MacroPore Protective Sheet is an absorbable, macroporous implant in sheet form manufactured from polylactic acid (PLA). The purpose of the sheet is to provide fixation of non-load bearing bone defects in the cranio-facial area of the mammalian skeletal system. MPS can be cut with scissors, is thermoplastic when heated to 55 C (for example, by the use of sterile hot water) and thus can be conformed three dimensionally to any bone defect. It can be rolled into a tube or used as a flat sheet. It can be used in conjunction with internal bone fixation devices such as plates and screws which can be also used to fixate the MPS and prevent dislocation. The system includes a selection of resorbable screws and tacks. MPS is provided in sheets of 40 x 40 mm and in premanufactured shapes and can be provided in other sizes as needed for particular surgical procedures. Its thickness ranges from 500 microns to 1000 microns according to the defect to be treated. The pore size ranges from 500 microns to 2000 microns with pores distributed uniformly throughout the sheet in an offset or aligned pattern.

AI/ML Overview

This document is a 510(k) premarket notification for the MacroPore Protective Sheet (Protego™ System) and does not describe a study involving acceptance criteria and device performance in the way a clinical study or AI/ML device validation might.

Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. Therefore, the "acceptance criteria" here relate to FDA's standards for substantial equivalence, primarily concerning intended use, design, and material composition, rather than statistical performance metrics of a specific study.

Here's a breakdown based on the provided text, addressing your points where applicable and noting where the information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are the characteristics of the predicate devices against which the MacroPore Protective Sheet (MPS) is compared for substantial equivalence. The "reported device performance" refers to how MPS aligns with these characteristics.

Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (MacroPore Protective Sheet)
Intended Use: For use in trauma and reconstructive procedures in the midface and craniofacial skeleton for comminuted fractures of naso-ethmoidal and infraorbital areas, frontal sinus wall, and general midface/craniofacial trauma/reconstruction. Not for mandible or full load-bearing.	Intended Use: Identical to predicate devices. For use in trauma and reconstructive procedures in the midface and craniofacial skeleton for comminuted fractures of naso-ethmoidal and infraorbital areas, frontal sinus wall, and general midface/craniofacial trauma/reconstruction. Not for mandible or full load-bearing.
Design: Thin sheet with perforations; various thicknesses (e.g., 500-1000 microns for LactoSorb); various sizes; specific pore sizes (e.g., 1500-2000 microns for LactoSorb); uniform aligned pattern.	Design: Sheet form, 500-1000 microns thickness; 40x40mm (can be other sizes); pore size 500-2000 microns, uniformly distributed in offset or aligned pattern. Can be cut, thermoplastically conformed, rolled.
Material: Resorbable polymer, specifically poly(L-lactide-co-glycolide) 82:18, low crystallinity (for LactoSorb). Titanium for other predicates.	Material: Absorbable polymer, specifically poly(L-lactide-co-D,L-lactide) 70:30, amorphous.
Degradation Profile: Maintains 70% strength for 6-8 weeks, fully degraded 9-15 months (for LactoSorb).	Degradation Profile: Degrades more slowly than LactoSorb, fully degraded after 36 months (shown in animal studies).
Sterilization: Ethylene Oxide sterilizable, validated per ANSI/AAMI/ISO 11135-1994, SAL 10^-4.	Sterilization: Ethylene Oxide sterilizable packaging; sterilization by EtO treatment; validated per ANSI/AAMI/ISO 11135-1994, SAL 10^-4.

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

Sample Size: Not applicable. This document does not describe a clinical study with a "test set" in the context of device performance evaluation. The substantial equivalence determination is based on a review of technical and performance characteristics compared to existing devices. The "animal studies" mentioned for degradation are not detailed in terms of sample size or provenance.
Data Provenance: Not applicable for a traditional test set. The data presented is descriptive of the device's characteristics and comparison to predicate devices, which are already marketed in the US.

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

Number of Experts/Qualifications: Not applicable. "Ground truth" in this context is established by the known characteristics and approved uses of the predicate devices, and the detailed technical specifications and material properties provided by the manufacturer for the new device. The FDA (specifically the General and Plastic Surgery Device Section of the Surgical and Rehabilitation Devices Panel) reviews this information to make the equivalence determination.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" or diagnostic/classification task requiring expert adjudication in this type of 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 is not applicable to a 510(k) premarket notification for a passive implantable medical device like the MacroPore Protective Sheet. Such studies are relevant for diagnostic imaging or AI-powered devices, which this is not.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the comparison of intended use, design, and material of the MacroPore Protective Sheet is derived from the FDA-cleared information and known characteristics of the predicate devices (LactoSorb Trauma Plating System, Tilghman Titanium Mesh Skeletal Orbit Liner, Motech Titanium Surgical Mesh, and Leibinger Titanium DynamicMesh), combined with the manufacturer's specifications and testing data (e.g., degradation in animal studies, sterilization validation) for the MPS itself.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This pertains to AI/ML device development, which is not relevant here.

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

Ground Truth for Training Set: Not applicable. This pertains to AI/ML device development.

Summary

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JUL 3 0 1998

MacroPore Protective Sheet (Protego™ System)

Image /page/0/Picture/3 description: The image shows a sequence of handwritten digits and a forward slash. The sequence starts with what appears to be the letter 'K', followed by the numbers '9', '7', '2', '9', then a forward slash '/', and finally the number '3'. The digits are written in a bold, dark font, making them stand out against the background.

June 2, 1998

ADMINISTRATIVE INFORMATION

Manufacturer Name:	MacroPore, Inc.3252 Holiday Court, Suite 223La Jolla, CA 92037
Official Contact:	Christopher J. CalhounTelephone (619) 458-0900Fax (619) 458-0994
Representative/Consultant:	Floyd G. LarsonPacific Materials and Interfaces4329 Graydon RoadSan Diego, CA 92130Telephone (619) 792-1235FAX (619) 792-1236
DEVICE NAME
Classification Name:	Plate, fixation, bone

Trade/Proprietary Name: MacroPore Protective Sheet (Protego™ System)

Common Name:

Plating System

ESTABLISHMENT REGISTRATION NUMBER

MacroPore, Inc. has not yet obtained an Establishment Registration Number.

DEVICE CLASSIFICATION

In the Federal Register of July 2, 1982 [FR 47 page 29052], FDA proposed that bone fixation systems be classified as Class II, as shown in 21 CFR 888.3030. Although the listed Classification Name in 21 CFR is "single/multiple component metallic bone fixation appliances and accessories," the LactoSorb Trauma Plating System, a system manufactured from resorbable polymers and a predicate device for this submission, has been cleared under an expanded definition of that Classification Name. The LactoSorb device was reviewed by

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the General and Plastic Surgery Device Section of the Surgical and Rehabilitation Devices Panel, and has been assigned Product Code 87HRS. We propose that MacroPore Protective Sheet (MPS), the subject of this Notification, be classified as shown above.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514. Voluntary standards with which the MacroPore Protective Sheet complies include American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/ISO 11135-1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.

PACKAGING/LABELING/PRODUCT INFORMATION

MacroPore Protective Sheet will be packaged in an Ethylene Oxide (EtO) sterilizable package consisting of double heat sealed pouches, each pouch composed of a 48 gage polyester/0.002 LDPE top web and an uncoated 10739 Tyvek bottom web. Sterilization will be accomplished by ethylene oxide treatment for 6-6.5 hours at 7-9 psig in 10% EtO/90% HCFC. Sterilization will be validated using ANSVAAMI/ISO 11135-1994, Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization. The sterility assurance level (SAL) that MacroPore intends to meet for the MacroPore Protective Sheet is 104. The device is not represented to be "pyrogen free."

INTENDED USE

MacroPore Protective Sheet (MPS) is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton:

1. Comminuted fractures of the naso-ethmoidal and infraorbital areas
1. Comminuted fractures of the frontal sinus wall
1. Trauma of the midface or craniofacial skeleton
1. Reconstructive procedures of the midface or craniofacial skeleton.

The system is not intended for use in the mandible and/or for full load bearing procedures.

DEVICE DESCRIPTION

Design Characteristics

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MPS can be cut with scissors, is thermoplastic when heated to 55 C (for example, by the use of sterile hot water) and thus can be conformed three dimensionally to any bone defect. It can be rolled into a tube or used as a flat sheet. It can be used in conjunction with internal bone fixation devices such as plates and screws which can be also used to fixate the MPS and prevent dislocation. The system includes a selection of resorbable screws and tacks.

MPS is provided in sheets of 40 x 40 mm and in premanufactured shapes and can be provided in other sizes as needed for particular surgical procedures. Its thickness ranges from 500 microns to 1000 microns according to the defect to be treated. The pore size ranges from 500 microns to 2000 microns with pores distributed uniformly throughout the sheet in an offset or aligned pattern.

Material Composition

MPS is fabricated from poly(L-lactide-co-D,L-lactide) 70:30.

EQUIVALENCE TO MARKETED PRODUCT

MacroPore Protective Sheet shares indications and design principles with the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: LactoSorb Trauma Plating System from W. Lorenz, a unit of Biomet, Inc. (K960988, K955729), Tilghman Titanium Mesh Skeletal Orbit Liner from TiMesh, Inc. (K922308), Motech Titanium Mesh from Biedermann MOTECH GmbH (K900138), and Leibinger Titanium DynamicMesh.

Intended Use

The indications for use of MacroPore Protective Sheet (MPS) are not new indications in that they are the same as or are included in those for the predicate devices. MPS is intended for use in the craniofacial skeleton for fracture fixation in surgical reconstruction. Specific indications are:

for use in trauma and reconstructive procedures in the midface and craniofacial skeleton (comminuted fractures of the naso-ethmoidal and infraorbital areas. comminuted fractures of the frontal sinus wall, trauma of the midface or craniofacial skeleton, reconstructive procedures of the midface or craniofacial skeleton).

The system is not intended for use in the mandible and/or for full load bearing procedures.

The predicate devices share intended uses with MPS as follows: The LactoSorb Trauma Plating System and the titanium mesh products have identical intended uses with regard to fracture fixation to those of MPS with a thickness of 1000 microns.

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Design and Materials

The design and functional characteristics of MacroPore Protective Sheet and the predicate devices are similar. The physical designs of MPS and the LactoSorb device both consist of a thin sheet with perforations. The LactoSorb Trauma Plating System is made from a copolymer of polylactic acid and polyglycolic acid and has low crystallinity. The composition and processing of LactoSorb devices are selected to permit 70% of its strength to be maintained in vivo for 6-8 weeks (sufficient time to facilitate fracture fixation), yet to degrade and be cleared from the body within 9 to 15 months. The poly(L-lactide-co-D,Llactide) 70:30 of which MPS is made has been shown in animal studies to degrade more slowly, and to be fully degraded after 36 months. Both Lacrosorb and MPS are essentially amorphous. It is believed that degradation of an amorphous matrix is less likely than that of a crystalline matrix to leave microscopic undegraded crystalline regions. Such material could cause osteolysis in the same way as does the polyethylene debris that results from wear of articulating surfaces.

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510(k) Summary

SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE

MacroPore Protective Sheet is substantially equivalent to the LactoSorl Liner, Motech Titanium Surgical Mesh and Titanium Dynamic Mesh ir

	Subject Device
	MacroPore Protective Sheet	LactoSorb TraumaSystem(K960988, K955)
INTENDEDUSE	For use in trauma andreconstructive procedures in themidface and craniofacial skeleton1. Comminuted fractures of thenaso-ethmoidal and infraorbitalareas2. Comminuted fractures of thefrontal sinus wall3. Trauma of the midface orcraniofacial skeleton4. Reconstructive procedures of themidface or craniofacial skeleton	For use in trauma andreconstructive procethe midface and craniskeleton1. Comminuted fracthe naso-ethmoicinfraorbital areas2. Comminuted fracthe frontal sinus3. Trauma of the mcraniofacial skele4. Reconstructive pof the midface orcraniofacial skele
DESIGN	Sheet of 500 and 1000 micronsthickness, size 60 x 80 mm or asrequired, with pores of 500 to 2000microns diameter arranged in auniform offset or aligned pattern	Sheets of 500 and 1000microns thickness, size25 mm to 50 x 50 mm withpores of 1500 to 2000microns diameter arranaged ina uniform aligned pattern
MATERIAL	poly(L-lactide-co-D,L-lactide)70:30 (Resomer® LR 708),amorphous	poly(L-lactide-co-glycolide)82:18, low crystallinity

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ง Trauma Plating System, Tilghman Titanium Mesh Skeletal Orbit n the following respects:

Predicate Devices
Plating(729)	Tilghman TitaniumMesh Skeletal OrbitLiner (K922308)	Motech TitaniumSurgical Mesh(K900138)	Titanium DynamicMesh
FHures iniofacialtures ofal andtures ofwalldface oritonrocedureston	For use in orbitalbony defect repair/reconstruction	For use in reinforcingweak bony tissuessuch as in acetabularcups, ... andreconstruction oforal-maxillo-cranio-facial surgeries	For defect-bridgingreconstruction ofnon-loadbearing bonystructures
100zes 25 xn, with0anged intern	Sheets formed tovarious shapes	Sheets of 1000microns thickness,formed to variousshapes	Sheets of 300 to 600microns thickness,sizes of 40 x 40 mmto 90 x 90 mm, withopen hole pattern,including screw holesof 1.0 mm to 2.3 mm
(colide)ty	Titanium	Titanium	Titanium

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Image /page/6/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

JUL 3 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MacroPore, Inc. c/o Pacific Materials and Interfaces Mr. Floyd G. Larson 4329 Graydon Road San Diego, California 92130

Re: K972913 Trade Name: Macropore Protective Sheet (Protego System) Regulatory Class: II Product Code: HRS and HWC Dated: June 5, 1998 Received: June 8, 1998

Dear Mr. Larson:

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 requirement, 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.

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Page 2 - Mr. Floyd G. Larson

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) 594-4595. 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/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: MacroPore Protective Sheet

Indications for Use:

MacroPore Protective Sheet (MPS) is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton:

1. Comminuted fractures of the naso-ethmoidal and infraorbital areas
1. Comminuted fractures of the frontal sinus wall
1. Trauma of the midface or craniofacial skeleton
1. Reconstructive procedures of the midface or craniofacial skeleton.

The system is not intended for use in the mandible and/or for full load bearing procedures.

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Prescription Use Over-Theounter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.