The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'singleuse' only. The system is not intended for spinal use.

Device Description

The BioPro- Infinity™ Plate Anchor System is a multiple plate system composed of a: 1). 2-hole Curved Plate, 2). 1-hole 10mm Plate, 3). 1-hole 12mm Plate, 4). 1-hole 14mm Plate, 5). 3-hole Flat Straight Plate, and 6). 3-hole T-Plate. Two(2) 3.0mm Cancellous Screws in a 15mm and 20mm length accompany the system for fixing the plate through soft-tissue to bone. Both the plates and screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. Ancillary screwdriver and K-wire instrumentation is offered as 'sterile' and disposable and is made available for implantation and removal of the device. The plate and screw implant combination with instrumentation is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

AI/ML Overview

The BioPro – Infinity™ Plate Anchor System is a medical device in the field of orthopedics, specifically designed for ligament reattachment or fixation.

Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in the typical format of metrics like accuracy, sensitivity, or specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Equivalence: The device materials are comparable to the predicate device.	The BioPro - Infinity™ Plate Anchor System and its screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. This is implicitly considered similar and acceptable to the predicate device, Synthes - Metallic Spiked Washers (K013806), which is also a metallic bone fixation appliance. (Note: Specific material details of the predicate are not provided in this summary, but the claim of similarity implies this was verified).
Geometry Design/Markings Equivalence: The device's design and markings are comparable to the predicate device.	The system includes various plates (2-hole Curved, 1-hole 10mm, 12mm, 14mm, 3-hole Flat Straight, 3-hole T-Plate) and 3.0mm Cancellous Screws in 15mm and 20mm lengths. The document states the system is "Similar in Material, Geometry Design/Markings, and Indications" to the predicate. This implies the design is functionally equivalent for its intended use.
Indications for Use Equivalence: The intended use is comparable to the predicate device.	The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. It explicitly states "The BioPro - Infinity™ Plate Anchor System is Similar in Material, Geometry Design/Markings, and Indications to the Synthes Metallic Spike Washers currently sold in the U.S. market." The predicate device likely has a similar indication related to soft-tissue fixation to bone.
Safety and Effectiveness: The device is safe and effective for its intended use.	The summary concludes: "The BioPro - InfinityTM Plate Anchor System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." This statement is based on the comparison to the predicate device and the assumption that if it's substantially equivalent in materials, design, and indications, it will also be safe and effective. Specific studies to demonstrate safety and effectiveness for this device are not detailed beyond the substantial equivalence claim.
Sterilization Method: The sterilization method is appropriate for a single-use, sterile device.	The sterilization method used is Ethylene Oxide. This is a common and accepted method for sterilizing medical devices.

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

The provided document does not contain information about a test set in the context of a clinical trial or performance study with human subjects or a defined dataset. The "study" for this device's acceptance is primarily a comparative analysis against a legally marketed predicate device (Synthes - Metallic Spiked Washers, K013806) to demonstrate substantial equivalence. Therefore, there is no explicit test set with a sample size or data provenance in the traditional sense of a performance study.

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

This information is not applicable as there was no test set in the context of diagnostic interpretation or a clinical performance study requiring expert ground truth establishment. The "ground truth" for demonstrating equivalence is based on engineering principles, material science, and regulatory evaluation by the FDA, correlating the new device's characteristics to those of the predicate.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. There was no test set requiring multi-reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI on human reader performance. The BioPro - Infinity™ Plate Anchor System is a surgical implant, not a diagnostic tool.

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

No, a standalone performance study was not done. This device is a passive surgical implant; it does not involve algorithms or AI, nor does it have a "standalone" operational mode in the way a diagnostic algorithm would. Its performance is tied to its mechanical properties and biocompatibility as an implant.

7. The Type of Ground Truth Used:

The "ground truth" used for the acceptance of this device is primarily regulatory precedent and engineering standards. The ground truth is that the predicate device (Synthes - Metallic Spiked Washers) is safe and effective and legally marketed. By demonstrating that the BioPro - Infinity™ Plate Anchor System is "substantially equivalent" in materials, design, and indications, the new device is then considered to share the safety and effectiveness profile of the predicate. This involves:

Engineering specifications and material property verification: Ensuring the titanium alloy meets ASTM F136 and the anodization is Type II.
Design comparison: Assessing the geometry and form factor against the predicate.
Intended use comparison: Verifying the indications are the same or highly similar.
Sterilization validation: Ensuring the Ethylene Oxide method is effective.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical implant and does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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BioPro, Inc. - Infinity™ Plate Anchor System - K132510 - 510{k} Summary:

510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:	BioPro, Inc.2929 Lapeer RoadPort Huron, MI 48060www.bioproimplants.com	OCT 24 2013
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com
DATE:	July 31, 2013
TRADE NAME:	BioPro - InfinityTM Plate Anchor System
COMMON NAME:	Soft-tissue Fixation Plate and Screw
DEVICE NAME:	Fastener, Soft-tissueWasher, Bolt NutScrew, Fixation, Bone
CLASSIFICATION:	Single/multiple Component Metallic Bone Fixation Appliances andAccessories, Class II (21CFR, Sec. 888.3030)Smooth or Threaded Metallic Bone Fixation Faxtener,Class II (21 CFR, Sec. 888.3040)
DEVICE PRODUCT CODE:	HTN
SUBSEQUENT PRODUCT CODE:	HWC
SUBSTANTIALLYEQUIVALENT DEVICE	Synthes - Metallic Spiked Washers (K013806)

Section XII

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DEVICE DESCRIPTION:

The BioPro - Infinity™ Plate Anchor System is indicated for ligament INTENDED USE: reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'single-use' only. The system is not intended for spinal use.

The BioPro - Infinity™ Plate Anchor System is Substantially EQUIVALENCE: Equivalent(SE) to the predicate system listed.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The BioPro - Infinity™ Plate Anchor System is Similar in Material, Geometry Design/Markings, and Indications to the Synthes Metallic Spike Washers currently sold in the U.S. market.

SUMMARY OF SAFETY AND EFFECTIVENESS:

The BioPro - InfinityTM Plate Anchor System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three figures connected by flowing lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2013

BioPro, Incorporated % Mr. Al Lippincott Engineering Consulting Services, Incorporated 3150 East 200th Street Prior Lake, Minnesota 55372

Re: K132510

Trade/Device Name: BioPro - Infinity" Plate Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: October 8, 2013 Received: October 16, 2013

Dear Mr. Lippincott:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical

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Page 2 - Mr. Al Lippincott

device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: DEVICE NAME: BioPro - Infinity™ Plate Anchor System

AND/OR XXXX Over-The-Counter-Use Prescription Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

Section XI Page 1

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.