(209 days)
The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position.
The Invacare® Tracer® SX5 Manual Wheelchair is intended to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The Invacare® Tracer® SX5 Recliner Manual Wheelchair is a Tracer SX5 model with the addition of a recline feature. This recliner model incorporates a mechanism that allows the backrest to recline in angles from 90° to 180°. Both models of the chair have a weight capacity of 250 to 300 lbs. depending on the seat width. Both models also come with an anti-tipper device to ensure the chair remains stable while in use.
The Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair has the same intended use as the Invacare® Tracer® SX5 Manual Wheelchair. However, the Tracer IV does not come with a recliner model and has a higher weight capacity of 350 lbs. depending on the configuration. Both models of Tracer IV chairs come with a push-to-lock or pull-to-lock feature to engage and disengage the wheel locks. Both models also come with anti-tippers that allow clearance of 1.5 to 2 inches.
The provided text describes the 510(k) premarket notification for three manual wheelchair models by Invacare Corporation: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, and Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair. The document focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of an AI/algorithm-based medical device.
Therefore, most of the requested information regarding acceptance criteria, study design for AI devices, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document. This is because the submission is for a mechanical medical device (manual wheelchairs), not a software or AI-driven device.
However, I can extract the relevant information from the document that pertains to the types of "performance testing" conducted to demonstrate substantial equivalence for these mechanical devices.
Here's a breakdown based on the document's content:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it states that "Verification Testing demonstrated that the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual are substantially equivalent to the marketed predicate and reference devices." This implies that the devices met the performance standards outlined in the referenced ANSI/RESNA and ISO standards. The performance reporting is implicit; the tests were successfully passed, indicating conformance with the standards.
| Test Performed (Standard Referenced) | Implied Acceptance Criteria (Based on passing the standard) | Reported Device Performance |
|---|---|---|
| ANSI / RESNA WC/Volume 1 2009, Section 1: Determination of Static Stability | Must meet the static stability requirements defined in the standard. | Demonstrated substantial equivalence; tests were successful. |
| ANSI / RESNA WC/Volume 1 2009, Section 3: Determination of Effectiveness of Brakes | Brakes must meet the effectiveness requirements defined in the standard. | Demonstrated substantial equivalence; tests were successful. |
| ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass and Maneuvering Space | Dimensions, mass, and maneuvering space must conform to the standard's specifications or be within acceptable variance from predicate. | Demonstrated substantial equivalence; tests were successful (implicitly, also supported by "design characteristics comparison"). |
| ANSI / RESNA WC/Volume 1 - 2009, Section 7: Measurement of Seating and Wheel Dimensions | Seating and wheel dimensions must conform to the standard's specifications or be within acceptable variance from predicate. | Demonstrated substantial equivalence; tests were successful (implicitly). |
| ANSI / RESNA WC/Volume 1 2009, Section 8: Static, Impact and Fatigue Strengths Tests | Must withstand static, impact, and fatigue stresses as defined in the standard. | Demonstrated substantial equivalence; tests were successful. |
| RESNA WC-1:2009 Section 11: Test Dummies | (This section concerns the test apparatus, not a device performance metric itself. Implies proper use of test dummies.) | N/A (Methodology, not a direct performance outcome) |
| RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test Surfaces | (This section concerns the test environment, not a device performance metric itself. Implies proper control of test surfaces.) | N/A (Methodology, not a direct performance outcome) |
| ANSI / RESNA WC/Volume 1 2009, Section 15: Requirements for Information Disclosure, Documentation and Labeling | Information disclosure, documentation, and labeling must comply with the standard. | Demonstrated substantial equivalence; tests were successful. |
| CAL117:2013, Section 1: Flammability Testing | Must meet flammability resistance requirements defined in the standard. | Tests were successful. |
| ISO 8191-1:1987 & 8191-2:1988: Flammability Testing | Must meet flammability resistance requirements defined in the standard. | Tests were successful. |
| Biocompatibility (AAMI / ANSI / ISO 10993-5:2009 & 10993-10:2010) | Must demonstrate acceptable levels of cytotoxicity and skin irritation. | Tests were successful. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the number of individual wheelchairs tested. It refers to "the subject Invacare® Tracer Manual Wheelchairs" and "the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual," suggesting representative samples were tested as per the standards. Specific quantities are not provided.
- Data Provenance: The testing was "Non-clinical laboratory testing" conducted on the subject devices. Location of testing and whether it was retrospective or prospective is not explicitly stated, but for a mechanical device undergoing performance testing, it would inherently be prospective testing of new models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The "ground truth" for mechanical performance tests like these is established by adherence to recognized international and national standards (e.g., ANSI/RESNA, ISO) and the physical properties and performance characteristics of the devices themselves, measured by accredited laboratories and engineers. It does not involve expert consensus in the way an AI diagnostic tool's ground truth would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments (e.g., medical image interpretation). Mechanical performance testing relies on objective measurements against established engineering standards.
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 is not applicable. MRMC studies are specific to AI-assisted diagnostic or interpretative tasks involving human readers. This submission is for mechanical manual wheelchairs.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This refers to an AI algorithm's performance independent of human input. The device is a mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these mechanical devices is established through adherence to recognized national and international performance standards (ANSI/RESNA, ISO, CAL117) via physical and material testing. For biocompatibility, the ground truth is established by the results of cytotoxicity and skin irritation tests conforming to ISO standards.
8. The sample size for the training set:
This is not applicable. "Training set" refers to data used to train machine learning models. This is a mechanical device.
9. How the ground truth for the training set was established:
This is not applicable.
§ 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).