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510(k) Data Aggregation
(105 days)
The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
The BREEZ Electric Transport Chair is a motorized device that allows caregivers to move patients up to 750 pounds in weight. The device has self-contained batteries to provide power that can be recharged by an on-board battery charger that can be plugged into a 120/240 VAC outlet when the device is not in use. The device is supported by four wheels whereby the front wheels provide the motive force to propel the unit in either the forward or reverse direction. The caregiver directs the movement of the device using a steering handlebar and various hand-operated controls attached to the rear of the device.
The provided text describes a 510(k) premarket notification for the BREEZ 1025 Electric Transport Chair. Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Voluntary Standards) | Reported Device Performance |
|---|---|
| CISPR 11 (Radiated/Conducted Emissions) | Met required performance criteria and functioned as intended. |
| EN61000-4-2: 2008-10 Electrostatic Discharge | Met required performance criteria and functioned as intended. |
| EN61000-4-3: 2008-4 Radiated Immunity Test | Met required performance criteria and functioned as intended. |
| Dimensional, performance, and static tests (according to RESNA WC-1: 2009 and RESNA WC-2: 2009) | Met required performance criteria and functioned as intended. |
| California Flammability Regulation (Bulletin 117, Section E) for seat material | Conforms to the California Flammability Regulation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of typical clinical or AI medical device studies (i.e., a dataset of patient cases used to evaluate an algorithm's performance). Instead, the testing appears to be engineering and product performance testing conducted on the device itself.
- Sample Size: The document does not explicitly state the number of BREEZ Electric Transport Chairs tested. It refers to "the BREEZ Electric Transport Chair" (singular), but this typically implies multiple units or systematic testing of a representative unit(s) to verify consistency, even if not explicitly stated as a "sample size."
- Data Provenance: This is not applicable in the context of clinical data provenance. The tests were conducted on the physical device by the manufacturer (Electro Kinetic Technologies, LLC) or a contracted testing facility. It is prospective in the sense that the device was manufactured and then tested to these standards. The country of origin of the data would be the location where these engineering and performance tests were performed (likely the US, given the submission location).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the type of testing described. "Ground truth" in the context of medical efficacy or diagnostic accuracy (e.g., for AI) is established by expert review, pathology, or outcomes. The acceptance criteria here relate to engineering performance and safety standards, where the "ground truth" is adherence to the specified technical requirements of the standards (e.g., a specific level of radiated emissions, a given static load capacity). The experts involved would be engineers or technicians with expertise in conducting and interpreting these specific tests.
4. Adjudication Method for the Test Set
This is not applicable for the type of testing described. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations of clinical data. For engineering standards, the outcome is typically a pass/fail against a defined technical specification.
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
No MRMC comparative effectiveness study was mentioned. This type of study is relevant for AI-powered diagnostic or assistive devices where human-in-the-loop performance is being evaluated. The BREEZ Electric Transport Chair is a purely mechanical/electrical transport device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance criteria is defined by the technical specifications and performance requirements set forth in the voluntary standards referenced (CISPR 11, EN61000 series, RESNA WC-1: 2009, RESNA WC-2: 2009, and California Flammability Regulation Bulletin 117, Section E). The device's performance was compared directly against these established engineering and safety benchmarks.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This device does not employ machine learning or AI algorithms that require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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