(298 days)
The Life Innovations Infant Sleep Beanie is an over-thecounter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.
The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat placed strategically on a baby's head while lying awake, sleeping or during travel.
This device, the "Infant Sleep Beanie," is a Class I medical device (pediatric position holder) and, as such, is exempt from stringent performance requirements typically associated with Class II or Class III devices. The submission explicitly states: "The FDA has not established special controls or standards for this device."
Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria are met is not applicable in this case. The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria.
Here's how to address each point given the provided information:
Acceptance Criteria and Device Performance for Infant Sleep Beanie (K082367)
This device, classified as a Class I pediatric position holder, is exempt from specific performance-based acceptance criteria established by the FDA. Therefore, the device's acceptance is primarily based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting predefined numerical performance targets from a clinical trial. The provided submission does not contain a performance study with defined acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The FDA has not established special controls or standards for this Class I device. Acceptance is based on substantial equivalence to predicate devices, focusing on technological characteristics and intended use. | The device's "Performance Summary" section states: "The FDA has not established special controls or standards for this device." Therefore, no specific performance metrics or results from a performance study are reported in this 510(k) summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a performance study with a test set. This 510(k) is a premarket notification for a Class I device, which relies on demonstrating substantial equivalence to predicates rather than clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study or comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical pediatric position holder, not an algorithm, and therefore "standalone performance" in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established or used as there is no performance study described. The basis for marketing this device is its substantial equivalence to other legally marketed pediatric position holders.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.
§ 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.