The provided document is a 510(k) summary for the Preceptis Medical Hummingbird Tympanostomy Tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document. The document explicitly states: "The tympanostomy tube met all performance acceptance criteria," but it does not elaborate on what those criteria were or how they were met beyond general statements about equivalence to the predicate device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	The tympanostomy tube met all performance acceptance criteria. (General statement; no specific metrics provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document does not describe a clinical study or a test set involving human subjects. The evaluation appears to be based on an engineering comparison and material properties.

3. 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/Not available. No human experts are mentioned as establishing ground truth for a test set in this 510(k) submission, as there is no described clinical or performance study with such a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not available. No test set or adjudication method is described.

5. 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. This is a medical device for implantation, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not available. For the "Performance Data" stated as "The tympanostomy tube met all performance acceptance criteria," the document implies that the ground truth for performance was likely established through engineering tests and material characterization to demonstrate that the device meets its design specifications and characteristics similar to the predicate device. No clinical outcomes data or pathology is referenced as ground truth for this submission, which focuses on substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

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

September 21, 2015

Preceptis Medical Mr. Keith Leland Vice President of Research and Developement 505 Highwav 169 North, #365 Plymouth, MN 55441

Re: K151830

Trade/Device Name: Hummingbird Tympanostomy Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: July 22, 2015 Received: July 23, 2015

Dear Mr. Leland:

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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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 devicerelated 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 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" (21 CFR 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 yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications For Use Statement

Indications for Use

510(k) Number (if known):

Device Name: Hummingbird™ Tympanostomy Tube

Indications For Use: Indicated where chronic Eustachian tube dysfunction does not respond to conventional therapy.

X Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ (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)

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Section 5

510k Summary

K151830

SubmitterInformation:	Preceptis Medical, Inc.505 Highway 169 North, #365Plymouth, MN 55441763.568.7819
Contact:	Keith Leland, VP of R&D
Date Prepared:	1 July 2015
Trade Name	Hummingbird™ Tympanostomy Tube
Product Code	ETD (21 CFR Part 874.3880)
Common Name	Tympanostomy Tube
Predicate Device	Summit Medical Ventilation Tubes, 510(k) #K830228
DeviceDescription	The tympanostomy tube is a silicone tube that is intended to provideventilation and drainage to the middle ear.
Indications ForUse	Indicated where chronic Eustachian tube dysfunction does not respondto conventional therapy.
TechnologicalCharacteristics	The tympanostomy tube is inserted through the tympanic membrane toallow for ventilation of the middle ear and the drainage of fluid.
PerformanceData	The tympanostomy tube met all performance acceptance criteria.

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Section 5 510k Summary

Overview of Device

The Hummingbird™ Tympanostomy Tube is a silicone tympanostomy tube.

It is intended to provide ventilation of the middle ear and drainage of fluids in instances where chronic Eustachian tube dysfunction does not respond to conventional therapy

The Hummingbird Tympanostomy Tube is preceded by the predicate: Summit Medical ventilation tubes (cleared under K830228). Similar to the predicate device, the Hummingbird Tympanostomy Tube is designed to be inserted using the Hummingbird Tympanostomy Tube System.

Substantial Equivalence Analysis

The key performance, safety and design characteristics of the devices that are used to establish equivalence are identified and are listed in the substantial equivalence table.

The device comparison table shows the similarities and differences between the Hummingbira™ Tympanostomy Tube and the predicate device. The indications for use for the devices are the same. The Hummingbird Tympanostomy tube is identical with respect to function and materials as the Summit Medical ventilation tubes. The Hummingbird Tympanostomy Tube is comparable dimensionally to Summit Medical ventilation tubes.

An analysis of the differences between the devices showed minor dimensional differences between the Hummingbird Tympanostomy Tube and the Summit Medical ventilation tubes. The devices are substantially equivalent.

Device Description

The Hummingbird™ Tympanostomy Tube consists of the following model:

Component/ Model	Description
Ventilation Tube/05-1026-009	Silicone Ventilation Tube

The ventilation tube is a standard, medical grade silicone otologic ventilation tube with a 1 mm inside lumen diameter as illustrated in diagram 1 (all dimensions are in millimeters.)

Image /page/4/Picture/13 description: The image shows a 3D rendering of a light blue plastic object. The object has a cylindrical body with a semi-circular opening at one end. A rectangular prism extends vertically from the top of the cylindrical body. The object appears to be a component or part of a larger mechanism.

Image /page/4/Figure/14 description: The image shows a technical drawing with measurements of an object. On the left, a side view shows a horizontal cylinder with a length of 5.45. A diagonal support with a length of 0.31 is angled at 55 degrees. A vertical rectangular prism with a width of 1.10 and height of 2.06 is placed on top of the cylinder. On the right, an end view shows a semi-circular base with a radius of 1.30 and a vertical cylinder with a diameter of 1.60 and a smaller cylinder with a diameter of 1.0.

Diagram 1 - 05-1026-009

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Section 5 510k Summary

Substantial Equivalence

The Hummingbird "11 Tympanostomy Tube is substantially equivalent with respect to the Summit Medical predicate as confirmed through dimensional attributes and material equivalence.

The device comparison table shows the similarities and differences between the Hummingbird™ Tympanostomy Tube and the predicate. The indications for use, materials, and method of sterilization are all the same.

Parameter	HummingbirdTMTympanostomy Tube(PN 05-1026-009)	Summit Medical OtologicVentilation Tubes - Predicate	Comparison
GeneralDescription	Ventilation Tube	Ventilation Tube
Indications forUse	Indicated where chronicEustachian tube dysfunctiondoes not respond toconventional therapy.	Indicated where chronicEustachian tube dysfunctiondoes not respond toconventional therapy.	Same
Intended use	IndicatedwherechronicEustachian tube dysfunctionnotdoestoconventional therapy.	Indicated where chronicEustachian tube dysfunctiondoes not respond toconventional therapy.	Same
Design	Silicone ventilation tube	Silicone ventilation tube	Same
TechnologicalCharacteristics	Silicone vent tube to beplaced across the tympanicmembrane to allow formiddle ear ventilation andfluid drainage.	Vent tube to be placed acrossthe tympanic membrane toallow for middle ear ventilationand fluid drainage.	Same
Dimensions(vent tube)	1 mm lumen diameter	0.89-1.14 mm lumen diameter	Similar
Materials	Medical Grade Silicone	Medical Grade Silicone	Same
Sterile	Sterile (EO)	Sterile (EO)	Same

Device Comparison Table

Summary of Similarities

Indications for use are the same. ■
Design and Technological Characteristics are the same. I
Materials are the same.
I Method of sterilization is the same.

Summary of Differences

There are minor dimensional differences between the Hummingbird Tympanostomy Tube and the Summit Medical predicate tubes, but the dimensions of the Hummingbird tube fall within the range covered by the predicates.
An analysis of the differences between the devices does not raise a question of safety or efficacy. The devices are substantially equivalent.

Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.