The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The AFFIRM™ Inflatable Bone Tamp is a bone tamp with an inflatable balloon attached to the distal end, designed to create a void in cancellous bone. The Inflatable Bone Tamp is a sterile, single-use device manufactured from polvurethane.

The system also contains access instruments (including drills, cannulas, jamshidi needles, and K-wires), biopsy needle, cavity preparation instruments (expanding scraper), sleeve, an inflation device, and cement delivery instruments (cement mixer, cement guns, and filler delivery needles).

AI/ML Overview

Here's an analysis of the provided text regarding the AFFIRM™ VCF System, structured to address your specific questions.

Important Note: The provided 510(k) summary (K110998) is for a medical device (an inflatable bone tamp system), not a diagnostic AI software. Therefore, many of your questions related to AI performance metrics, ground truth, expert consensus, and specific clinical study designs (like MRMC) are not applicable to this type of submission. This document focuses on the mechanical and biological performance of the physical device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must achieve)	Reported Device Performance (How the device met the criteria)
Functional specifications	"The AFFIRM™ VCF System meets the specification and performance characteristics..."
Fatigue resistance during insertion and withdrawal	"...functional testing, such as fatigue insertion and withdraw..."
Inflation capabilities	"...inflation..."
Burst strength	"...burst..."
Bond strength of components	"...bond strength."
Biocompatibility with human tissue (meeting FDA and international standards)	"Biocompatibility testing confirmed that the AFFIRM™ VCF System components are biocompatible and meet the applicable requirements of the FDA Blue Book Memorandum G95-1: Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
Substantial equivalence to predicate device (KyphX® Inflatable Bone Tamps, K041454)	"The AFFIRM™ VCF System is substantially equivalent to the legally marketed predicate KyphX Inflatable Bone Tamps in terms of intended use, technological characteristics, safety, and effectiveness."
No new concerns regarding safety and efficacy compared to predicate	"The AFFIRM™ VCF System does not raise any new concerns of safety and efficacy when compared to the legally marketed predicate device."

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes (e.g., number of devices tested) for the functional testing. It refers to "functional testing" and "biocompatibility testing" in general terms.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or mentioned as this involves testing of a physical medical device, not analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device relates to its engineering specifications and biological safety, which are evaluated through standardized tests and material science, not human expert consensus.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as this pertains to the evaluation of a physical device's performance against engineering and biological standards, not a diagnostic interpretation.

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

Not applicable. This device is a physical medical instrument (an inflatable bone tamp system), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device would be established by:

Engineering specifications and standards: For functional tests like fatigue, inflation, burst, and bond strength. These are objective measurements against predefined thresholds.
International biocompatibility standards (ISO-10993): For biocompatibility testing, which involves laboratory tests on materials (e.g., cytotoxicity, sensitization, irritation).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

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

Summary

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K110998

OCT 2 5 - 2011

510(k) SUMMARY: AFFIRM™ VCF System

Algea Therapies Company: 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800

Kelly J. Baker, Ph.D Contact: Vice President. Requlatory and Clinical Affairs
Date Prepared: May 26, 2011
Device Name: AFFIRM™ VCF System
Classification: Per 21CFR as follows: §888.1100: Arthroscope &88.3027: Cement/Bone Vertebroplasty Product Code: HRX, NDN Regulatory Class: II, Panel Code: 87
KyphX® Inflatable Bone Tamps (K041454) Predicate(s): SE date: September 30, 2005

Purpose:

The purpose of this submission is to request clearance for the AFFIRM™ VCF System.

Device Description:

Indications for Use:

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indicated for use during percutaneous vertebral augmentation, such as kvphoplasty.

Performance Data:

The AFFIRM™ VCF System meets the specification and performance characteristics and is substantially equivalent to the predicate devices. The testing that was conducted included functional testing, such as fatigue insertion and withdraw, inflation, burst, and bond strength.

Biocompatibility testing confirmed that the AFFIRM™ VCF System components are biocompatible and meet the applicable requirements of the FDA Blue Book Memorandum G95-1: Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

Basis for Substantial Equivalence:

The AFFIRM™ VCF System is substantially equivalent to the legally marketed predicate KyphX Inflatable Bone Tamps in terms of intended use, technological characteristics, safety, and effectiveness. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications. The AFFIRM™ VCF System does not raise any new concerns of safety and efficacy when compared to the legally marketed predicate device. Therefore, the AFFIRM™ VCF System is substantially equivalent to the existing predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

OCT 2 5 2011

Algea Therapies % Kelly J. Baker, Ph.D. Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K110998

Trade Name: AFFIRM™ VCF System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: September 20, 2011 Received: September 21, 2011

Dear Dr. Baker:

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

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Page 2 - Kelly J. Baker, Ph.D.

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 (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

Device Name:

AFFIRM™ VCF System

Indications:

The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethyImethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

x Prescription Use __ (Per 21 CFR §801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110998

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”