The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

Device Description

The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

. Full face and Nasal style
. Integral anti-asphyxia valve
Headgear for attachment .
. Single use disposable and Single patient, multi-use

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (GaleMed CPAP mask). Such notifications typically aim to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device would.

Based on the information provided, here's an analysis of the "acceptance criteria" and "study" as they relate to this type of submission:

Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as the predicate device. In this specific case, the submission asserts that the proposed device is identical to the predicate device (Hsiner K063268) in features, indications for use, environment of use, patient population, contraindications, single patient/multi-use, components, anti-asphyxia valve, and materials.

The "study" that proves this substantial equivalence is described as "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." The report states these tests are "Identical" to those performed for the predicate. This implies that the GaleMed CPAP mask performed equivalently to the predicate device on these established engineering and performance tests relevant to CPAP masks.

Here's how to frame the information, even though it's not a typical "acceptance criteria" table from a clinical study:

Table: Acceptance Criteria and Reported Device Performance (as demonstrated by Substantial Equivalence)

Acceptance Criteria Category (based on predicate device)	Specific Criteria (Implicitly met by "Identical" or "Same")	Reported Device Performance (from comparison)
Indications for Use	Same as Predicate Hsiner K063268	Identical
Environment of Use	Same as Predicate Hsiner K063268	Same
Patient Population	Same as Predicate Hsiner K063268	Same
Contraindications	Same as Predicate Hsiner K063268	None (Same as Predicate)
Single patient, Multi-use	Yes (Same as Predicate Hsiner K063268)	Yes
Components	Headgear, Anti-asphyxia valve (Same as Predicate)	Headgear, Anti-asphyxia valve
Anti-asphyxia valve	Yes (Same as Predicate Hsiner K063268)	Yes
Materials	Polycarbonate, Silicone (Same as Predicate K063268)	Identical K063268
Safety and Efficacy Testing	Flow vs. Leak / Pressure performance	Identical to Predicate
	Dead space measurements	Identical to Predicate

Additional Information based on the provided document:

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." However, it does not specify the sample size for these tests. It simply states that they were "Identical" to the testing for the predicate device.
- The data provenance is not specified regarding the "Comparative testing." Given that the applicant is from Taiwan (GaleMed, Taiwan), it's plausible the testing was conducted there, but this is not explicitly stated. The nature (retrospective/prospective) of these engineering tests is also not detailed.
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):
- This question is generally not applicable to a 510(k) submission for a device like a CPAP mask, especially when the claim is substantial equivalence based on engineering and material comparisons. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or diagnoses) is not established or discussed here. The "ground truth" for the performance claims rests on the technical specifications and engineering test results being "identical" to a legally marketed device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies. The provided document details engineering tests comparing a new device to a predicate, not a clinical study requiring expert adjudication of results.
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 is a question relevant to AI-powered diagnostic aids, not a CPAP mask. The submission does not involve AI or human "readers" in the context of comparative effectiveness.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question relates to AI algorithms operating independently. The GaleMed CPAP mask is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance claims, the "ground truth" is based on engineering performance specifications and measurements (e.g., flow, leak, pressure, dead space) which are asserted to be identical to those of the predicate device. There is no mention of clinical outcomes data, expert consensus on patient outcomes, or pathology results being used as ground truth for this submission.
The sample size for the training set:
- Not applicable. This refers to the training of machine learning models. The submission is for a physical medical device and does not involve a training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm in this submission.

Summary

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K072755

GaleMed CPAP mask

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 26-Sept-07

87, Li-gong, 2nd Road
Wu-jia, I-Lan, 268, TaiwanTel – 011-3-990-8618
Official Contact:Thomas Loescher	NOV 】 6 200
Proprietary or Trade Name:CPAP masks
Common/Usual Name:Patient interface for use with CPAP systems
Classification Name:BZD - 868.5905	Ventilator. non-continuous (respirator), accessory
Device:CPAP masks
Predicate Devices:Hsiner Co., Ltd. - K063268

Device Description:

The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

. Full face and Nasal style
. Integral anti-asphyxia valve
Headgear for attachment .
. Single use disposable and Single patient, multi-use

Indications for Use:	The GaleMed CPAP masks are intended to be used in a home,hospital or institutional environment for patients who have beenprescribed CPAP/VPAP therapy. This device is intended to beused under the specific direction of a physician. Disposable andSingle patient, multi-use styles.
Patient Population:	Adults with OSA
Environment of Use:	Hospitals, Home, sub-acute care settings
Contraindications:	None

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Sept-07

Comparative table:

Features	Predicate HsinerK063268	Proposed Device
Indications for use	The Hsiner CPAP masks areintended to be used in a home,hospital or institutional environmentfor patients who have beenprescribed CPAP/VPAP therapy.This device is intended to be usedunder the specific direction of aphysician. Disposable and Singlepatient, multi-use styles.	Identical
Environment of Use	Home, Hospital, Sub-acuteInstitutions	Same
Patient Population	Adult	Same
Contraindications	None	None
Single patient,Multi-use	Yes	Yes
Components	HeadgearAnti-asphyxia valve	HeadgearAnti-asphyxia valve
Anti-asphyxia valve	Yes	Yes
Materials	PolycarbonateSilicone	Identical K063268
Comparative testingfor safety andefficacy	Flow vs. Leak / PressureDead space	Identical

Differences Between Other Legally Marketed Predicate Devices:

The proposed device is identical to the predicate device, K063268.

There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galemed Corporation C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, # 102 Bonita Springs, Florida 34134-2015

Re: K072755

Trade/Device Name: CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 26, 2007 Received: September 27, 2007

Dear Mr. Dryden:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R.C. dyl
for

Chiu Lin, Ph.D. 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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Indications for Use Statement

Page 1 of 1

(To be assigned) 510(k) Number: CPAP mask Device Name: The GaleMed CPAP masks are intended to be used in a Indications for Use: home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Müll Thul

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).