(57 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KARMA Manual Wheelchair, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
Here's an analysis of the provided text regarding the KARMA Manual Wheelchair, Budget 800, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Study for KARMA Manual Wheelchair, Budget 800
Based on the provided document, the KARMA Manual Wheelchair, Budget 800 demonstrates compliance by meeting established performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria / Standard | Reported Device Performance |
|---|---|
| Performance Requirements (General) | Meets applicable requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. |
| Weight Capacity | 115 kgs (same as predicate device) |
| Frame Warranty | 5 years |
| Overall Dimensions (e.g., Frame Width, Depth) | Similar to predicate device, with minor differences noted as not impacting safety. |
| Tire Sizes | Differences noted from predicate device, but not impacting safety. |
| Back Upholstery Material | Resistance-ignitability fabric (same as predicate device) |
| Light and Portable Weight | Similar to predicate device, offering convenient transport. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "Performance Testing" indicating a device or devices were tested, but does not specify the number of units or the specific test protocols followed beyond citing the standards.
- Data Provenance: Not explicitly stated beyond the fact that the testing was performed, presumably by or for the manufacturer, KARMA Medical Products Co., Ltd., based in Taiwan, R.O.C. The document does not specify if the tests were conducted retrospectively or prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of information is not applicable to this device and its regulatory submission. The "ground truth" for a mechanical device like a wheelchair is established by standardized performance tests (e.g., durability, stability, strength, static loads) against international and national engineering standards (ANSI/RESNA WC Vol. 1, ISO 7176). There is no "expert consensus" on diagnostic images or clinical outcomes required to determine if a wheelchair meets mechanical safety and performance criteria.
4. Adjudication Method for the Test Set:
- This concept is not applicable to this device. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations of subjective interpretations (e.g., reading medical images) where multiple experts might disagree on an outcome and a method is needed to reach a definitive "ground truth." For mechanical performance testing, the results are typically quantitative and objective measurements against defined pass/fail criteria in a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was performed or is relevant for this device. An MRMC study is used to assess the change in diagnostic performance of human readers (e.g., radiologists) when assisted by an AI algorithm, compared to reading without AI. This is a mechanical device, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No standalone algorithm performance study was performed or is relevant for this device. This is a mechanical wheelchair; there is no embedded algorithm requiring standalone performance evaluation.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by objective measurements and observations against the pass/fail criteria defined in the referenced standards: ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. These standards quantify safety, durability, static strength, impact resistance, stability, and other mechanical aspects.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 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).