(83 days)
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
Here's an analysis of the provided text regarding the COMFORT Standing Wheelchair, HERO series, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Mechanical Conformity to Standards: | |
| - ANSI / RESNA WC/Vol.2-1998 (Wheelchairs) | Not explicitly stated as "met," but implied by the statement: "The safety and performance functions of two systems [new and predicate device] are assured and validated. They are substantially equivalent." |
| Electromagnetic Compatibility (EMC) Standards: | |
| - CISPR 11: 1990 | "EMC Report" (indicating testing was performed). The statement "the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge" suggests conformity to electronic safety and performance standards, which would include EMC. The document explicitly lists CISPR 11: 1990 as a standard used for performance testing. |
| - EN61000-3-2: 1995 | Same as above. The document explicitly lists EN61000-3-2: 1995 as a standard used for performance testing. |
| - IEC61000-3-3: 1995 | Same as above. The document explicitly lists IEC61000-3-3: 1995 as a standard used for performance testing. |
| Ignition Resistance (Upholstery): | |
| - Resistance ignition test (by SGS) | "the back upholstery is the same material, and also passed the resistance ignition test by SGS." |
| Other Functional Equivalence: | |
| - Overall dimensions | "the overall dimensions and visional appearance are similar" to the predicate device. |
| - Electronic systems (UL certified) | "the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge." |
| - Suspension of cross brace, footplates, etc. | "the suspension of cross brace, footplates, incline degree 12°, armrest type, the size of tires, the weight limit, and warranty are all the same" as the predicate device. |
| - Intended use | The new device and predicate device "have the same intended use." This is crucial for substantial equivalence. |
| - Technological aspects | The new device and predicate device "have the same technological aspects." |
Study Proving Acceptance Criteria Met:
The provided document describes a substantial equivalence comparison study rather than a traditional research study with statistically significant endpoints against specific acceptance criteria. The primary method used to demonstrate device performance and safety is by showing its equivalence to a legally marketed predicate device, the COMFORT Standing Wheelchair, HERO 2 (K031618).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this submission. The comparison is made against the predicate device based on its established performance and adherence to standards. The document doesn't describe a separate "test set" of patients or devices for a new clinical trial. Instead, it relies on testing the subject device against relevant engineering and safety standards and comparing its features and performance to the predicate device.
- Data Provenance: The device manufacturer, COMFORT ORTHOPEDIC CO., LTD., is located in Taiwan, R.O.C. The performance testing (EMC, ignition resistance) was conducted based on international standards (ANSI/RESNA, CISPR, EN, IEC) and by an accredited body (SGS for ignition resistance). This implies prospective testing of the new device against these standards. The comparison data for substantial equivalence is derived from the predicate device, K031618, which was previously cleared by the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission focuses on engineering and performance standards conformity and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth in a clinical sense. The "ground truth" here is adherence to recognized industry standards and the demonstrated safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is described as this is not a study involving human reader interpretations of data. The assessment is based on objective testing against technical standards and a direct comparison of specifications and features with the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The COMFORT Standing Wheelchair is a physical medical device (wheelchair), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical standing wheelchair, not an algorithm or AI system. Its performance is inherent to its physical and electronic design and functionality, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this submission is primarily:
- Adherence to recognized international and national engineering and safety standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and general "UL certified" for electronic components.
- Demonstrated safety and effectiveness of the predicate device (K031618): The predicate device serves as the established benchmark for what constitutes an acceptable standing wheelchair. The new device's "sameness" in critical aspects to this predicate device forms the basis of its "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" described in the context of this device. This is not an AI/machine learning device that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).