(191 days)
The intended use of the device is to provide mobility to persons limited to a sitting position.
The Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven device controlled by the MK6i™ (MK6i) electronics platform. The intended use of the device is to provide mobility to persons limited to a sitting position. Use environments include, but are not limited to, the user's home, assisted living facilities, nursing homes, vocational settings, health care facilities and outdoors on firm terrain. Adult seating has a weight limit of 300 lbs. and junior seating has a weight limit of 165 lbs.
The subject device is the next generation of the TDX Power Wheelchair with:
- Enhanced suspension and stability; ●
- Additional back and arm types as well as leg rest types; and ●
- . A new controller, the MK6i, which incorporates upgraded software.
The Invacare® TDX® SP2 Power Wheelchair includes an upgraded Gyroscope Module (G-Trac Control Module) and Enhanced SureStep® Suspension with Stability Lock.
The provided text describes the Invacare® TDX® SP2 Power Wheelchair and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria and the detailed study proving the device meets those criteria.
The document discusses performance data in terms of compliance with various ANSI/RESNA WC standards and ISO 10993 for biocompatibility. It lists a series of sections from ANSI/RESNA WC-1:2009 and ANSI/RESNA WC-2:2009. While these are standards the device was tested against, the document does not explicitly state the specific acceptance criteria (e.g., "maximum static tipper angle must be > 10 degrees") or the reported device performance against those specific criteria (e.g., "device achieved 12 degrees").
Therefore, I cannot directly populate the requested table or provide details about sample sizes, ground truth establishment, or expert involvement as those specific details are not present in the provided text.
Here is a general outline of how the requested information would be presented if it were available, based on the types of performance data mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Derived from Standard) | Acceptance Criteria (Threshold/Range) | Reported Device Performance (Actual Value/Result) |
|---|---|---|
| Static Stability (ANSI/RESNA WC-1:2009 Sec 1) | [Specific minimum angle, e.g., > 6°] | [Actual measured angle] |
| Dynamic Stability (ANSI/RESNA WC-2:2009 Sec 2) | [Specific requirements, e.g., no tip-over under defined conditions] | [Result of test, e.g., passed, no tip-over] |
| Brake Effectiveness (ANSI/RESNA WC-2:2009 Sec 3) | [Specific stopping distance or holding capacity] | [Actual stopping distance or capacity achieved] |
| Energy Consumption / Theoretical Distance (ANSI/RESNA WC-2:2009 Sec 4) | [Specific minimum distance, e.g., > 12 miles with 22NF batteries] | [Actual measured distance > 12 miles with 22NF batteries, > 15 miles with GP24 batteries] |
| Dimensions, Mass, Maneuvering Space (ANSI/RESNA WC-1:2009 Sec 5) | [Specific ranges/limits] | [Measurements provided in comparison table, e.g., 35.5" length, 25.5" width] |
| Maximum Speed, Acceleration, Deceleration (ANSI/RESNA WC-2:2009 Sec 6) | [Specific maximum/minimum values] | [Maximum speed of 5.8 mph reported] |
| Biocompatibility (ISO 10993) | [Compliance with specified parts of ISO 10993, e.g., no cytotoxicity, irritation, sensitization] | [Confirmation of compliance] |
| Electromagnetic Compatibility (ANSI/RESNA WC-2:2009 Sec 21) | [Compliance with EMC limits] | [Confirmation of compliance] |
| ... (and so on for other standards listed) | --- | --- |
Missing Information from the Provided Document:
- Specific numeric acceptance criteria: The document lists the standards applied (e.g., ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability), but does not detail what specific quantitative or pass/fail thresholds constituted "acceptance" for each standard.
- Specific reported device performance values: While some performance characteristics are given in the comparison table (e.g., Max Speed 5.8 mph, Range >12 miles), these are generally summarized or compared to the predicate, and not directly stated as "reported device performance against an acceptance criterion" for a specific test. The document states "performance testing demonstrates that these differences do not raise any new questions of safety or effectiveness," implying the criteria were met, but without providing the data.
Since the document is a 510(k) summary, it often summarizes compliance rather than providing raw test data or detailed criteria/results for every test.
Regarding the other points requested:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the document. Performance testing for medical devices like wheelchairs typically involves a fixed number of prototypes or production units, but the exact count is not here. The data would be prospective, as it involves testing the new device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in this context. For a physical device like a power wheelchair, "ground truth" isn't established by experts in the typical sense of diagnostic imaging or clinical outcomes. Instead, performance is measured against established engineering and safety standards using calibrated equipment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for reconciling expert opinions or diagnostic disagreements, not for objective engineering tests.
- 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 a physical device (power wheelchair), not an AI-assisted diagnostic tool for "human readers."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm. The device itself operates "standalone" in the sense that it functions mechanically and electronically according to its design without human intervention in its core operating principles during testing, though it requires a human user for its intended use.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a power wheelchair, the "ground truth" is compliance with international and national performance and safety standards (e.g., ANSI/RESNA, ISO). These standards define objective, measurable parameters (e.g., static stability angles, brake effectiveness, electromagnetic compatibility limits, biocompatibility requirements).
- The sample size for the training set: Not applicable. This is not an AI/machine learning model that requires a "training set." It's a manufactured physical device.
- How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).