MacroPore Protective Sheet is intended for use in trauma and reconstructive procedures in the oral cavity in conjunction with rigid internal fixation. The following specific indications are included:

1. to maintain the position of bony fragments in bone graft procedures of the mandible or maxilla,
1. for regeneration of bone tissue of the mandible or maxilla.
  The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.
  In addition to its function of providing fixation of non-load bearing areas, MPS serves as a protective sheathing to prevent soft tissue prolapse into defects that remain, or to prevent dislocation of autograft, allograft and/or bone graft substitutes that may be necessary in the reconstructive procedures. The macroporosity of the system permits mesenchymal stem cells from surrounding tissues to populate the defect and allows the ingrowth of blood vessels. This, combined with the inherent strength of MPS, facilitates osteogenesis by allowing the natural healing processes of the body to proceed in a protected environment without interference due to undesired interposition of soft tissue.

Device Description

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 and to protect non-load and low-load bearing bone defects in the oral cavity from soft tissue interposition from adjacent soft and connective tissues (e.g. musculature) but allow, due to its porosity, for the proliferation of blood vessels and the migration of bone forming cells from such soft tissues into the bone defect. This facilitates bone regeneration.
MPS can be cut with scissors, is thermoplastic when heated to 55C (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 either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MPS and prevent dislocation. In the mandible or in any load bearing region, rigid internal fixation is essential. The system includes a selection of resorbable screws and tacks and associated manual instruments.
MPS is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. Its thickness ranges from 250 microns to 1000 microns according to the defect to be treated.

AI/ML Overview

The provided 510(k) summary (K983360) describes MacroPore Protective Sheet, a medical device intended for use in trauma and reconstructive procedures in the oral cavity. The submission aims to establish substantial equivalence to predicate devices rather than proving a pre-defined set of acceptance criteria in the manner of a clinical trial for a new drug or a novel, high-risk device. Therefore, the "acceptance criteria" discussed below are inferred from the equivalence argument made by the manufacturer and the FDA's regulatory framework for 510(k) submissions.

The study that "proves" the device meets acceptance criteria is primarily a comparison of the subject device (MacroPore Protective Sheet) to legally marketed predicate devices based on intended use, design, and material characteristics, along with various in vitro and in vivo tests to support these comparisons.

Here's an analysis of the provided information, formatted to align with your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds against which the device was tested to "pass." Instead, the criteria are the characteristics of the predicate devices that the MacroPore Protective Sheet must demonstrate substantial equivalence to. The reported performance is the evidence presented to show this equivalence.

Acceptance Criterion (Inferred from Predicate Devices)	Reported Device Performance (MacroPore Protective Sheet)
Intended Use Equivalence: - Maintain position of bony fragments in bone graft procedures (mandible/maxilla) - Regeneration of bone tissue (mandible/maxilla) - Protection from soft tissue prolapse/stabilize bone grafts	Equivalence Claimed: - Intended uses are the same as or included in predicate devices (e.g., LactoSorb Panels and Fasteners for mandibular graft procedures; M-TAM and TRAM for fixation, reconstruction, and graft containment). - Serves as a protective sheathing to prevent soft tissue prolapse and stabilize bone grafts, facilitating osteogenesis.
Design Equivalence (Physical Form, Macroporosity): - Thin sheet with macroporosity - Varying sizes/thicknesses	Equivalence Claimed: - "Similar physical designs" to predicate devices (Lactosorb, titanium mesh). - Provided in sheets 20x20mm to 120x120mm, thickness 250-1000 microns. - Macroporous design to prevent soft tissue prolapse, stabilize grafts, permit fluid/cell exchange, allow blood vessel proliferation.
Material Equivalence (Biocompatibility, Degradation Profile): - Specific polymer composition (for bioresorbable predicates) - Degradation characteristics suitable for clinical use	Equivalence Claimed: - Fabricated from poly(L-lactide-co-D,L-lactide) 70:30, amorphous (contrasted with LactoSorb's 82:18 poly(L-lactide-co-glycolide) and titanium's non-resorbability). - Accelerated degradation testing showed similar degradation rate to Polypin (same material). Slower mechanical property degradation than LactoSorb. - Mechanical stability unchanged for nine months; complete resorption in 12-36 months. No late inflammatory reactions expected due to amorphous nature (contrasted with mixed crystallinity polymers).
Mechanical Properties (Stiffness, Strength, Shapeability): - Resistance to deformation, sufficient strength for non-load bearing/supplemental fixation. - Ability to be shaped to anatomical structures.	Demonstrated: - Stiffness: Laboratory test showed MPS stiffness >9x M-TAM and >200x Prolastic Sheeting in a cylindrical configuration. - Strength: Data on related Protego FX plates and screws (K972913) shows significant strength in tension and bending, and screws have appropriate shear/pullout strength for supplemental fixation. - Shapeability: Thermoplastic when heated to 55°C, can be conformed 3D. Viscosity tests showed minimal effect of prolonged heating (120 min at 60°C).
Sterilization: - Sterility assurance level (SAL).	Demonstrated: - Sterilization by electron beam irradiation; SAL of 10-6.

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

Test Set Sample Size: The document does not specify a "test set" in the context of a statistical clinical trial with human subjects. The evidence comes from:
- In vitro tests: No sample sizes are provided for the material degradation, viscosity, or stiffness tests.
- In vivo animal studies:
  - One landmark study by Lemperle et al. used "edentulated canine mandible" (number of animals not specified) and "parietal bones" (number of animals not specified).
  - Another animal study extended these findings using a "30 mm (critical size) segmental defect in the canine radius" (number of animals not specified).
Data Provenance:
- In vitro testing: Conducted internally or by a contracting lab (not explicitly stated, but implied as part of the manufacturer's submission).
- In vivo testing: From animal studies (canines), both cited literature (Lemperle et al.) and directly conducted for resorbable polymers.
- Retrospective/Prospective: The animal studies would be considered prospective experimental studies. The comparison to predicate devices is a retrospective analysis of existing device characteristics.

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

This query is not directly applicable to a 510(k) submission based on substantial equivalence, especially for a device of this nature. "Ground truth" from experts is typically associated with diagnostic imaging AI devices or observational studies where expert consensus defines the 'true' condition.

For this device:

For in vitro material properties: The "ground truth" is defined by scientific measurement standards and established material science principles. No human experts are used for this type of ground truth establishment in this context.
For in vivo animal studies: The "ground truth" (e.g., new bone formation, healing) is established by histological and radiological assessment by veterinary pathologists/researchers involved in the studies, not a panel of experts. Their qualifications are not specified in the summary.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, there isn't a "test set" in the sense of human cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. This type of study assesses how human readers perform with and without AI assistance, which is not relevant for a physical implantable device like the MacroPore Protective Sheet.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

In vitro tests: Standardized material property measurements (e.g., degradation rate, viscosity, stiffness, tensile strength, shear strength, pullout strength).
In vivo animal studies: Histological and radiological evidence of bone formation, healing, and soft tissue exclusion in animal models. The "concept of protecting bone defects from soft tissue interposition to facilitate bone regeneration" was the core hypothesis validated in these animal studies.
For the 510(k) submission itself: The "ground truth" for substantial equivalence is the set of established characteristics and intended uses of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set."

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

Not applicable. There is no training set for this device.

Summary

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

510(k) Summarv

K983360

ADMINISTRATIVE INFORMATION

Manufacturer Name:	MacroPore, Inc.6740 Top Gun StreetSan Diego, CA 92121
Official Contact:	Christopher J. CalhounTelephone (619) 458-0900Fax (619) 458-0994
Representative/Consultant:	Floyd G. LarsonPacific Materials and Interfaces

4329 Graydon Road San Diego, CA 92130 Telephone (619) 792-1235 FAX (619) 792-1236

DEVICE NAME

Classification Name:	Plate, bone
Trade/Proprietary Name:	MacroPore Protective Sheet
Common Name:	Bone Plate

ESTABLISHMENT REGISTRATION NUMBER

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

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 872.4760, bone plates intended for the oral cavity are classified as Class II. They have been assigned Product Code 76 JEY.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514. Voluntary standards with which the MacroPore Protective Sheet (MPS) complies include American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/ISO 11137-1994; Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization.

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

Page 2

PACKAGING/LABELING/PRODUCT INFORMATION

MacroPore Protective Sheet and accompanying tacks and screws will be packaged in a heatsealed aluminum pouch (for moisture protection), which will be packaged in an outer heatsealed Tyvek pouch. Sterilization will be accomplished by electron beam irradiation. The sterility assurance level (SAL) that MacroPore intends to meet for the MacroPore Protective Sheet is 106. The device is not represented to be "pyrogen free."

INTENDED USE

MacroPore Protective Sheet is intended for use in trauma and reconstructive procedures in the oral cavity in conjunction with rigid internal fixation. The following specific indications are included:

1. to maintain the position of bony fragments in bone graft procedures of the mandible or maxilla,
1. for regeneration of bone tissue of the mandible or maxilla.

The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.

In addition to its function of providing fixation of non-load bearing areas, MPS serves as a protective sheathing to prevent soft tissue prolapse into defects that remain, or to prevent dislocation of autograft, allograft and/or bone graft substitutes that may be necessary in the reconstructive procedures. The macroporosity of the system permits mesenchymal stem cells from surrounding tissues to populate the defect and allows the ingrowth of blood vessels. This, combined with the inherent strength of MPS, facilitates osteogenesis by allowing the natural healing processes of the body to proceed in a protected environment without interference due to undesired interposition of soft tissue.

DEVICE DESCRIPTION

Design Characteristics

MPS can be cut with scissors, is thermoplastic when heated to 55C (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 either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the

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

MPS and prevent dislocation. In the mandible or in any load bearing region, rigid internal fixation is essential. The system includes a selection of resorbable screws and tacks and associated manual instruments.

MPS is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. Its thickness ranges from 250 microns to 1000 microns according to the defect to be treated.

Material Composition

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

In Vitro Testing

Accelerated degradation testing showed that the degradation rate of the subject device is very similar to that of the Polypin, which is made of the same material. While the comparison with Lactosorb was limited by the poor ability of the Lactosorb tensile specimens to survive exposure and the handling necessary to flatten them for testing, it appears that the rate of mechanical property degradation of the subject device is significantly lower than that of Lactosorb samples of similar configuration.

Because MPS is intended to be heated in the surgical suite to above the glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60C on inherent viscosity. Testing showed that viscosity stayed within an appropriate range even after 120 minutes exposure. Therefore, the relatively brief exposure anticipated during the surgical preparation of MPS is not expected to have a significant effect on its mechanical properties.

To determine the resistance of MPS to deformation under the pressure of soft tissue and muscle, a laboratory test was performed. A cylinder was formed from the material and the force necessary to deform it was determined using a standard indenter. MPS was compared with comercially available Micro Titanium Augmentation Mesh (M-TAM) and reinforced Prolastic Sheeting (a silicone material used for bone regeneration in the craniofacial skeleton, particularly in the orbital floor). The results demonstrate that the stiffness of MPS in this configuration is over nine times that of M-TAM and over two hundred times that of Prolastic Sheeting.

MacroPore has submitted data to FDA on related devices intended for use in craniofacial fixation under K972913. The device, termed MacroPore Protective Sheet or Protego™ System, was determined for this indication to be Substantially Equivalent to legally marketed devices. Significant portions of the data presented in the submission were developed for the craniofacial fixation indication, but are also relevant to the oral cavity indications. In particular, data on mechanical properties of Protego FX plates and screws show that the material has significant strength in tension and bending, and that screws have shear and pullout strength that make them appropriate for supplemental fixation in the configurations that are the subject of this submission. Primary fixation is not an intended use for the device as submitted herein.

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

In Vivo Testing

The concept of protecting bone defects from soft tissue interposition to facilitate bone regeneration was demonstrated in a landmark study by Lemperle, Calhoun, Curran and Holmes. This study used macroporous titanium sheet to bridge 30 mm (critical size) segmental defects in the edentulated canine mandible and 15 mm x 20 mm full thickness window defects in the parietal bones. New bone formation in the mandibular defects united the cut ends at four months regardless of whether the defects were empty, were implanted with coralline hydroxyapatite blocks or were filled with iliac cancellous bone. This remarkable finding led to the concept of replacing the macroporous titanium sheet with a macroporous bioresorbable polymer to protect bone defects from soft tissue prolapse, contain graft material and facilitate bone regeneration.

An animal study that extends the findings of the Lemperle, et. al., study to the use of resorbable polymers was performed using a 30 mm (critical size) segmental defect in the canine radius. Results confirm the findings of the Lemperle, et. al., study and support the use of MPS for containment of graft material and for regeneration of bone in defects that would not be expected to heal without protection from soft tissue prolapse.

EQUIVALENCE TO MARKETED PRODUCT

MacroPore submits the following information to demonstrate that MacroPore Protective Sheet shares indications and design principles with the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices: Micro Titanium Augmentation Mesh (M-TAMTM) (K862532) from Leibinger, Lactosorb Panels and Fasteners (K980927) from Biomet and Titanium Ridge Augmentation Material (TRAM) (K963394) from Osteomed.

Intended Use

The intended uses of MacroPore Protective Sheet (MPS) are not new in that they are the same as or are included in those for the predicate device. MPS is intended for use in the oral cavity for fracture fixation and fixation in surgical reconstruction. It also serves as a sheathing to protect skeletal defects from soft tissue prolapse or to stabilize bone grafts, permitting the natural bone healing processes of the body to take place without interference from interposed soft tissue. Specific uses are:

to maintain the position of bony fragments in bone graft procedures of the mandible or maxilla,

for regeneration of bone tissue of the mandible or maxilla.

1 Lemperle SM, Calhoun CJ, Curran RW, Holmes RE. Bony healing of large cranial and mandibular defects protected from soft-tissue interpositive study of spontaneous bone regeneration, osteoconduction and cancellous autografiing in dogs. Plast. Reconstr. Surg. 1998 March; 101(3): 660-72

{4}------------------------------------------------

The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.

The predicate devices share intended uses with MPS as follows: LactoSorb Panels and Fasteners are used to maintain the position of bony fragments in mandibular graft procedures and are used in conjunction with rigid internal fixation. M-TAM and TRAM are used for fixation as well as for reconstruction of bone defects and containment of grafting material.

Design and Materials

The design and functional characteristics of MacroPore Protective Sheet and the predicate devices are similar. The LactoSorb Panels and Fasteners are made from a copolymer of polylactic acid and polyglycolic acid and have 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. MPS is made from a more stable polymer than LactoSorb Panels and Fasteners. Mechanical stability of MPS is unchanged for nine months, and complete resorption occurs in 12 to 36 months. Both MPS and LactoSorb Panels and Fasteners are essentially amorphous, in contrast with polymers that have significant crystalline regions in an amorphous matrix. Mixed crystallinity polymers, such as PLLA, have been shown to cause late inflammatory reactions, believed to microscopic undegraded crystalline regions.

The physical designs of MPS and all of the predicate devices (Lactosorb and the titanium mesh devices) are similar, consisting of a thin sheet with macroporosity. The sheet serves to prevent the prolapse of soft tissue and to stabilize grafting material. The perforations permit the exchange of fluids and permit cells to migrate through the sheet, allowing the defect to be populated by mesenchymal stem cells. Furthermore, the macroporosity allows for the proliferation of blood vessels from the adjacent soft tissue into the bone defect. Claims made for M-TAM and TRAM include stability (based on materials and design), with sufficient strength against chewing and soft tissue pressure and sufficient rigidity to stabilize autogenous bone grafts. The titanium devices differ from MPS and the Lactosorb device in that they may be left in place permanently or must be removed surgically, whereas the polymer devices are intended to be metabolized by the body and do not require removal.

{5}------------------------------------------------

510(k) Notification

MacroPore Protective Sheet

SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE

	Subject Device	Predicate Devices
	MacroPore Protective Sheet	Micro Titanium AugmentationMesh (M-TAM™)(K862532)Leibinger	LactoSorb Panels and Fasteners(K980927)Biomet	Titanium Ridge AugmentationMaterial (TRAMTM)(K963394)Osteomed
INTENDEDUSE	For use in trauma and reconstructiveprocedures in the oral cavity inconjunction with rigid internalfixation:1. To maintain the position of bonyfragments in bone graft proceduresof the mandible or maxilla2. For regeneration of bone tissue ofthe mandible or maxillaFor use as a protective sheathing tofacilitate osteogenesis and to stabilizebone grafts	For use in lower jawreconstruction to restore bonycontinuity, for reconstruction ofthe extremely atrophic maxillaryalveolar ridge, for semirigidfixation of fractures andosteotomies, for stabilization ofautogenous bone grafts	For use in trauma andreconstructive procedures in theoral cavity in conjunction withrigid internal fixation, tomaintain the position of bonyfragments in mandibular bone	To build a stable protectivespace, tent the periosteum andprotect a graft site in themandible or maxilla, whileproviding enhanced vascularity
DESIGN	Sheets of 250 to 1000 micronsthickness, size 20 x 20 mm to 120 x120 mm or as required	Sheets of 100 and 200 micronsthickness, size 60 x 60 mm and120 x 120 mm	Sheets of 500 and 1000 micronsthickness, sizes 25 x 25 mm to50 x 50 mm	Sheets of titanium withmacroporosity
MATERIAL	poly (L-lactide-co-D,L-lactide) 70:30,amorphous	Titanium	poly (L-lactide-co-glycolide)82:18, low crystallinity	Titanium

Page 6

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Mr. Floyd G. Larson Pacific Materials and Interfaces 4329 Graydon Road San Diego, California 92130

K983360 Re : MacroPore Protective Sheet Trade Name: Requlatory Class: II Product Code: JEY Dated: February 15, 1999 February 22, 1999 Received:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP FDA regulation may result in regulatory action. In addition, 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

{7}------------------------------------------------

Page 2 — Mr. Larson

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) 594-4692. 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.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Clatohuls

Ulatowski thy A. Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Device Name: MacroPore Protective Sheet

Indications for Use:

MacroPore Protective Sheet is intended to facilitate healing in trauma, reconstruction and bone augmentation procedures of the mandible. The following specific indications are included:

to maintain the relative position of bony fragments in trauma and bone graft procedures, and .
to contain and prevent migration and shifting of autograft, allograft and/or bone graft . substitutes that may be necessary in reconstructive procedures.

The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

Division Sign-off

Division of Dental, Infection Control and General Hospital Devices

510(k) Number K983360

Prescription Use ir

Over-The-Counter Use_

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.