The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

Device Description

MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film 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 Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

AI/ML Overview

This document is a 510(k) premarket notification for the MacroPore Surgical Barrier Film. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested categories (like MRMC study, sample size for training set, number of experts for ground truth) are not applicable or directly derivable from this type of document.

However, I can extract the "acceptance criteria" through the lens of proving substantial equivalence, which revolves around demonstrating similar performance to predicate devices, and the "study" is the in vitro testing and comparison described.

Here's the information formatted to the best extent possible given the document type:

Acceptance Criteria and Device Performance for MacroPore Surgical Barrier Film

Note: This document is a 510(k) for substantial equivalence, not a clinical trial report. "Acceptance criteria" are inferred from the requirements for substantial equivalence, and "reported device performance" refers to the results of the described in vitro tests and comparisons to predicate devices. A "study" in this context refers to the non-clinical testing performed to support the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred from 510(k) Requirements)	Specific Criterion (Inferred)	Reported Device Performance/Findings
Material Stability	Maintain appropriate viscosity after heating at 60°C for ~120 minutes (to simulate surgical preparation).	Viscosity stayed within an appropriate range over 120 minutes of heating in saline at 60°C. Brief exposure during surgical preparation is not expected to significantly affect mechanical properties.
Mechanical Strength (Aging)	Retain sufficient strength for the indicated use after aging.	Testing demonstrated that the MacroPore Surgical Barrier Film is strong enough for the indications for use.
Mechanical Strength (Comparison to Predicate)	Be substantially equivalent in mechanical strengths (e.g., tensile, suture pull-out) to predicate devices under indication for use conditions.	Mechanical testing determined the MacroPore Surgical Barrier Film to be substantially equivalent to the mechanical strengths of the predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant) under indication for use conditions (as measured by tensile and suture pull-out testing).
Indications for Use (Comparison)	Share identical indications for use principles with predicate devices.	MacroPore Surgical Barrier Film shares identical indications for use principles with the predicate devices; both are indicated for the same surgical procedures (orbital implant wrap for enucleation surgery and protecting surrounding orbital tissue).
Design and Materials (Comparison)	Be substantially equivalent in physical design (thin semirigid sheets, contourability, dimensions, malleability) and material (PLA vs. bovine pericardium).	Physical designs are substantially equivalent (thin semirigid sheets). Both allow for contouring (MacroPore when heated to 55°C). Dimensions (rectangular sheets, several cm) are comparable. Material is PLA, which is different from predicate bovine pericardium, but the overall design and function are deemed equivalent.
User Adaptability (Comparison)	Allow end-user cutting to specific shapes and sizes.	Both the MacroPore Surgical Barrier Film and the predicate devices can be cut to specific shapes and sizes by the end user.

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

Sample Size for Test Set: Not explicitly stated as this is non-clinical testing. The "test set" would refer to the samples of the MacroPore Surgical Barrier Film subjected to in vitro heating, aging, and mechanical tests. The number of samples tested for each specific test (e.g., viscosity, tensile strength) is not quantified in this summary.
Data Provenance: The data is from in vitro laboratory testing performed by MacroPore Biosurgery, Inc. It is considered prospective in the sense that the tests were specifically conducted for this 510(k) submission. Country of origin for data generation is likely the USA, implicitly where the manufacturer is located (San Diego, CA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable / not provided. This is an in vitro device and a 510(k) submission. It does not involve human subjects or expert assessment for establishing "ground truth" in a clinical sense. The "ground truth" for the material properties would be established by standard engineering and materials science principles and testing protocols.

4. Adjudication Method for the Test Set

Not applicable / none. Since the "test set" refers to in vitro measurements against established material science parameters and comparisons to predicate device specifications, there is no need for expert adjudication.

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

No. An MRMC study is a type of clinical comparative effectiveness study involving multiple human readers evaluating diagnostic cases. This document describes an in vitro device and a 510(k) submission for substantial equivalence based on material properties and design, not diagnostic accuracy requiring human reader performance.

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

Partially applicable, but in a non-AI context. The "standalone" performance here refers to the intrinsic material and mechanical properties of the device itself (e.g., its viscosity retention, strength, malleability, dimensions) as measured in laboratory tests, without human interaction beyond the initial setup and measurement. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

Engineering and Material Science Standards / Predicate Device Specifications. The "ground truth" for the in vitro tests is derived from:
- Established scientific principles for material behavior (e.g., viscosity, mechanical strength).
- Comparison to the known performance and specifications of legally marketed predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant).
- The assumption that the predicate devices are safe and effective for their intended use.

8. The Sample Size for the Training Set

Not applicable / No training set in the AI sense. This is not an AI/machine learning device. The "training" for the device itself would refer to its manufacturing and design process, informed by polymer science and surgical needs, not a data-driven training set.

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

Not applicable. As there is no AI training set, this question is not relevant. The device's design and material selection are based on established engineering principles, material properties of polylactides, and the functional requirements for an orbital implant wrap, with reference to predicate devices.

Summary

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FEB 21 2003
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K023643 SUMMARY	MacroPore Surgical Barrier Film	Page 1 of 3
ADMINISTRATIVE INFORMATION
Manufacturer Name:	MacroPore Biosurgery, Inc.6740 Top Gun StreetSan Diego, CA 92121

Official Contact:

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

DEVICE NAME

Implant, Eye Sphear Classification Name:

Trade/Proprietary Name:

MacroPore Surgical Barrier Film

ESTABLISHMENT REGISTRATION NUMBER 2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 886.3320, an eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball. These devices are classified as Class II. Eye sphere implants have been assigned Product Code HP2.

INTENDED USE

The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbiral implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

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DEVICE DESCRIPTION

Design Characteristics

The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater

Material Composition

The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

In Vitro Testing

Because the MacroPore Surgical Barrier 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 Surgical Barrier Film is not expected to have a significant effect on its mechanical properties.

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

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

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EQUIVALENCE TO MARKETED PRODUCT

MacroPore Surgical Barrier Film shares indications and design principles with the following predicate devices, which have been determined by FDA to be substantially equivalent to the following pre-amendment devices: Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant: Class II medical devices that were cleared for marketing in the United States.

Indications For Use

MacroPore Surgical Barrier Film shares identical indications for use principles with the predicate devices as both the MacroPore Surgical Barrier Film and the predicate devices are indicated for the same surgical procedures.

Design and Materials

The physical designs of MacroPore Surgical Barrier Film and the predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant) are substantially equivalent, consisting of thin semirigid sheets. The MacroPore Surgical Barrier Film and the bovine pericardium predicates also share design features of allowing for contouring. The MacroPore Surgical Barrier Film is fully contourable when heated to approximately 55°C. The dimensions of the predicate devices are also comparable to the MacroPore Surgical Barrier Film as both devices are provided in rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore Surgical Barrier Film are substantially equivalent to the predicate devices with respect to mechanical strength as measured by tensile and suture pull out testing. In addition to physical characteristics, both the predicate device and the MacroPore Surgical Barrier 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 the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

MacroPore Biosurgery, Inc. c/o Kenneth K. Kleinhenz 6740 Top Gun St. San Diego, CA 92121

Re: K023643

Trade/Device Name: MacroPore Surgical Barrier Film Regulation Name: Eye Sphere Implant Regulation Number: 21 CFR 886.3320 Regulatory Class: Class II Product Code: MTZ Dated: January 22, 2003 Received: January 23, 2003

Dear Mr. Kleinhenz:

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 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 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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Page 2 – Kenneth K. Kleinhenz

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalpi 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

Enclosure

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Device Name: MacroPore Surgical Barrier Film

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Oph
Nose and Thro:
510(k) Number K0 23643

Regulation Number and Section

§ 886.3320 Eye sphere implant.

(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.