(92 days)
The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.
The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.
The provided text is a 510(k) summary for the "Head Bed™ Infant Sleep Positioner." This document establishes substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include information about the performance claims (e.g., sensitivity, specificity, accuracy) that would be evaluated in such a study.
The document details the device description, intended use, and a comparison to a predicate device ("NightForm™ Infant Sleep Positioner"). It also includes the FDA's clearance letter.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on substantial equivalence based on design, materials, and intended use, not on specific performance metrics or clinical study results demonstrating efficacy or safety beyond the predicate.
- Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
- Adjudication method for the test set: Not applicable as no performance study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it's a physical infant positioner.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable as no performance study is described.
- The sample size for the training set: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria. Such a study would typically be required for devices making new performance claims or those classified differently.
§ 880.5680 Pediatric position holder.
(a)
Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.(b)
Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.