MacroPore IB Resorbable Plug is a resorbable implant manufactured from poly lactic acid (PLA). The MacroPore IB Resorbable Plug is designed to wedge into the inter medullary region of long bones to restrict the flow of cement. The MacroPore IB Resorbable Plug is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Resorbable Plug is provided in various shapes such as rectangles, ovals, and MacroPore IB cylinders and will be provided in other similar shapes and sizes as needed for particular surgical procedures. The wall thickness of the MacroPore IB Resorbable Plug ranges from 0.5 mm to 4.0 mm according to the region to be treated. The major outer diameter of the MacroPore IB Resorbable Plug ranges from 4mm to 30mm according to the region to be treated. A minimum of two sides of the MacroPore IB Resorbable Plug contain fenestrated edges to assure fit within the inter medullary region and to prevent dislodging. These fenestrated edges also allow for a secure fit between segmental defects.

AI/ML Overview

Here's an analysis of the provided text regarding the MacroPore IB Resorbable Plug, focusing on acceptance criteria and supporting studies:

It's important to note that the provided documents are a 510(k) Summary and the FDA's Substantially Equivalent Letter. This type of submission generally doesn't contain the detailed, formal acceptance criteria and comprehensive study results one would find in a Pre-Market Approval (PMA) application or a peer-reviewed publication. Instead, 510(k)s rely on demonstrating substantial equivalence to a predicate device. This means the studies conducted often aim to show similar performance characteristics rather than proving specific, pre-defined quantitative acceptance criteria against a clinical gold standard.

Based on the provided information, I will infer the "acceptance criteria" as the performance characteristics the manufacturer tested to demonstrate equivalence, and "device performance" as their reported findings.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Mechanical Properties after Heating (Prolonged exposure to 60°C saline)	Viscosity remained within an appropriate range over 120 minutes. The brief anticipated surgical exposure is not expected to significantly affect mechanical properties.
Material Crystallinity (Amorphous nature)	Tests on sterile and non-sterile samples revealed no endothermic spikes, confirming the amorphous (non-crystalline) nature of the implants.
Indications for Use (Substantial Equivalence)	Shares substantially equivalent indications for use as a cement restrictor in the femur, tibia, and humerus with predicate devices.
Design Features, Principles of Operation, and Materials (Substantial Equivalence)	Shares substantially equivalent design features, principles of operation, and materials with predicate devices.

No formal, quantitive acceptance criteria with specific thresholds (e.g., "sensitivity must be >X%") are stated in this 510(k) summary. The focus is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through in vitro testing of material properties and a comparison of design and indications.

Study Details

Given the nature of a 510(k) for a Class II device like this, clinical trials demonstrating clinical performance against a human or pathology-based ground truth are typically not required if substantial equivalence can be shown through other means (e.g., material testing, biomechanical testing, comparison to predicates). The document focuses on in vitro testing.

Sample size used for the test set and the data provenance:
- Test Set (Material Testing): The document doesn't explicitly state the sample size (number of plugs) used for the in vitro tests (heating/viscosity and crystallinity). It refers to "the testing" and "tests ran on the sterile and non-sterile samples," implying some number of samples were used, but no specific count is given.
- Data Provenance: The nature of the tests (material composition, in vitro studies) indicates the data was generated in a lab setting, likely by the manufacturer, MacroPore, Inc., based in San Diego, California, USA. This would be considered prospective in vitro testing undertaken specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. The "ground truth" for the in vitro material tests is based on established scientific principles and analytical methods (e.g., measuring viscosity, DSC for crystallinity). These are objective measurements, not subject to expert interpretation for ground truth establishment. Equivalence to the predicate is established through comparison of design, materials, and intended use, which is reviewed by FDA experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to determine a clinical outcome or diagnosis for a test set. The tests described are objective material science evaluations.
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:
- Not applicable. This device is a resorbable medical plug, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic accuracy and reader performance, usually for imaging or AI-based systems.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the in vitro testing is based on objective physical and chemical properties measured against scientific standards. For example, viscosity measurement using established methods, and crystallinity detection via DSC.
- For the overall substantial equivalence determination, the "ground truth" is the established safety and effectiveness of the existing predicate devices already cleared by the FDA. The new device is compared to these predicates in terms of indications, design, materials, and performance characteristics (as demonstrated by in vitro tests).
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The material properties are inherent to the PLA material and manufacturing process, not learned from data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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AUG 2 7 2001

Koll715-

510K Summary

MacroPoreIB Resorbable Plug

Page 1 of 2

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

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

Kenneth K. Kleinhenz Director of Regulatory Affairs

DEVICE NAME

Classification Name:

Trade/Proprietary Name:

Hip Joint Cemented Prosthesis

MacroPore IB Resorbable Plug

ESTABLISHMENT REGISTRATION NUMBER 2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 888.3350 Hip Joint Cemented Prosthesis are intended for use in orthopedic cementing procedures and are classified as Class II. Hip Joint Cemented Prosthesis have been assigned Product Code JDK.

INTENDED USE

MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.

DEVICE DESCRIPTION

Design Characteristics

Resorbable Plug is provided in various shapes such as rectangles, ovals, and MacroPore IB cylinders and will be provided in other similar shapes and sizes as needed for particular surgical procedures. The wall thickness of the MacroPore IB Resorbable Plug ranges from 0.5 mm to 4.0 mm according to the region to be treated. The major outer diameter of the MacroPore IB Resorbable Plug ranges from 4mm to 30mm according to the region to be treated. A minimum of two sides of the MacroPore IB Resorbable Plug contain fenestrated edges to assure fit within the inter medullary region and to prevent dislodging. These fenestrated edges also allow for a secure fit between segmental defects.

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Material Composition

The MacroPore IB Resorbable Plug is fabricated from polylactic acid (PLA).

In Vitro Testing

Because the MacroPore IB Resorbable Plug 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 IB Resorbable Plug is not expected to have a significant effect on its mechanical properties.

Crystallinity was tested for by DSC (differential scanning calorimetery). This test measures the amount of heat energy that is absorbed by a material. A crystalline material will require more energy once it reaches it's melting point. This release of heat energy can be seen on a graph as a sharp spike and is referred to as a "melting endotherm". The tests ran on the sterile and non-sterile samples revealed no endothermic spikes, confirming the amorphous (non-crystalline) nature of the implants.

EQUIVALENCE TO MARKETED PRODUCT

MacroPore IB Resorbable Plug shares indications and design principles with the following predicate device, which has been determined by FDA to be substantially equivalent to the following pre- amendment devices: Medtonic Sofamor Danek Cement Restrictor, Medtronic Sofamor Danek Titanium Cement Restrictor, and the MacroPore OS Protective Sheet, Class II medical device that were cleared for marketing in the United States under K010529, K003718 and K994158 respectively.

Indications For Use

The MacroPore IB Resorbable Plug and the predicate device share substantially equivalent indications for use as they both are indicated for cement restriction. Specifically, the MacroPore IB Resorbable Plug is intended for use as a cement restrictor in the femur, tibia and humerus.

Design and Materials

The MacroPore IB Resorbable Plug and the predicate device share substantially couivalent design features, principles of operation, and materials.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 4 2001

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

Re: K011715

Trade Name: MacroPore IB Resorbable Plug Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: June 1, 2001 Received: June 4, 2001

Dear Mr. Kleinhenz:

This letter corrects our substantially equivalent letter of August 27, 2001.

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 above and we nave acterificated predicate devices marketed in interstate commerce stated in the cherobard, to cenactment 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 Cosmotions of the Act and the limitations described below. The general controls provisions of the provisions of the Act the miral registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Dovice Drailation has associdentified in the proposed labeling and that such use device with be abour ror an accordance with Section 513(i)(1)(E) of the Act, the following vourd canso na appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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 ( Femanet I repression) in the Code of Federal Regulations, Title 21, Parts 800 to 895.

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Page 2 - Mr. Kenneth K. Kleinhenz

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 inspections, and Drig 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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I herefore, a new 510(k) is required before these limitations are modificd in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 production the regulation on your responsibilities under the Act may be obtained from 001:37): Other Echeral Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) the DIVibion of Billan The address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Bert Estlat

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: _MacroPore IB_Resorbable Plug

Indications for Use:

MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.

Koll715

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use yes Over-The-Counter Use No

for Mark n OR Mulker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K011715
510(k) Number

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.