The Xomed EpiFilm™ Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. EpiFilm™ Otologic Lamina is indicated for use in myringoplastic and tympanoplastic surgical procedures.

Device Description

Xomed EpiFilm Otologic Lamina is a biomaterial composed of HYAFF® an ester of hyaluronic acid, a naturally occurring constituent of the extracellular matrix. The transparent lamina has micro-perforations to allow permeability facilitating drainage of exudate at the surgical site.

AI/ML Overview

This document is a 510(k) summary for the Xomed EpiFilm™ Otologic Lamina, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly defining and meeting acceptance criteria through a standalone study with performance metrics in the way a novel AI/software medical device might.

Therefore, the requested information elements related to AI/software device performance criteria and studies are not directly applicable or available in this document. I will extract the information that is present and explain why other sections are not applicable.

Here's a breakdown based on the provided text:

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

This information is not explicitly provided in the document in the format of acceptance criteria and performance metrics typically seen for AI/software devices (e.g., sensitivity, specificity thresholds). For a 510(k) for a material implant, the "acceptance criteria" are generally demonstrating substantial equivalence to a predicate device, which includes biocompatibility, intended use, and similar performance characteristics.

The document states:

"The material has been demonstrated non-toxic and biocompatible according to ISO 10993 standards, and in clinical study has presented no new issues of safety or effectiveness for the intended use."
"In conclusion, Xomed EpiFilm™ Otologic Lamina has the same intended use as the predicate devices and differs only in the material which has been shown as biocompatible, as based on the data in the submission, and raises no new issue of safety or effectiveness."

This suggests the "performance" demonstrated was biocompatibility and lack of new safety/effectiveness issues in comparison to predicate devices, rather than a specific performance metric.

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 in the summary. The document mentions "clinical study" but does not detail its design, sample size, or provenance.

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. This concept of "ground truth" and expert adjudication is more relevant to diagnostic AI/software devices. For a material implant, the safety and effectiveness would be evaluated through pre-clinical (biocompatibility) and clinical (e.g., patient outcomes, adverse events) studies, not typically by expert consensus on image interpretation.

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

This information is not provided and is not applicable to the type of device and submission.

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

This information is not provided and is not applicable to an implantable biomaterial device. MRMC studies are for evaluating diagnostic performance, often with AI assistance for human readers.

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

This information is not provided and is not applicable to an implantable biomaterial device. This type of study applies to AI/software algorithms.

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

The "ground truth" for a material implant would primarily be derived from:

Biocompatibility testing results (pre-clinical): Adherence to ISO 10993 standards for non-toxicity and biocompatibility.
Clinical outcomes data: Absence of adverse events, successful healing, and performance comparable to predicate devices in surgical procedures.

The summary states: "The material has been demonstrated non-toxic and biocompatible according to ISO 10993 standards, and in clinical study has presented no new issues of safety or effectiveness for the intended use." This points to both pre-clinical data (ISO standards) and clinical outcomes data.

8. The sample size for the training set

This information is not provided and is not applicable. "Training set" refers to data used to train an AI algorithm. This device is a biomaterial, not an AI.

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

This information is not provided and is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "XOMED" in bold, black letters. To the right of the word is a registered trademark symbol, followed by a circular design with a cross shape inside. The cross shape is made up of four arrows pointing towards the center of the circle.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS X.

K 982870

Date Prepared 1.0

August 12, 1998

2.0 Submitter (Contact)

Rov Berens, Manager Quality System Regulations Xomed Surgical Products Jacksonville, FL 32216 Telephone: 904-296-6454 Fax: 904-281-1057 rberens@xomed.com e-mail:

3.0 Device Name

Proprietary Name:	Xomed EpiFilm™ Otologic Lamina
Common Name(s):	Synthetic Polymer Implant MaterialSurgical Implant Polymer MaterialSurgical Adjunct Polymer Material
Classification Name:	Ear, nose, and throat synthetic polymer material

4.0 Device Classification

Ear, nose, and throat synthetic polymer material ProCode KHJ Class II ; 21 CFR 874.3620

5.0 Device Description

6.0 Intended Use

The Xomed EpiFilm™ Otologic Lamina is intended for use as an implant material to aid in surqical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. EpiFilm™ Otologic Lamina is indicated for use in myringoplastic and tympanoplastic surgical procedures.

{1}------------------------------------------------

7.0 Substantial Equivalence

EpiFilm™ Otologic Lamina is an ENT polymeric implant material for prescription use supplied sterile in individual pouches containing a single 2.5 cm x 2.5 cm square of the device. EpiFilm™ squares feature microholes to provide a permeable surface and are intended for aid in surgical repairs and is an adjunct to aid in the natural healing process in various otologic procedures by providing a biocompatible covering surface.

Both the subject and predicate devices are intended for use as long term implant materials for ENT surgical repairs. Both use biocompatible polymeric materials in the form of thin sheeting which may be trimmed to meet the specific needs of the patient, are sterile, single use. The difference is that the predicate devices are made of silicone whereas EpiFilm™ is made of the benzyl ester of hyaluronic acid which typically dissolves in about six (6) to eight (8) weeks after implantation.

material comprising EpiFilm™ has been subjected to extensive The biocompatibility testing according to the ISO/EN standards for material testing for toxicity and biocompatibility. The material has been demonstrated non-toxic and biocompatible according to ISO 10993 standards, and in clinical study has presented no new issues of safety or effectiveness for the intended use.

In conclusion, Xomed EpiFilm™ Otologic Lamina has the same intended use as the predicate devices and differs only in the material which has been shown as biocompatible, as based on the data in the submission, and raises no new issue of safety or effectiveness.

{2}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Roy Berens Manager, Quality Systems Regulations Xomed 6743 Southpointe Dr. N. Jacksonville, FL 32216-0980

Re:

K982870

EpiFilm® Otologic Lamina Dated: October 7, 1998 Received: October 8, 1998 Regulatory class: II 21 CFR 874.3620/Procode: 77 KHJ

Dear Mr. Berens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrt/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

{3}------------------------------------------------

Intended Use Statement

510(k) Number (if known): K_ 48 d 8 7 10

Device Name: EpiFilm™ Otologic Lamina

Indications for Use: The Xomed EpiFilm™ Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Simid le. byman
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 82870 510(k) Number .

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.