(39 days)
The device indicated for patients who need to be placed in an oxygen enriched environment.
Disposable Infant hood with drape
This medical device submission is for a Burlew Infant Hood, which is an infant oxygen hood. The document does not describe a study involving acceptance criteria and device performance in the way typically found for diagnostic or AI-driven devices (e.g., sensitivity, specificity, accuracy). Instead, it focuses on comparing the Burlew Infant Hood to predicate devices based on various attributes.
Here's an analysis based on the provided text, recognizing its limitations regarding the specific type of "study" requested in the prompt:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present explicit "acceptance criteria" with numerical performance metrics like a diagnostic device. Instead, the "Performance Testing" attribute is listed as "Yes" for the Burlew device and its predicates, implying that such testing was done, but the details (criteria and results) are not provided in this summary.
The comparison table below highlights attributes where the Burlew Infant Hood matches or improves upon predicate devices. These can be considered the "performance metrics" being assessed for this type of device, related to its design and functional capabilities rather than diagnostic accuracy.
| Attribute | Acceptance Criteria (Implied) | Burlew Infant Hood Performance (Reported) |
|---|---|---|
| Use with patient for oxygen-rich environment | Capable of providing an oxygen-rich environment | Yes |
| Use in Respiratory Therapy (RT) | Suitable for RT settings | Yes |
| Use in Intensive Care Unit (ICU) | Suitable for ICU settings | Yes |
| Use in transport | Designed for transport | Yes (Superior to some predicates) |
| Single patient use | Disposable/single-use | Yes |
| Use with neonate and pediatric | Suitable for neonate and pediatric populations | Yes |
| Clear patient area | Provides visibility of patient | Yes |
| Fittings for oxygen connection | Has necessary fittings for oxygen source | Yes |
| Different sizes | Available in multiple sizes | Yes |
| Flexible drape to cover patient | Incorporates a flexible drape | Yes (Differentiating feature from one predicate) |
| Collapsible for easy storage | Designed for easy storage | Yes (Differentiating feature from predicates) |
| Panel removable for easy patient access | Allows for easy access to patient | Yes |
| Materials (Plexiglas/polycarbonate) | Uses specified hood materials | Yes |
| Materials (PVC drape) | Uses specified drape material | Yes |
| Performance Testing (General) | Undergone appropriate performance testing for safety/effectiveness | Yes (Specific results not detailed) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of diagnostic performance. There's no mention of patient data, images, or clinical studies with specific sample sizes. The "Performance Testing" mentioned is likely related to engineering or functional checks of the device itself (e.g., oxygen delivery rates, material strength, leakage) rather than a clinical trial with a "test set" of patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document does not describe a study involving expert review for establishing ground truth for a diagnostic output.
4. Adjudication Method
Not applicable. There is no diagnostic output requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an infant oxygen hood, not an AI or diagnostic tool where MRMC studies are typically performed.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the context of a diagnostic or AI study. The "ground truth" for this device would be its demonstrated functional capability to provide an oxygen-enriched environment safely and effectively, and its material properties meeting specifications. The comparison table essentially acts as a "ground truth" for its features compared to predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 868.5700 Nonpowered oxygen tent.
(a)
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.(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 § 868.9.