(281 days)
The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
The Ki Mobility Little Wave Arc is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the seated pressure distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as eating, breathing and social interaction. The Little Wave Arc offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.
The Ki Mobility Little Wave Flip is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as ocial interaction. The Little Wave Flip offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.
The provided document is a 510(k) Premarket Notification from the FDA for two manual wheelchairs, the "Little Wave Arc" and "Little Wave Flip." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (R82 Kudu).
This document does not describe acceptance criteria for a medical device that relies on algorithms or AI assistance, nor does it detail a study proving such a device meets acceptance criteria. The devices in question are mechanical wheelchairs.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance for an AI/algorithmic device.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size with AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document instead focuses on non-clinical testing for mechanical wheelchairs against recognized consensus standards.
Here's the relevant information that is present in the document about the mechanical wheelchairs:
Acceptance Criteria and Study for Mechanical Wheelchairs:
The acceptance criteria for the "Little Wave Arc" and "Little Wave Flip" manual wheelchairs are implied by their successful testing against a series of recognized consensus standards for mechanical wheelchairs. The study described is a non-clinical testing summary.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Implied by Standards) Reported Device Performance (as stated in document) Compliance with ANSI/RESNA WC -4:2017 Section 19 (Wheelchairs in motor vehicles) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO-7176-1:2014 (Static stability) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-5:2008 (Dimensions, mass, maneuvering space) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-7:1998 (Seating and wheel dimensions) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-8:2014 (Static, impact, and fatigue strengths) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Specifically, the aluminum base frames have been "qualified through fatigue testing." Compliance with ISO 7176-11:2012 (Test Dummies) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-13:1989 (Coefficient of friction of test surfaces) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-15:1996 (Information disclosure documentation/labeling) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-16:2012 (Resistance to ignition of postural support devices) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-19:2022 (Wheeled mobility devices for use as seats in motor vehicles) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-22:2014 (Set-up procedures) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Maintain intended function and safety (Overall) The non-clinical testing "exhibits that the device will perform as intended and risk analysis has documented risk reduction and identified requirements for labeling for safe and effective use of the device." -
Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithmic device. For the mechanical wheelchairs, the testing would involve specific samples (e.g., a certain number of manufactured units) tested under laboratory conditions to the specified standards. The document does not specify the exact number of units tested, but rather confirms that "Design testing... met or passed the recognized test standard requirements."
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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. The "ground truth" for mechanical performance is defined by the objective pass/fail criteria of the engineering standards.
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Adjudication method: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is non-clinical performance testing of mechanical devices.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are mechanical devices, not algorithms.
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The type of ground truth used: Not applicable in the AI/algorithmic sense. For mechanical testing, the "ground truth" is defined by the technical specifications and pass/fail criteria set forth in the international and national consensus standards (e.g., ISO, ANSI/RESNA).
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The sample size for the training set: Not applicable. These are mechanical devices, not AI/ML models.
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How the ground truth for the training set was established: Not applicable.
§ 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).