(178 days)
The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.
The Invacare 3G Tarsys is a battery powered, motorized seating system designed for use with power wheelchairs. The seating system is rated for 300 pounds. Tilt only and recline only versions are rated for 400 pounds. An electrically operated linear actuator drives the tilt and recline functions with weight balance maintained through the stability of the base. The recline function incorporates a mechanical sliding back mechanism to reduce back shear as well as optional power elevating leg rests. The elevate function is driven by an electrically operated linear ball screw actuator mounted in a vertical fashion and allows the seat to be elevated to a maximum of 7" ± .25". The tilting, reclining and elevating systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline/elevate system, a combination of tilt/recline, tilt/elevate or as separate tilt only, elevate only systems depending on the user's needs. The joystick in conjunction with the Tilt Recline Elevate Control Mechanism (TRECM) and the Invacare MK V EX controller activates the power positioning modules.
This response is based on the provided text, which is a 510(k) summary for the Invacare 3G Tarsys seating system. The document focuses on regulatory approval based on substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria. As such, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert ground truth, and comparative effectiveness studies, is not present in the provided text.
Here's an analysis of what can be extracted and what is missing:
Invacare 3G Tarsys Seating System: Acceptance Criteria and Study Details
The provided 510(k) summary describes the Invacare 3G Tarsys seating system, a battery-powered, motorized seating system for power wheelchairs, and seeks to establish its substantial equivalence to legally marketed predicate devices. The document does not contain a detailed study proving the device meets specific quantitative acceptance criteria in the format typically seen for algorithm performance. Instead, it relies on demonstrating that the device's design, intended use, and performance characteristics are similar to existing approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of quantitative acceptance criteria with corresponding performance data in the typical sense of a clinical study or algorithm validation. The "performance" discussed is primarily related to safety, operational features, and design equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety - Drive Lock-out | Prevents driving when tilted beyond a pre-set limit of 20 degrees. |
| Safety - Stability | Stability of the power wheelchair is not compromised by the addition of the seating system (tested in Invacare facility). |
| Weight Capacity (Tilt/Recline/Elevate) | Rated for a combined user and accessory weight of 300 pounds. |
| Weight Capacity (Tilt-only/Recline-only) | Rated for a combined user and accessory weight of up to 400 pounds. |
| Elevate Function - Max Elevation | Allows the seat to be elevated to a maximum of 7" ± .25". |
| Flammability Standard | Tested to meet the CAL 117 flammability standard. |
| Industry Standards | Tested to ANSI/RESNA Section 7 (although no industry or ISO standards for power tilt/recline/elevating systems are explicitly mentioned as acceptance criteria, this serves as a general performance standard). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an algorithm or device performance study involving human subjects or collected data specific to the 3G Tarsys. The testing mentioned appears to be internal engineering verification and validation.
- Sample Size for Test Set: Not applicable/Not mentioned for performance claims. The "testing" referred to appears to be internal engineering verification on the device itself.
- Data Provenance: Not applicable. No external data or clinical data is cited for performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present. The 510(k) summary does not describe a study that used expert consensus to establish ground truth for performance metrics.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is described as there is no mention of a clinical or performance "test set" requiring expert review for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or is mentioned. The submission focuses on device design and functional equivalence to predicate devices, not on comparing reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical power wheelchair seating system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the claims appears to be derived from:
- Engineering specifications and measurements: E.g., 7" ± .25" elevation.
- Internal safety testing: E.g., drive lock-out functionality, stability testing.
- Compliance with recognized standards: E.g., CAL 117 flammability, ANSI/RESNA Section 7.
- Substantial equivalence to predicate devices: The primary basis for regulatory clearance, implying that if predicate devices are safe and effective, a substantially equivalent new device will also be.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set exists for this type of device submission.
In summary: The provided text is a regulatory submission (510(k) summary) focused on demonstrating "substantial equivalence" of a physical medical device (a power wheelchair seating system) to pre-existing, legally marketed predicate devices. It outlines the device's features, intended use, and general safety considerations, along with basic performance specifications (like weight capacity and elevation range) determined through internal testing and adherence to relevant industry standards. It does not contain information about clinical studies with specific acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics, as these are typically not required for this type of 510(k) submission for a mechanical 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).