptance criteria" column is not explicitly defined in the document for each performance characteristic:

The document emphasizes that the F5 Corpus VS passes the requirements in ISO 7176 and RESNA WC-1:2009 Section 20.

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 refers to "Non-Clinical Testing" which involves compliance with a long list of ISO standards and RESNA WC-1. These are physical performance tests for the device itself (e.g., stability, brake effectiveness, strength).

• Sample size for the test set: Not explicitly stated as a number of devices or units. Typically, for device performance testing against standards, a representative sample (e.g., a few units or prototypes) is tested. The nature of these tests does not involve patient data or human subjects for the "test set" in the context of an AI/algorithm study.
• Data provenance: Not applicable in the context of patient data for an algorithm. The tests are for the physical wheelchair device. The Permobil AB company is based in Sweden. The tests were conducted to international standards.

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 applicable as the device is a physical powered wheelchair, not an AI/algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance of the device as measured by standardized engineering and safety tests.

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

This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm study involving adjudication of clinical findings. Compliance with standards is typically measured objectively through specified test procedures.

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. The device is a physical powered wheelchair. There is no AI component or human reader in the context of medical image interpretation that would warrant an MRMC study.

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

This information is not applicable. The device is a physical powered wheelchair, not a standalone algorithm.

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

The "ground truth" for the F5 Corpus VS device is its physical performance, safety, and functional characteristics as measured and validated against established international standards (ISO 7176 series and RESNA WC-1:2009 Section 20). These standards define objective test methods and acceptable performance limits.

8. The sample size for the training set

This information is not applicable. The device is a physical powered wheelchair. There is no AI/algorithm being trained on a dataset. The design and manufacturing process would involve engineering principles and testing, not machine learning training.

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

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

Ask a specific question about this device

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.

Ask a specific question about this device