The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene.

The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.

An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Reverse Pull Adjustable Facemask." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the study design and acceptance criteria outlined in your request (related to AI performance, human readers, ground truth, and comprehensive clinical trials) are not applicable to this specific document. This document focuses on demonstrating physical and material equivalence to an already approved device.

However, I can extract information related to the performance testing and comparisons made in this 510(k) submission, even though it doesn't align with a clinical or AI-driven evaluation.

Here's a breakdown of the relevant information from the document, tailored as much as possible to your request, but highlighting where your schema doesn't apply:

Acceptance Criteria and Study for Reverse Pull Adjustable Facemask

This device is a Class II medical device (Extraoral Orthodontic Headgear) seeking clearance via a 510(k) submission, which means it aims to demonstrate substantial equivalence to a predicate device, not necessarily prove novel safety and effectiveness through extensive clinical trials. The "acceptance criteria" here therefore relate to demonstrating physical and material similarity and comparable mechanical performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance and Basis for Acceptance
Indications for Use: Same as predicate	Met: "Use as a treatment option for Class III malocclusion." (Identical to predicate)
Principle of Operation: Same as predicate	Met: "Extra oral anchorage support for elastics from intra oral appliances." (Identical to predicate)
Anatomical Location of Use: Same as predicate	Met: "Face of patient." (Identical to predicate)
Patient Contact: Same as predicate	Met: "Forehead and chin." (Identical to predicate)
Main Frame Material: Same as predicate	Met: "304 Stainless Steel." (Identical to predicate)
Main Frame Cross Section: Comparable to predicate	Met: Subject device: 0.146"x0.116" vs. Predicate: 0.140"x0.115". Deemed substantially equivalent.
Mobilization Screw on Chin Cup: Same as predicate	Met: "Allen Screw M3 length 4mm Present." (Identical to predicate)
Chin Cup Support Material: Same as predicate	Met: "EVA Plastic foam." (Identical to predicate)
Chin Cup Mobility: Same as predicate	Met: "Immobile during use." (Identical to predicate)
Forehead Support Material: Same as predicate	Met: "EVA Plastic foam." (Identical to predicate)
Air Vents in Forehead Support: Same as predicate	Met: "Present." (Identical to predicate)
Crossbar Construction: Same as predicate	Met: "Capstan circular." (Identical to predicate)
Crossbar Material: Predicate uses ABS Plastic; Subject uses 304 Stainless Steel	Met (Difference Justified): Subject device uses "304 Stainless Steel." This material difference is not highlighted as problematic for substantial equivalence, likely indicating it does not raise new safety/effectiveness concerns or might even be considered an improvement in strength.
Protection Buttons end of Main Frame: Same as predicate	Met: "Present." (Identical to predicate)
Appliance Weight: Comparable to predicate	Met: Subject device: 1.86 oz vs. Predicate: 1.90 oz. Deemed substantially equivalent.
Screw Type: Same as predicate	Met: "Allen Screw M3 length 4mm." (Identical to predicate)
Time-Dependent Degradation: Low likelihood, same as predicate	Met: "Low likelihood." (Identical to predicate)
Tensile Strength: Comparable to predicate	Met: "The subject device has a similar tensile strength as the predicate and is therefore substantially similar to the predicate."
Biocompatibility: Evaluated and acceptable	Met: "Biocompatibility was evaluated by preparing a risk assessment as per ISO 14971."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For the tensile strength testing, the document states "Performance tests in accordance to ISO 6892-1:2016 for tensile testing of metallic materials at room temperature was conducted on the final finished device configuration as well as the predicate device." It does not specify the exact number of units tested.
Data Provenance: This is a premarket submission by Sawbros Industries Pvt., Ltd. from India. The testing would have been conducted as part of their R&D and quality control processes. The data is retrospective in the sense that it's gathered specifically for this submission to demonstrate equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This submission is for a physical medical device (orthodontic facemask), not an AI/software device that relies on expert interpretation for "ground truth" of images or clinical outcomes. The "ground truth" here is the physical and mechanical properties of the device and its predicate.

4. Adjudication Method for the Test Set

Not Applicable. As above, no "adjudication" in the sense of reconciling expert opinions on clinical cases is relevant. The "adjudication" is essentially the direct measurement of physical properties per ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI-assisted diagnostic or prognostic device. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Physical and Mechanical Properties: The "ground truth" for this substantial equivalence argument is derived from the established physical dimensions, material composition, and mechanical performance (e.g., tensile strength) of both the subject device and the predicate device, as measured against relevant ISO standards.
Predicate Device Characteristics: The characteristics of the legally marketed predicate device (K000358, Multi Adjustable Facemask) serve as the primary reference for "ground truth" in terms of design and material.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that requires a training set. The device is manufactured based on design specifications.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, no training set. The design specifications and material choices are based on engineering principles and similarity to existing, legally marketed devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

August 28, 2017

Sawbros Industries Pvt., Ltd. Dhruv Sawhney Manager Regulatory A-68 Sector 2 Noida, Uttar Pradesh 201301 INDIA

Re: K162543

Trade/Device Name: Reverse Pull Adjustable Facemask Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral orthodontic headgear Regulatory Class: Class II Product Code: DZB Dated: July 6, 2017 Received: July 25, 2017

Dear Dhruv Sawhney:

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 Actinclude 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device comples 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.gov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162543

Device Name Reverse Pull Adjustable Facemask

Indications for Use (Describe) Use as a treatment option for Class III malocclusion.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (8/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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SAWBROS INDUSTRIES Pvt. Ltd.

B(35, LAJPAT NAGAR – II, NEW DELHI – 110 024 INDIA TEL: +91(11(298(17252, +91(120(432(0244 E(MAIL: contact@sawbros.com

510(k) Summary

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.(c)

Submitter

807.92(a)(1)

Name	Sawbros Industries Pvt., Ltd.
Address	B(35 Lajpat Nagar – II,New Delhi 110024,India
USFDARegistration No.	3008959450
Phone	+91(99(1111(7584
Fax	+971(4(359(6556
Contact	Dhruv Sawhney, Manager (Regulatory Affairs)
Date Prepared	6th July 2017

U.S Contact

Name	Mike Sobotka
Address	124(02 Metropolitan Avenue,Kew Gardens,NY 11415(2712
Phone	718(441(0526
Cell	917(620(3091

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WBROS INDUSTRIES Pvt. Ltd.

B(35, LAJPAT NAGAR – II, NEW DELHI – 110 024 INDIA TEL: +91(11(298(17252, +91(120(432(0244 E(MAIL: contact@sawbros.com

807.92(a)(2)

Device Name:

Trade Name	Reverse Pull Adjustable Facemask
Common Name	Orthodontic Facemask, Chin Cup, Adjustable Facemask, Reverse Pull Headgear
Classification Name	Extraoral Orthodontic Headgear
Regulation No.	21CFR872.5500
Classification Code	DZB

807.92(a)(3)

Predicate Device

	Device Name	510 (k)	Company Name
Primary Predicate	MULTI ADJUSTABLE FACE MASK	K000358	ORTHOTECHNOLOGY

807.92(a)(4)

Device Description

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to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.

Model#	Description
426(055RM	Reverse Pull Adjustable Facemask (Blue)
426(056RM	Reverse Pull Adjustable Facemask (Teal)
426(057RM	Reverse Pull Adjustable Facemask (Red)
426(058RM	Reverse Pull Adjustable Facemask (Pearl)
426(050RM	Chin Cup

Table 1. List of models included within this submission

807.92(a)(5)

Indications for Use

Use as a treatment option for Class III malocclusion.

807.92(a)(6)

Basis for Substantial Equivalence

The Reverse Pull Adjustable Facemask has almost identical components and construction as the predicate device. The similarity in design and construction between the Reverse Pull Adjustable Facemask and the predicate device supports the equivalence of the Reverse Pull Adjustable Facemask for the indicated use as demonstrated in table 2.

			Table 2. Comparison of Subject device with Primary Predicate
--	--	--	--------------------------------------------------------------	--	--

	Subject Device	Primary Predicate
510(K) Number	K162543	K000358
Device Name	Reverse Pull Adjustable Facemask	Multi Adjustable Facemask
Applicant	Sawbros Industries Pvt. Ltd.	Ortho Technology
Indication forUse	Reverse Pull Adjustable Facemask isused as a treatment option for ClassIII malocclusion.	Multi Adjustable Facemask is usedas a treatment option for Class IIImalocclusion.
Principle ofOperation	Extra oral anchorage support for	Extra oral anchorage support for
Operation	elastics from intra oral appliances.	elastics from intra oral appliances.
Anatomicallocation of use	Face of patient.	Face of patient.
Patient Contact	Forehead and chin	Forehead and chin
Components
Main FrameMaterial	304 Stainless Steel	304 Stainless Steel
Main FrameCross Section	0.146"x0.116"	0.140"x0.115"
MobilisationScrew on ChinCup	Allen Screw M3 length 4mm Present	Allen Screw M3 length 4mm Present
Chin Cup Supportmaterial	EVA Plastic foam	EVA Plastic foam
Upper/LowerStop Screw forChin	Absent	Absent
Chin CupMobility	Immobile during use	Immobile during use
Foreheadsupport material	EVA Plastic foam	EVA Plastic foam
Air Vents inForeheadSupport	Present	Present
CrossbarConstruction	Capstan circular	Capstan circular
CrossbarMaterial	304 Stainless Steel	ABS Plastic
Protectionbuttons end ofMain frame	Present	Present
ApplianceWeight	1.86 oz	1.90 oz
Screw	Allen Screw M3 length 4mm	Allen Screw M3 length 4mm
Time dependantdegradation	Low likelihood	Low likelihood
Appearance	Image: Blue orthodontic headgear	Image: Blue orthodontic headgear

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As demonstrated in table 2, Reverse Pull Adjustable Facemask is substantially equivalent to the predicate device in terms of indications for use, material, composition and design.

807.92(b)(1)

Nonclinical Tests Discussion

Performance tests in accordance to ISO 6892(1:2016 for tensile testing of metallic materials at room temperature was conducted on the final finished device configuration as well as the predicate device to determine the equivalence. Biocompatibility was evaluated by preparing a risk assessment as per ISO 14971. The subject device has a similar tensile strength as the predicate and is therefore substantially similar to the predicate.

807.92(b)(2)

Clinical Tests Discussion

No clinical field trials have been conducted with Reverse Pull Adjustable Facemask.

807.92(b)(3)

Conclusion

The Reverse Pull Adjustable Facemask has an equivalent intended use, identical operation and substantially similar technological specifications as the predicate device. Based on the information provided in this premarket notification we conclude that the Reverse Pull Adjustable Facemask is equivalent as the predicate device.

Regulation Number and Section

§ 872.5500 Extraoral orthodontic headgear.

(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.