MacroPore ENT Reconstruction Film is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore ENT Reconstruction Film can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore ENT Reconstruction Film to the desired shape or size.

MacroPore ENT Reconstruction Film Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore ENT Reconstruction Film can be rolled into a tube or used as a flat sheet. It can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore ENT Reconstruction Film and prevent dislocation. The MacroPore ENT Reconstruction Film may be used in conjunction with various MacroPore manual instruments.

MacroPore ENT Reconstruction Film is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore ENT Reconstruction Film is provided in sheets of 10mm x 10mm to 120mm x 120mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore ENT Reconstruction Film ranges from 0.02 mm to 2.0 mm according to the region to be treated. The MacroPore ENT Reconstruction Film is provided with and without macroporous holes. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and may be in aligned, offset, or random patterns. The borders of the sheets may be aligned with holes to attach suture material

AI/ML Overview

The provided 510(k) summary for the MacroPore ENT Reconstruction Film outlines the device's characteristics and its equivalence to predicate devices, but it does not contain details about specific acceptance criteria, a study proving those criteria were met, or the metrics involved in such a study.

Instead, the document details physical and material properties, in vitro and in vivo testing for safety and efficacy, and a comparison with existing devices to establish "substantial equivalence." The "acceptance criteria" presented below are inferred from the types of tests and comparisons mentioned in the document, as the 510(k) process focuses on demonstrating equivalence rather than meeting pre-defined performance criteria like those found in a clinical trial for a novel device.

Here's an attempt to structure the information based on your request, highlighting the limitations due to the nature of the provided document:

Acceptance Criteria and Device Performance (Inferred from 510(k) Submission)

Acceptance Criteria (Inferred from 510(k) Requirements for Equivalence)	Reported Device Performance (as described in the 510(k) Summary)
Material Composition Must be fabricated from a resorbable, biocompatible polymer suitable for ENT applications.	Fabricated from polylactic acid (PLA).
Mechanical Strength Must be strong enough for the indicated uses and comparable to predicate devices.	"Testing demonstrated that the MacroPore ENT Reconstruction Film is strong enough for the indications for use." "Mechanical testing was performed on the MacroPore ENT Reconstruction Film which determined the MacroPore ENT Reconstruction Film to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
Flexibility/Malleability Must be able to be shaped and conformed to anatomical structures.	"Fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation." "Can be cut with scissors to the desired shape and size."
Material Stability after Heating Must maintain appropriate viscosity and mechanical properties after heating for shaping.	"Testing demonstrates that viscosity stayed within an appropriate range over 120 minutes [after heating in saline at 60°C]."
Indications for Use Equivalence Must have identical indications for use principles as predicate devices.	"The MacroPore ENT Reconstruction Film shares identical indications for use principles with the predicate devices." (Lists 5 specific ENT surgical applications).
Design Characteristics Equivalence Must have similar design principles (e.g., thin, semi-rigid sheet, cuttable, varying sizes/thicknesses) as predicate devices.	"Consisting of a thin semi-rigid sheets that allow for contouring." "Thickness range of .02mm - 2.0mm which is substantially equivalent to the predicate devices that range in thickness from .05mm - 2.0mm." "Produced in rectangular sheets that are several centimeters in size."
Safety and Efficacy (In Vivo) Must demonstrate safety and efficacy suitable for the indications for use in an animal study.	"An animal study was conducted to demonstrate safety and efficacy of the MacroPore ENT Reconstruction Film materials are appropriate for the indications for use."

Study Details:

The provided document describes neither a specific "test set" nor "training set" in the context of an algorithm or AI model, nor does it detail a study proving specific acceptance criteria in the way a clinical trial would. Instead, it refers to pre-clinical (in vitro and in vivo animal) testing and a substantial equivalence comparison to predicate devices.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for "Test Set" as defined for AI/Algorithm performance. The document refers to "in vitro testing" and an "animal study."
- In vitro testing: No sample sizes are explicitly stated for the in vitro tests (viscosity, aging, mechanical testing). The provenance is not stated, but it would typically be conducted by the manufacturer (MacroPore, Inc.) in their labs in San Diego, CA, USA.
- Animal study: The document states "An animal study was conducted," but no details on the number of animals, species, or study design are provided. The provenance is not stated.
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. "Ground truth" in this context would implicitly be established through standard scientific and pre-clinical methodologies for evaluating material properties and biological response in animal models. No expert panel for "ground truth" adjudication in the context of a dataset evaluation is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to expert review of data for AI/algorithm validation, which is not described.
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. This is a medical device (reconstruction film), not an AI algorithm intended to assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm, so standalone performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the in vitro testing: The "ground truth" would be the objective measurements obtained from the laboratory tests (e.g., viscosity readings, tensile strength, elongation).
- For the animal study: The "ground truth" for safety and efficacy would be based on histological analysis, clinical observations, potential pathology, and biocompatibility assessments in the animal model.
The sample size for the training set
- Not applicable. This is not an AI/algorithm submission.
How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm submission.

Summary of the Study that "Proves" Equivalence:

The "study" or rather the evidence provided to the FDA for 510(k) clearance consists of:

In vitro testing: This included viscosity testing (after heating at 60°C for 120 minutes, showing it stayed in an "appropriate range"), aging testing (demonstrating sufficient strength), and mechanical testing (demonstrating substantial equivalence to predicate devices). The details of these tests (e.g., number of samples tested, specific methods, raw data) are not provided in this summary.
In vivo animal study: Conducted to demonstrate "safety and efficacy" and that the materials are "appropriate for the indications for use." No details on the study design, species, number of animals, or specific outcomes are included in this summary.
Substantial Equivalence Comparison: A detailed comparison of the MacroPore ENT Reconstruction Film's indications for use, design characteristics (material composition, malleability, thickness range, dimensions, mechanical characteristics, ability to be cut), and general performance with a list of predicate devices (Pillar Prolastic Sheeting, SupraFOIL, Seare Silicone Sheeting, Durasil I and Durasil II, Specialty Surgery Silicone Elastomer, Lactosorb Ethmoid Stent, and MacroPore Protego System). The core argument for clearance is that the MacroPore device is sufficiently similar to these legally marketed devices that it can be considered safe and effective.

Summary

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OCT 2 5 2001

019769

MacroPore ENT Reconstruction Film Page 1 of 3 510(k) SUMMARY

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

MacroPore, Inc. 6740 Top Gun Street San Diego, CA 92121

Kenneth K. Kleinhenz Director of Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994

DEVICE NAME

Classification Name:

Ear, nose, and throat synthetic polymer material

Trade/Proprietary Name:

MacroPore ENT Reconstruction Film

ESTABLISHMENT REGISTRATION NUMBER 2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 874.3620, Ear, nose, and throat synthetic polymer materials are synthetic AS shown in 21 21 cr of 1.50by bed, for use as a space-occupying substance in reconstructive surgery procedures of the head and neck. The device is intended to be shaped and formed by the surgeon to conform to the patient's needs. These devices are classified as Class II. Ear, nose, and throat synthetic polymer materials have been assigned Product Code NHB.

INTENDED USE

The MacroPore ENT Reconstruction Film is indicated for the following surgical applications:

1). Tympanic membrane repair.
2). Tympanoplasty in the middle car.
3). Nasal splinting and surgical repair of nasal septum.
4). Guided tissue regeneration of the external ear.
5). Prevents adhesions between the septum and the nasal cavity

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DEVICE DESCRIPTION

Design Characteristics

Material Composition

The MacroPore ENT Reconstruction Film is fabricated from polylactic acid (PLA).

In Vitro Testing

Because the MacroPore ENT Reconstruction Film is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical preparation of MacroPore ENT Reconstruction Film is not expected to have a significant effect on its mechanical properties.

Aging testing was performed on MacroPore ENT Reconstruction Film. Testing demonstrated that the MacroPore ENT Reconstruction Film is strong enough for the indications for use.

Mechanical testing was performed on the MacroPore ENT Reconstruction Film which determined the MacroPore ENT Reconstruction Film to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.

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510(k) SUMMARY

In Vivo Testing

An animal study was conducted to demonstrate safety and efficacy of the MacroPore ENT An animal study was ochial. The animal studies demonstrated that the MacroPore ENT Reconstruction Film materials are appropriate for the indications for use.

EQUIVALENCE TO MARKETED PRODUCT

MacroPore ENT Reconstruction Film shares indications and design principles with the following predicate devices, which have been determined by FDA to be substantially equivalent to the Pillar Prolastic Sheeting, SupraFOIL, Seare Silicone following pre-amendment devices: Sheeting, Durasil I and Durasil II, Specialty Surgery Silicone Elastomer, Lactosorb Ethmoid Stent, and MacroPore Protego System.

Indications For Use

The MacroPore ENT Reconstruction Film shares identical indications for use principles with the The Macror of 214 "Recombile to Pore ENT Reconstruction Film and the predicate devices are indicated for the same surgical procedures.

Design and Materials

Design and MacroPore ENT Reconstruction Film and the predicate devices Pillar Prolastic Sheeting, SupraFOIL, Seare Silicone Sheeting, Durasil I and Durasil II, Specialty Fronotic Silicone Elastomer, Lactosorb Ethomoid Stent, and MacroPore Protego System) are substantially equivalent, consisting of a thin semi-rigid sheets that allow for contouring. Both the predicate devices and the MacroPore ENT Reconstruction Film have a semi-rigid construction. predicate also Reconstruction Film and the predicates also share design features of allowing for contouring. The MacroPore ENT Reconstruction Film is fully contourable when heated to for contrately 55°C. The thickness of the predicate devices and the MacroPore ENT approximatory 55 O. The are substantially equivalent as the MacroPore ENT Reconstruction Film thickness ranges are essentially a subset of the predicate ranges. The MacroPore ENT Reconstruction Film has a thickness range of .02mm - 2.0mm which is substantially equivalent to the predicate devices that range in thickness from .05mm - 2.0mm. The dimensions of the predicate device are also comparable to the MacroPore ENT Reconstruction Film as both devices produced in rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore ENT Reconstruction Film are also substantially equivalent to the predicate devices. In addition to physical characteristics, both the predicate device and the MacroPore ENT Reconstruction Film can be cut to specific shapes and sizes by the end user.

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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular and contains an image of an eagle. The eagle is facing to the right. The text "U.S. Department of Health & Human Services" is written around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2001

MacroPore, Inc. c/o Kenneth K. Kleinhenz Director of Regulatory Affairs 6740 Top Gun Street San Diego, CA 92121

Re: K012769

Trade/Device Name: MicroPore ENT Reconstruction Film Regulation Number: 21 CFR 874.3620; 21 CFR 874.4780 Regulation Name: Ear Nose and Throat Synthetic Polymer Material Intranasal Splint Regulatory Class: Class II; Class I Product Code: NHB: LYA Dated: August 15, 2001 Received: August 17, 2001

Dear Mr. Kleinhenz:

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.

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and the country of the county of

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to obgin mailing of substantial equivalence of your device to a legally prematication. "The PDF missily sification 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 If you desire specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF 1 F a c 613. Additionally, for questions on the promotion and advertising of Complance at (301) 591-1019 Fridaes Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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012769

Device Name: MacroPore ENT Reconstruction Film

Indications for Use:

and the comments of the comments

Thurcations for 'OSC.
The MacroPore ENT Reconstruction Film is indicated for the following surgical applications:

1). Tympanic membrane repair.
2). Tympanoplasty in the middle ear.
3). Nasal splinting and surgical repair of nasal septum.
4). Guided tissue regeneration of the external ear.
5). Prevents adhesions between the septum and the nasal cavity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Division of Ophthalmic I 510(k) Number

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.