(32 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KARMA Power Wheelchair, KP-25 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Here's a breakdown of the acceptance criteria and the study details for the KARMA Power Wheelchair, KP-25, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full de novo clinical study with extensive acceptance criteria and detailed performance statistics. Therefore, the information available is limited to what's typically required for a 510(k) submission.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., speed, range, turning radius, battery life) with corresponding target values. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and substantial equivalence to a legally marketed predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance: | |
| ANSI / RESNA WC/Vol.2-1998 (Electrically Powered Wheelchairs) | The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements. |
| CISPR 11: 1990 (EMC) | The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements. Additionally, the electronic systems are stated as "all passed by the UL certificated." |
| EN61000-3-2: 1995 (EMC - Harmonics) | The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements. |
| IEC61000-3-3: 1995 (EMC - Flicker) | The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements. |
| Substantial Equivalence to Predicate Device: | |
| Electronic systems (controller, batteries, charger, switches) | "The electronic systems between two devices are the same and all passed by the UL certificated... Thus the same safety level for the two devices is assured." |
| Foldable frame | "the two devices are the same foldable frame..." |
| Maximum speed | "...same maximum speed..." |
| Removable arm type | "...same removable arm type..." |
| Warranty on component and frame | "...same warranty on component and frame..." |
| Back upholstery material (resistance ignition test) | "...back upholstery are the same material that also be passed the resistance ignition test by SGS." |
| Differences (overall dimension and weight) are not safety-related | "The major differences existing of the two Powered Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect." |
Study Details
The provided document describes a bench and engineering testing approach to demonstrate substantial equivalence, rather than a clinical study with a test set of data, human readers, or ground truth developed by experts.
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Sample size used for the test set and the data provenance:
- No "test set" of patient data is mentioned in the context of a clinical study.
- The "test set" for performance testing refers to the physical device itself. The tests were performed on the KARMA Power Wheelchair, KP-25.
- Data Provenance: The testing appears to be conducted in a laboratory/engineering setting, likely by KARMA Medical Products Co., Ltd. or contracted testing facilities (e.g., UL, SGS). The manufacturer is in Taiwan, R.O.C., so the testing likely occurred there or by international certification bodies. The document does not specify whether the data is retrospective or prospective, but in the context of device performance testing against standards, it would be prospective data generated specifically for the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no "ground truth" established by clinical experts for a test set in this type of submission. Ground truth for engineering tests is typically defined by the specified parameters and methodologies within the adopted standards (e.g., a certain current, a specific speed measurement, a strength test).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no adjudication process as described for clinical interpretation. The performance testing against standards involves objective measurements and pass/fail criteria as defined by the standards.
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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:
- Not applicable. This is a medical device (power wheelchair), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not feature an algorithm that would be tested in a standalone capacity.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is objective measurements against engineering standards (e.g., EMC compliance, structural integrity, speed). This is determined by the test methodologies of standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3, and independent certification bodies like UL and SGS.
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The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a training set mentioned in this submission.
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How the ground truth for the training set was established:
- Not applicable (as above).
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).