The K Series CPAP with Heated Humidifier System is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

Device Description

The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.

AI/ML Overview

The provided text describes the K Series CPAP Systems for treating Obstructive Sleep Apnea. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria based on algorithm performance, sample sizes for test sets (beyond what can be inferred from the comparison table), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone studies, training set details, or how training ground truth was established.

This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device (Respironics Remstar Pro M Series) for a physical medical device (CPAP machine), not a software algorithm that requires performance metrics against a defined ground truth. The "Summary of Performance Data and Substantial Equivalence" section states that tests confirmed the product met "predefined acceptance criteria" and was "compliant with the following standards documents," but it does not specify what those criteria were in a numerical sense for algorithmic performance or provide the study details you're looking for.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:

Acceptance Criteria and Device Performance

The provided document does not specify acceptance criteria and device performance in the context of an AI/algorithm-based study with metrics like sensitivity, specificity, or accuracy compared to a ground truth. Instead, the "acceptance criteria" referred to in this 510(k) summary are related to the manufacturing conformance and safety/effectiveness of a physical medical device (CPAP machine) against established industry standards and its predicate device.

The table below summarizes the comparison parameters between the K Series CPAP and its predicate device, which serves as the "performance" demonstrated for substantial equivalence rather than algorithmic performance.

Parameter	Acceptance Criteria (Predicate Device Performance) Respironics Remstar Pro M Series (K072996)	Reported Device Performance Curative Medical Inc. K Series CPAP
General Device
Device Size (cm)	19x12.7x7.9	Curasa: 17x11.7x9.3; Floton: 18x21x10.5
Weight (kg)	1.0	Curasa: 1.4; Floton: 1.6
Product Use, Transport, Storage(°C)	5 to 35	5 to 35
Operation (°C)	5 to 35	5 to 35
Transport & Storage (°C)	-20 to 60	-20 to 60
Atmosphere Pressure (Operation)	77 to 101 kPa	70 to 106 kPa
Mode of Operation	Continuous	Continuous
Type of Protection Against Electric Shock	Class II Equipment	Class II Equipment
Degree of Protection Against Electric Shock	Type BF Applied Part	Type B Applied Part
Degree of Protection Against Ingress of Water	IPX1	IPX1
Pressure Range (cm H2O)	4-20	4-20
Pressure Stability (cm H2O)	4-20 cm H2O, +/- 1.0 cm H2O	4-20 cm H20 +/- 2.0 cm H20
Maximum Flow (LPM)	35	35
Humidifier
Water reservoir	1 2/3 cup	240 ml
Dimensions:	8.25" x 8.75" x 4"	6.5" x 3.3" x 4"
Weight	2.2 lbs	< 0.9 lbs
Electrical shock protection:	Class II	Class II
Drip Proof Equipment	IPX1	IPX1
Heater Setting	1 - 5	continuous
Standards Compliance
IEC-60601-1	Yes	Yes
IEC-60601-2	Yes	Yes
ISO 17510-1	Yes	Yes
ISO 8185	Yes	Yes

Note: The "acceptance criteria" here are essentially the performance characteristics of the predicate device, against which the new device (K Series CPAP) demonstrates "substantial equivalence" based on similar specifications or compliance with the same regulatory standards.

Additional Requested Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the document. The testing mentioned refers to general product verification rather than a clinical trial with a defined patient sample size for performance evaluation in the context of an AI/algorithmic device.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
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. This device is a physical CPAP machine, not an AI/algorithmic device that generates diagnostic outputs requiring expert-established ground truth. The "testing" referred to appears to be engineering and compliance testing (e.g., electrical safety, pressure stability).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for evaluating agreement among human experts or between AI and human experts in diagnostic tasks.
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:
- No MRMC study was mentioned. This type of study is not relevant for a physical CPAP machine.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a CPAP system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of algorithmic performance. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated through various tests (e.g., electrical, mechanical, humidification performance).
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable.

Conclusion based on the provided text:

The provided 510(k) summary for the Curative Medical Inc. K Series CPAP Systems focuses on demonstrating substantial equivalence to a predicate device (Respironics Remstar Pro M Series) through a comparison of design, operating principles, intended use, and compliance with recognized standards (e.g., IEC, ISO). The performance data presented relates to the physical and functional characteristics of the CPAP device and its humidifier, not to the performance of an AI or algorithm in image analysis or diagnostic tasks. Therefore, most of the specific questions regarding acceptance criteria for AI algorithms, expert ground truth, and study methodologies (like MRMC or standalone performance evaluations) are not addressed in this type of regulatory document.

Summary

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510(k) SUMMARY K / 202 85

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:	Curative Medical Inc.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782
Company ContactPerson:	Cuong Tran, Director Research and Development
Phone:	(408) 605 9917
Fax:	(408) 413-3000
Email:	ctran@curativemedical.com
SubmissionCorrespondent:	Amy McKinney, Regulatory Affairs Consultant
Address:	63 Chicory Ct., Lake Jackson, TX 77566
Phone:	(979) 236-1622
Email:	amckinne@comcast.net
Device Name:	K Series CPAP SystemsCurasa Model (Product # 31011321)Floton Model (Product # 31015121)
Device ClassificationName:	Non-continuous ventilator (BZD)21 CFR 868.5905
Predicate Devices:	Respironics Remstar Pro M Series with heated humidifier(K072996)
Date of Preparation:	May 28, 2012

Device Description:

The K Series CPAP with heated humidifier system has the following similarities to the previous cleared predicate device:

Same intended use .
Same operating principle .
Similar technologies .

The following table provides a comparison to the predicate device:

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Comparison Parameter	Respironics Remstar Pro M Series (K072996)	Curative Medical Inc. K Series CPAP
Device Size (cm)	19x12.7x7.9	Curasa: 17x11.7x9.3Floton: 18x21x10.5
Weight (kg)	1.0	Curasa: 1.4Floton: 1.6
Product Use, Transport,Storage	5 to 35	5 to 35
Operation(degreeCelsius.)	5 to 35	5 to 35
Transport & Storage(degree Celsius.)	-20 to 60	-20 to 60
Atmosphere Pressure(Operation)	77 to 101 kPa	70 to 106 kPa
Mode of Operation	Continuous	Continuous
Type of Protection AgainstElectric Shock	Class II Equipment	Class II Equipment
Degree of ProtectionAgainst Electric Shock	Type BF Applied Part	Type B Applied Part
Degree of ProtectionAgainst Ingress of Water	IPX1	IPX1
Pressure Range (cm H2O)	4-20	4-20
Pressure Stability(cm H2O)	4-20 cm H2O, +/- 1.0 cm H2O	4-20 cm H20 +/- 2.0 cm H20
Maximum Flow (LPM)	35	35
Humidifier
Water reservoir	1 2/3 cup	240 ml
Dimensions:	8.25" x 8.75" x 4"	6.5" x 3.3" x 4"
Weight	2.2 lbs	< 0.9 lbs
Power Consumption
Electrical shock protection:	Class II	Class II
Drip Proof Equipment	IPX1	IPX1
Heater Setting	1 - 5	continuous
Standards Compliance
IEC-60601-1	Yes	Yes
IEC-60601-2	Yes	Yes
ISO 17510-1	Yes	Yes
ISO 8185	Yes	Yes

Intended Use:

The K Series CPAP (Continuous Positive Airway Pressure) with heated humidifier systems are intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital /institutional environment.

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Contraindications:

Bullous Lung Disease .
Pathologically Low Blood Pressure .
. Bypassed Upper Airway
. Pneumothorax
Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway . Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus.
. The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of sinus or middle ear infection. Not for use with patients whose upper airways are by-passed.

Summary of Performance Data and Substantial Equivalence:

The K Series CPAP with heated humidifier systems were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the predefined acceptance criteria. Curative Medical Inc. has determined that the K Series is safe and effective for CPAP treatment of OSA in adults. The K Series CPAP with heated humidifier systems have been tested and shown to be compliant with the following standards documents:

1. EN 60601-1-1:1995 + A1:1993 + A2:1995 Medical Electrical equipment - Part 1: General requirement for Safety
1. EN 60601-1-2:2001 Medical Electrical equipment - Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
1. EN ISO 8185:1997 Respiratory Tract humidifiers for medical use - Particular requirements for respiratory humidifier systems
1. EN ISO 17510:2002 Sleep Apnoea Breathing therapy - Part 1: Sleep apnoea breathing therapy equipment

This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that K series CPAP with heated humidifier system is substantially equivalent to the Respironics Remstar Pro M Series (K072996).

Testing was conducted to demonstrate the performance of K series CPAP with heated humidifier system is as safe and effective as its predicate device in its intended environment.

Conclusion:

The information and data provided in this 510(k) Notification establishes that the K Series CPAP with heated humidifier systems are substantially equivalent to the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Curative Medical, Incorporated C/O Ms. Amy Mckinney, MS, RAC Regulatory Affairs Consultant 63 Chicory Court Lake Jackson, Texas 77566

2 2012 JUL

Re: K120285

Trade/Device Name: K Series CPAP Systems Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 1, 2012 Received: June 4, 2012

Dear Ms. Mckinney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Mckinney

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh fa

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4. Indications for Use Statement

510(k) Number (if known):

Device Name: K Series CPAP Systems

Indications For Use:

The K Series CPAP with Heated Humidifier System is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg.

It is intended to be used in the home or hospital/institutional environment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Shults

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

0285 510(k) Number:

Traditional 510(k) - K Series CPAP with Heated Humidifier

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).