The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

Device Description

The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.

AI/ML Overview

The provided text describes the Entellus Medical Flexible Endoscope and Eyepiece. However, it does not contain a detailed study report that includes specific acceptance criteria and a comprehensive study proving the device meets those criteria, as typically found in a clinical trial or performance efficacy study.

The document mainly focuses on regulatory aspects for a 510(k) submission, confirming substantial equivalence to predicate devices based on general performance data.

Here's a breakdown of the information that is and is not available based on your request:

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

Acceptance Criteria: Not explicitly stated in a quantitative, measurable format (e.g., minimum resolution, specific illumination levels, durability cycles). The document broadly states "the device meets its established specifications," but these specifications are not detailed.
Reported Device Performance: The document states that "The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures."
- Specifics are lacking. We know what types of tests were done (biocompatibility, dimensional, bench, reprocessing), but not the results or the numeric targets for those tests.

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

This information is not provided. The 510(k) summary does not detail the sample sizes for any tests, nor does it specify if the data was retrospective or prospective, or its country of origin.

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)

This information is not provided. The document describes a "device performance test data" but does not mention any expert review or ground truth establishment relevant to diagnostic accuracy. This type of device (an endoscope) is a visualization tool, and its performance evaluation would typically focus on aspects like image quality, illumination, field of view, and durability, rather than diagnostic accuracy established by experts on a test set.

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

This information is not provided. As no expert review or diagnostic study is mentioned, adjudication methods for ground truth would not be applicable.

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, an MRMC comparative effectiveness study was not done. The device described is a basic flexible endoscope, a visualization tool. It does not incorporate AI, nor is it a diagnostic aid that would typically be evaluated in an MRMC study comparing human performance with and without AI assistance.

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

No, a standalone algorithm performance study was not done. The device is a physical endoscope, not a software algorithm.

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

This information is not applicable/provided. The performance data mentioned (biocompatibility, dimensional, bench, reprocessing) for a viewing device like an endoscope does not typically rely on "ground truth" derived from expert consensus, pathology, or outcomes data in the same way an AI diagnostic tool would. Its performance is about its physical and functional integrity.

8. The sample size for the training set

This information is not applicable/provided. As the device is a physical endoscope and not an AI algorithm, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided. See point 8.

In summary:

The provided 510(k) summary for the Entellus Medical Flexible Endoscope and Eyepiece details a regulatory submission for a physical medical device (an endoscope). It asserts that performance testing (biocompatibility, dimensional, bench, reprocessing) was conducted and demonstrated that the device meets its specifications and performs as intended. However, the document does not provide the specific quantitative acceptance criteria or detailed results of these tests, nor does it describe studies involving expert readers, AI algorithms, or "ground truth" establishment as you've requested, because these types of studies are typically not relevant for this class and type of device. The clearance is based on substantial equivalence to predicate devices, supported by general performance and safety data.

Summary

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510(k) Summary K082569

SEP 1 8 2008

Date Prepared:Submitted By:	September 17, 2008
Company:	Entellus Medical, Inc.
Address:	6705 Wedgwood Court North
	Maple Grove, MN 55311
Establishment Reg:	Not Yet Assigned
Owner/Operator #:	10025424
Contact Person:	Deborah Neymark
	V.P., Regulatory Affairs, Clinical Research and Quality
	763-463-7056 (phone)
	763-463-1599 (fax)
Device Information:
Trade Name:	Entellus Medical Flexible Endoscope and Eyepiece
Common Name:	Flexible Endoscope
Classification Name:	Nasopharyngoscope (flexible and rigid)
Classification:	21 CFR 874.4760
Product Code:	EOB

Predicate Device:

The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the following devices:

Karl Storz Miniature Endoscope (K070752) ●
Karl Storz Video Rhino-Laryngoscope System (K072387) .
Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786)

Device Description:

The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.

Indications for Use:

The Entellus Flexible Endoscope and Eyepicce is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

Performance Data:

The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures.

Conclusion:

The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the identified predicate device based on a companson of the indications for use, the technological characteristics of the device and an assessment of the submitted performance data.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2008

Entellus Medical Inc. c/o Mark Job Regulatory Technology Services 1394 25th Street. NW Buffalo, MN 55313

Re: K082569

Trade/Device Name: Entellus Medical Flexible Endoscope and Eyepiece Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible and rigid) Regulatory Class: Class II Product Code: EOB Dated: September 4, 2008 Received: September 5, 2008

Dear Mr. Job:

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 mav 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 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 (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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. B. Egerlins, mnd

Malvina B. Evdelman. 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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KOB-2569

Indications for Use Statement

510(k) Number:

K082569

Device Name:

Entellus Medical Flexible Endoscope and Eyepiece

Indications for Use:

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)

Sein Mardin

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number

X cription Use r 21 CFR 801.109)

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.