The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

Device Description

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, nonimplantable device that is used to properly position and deliver the implant. It consists of a nitino! Kiva Coil, which is guided through a deployment cannula into the bone via a hand operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Once the Implant is placed into the vertebral body. PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps minimize posterior extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment.

AI/ML Overview

The provided text discusses the Kiva® VCF Treatment System, focusing on its substantial equivalence to predicate devices rather than defining specific acceptance criteria for a new device's performance against a numerical benchmark. The document describes a clinical trial (KAST trial) but uses its findings to support substantial equivalence, not to explicitly state and prove performance against pre-defined acceptance criteria with specific metrics.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics cannot be directly extracted from the provided text. The document focuses on regulatory approval through substantial equivalence, which often relies on demonstrating similar safety and effectiveness to existing devices, rather than achieving independent, predefined performance thresholds.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide explicit acceptance criteria in numerical or precise qualitative terms typical for device performance studies (e.g., sensitivity, specificity thresholds, or specific success rates). Instead, it states:

"The results demonstrate the safety and effectiveness of the Kiva® VCF Treatment System and support substantial equivalence to predicate devices."
"Results demonstrated that the Kiva® VCF Treatment System is biocompatible."
"Results of the testing confirm that the Kiva® VCF Treatment System can reliably perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: 300 subjects
Data Provenance: Prospective, multi-center, randomized, controlled study. Conducted at 21 sites in the US, Canada, and Europe.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The KAST trial evaluated "safety and effectiveness," with "primary endpoint was a composite of reduction in pain or improvement in function in the absence of device related serious adverse events." This suggests patient-reported outcomes and adverse event monitoring, not necessarily expert adjudication for image-based ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text. Given the nature of the primary endpoint (pain/function, adverse events), it's unlikely a specific "adjudication method" in the context of image interpretation or diagnostic performance would apply directly.

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

MRMC Study: No, this was not an MRMC study. It was a clinical trial comparing the Kiva® VCF Treatment System to balloon kyphoplasty (another treatment method).
Effect Size of human readers with/without AI: This is not applicable as the device is a VCF treatment system, not an AI or diagnostic imaging device.

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

This is not applicable as the Kiva® VCF Treatment System is a medical device for treating spinal fractures, not a standalone algorithm. Its performance is intrinsically linked to its use in a human-led procedure.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the primary endpoint relates to:

Patient-reported outcomes: reduction in pain or improvement in function
Absence of device-related serious adverse events

Secondary endpoints included:

Vertebral height restoration
Cement volume
Quality of life
Ambulatory status
Subject satisfaction
Cement extravasation
Device or cement migration
Subsequent fracture

These would have been assessed through various clinical measures, imaging, and patient self-assessment – a combination of outcomes data and clinical/imaging assessments.

8. The sample size for the training set

This information is not provided as the Kiva system is a physical device, not an AI model that requires a "training set" in the computational sense. The "KAST trial" is a clinical evaluation, not a dataset for training.

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

This is not applicable for the same reason as point 8.

Summary

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K 132817 Page 1 of 5 .

JAN 2 4 2014

510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92

510(k) Owner:

Barbara S. Lindsay Vice President, Clinical, Regulatory and Quality Affairs BENVENUE MEDICAL, INC 3052 Bunker Hill Lane, Suite 120 Santa Clara, CA 95054 Phone: (408) 454-9300 Fax: (408) 982-9023

510(k) Contact:

Cindy Domecus, R.A.C. (US & EU) Principal Domecus Consulting Services LLC Consultant to Benvenue Medical, Inc. Phone: (650) 343-4813 Fax: (650) 343-7822 domecusconsulting@comcast.net

Date Prepared: January 23, 2014

Kiva® VCF Treatment System Device Trade Name:

Common Name:

Polymethylmethacrylate (PMMA) Bone Cement

Classification Name:

Polymethylmethacrylate (PMMA) Bone Cement (21 CFR

888.3027)

Device Product Code:

NDN, LOD

Page 1 of 5

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Predicate Device(s): The Kiva® VCF Treatment System is substantially equivalent to the following devices:

Device	Manufacturer	510(k)
StaXxTM FX System	SpineWave, Inc	K063606
Benvenue VCF Osteo Coil System	Benvenue Medical, Inc	K070293
KyphX® HV-RTM Bone Cement	Kyphon, Inc. (Medtronic)	K041584
KyphX® Inflatable Bone Tamp	Kyphon, Inc. (Medtronic)	K010246

Device Description:

Statement of Intended Use:

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Sterilization:

The Kiva® VCF Treatment System is terminally sterilized via irradiation according to the requirements of ANSI/AAMI/ISO 11137 to ensure a sterility assurance level (SAL) of 10°

Biocompatibility:

The materials comprising the Kiva® VCF Treatment System (implant, deployment system, and access instrumentation) have been evaluated and tested for biocompatibility according to applicable requirements of ANSI/AAMI/ISO 10993. Results demonstrated that the Kiva® VCF Treatment System is biocompatible.

Non-Clinical/Mechanical Testing:

The safety and performance of the Kiva® VCF Treatment System have been substantiated through extensive non-clinical mechanical testing. Results of the testing confirm that the Kiva® VCF Treatment System can reliably perform as intended.

Clinical Performance Discussion:

A clinical trial was conducted under an approved IDE. The study is titled Kiva® System as a Vertebral Augmentation Treatment -- A Safety and Effectiveness Trial (KAST trial). This was a prospective, multi-center, randomized, controlled study designed to evaluate the safety and effectiveness of the Kiva® VCF Treatment System in comparison to balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures (VCF). The primary endpoint was a composite of reduction in paintenance or improvement in function in the absence of device related serious adverse events. Secondary endpoints include vertebral height restoration, cement volume, quality of life, ambulatory status, subject satisfaction, cement extravasation, device or cement migration, and subsequent fracture. A total of 300 subjects were enrolled at 21 sites in the US, Canada, and Europe. The results demonstrate the safety and effectiveness of the Kiva® VCF Treatment System and support substantial equivalence to predicate devices.

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Substantial Equivalence:

The rationale for substantial equivalence of the Kiva® VCF Treatment System to cited predicates is summarized in the following bullet points:

A substantial part of this device (Kiva Coil and Deployment System) is the cleared . Benvenue VCF Osteo Coil System.
The implantable PEEK Optima Kiva Implant part of the device is substantially . equivalent to the stackable PEEK wafers of the Spine Wave StaXxTM FX device.
The Kiva® VCF Treatment System reduces compression fracture via height . distraction as do the predicate devices.
The Kiva® VCF Treatment System functions in concert with PMMA bone cement to . achieve fracture reduction and treatment as do the predicate devices. The following table describes and shows similarities of the indications for use among the predicate devices and the Kiva® VCF Treatment System.

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Device	Indications for Use
StaXx™ FX System	The StaXx™ FX System is indicated for use in the reductionof spinal fractures. It is intended to be used in combinationwith Stryker Spineplex Radiopaque Bone Cement.
Benvenue VCF Osteo CoilSystem	The Benvenue VCF Osteo Coil System is indicated for thetreatment of pathological compression fractures of thevertebral body that may result from osteoporosis, benignlesions, and/or malignant lesions, by creating channels in theexisting spinal bone structure for the flow of PMMA bonecement.
KyphX® HV-R™ BoneCement	KyphX® HV-R™ Bone cement is indicated for the treatmentof pathological fractures of the vertebral body due toosteoporosis, cancer, or benign lesions using a balloonkyphoplasty procedure. Cancer includes multiple myelomaand metastatic lesions, including those arising from breast orlung cancer or lymphoma. Benign lesions include hemagiomaand giant cell tumor.
KyphX® Inflatable BoneTamp	KyphX® Inflatable Bone Tamps are intended to be used asconventional bone tamps for the reduction of fractures and/orcreation of a void in cancellous bone in the spine (includinguse during balloon Kyphoplasty with KyphX® HV-R™ BoneCement), hand, tibia, radius and calcaneus.
Kiva® VCF TreatmentSystem	The Kiva® VCF Treatment System is indicated for use in thereduction and treatment of spinal fractures in the thoracicand/or lumbar spine from T6-L5. It is intended to be used incombination with the Benvenue Vertebral AugmentationCement Kit.

The extensive non-clinical and clinical testing performed on this device provides . support that the Kiva® VCF Treatment System performs as intended and presents no different questions of safety or effectiveness.
The Kiva® VCF Treatment System device technological characteristics compared to predicate devices, indications for use compared with predicate devices, non-clinical test results, and clinical data demonstrate that the Kiva® VCF Treatment System is safe, effective, performs as intended, and is substantially equivalent to the currently marketed predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

January 24, 2014

Benvenue Medical, Incorporated % Ms. Cindy Domecus, Regulatory Affairs Consultant Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K132817

Trade/Device Name: Kiva® VCF Treatment System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: January 6, 2014 Received: January 7, 2014

Dear Ms. Domecus:

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 (reporting of medical

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Page 2 - Ms. Cindy Domecus

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

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

Enclosure

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BENVENUE MEDICAL, INC KIVA® VCF TREATMENT SYSTEM - TRADITIONAL 510(k) PREMARKET NOTIFICATION

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K132817

Device Name: Kiva® VCF Treatment System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132817

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.”