(89 days)
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
This document is a 510(k) summary for a medical device (Heelbo Security Belt). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic or AI-driven performance.
The information provided relates to the physical characteristics, materials, and intended use of a restraint belt, and its equivalence to an older version of the same product, primarily focusing on labeling changes.
Therefore, I cannot provide the requested information. The document does not describe:
- Acceptance criteria for a performance study (e.g., sensitivity, specificity, accuracy thresholds).
- Reported device performance statistics against such criteria.
- Sample sizes for test sets in a "study" of performance as typically understood for AI or diagnostic devices.
- Data provenance for such studies.
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance study.
- Type of ground truth (e.g., pathology, outcomes).
- Sample size for the training set.
- How ground truth for the training set was established.
The "study" referenced in Section 8 is a conclusion based on substantial equivalence to a predicate device, primarily due to identical physical characteristics and materials, with the only change being a revision to product labeling to comply with FDA guidance. This is a regulatory pathway, not a performance study as would be conducted for a new diagnostic or AI-based device.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.