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.

Summary

{0}------------------------------------------------

K962182

Image /page/0/Picture/1 description: The image shows the logo for ProMedic, Inc. The text "ProMedic, Inc." is written in a serif font. To the right of the text is a stylized drawing of a lightbulb.

150

Non-Confidential Summary of Safety and Effectiveness June 3, 1996

page 1 of 3

ProMedic, Inc.6329 W. Waterview Ct.McCordsville, IN 46055	Tel - 317-335-3780Fax - 317-335-9270
Official contact:	Paul Dryden, President
Proprietary or Trade Name:	Burlew Infant Hood
Common/Usual Name:	Infant hood
Classification Name:	73 BYL or FOG - Infant oxygen tent / hoodSubsection 868.5700
Intended device:	Disposable Infant hood with drape
Predicate devices:	Nova Health Systems - K893713Sunnydale - K# unknownUtah Medical - Disposa-Hood - K# unknown
Device description:

Indicated use:

The device indicated for patients who need to be placed in an oxygen enriched environment.

Target Population:

Neonates and pediatrics

Environment of use:

Hospital, ICU ( neonatal and pediatric), respiratory therapy and transport isolettes / incubators

page 3 of 23

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996

page 2 of 3

Comparison to predicate devices:

Attribute	BurlewIntended device	Nova / SunnydaleTent	Utah MedicalDisposa-Hood
UseIntended for use with patientfor an oxygen rich environment	Yes	Yes	Yes
Intended for use in RT	Yes	Yes	Yes
Indicated for use in ICU	Yes	Yes	Yes
Intended to be used in transport	Yes	No	No
Indicated for single patient use	Yes	Yes	Yes
Indicated for use withneonate and pediatric	Yes	Yes	Yes
DesignClear patient area	Yes	Yes	Yes
Fittings for connectionto oxygen source	Yes	Yes	Yes
Different sizes	Yes	Yes	Yes
Flexible drape to cover patient	Yes	Yes	No
Collapsible for easy storage	Yes	No	No
Panel removable foreasy patient access	Yes	Yes	No
MaterialsPlexiglas /polycarbonate hood	Yes	No	Yes
PVC drape	Yes	Yes	No
Performance Testing	Yes	Yes	Yes

page 4 of 23

{2}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996

page 3 of 3

Differences

The only difference in the intended device is that it incorporates the feature of the two predicate into one device - a rigid patient hood and flexible body drape.

Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.

page 5 of 23

Regulation Number and Section

§ 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.