Search Results

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

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.

Ask a specific question about this device

The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.

Device Name: RES-Q Infant Wedge & Sling
Classification/Common Name: Holder, Infant Positioner
Code FRP, CFR 880.5680
Class 1

The provided text is a 510(k) summary for the RES-Q Infant Wedge & Sling, which is an infant positioner. It does not contain information about a study with acceptance criteria, reported device performance, or details typically associated with the evaluation of AI/ML devices or diagnostic tools.

The document states: "FDA has not established special controls or performance standards for this device."

Therefore, I cannot provide the requested information from the given text as it is not present. This device is a Class I medical device, which typically has lower regulatory scrutiny and does not require extensive performance studies and acceptance criteria as would be expected for a diagnostic or AI-powered device.

Ask a specific question about this device

The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly

Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.

The provided 510(k) summary for the "Kozy Comfort™ Infant Positioner" (K062143) does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document states: "FDA has not established special controls or performance standards for this device." This indicates that the device was approved based on substantial equivalence to predicate devices, rather than through a performance study against specific acceptance criteria.

Therefore, for each of your requested points, the answer is that the information is not available in the provided text.

Here's a breakdown based on your request, explicitly stating why the information is not present:

1. A table of acceptance criteria and the reported device performance

   • Not available. The document states no special controls or performance standards exist for this Class I device. As such, no defined acceptance criteria are presented, nor is there a study reporting performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not available. No performance study is mentioned or referenced.

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 available. No performance study requiring expert adjudication or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not available. No performance study or 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 available. This device is an infant positioner, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not available. This device is an infant positioner, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not available. No performance study requiring ground truth is described.

8. The sample size for the training set

   • Not available. No training set is applicable or described for this type of device.

9. How the ground truth for the training set was established

   • Not available. No training set or ground truth establishment is applicable or described.

In summary, the provided 510(k) summary is for a Class I medical device (infant positioner) that was cleared based on substantial equivalence to existing predicate devices, without the need for performance studies against specific acceptance criteria. Therefore, the information you requested about performance studies, data, and ground truth is not part of this 510(k) submission.

Ask a specific question about this device

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:

1. 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.
2. Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
3. 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.
4. Adjudication method for the test set: Not applicable as no performance study is described.
5. 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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable as no performance study is described.
8. 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.
9. 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.

Ask a specific question about this device

The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.

The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Robin Hood Vest™, which is a pediatric position holder. It declares the device's substantial equivalence to a predicate device based on its intended use and description, but it does not detail any performance studies, acceptance criteria, or specific data about the device's effectiveness or accuracy in preventing skull deformities.

Therefore, I cannot provide the requested table and information about a study based on the given text.

Summary of what cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory submission and substantial equivalence, not performance metrics.
2. Sample size used for the test set and the data provenance: Not present. No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method for the test set: Not present. No test set or adjudication is mentioned.
5. 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 relevant or present. This device is a physical pediatric position holder, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant or present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

Ask a specific question about this device

The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, known as Deformational (or positional) plagiocephaly.

NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.

The provided text describes a 510(k) premarket notification for the "NightForm Infant Sleep Positioner." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results.

Therefore, there is no information available in the provided text to fulfill the request for acceptance criteria and the study that proves the device meets those criteria. The document explicitly states: "Performance Summary: FDA has not established special controls or performance standards for this device."

The text contains the following details that are relevant to the device's regulatory submission but do not address performance criteria:

• Device Name: NightForm™ Infant Sleep Positioner
• Intended Use: To be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly.
• Predicate Device: Pedicraft Infant Reflux Wedge (K905629)
• Predicate Comparison Table: Compares the new device to the predicate device on application, target population, purpose, and materials. This is for demonstrating substantial equivalence, not for presenting performance study results against specific criteria.
• Regulatory Classification: Class I, Product Code FRP, Regulation Number 880.5680 (Pediatric Position Holder).
• FDA Communication: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. This is a regulatory approval based on equivalence, not a performance study outcome.

Ask a specific question about this device

Ask a specific question about this device