The BEAR CUB 750 PSV Infant Ventilator is intended to provide clinically accepted features for the ventilation management of a patient population ranging from the small neonate (500 grams and larger) to a small pediatric patient (up to 30 kilograms).

The etiologies to which these devices may be applied consistent with current clinical practices include:

Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration

Device Description

The BEAR CUB 750 PSV Infant ventilators is a modification from the BEAR CUB 750 vs. The BEAR CUB 750 PSV Infant ventilators incorporate all previous (3) three modes with the addition of (4) four new modes. The additional modes are, Flow Cycle Assist Control, Flow Cycle SIMV, SIMVPSV, and PSV. The BEAR CUB 750 PSV Infant ventilators incorporate all previous function for the Bear Cub 750vs with the addition of, digital PEEP, monitored inspired tidal volume, a low minute volume alarm, an audible silence for the volume limit, CPAP/PSV back up function and the Low Inspiratory Pressure threshold was changed to a calculated threshold function.

AI/ML Overview

The provided text is a 510(k) summary for the BEAR Cub 750 PSV Infant Ventilator. It describes the device, its intended use, and lists predicate devices. However, this document does not contain information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment for software or AI-driven device performance.

Therefore, I cannot fulfill your request for the specific information points you've asked for, as the document primarily focuses on the regulatory submission and device description, not on detailed performance validation studies that would include acceptance criteria and specific study methodologies.

Here's a breakdown of why each point cannot be addressed based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes the device's features and intended use but does not provide specific performance metrics or acceptance criteria for those features.
Sample size used for the test set and the data provenance: Not mentioned. No test set or data provenance is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 and not mentioned. This device is a ventilator, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device (ventilator), not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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K992788

SEP 1 6 1999

510(k) Summary BEAR Cub 750 PSV Infant Ventilator

Bear Medical Systems, Inc. 1100 Bird Center Drive Palm Springs, California 92262

Contact:

Neil Battiste Phone Number (760) 778-7341 FAX (760) 778-7288

August 13, 1999 Date:

1.	TRADE/PROPRIETARY NAME:	BEAR Cub 750 PSV Infant Ventilator
	CLASSIFICATION NAME:	Ventilator, Continuous (Respirator)
	COMMON/USUAL NAME:	Neonatal/Infant Ventilator
2.	ESTABLISHMENT REGISTRATION NUMBER:	2022747
3.	PRODUCT CLASSIFICATION	Class II
4.	ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK)

Predict Device

Siemens Servo 300 A Ventilator	(K970839)
V.I.P. Bird Ventilator	(K895541)
Baby Log 8000 Plus Ventilator	(K974176)

Device Description

Statement of Intended use:

The etiologies to which these devices may be applied consistent with current clinical practices include:

Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1999

Mr. Darryl L. Shelby Bear Medical Systems, Inc. 1100 Bird Center Drive Palm Springs, CA 92262

Re: K992788 BEAR Cub 750 PSV Infant Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: August 11, 1999 Received: August 19, 1999

Dear Mr. Shelby:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any . obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Darryl L. Shelby

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended use:

The BEAR CUB 750 PSV Infant Ventilator is intended to provide ventilators support for a patient we to 2 The BEAK COD 750 F SV Intain Ventiator is Incenter to a small pediatric patient up to 30 kilograms.

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(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

$\swarrow$ Prescription Use

OTC

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).