(203 days)
The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults limited to a sitting position.
The Invacare® Solara® 3G Manual Wheelchair is an attendant operated and self-propelled, mechanical wheelchair for adults. The indication for use of the Invacare® Solara® 3G Manual Wheelchair is to provide mobility to adults limited to a sitting position. The indication for use of the Invacare® Solara® 3G Spree Manual Wheelchair is to provide mobility to person limited to a sitting position. These devices are rigid, "non-folding" type wheelchairs that incorporate a solid seating surface (seat pan).
The Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs were evaluated for substantial equivalence to their predicate devices through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" against which performance is measured for each test, but rather states that design verification testing demonstrated the device met the requirements and was substantially equivalent. The performance data focuses on demonstrating equivalence to the predicate devices through adherence to ANSI/RESNA WC-1:2009 standards and other relevant tests.
| Test Conducted | Reported Device Performance |
|---|---|
| ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability | Design Verification Testing demonstrated that the subject Invacare® Solara® 3G Manual Wheelchairs (300/400 lbs) and Solara® 3G Spree Manual Wheelchair (200 lbs) "are substantially equivalent to the marketed predicate devices" regarding static stability. |
| ANSI/RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding effectiveness of brakes. |
| ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass and Maneuvering Space | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding dimensions, mass, and maneuvering space. |
| ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding measurement of seating and wheel dimensions. |
| ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding static, impact, and fatigue strengths. |
| ANSI/RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, Documentation and Labeling | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding information disclosure, documentation, and labeling. |
| ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test Surfaces | Design Verification Testing demonstrated that the subject devices "are substantially equivalent to the marketed predicate devices" regarding coefficient of friction of test surfaces. |
| ANSI/RESNA WC-1:2009 Section 11: Test Dummies | Used as part of the testing methodology for other sections where dummies are relevant (e.g., static stability, impact, fatigue strengths). Performance is implicitly covered by the "substantially equivalent" statements for those sections. |
| CAL 117:2013, Section 1: Flammability Test | Biocompatibility evaluation was conducted. (Assumed to meet standard if listed, no specific performance pass/fail provided). |
| ISO 8191-1:1987 & 8191-2:1988: Flammability Testing | Biocompatibility evaluation was conducted. (Assumed to meet standard if listed, no specific performance pass/fail provided). |
| AAMI / ANSI / ISO 10993-5:2009: Tests for in vitro Cytotoxicity | Biocompatibility evaluation was conducted in accordance with FDA Blue Book Memorandum #G95 – 1 and ISO 10993-1. Specific results are not provided, but the statement implies the device passed these tests to meet "Biocompatibility Testing" requirements. |
| AAMI / ANSI / ISO 10993-10:2010: Tests for Skin Irritation | Biocompatibility evaluation was conducted in accordance with FDA Blue Book Memorandum #G95 – 1 and ISO 10993-1. Specific results are not provided, but the statement implies the device passed these tests to meet "Biocompatibility Testing" requirements. |
| Risk Management (ISO 14971:2012) | A Risk Assessment Device Hazard Analysis (DHA) was performed. "The subject device's risk profile remained unchanged and there is no significant impact on the safety or effectiveness of the subject device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices or components tested. It generally refers to "the subject device" or "the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs."
- Data Provenance: The tests are non-clinical laboratory tests, likely conducted at an Invacare facility or a contracted testing lab. The location/country of origin for the testing is not specified, but the manufacturer is listed as INVAMEX S.DE R.L. DE C.V. in Reynosa Tamaulipas, Mexico. The nature of the tests (e.g., static stability, impact tests) indicates they are typically prospective, conducted specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. This is a medical device for mobility (manual wheelchair) and the testing is based on engineering and safety standards (e.g., ANSI/RESNA, ISO), not expert interpretation of medical images or conditions. The "ground truth" for these tests is the performance against specified physical and mechanical standards.
4. Adjudication method for the test set:
Not applicable. As this involves objective non-clinical performance testing against established standards, an adjudication method for expert consensus is not relevant. The pass/fail criteria are defined by the standards themselves.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a manual wheelchair, not an AI-powered diagnostic or assistive tool for human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical testing of the manual wheelchairs is the adherence to the objective performance specifications and safety requirements outlined in recognized national and international standards, such as ANSI/RESNA WC-1:2009, CAL 117:2013, ISO 8191, and ISO 10993. This is best described as objective engineering and safety standards conformance.
8. The sample size for the training set:
Not applicable. There is no AI model or algorithm being trained for this device. The "training set" concept does not apply to non-clinical performance testing of a physical medical device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).