A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, III) fractures. 5). Orbital floor fractures. 6). Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones. B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications: 1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.). 2). Lefort (I, II, III) osteotomies. 3). Tumor reconstruction in midface or craniofacial procedures. 4). Bone graft procedures in the midface or craniofacial skeleton. 5). Pediatric reconstructive procedures. 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. 7). Craniotomy flap fixation.

Device Description

MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets 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 Plates and Protective Sheets to the desired shape or size. The MacroPore Plate and Protective Sheets are 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 FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer. Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.

AI/ML Overview

This document describes the MacroPore FX, PS, NS, LP bone fixation system, which is a medical device. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing acceptance criteria and device performance in the way typically seen for a new AI/software-based medical device.

Therefore, many of the requested categories related to clinical study design and results for acceptance criteria cannot be directly answered from this document. This document details in vitro testing for mechanical properties and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of performance metrics for a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of:

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Properties (Substantially equivalent to predicate)	"Mechanical testing of the MacroPore FX, PS, NS, LP System demonstrates that the device is substantially equivalent to the predicate. Test results indicate that the mechanical properties of the MacroPore FX, PS, NS, LP are substantially equivalent to the mechanical properties of the predicate devices: MacroPore PX Pediatric System and MacroPore Protego System (plates, and screws) under indication for use conditions." No specific quantitative thresholds or numerical results are provided, only the qualitative statement of "substantially equivalent."
Indications for Use (Identical/Substantially equivalent to predicate)	The MacroPore FX, PS, NS, LP and the MacroPore PX Pediatric System predicate share "identical indications for use." The MacroPore FX, PS, NS, LP and the MacroPore Protego System have "substantially equivalent indications for use as they are both indicated for the trauma and reconstructive procedures in the midface and craniofacial skeleton." The specific indications are listed in the "Intended Use" and "Indications for Use" sections, covering various fractures, osteotomies, and reconstructive procedures.
Design and Materials (Substantially equivalent to predicate)	Design: "The physical designs of MacroPore FX, PS, LP and the predicate devices are substantially equivalent, consisting of a plates, screws, tacks, and protective sheets." Also, "both the predicate device and the MacroPore FX, PS, NS, LP can be cut and molded to specific shapes and sizes by the end user." Materials: "Both the MacroPore FX. PS. NS. LP and the predicate devices are manufactured from bioabsorbable materials under substantially equivalent conditions." Specifically, "The material used in the MacroPore FX, PS, NS, LP is also substantially equivalent to the predicate devices as they are resorbable polylactide and polyglycolide polymers."

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

Sample Size for Test Set: The document describes in vitro mechanical testing but does not specify the sample size (number of devices or tests performed) for this testing.
Data Provenance: The testing appears to be conducted by the manufacturer ("MacroPore, Inc."). The document does not specify the country of origin of the data beyond implying it's part of the manufacturer's submission for FDA clearance in the USA. It is in vitro data, not human patient data (retrospective or prospective).

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

This is not applicable as the study involved in vitro mechanical testing comparing device properties, not a clinical assessment requiring expert interpretation of patient data or establishment of a clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable, as it involved in vitro mechanical testing, not a clinical assessment requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI

Not applicable. This is not an AI/software-based device, and no MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established mechanical properties and design characteristics of the predicate devices. The new device's performance was measured in vitro and compared against these established characteristics to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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

SEP 1 8 2001

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

K012412

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:

Trade/Proprietary Name:

Plate, Bone

MacroPore FX, PS, NS, LP

ESTABLISHMENT REGISTRATION NUMBER

2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 872.4760 - Bone Plates are intended to stabilize fractured bone structures in the oral cavity and are classified as Class II. Bone Plates have been assigned Product Code JEY.

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

INTENDED USE

A. General Indications: Trauma procedures of the midface or craniofacial skeleton.

Specific Indications:

1). Comminuted fractures of the naso-ethmoidal infraorbital areas.

2). Comminuted fractures of the frontal sinus wall:

3). Pediatric midface or craniofacial trauma
4). Lefort (I, II, III) fractures. ·

5). Orbital floor fractures.

6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, temporal , sphenoid, and occipital bones.

B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications:

1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).

2). Lefort (I, II, III) osteotomies.
3). Tumor reconstruction in midface or craniofacial procedures.
4). Bone graft procedures in the midface or craniofacial skeleton.
5). Pediatric reconstructive procedures.
6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
7). Craniotomy flap fixation.

DEVICE DESCRIPTION

Design Characteristics

The MacroPore Plate and Protective Sheets are 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 FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer.

Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.

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

Material Composition

The MacroPore FX, PS, NS, LP are fabricated from polylactic acid (PLA).

In Vitro Testing

Mechanical testing of the MacroPore FX, PS, NS, LP System demonstrates that the device is substantially equivalent to the predicate. Test results indicate that the mechanical properties of the MacroPore FX, PS, NS, LP are substantially equivalent to the mechanical properties of the predicate devices: MacroPore PX Pediatric System and MacroPore Protego System (plates, and screws) under indication for use conditions.

EQUIVALENCE TO MARKETED PRODUCT

The MacroPore FX, PS, NS, LP shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MacroPore PX Pediatric System and the MacroPore Protective Sheet (Protego System) Class II medical devices that were cleared for marketing in the United States under K002207, K972913 respectively.

Indications For Use

The MacroPore FX, PS, NS, LP and the predicate devices share identical indications for use with the MacroPore PX Pediatric System predicate. Additionally, the MacroPore FX, PS, NS, LP devices have substantially equivalent indications for use with the MacroPore Protego Ssytem as they are both indicated for the trauma and reconstructive procedures in the midface and craniofacial skeleton.

Design and Materials

Both the MacroPore FX. PS. NS. LP and the predicate devices are manufactured from bioabsorbable materials under substantially equivalent conditions. The physical designs of MacroPore FX, PS, LP and the predicate devices are substantially equivalent, consisting of a plates, screws, tacks, and protective sheets. The mechanical characteristics of the MacroPore FX, PS, NS, LP and the predicate devices are substantially equivalent to the predicate device under indications for use conditions. The material used in the MacroPore FX, PS, NS, LP is also substantially equivalent to the predicate devices as they are resorbable polylactide and polyglycolide polymers. In addition to physical characteristics, both the predicate device and the MacroPore FX, PS, NS, LP can be cut and molded to specific shapes and sizes by the end user.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

SEP 1 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth K. Kleinheinz Director of Regulatory Affairs MacroPore, Incorporated 6740 Top Gun Street San Diego, California 92121

Re: K012413

Trade/Device Name: MacroPore FX, PS, NS, LP Regulation Number: 872.4760 Regulation Name: Plate Bone Regulatory Class: II Product Code: JEY Dated: July 27, 2001 Received: July 30, 2001

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

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

Page 2 - Mr. Kleinhenz

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and registered to the limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Furt 067), assetses (QS) regulation (21 CFR Part 820); and if requirents as sectorin in allo qualify adiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF 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 If you desire specific as for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Compliance at (301) 59 - e, please contact the Office of Compliance at (301) 594-4639. advertibing or your the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the notification (210) 10 00197) - 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,

L. Clatrand

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

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

K012413

Device Name: MacroPore FX, PS, NS, LP

Indications for Use:

A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications:

1). Comminuted fractures of the naso-ethmoidal infraorbital areas.

2). Comminuted fractures of the frontal sinus wall.

3). Pediatric midface or craniofacial trauma

4). Lefort (I, II, III) fractures.

5). Orbital floor fractures.

5). Oronal noor fractares. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones.

B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications:

1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).

2). Lefort (I, II, III) osteotomies.
3). Tumor reconstruction in midface or craniofacial procedures.

4). Bone graft procedures in the midface or craniofacial skeleton.

5). Pediatric reconstructive procedures.
6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
7). Craniotomy flap fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Susan Pump OR

Over-The-Counter Use

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _

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.