(9 days)
The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The RTm and Oval wheelchairs are mechanical wheelchairs.
The provided document is a 510(k) summary for a medical device, specifically the RTm and Oval manual wheelchairs. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs for performance, sample sizes for test and training sets, expert qualifications, and adjudication methods (which are standard for SaMD validation) are not applicable to this document. This submission pertains to a physical, mechanical device, not an algorithm or AI product.
Here's an analysis based on the provided text, addressing what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of numerical acceptance criteria with corresponding device performance values as would be expected for an AI/SaMD product. Instead, the acceptance criteria are implicitly defined by compliance with established international and national standards for manual wheelchairs, and the performance is reported as successful passage of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space | Successfully passed testing to voluntary standards, including ISO 7176-5. |
| Compliance with ISO 7176-15 Requirements for information disclosure, documentation, and labeling | Successfully passed testing to voluntary standards, including ISO 7176-15. |
| Compliance with ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods | Successfully passed testing to voluntary standards, including ISO 7176-16. |
| Compliance with ISO 7176-1 Determination of Static Stability | Successfully passed testing to voluntary standards, including ISO 7176-1. |
| Compliance with ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions | Successfully passed testing to voluntary standards, including ANSI/RESNA WC Vol 1-1998 Section 93. |
| Substantial equivalence to predicate device (Sunrise Medical Model Quickie GT Manual Wheelchair) | "This device has a similar intended use and technological characteristics as the predicate device. The device and the predicate device are both mechanical wheelchairs. Comparisons demonstrate substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states, "Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used." This refers to a test dummy used for physical testing, not a "test set" of data or patient cases in the context of AI/SaMD. The number of physical units tested is not explicitly stated, but typically for such evaluations, a representative sample of manufactured devices would be tested, or a prototype.
- Data Provenance: Not applicable in the context of an AI/SaMD. The "data" here comes from physical tests of the wheelchair itself, not from patient records or imaging.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic or prognostic task. The "ground truth" for the performance of the physical wheelchair is determined by the physical properties of the wheelchair and its behavior under standardized testing conditions.
4. Adjudication Method for the Test Set:
Not applicable. There is no "adjudication method" in the sense of resolving discrepancies between expert opinions, as this is not an interpretive diagnostic study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is not an AI/SaMD. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for compliance of the RTm and Oval wheelchairs is established through physical testing against recognized industry standards. For example, the static stability of the wheelchair (a performance characteristic) is evaluated according to the procedures outlined in ISO 7176-1. The successful completion of these tests serves as the "ground truth" for compliance with the standards.
8. Sample Size for the Training Set:
Not applicable. This is a physical device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is a physical device, not an AI/ML system requiring a training set with established ground truth.
§ 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).