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, non- implantable device that is used to properly position and deliver the implant. It consists of a nitinol 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. Up to 5 loops of implant may be deployed, corresponding with a maximum height of 15mm. 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 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. Other instruments are optional for the physician and not provided as part of the Kiva® VCF Treatment System including a Bone Drill, a Bone Biopsy Needle and Kiva Pilot.

AI/ML Overview

The provided text describes the Kiva® VCF Treatment System, a medical device for treating spinal fractures. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, nor does it mention any AI components, human readers, or ground truth establishment in the context of an AI-powered diagnostic or treatment device.

The document is a 510(k) summary for a physical medical device that augments vertebral bodies with cement. The "acceptance criteria" and "study" described in the provided text relate to the mechanical and biomechanical performance of an implantable device, specifically comparing a 5-loop version to a 4-loop version.

Therefore, most of your requested information (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, training set sample size, ground truth for training set) is not applicable or present in this document, as it pertains to AI/algorithm studies, not the mechanical testing of a physical implant.

I can, however, extract the acceptance criteria and performance data relevant to the physical device's mechanical integrity and deployment performance as described in the document.

Acceptance Criteria and Device Performance (for the physical Kiva® VCF Treatment System)

Acceptance Criteria Category	Reported Device Performance
Biomechanical Performance (Static & Dynamic)	The 5-loop system met all pre-defined criteria per ASTM F2077-11 and ASTM F1877-05 (evaluated without PMMA cement present, as a worst-case scenario). This was equivalent to the original 4-loop system.
Deployment Performance	The 5-loop system met all pre-defined criteria in a simulated clinical-use protocol. This was equivalent to the original 4-loop system.

Study Information (related to the physical device's mechanical and deployment performance):

Sample size used for the test set and the data provenance:
- Biomechanics: Not explicitly stated as a "sample size" of devices evaluated, but indicates testing per ASTM F2077-11 and ASTM F1877-05 for both the 4-loop and 5-loop systems. These standards specify how many samples are typically tested.
- Deployment Performance: "a total of 30 units" for the 5-loop system.
- Data Provenance: The cadaveric spines and urethane foam analogs would be considered laboratory/bench testing data. The origin isn't specified (e.g., country), but it's a controlled test environment. This is prospective testing for the device modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is meeting engineering specifications (e.g., structural integrity, successful deployment), not expert clinical interpretation.
Adjudication method for the test set: Not applicable. This refers to mechanical testing against engineering standards.
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 document does not describe a study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a physical medical device, not an algorithm.
The type of ground truth used:
- Biomechanical Performance: Adherence to established ASTM standards (material and mechanical engineering specifications).
- Deployment Performance: Successful completion of a predefined simulated clinical-use protocol (i.e., successful deployment of the implant within specified parameters).
The sample size for the training set: Not applicable. There is no algorithm or "training set" mentioned.
How the ground truth for the training set was established: Not applicable. There is no algorithm or "training set" mentioned.

Summary of the document's relevance:

This document is a regulatory submission demonstrating the substantial equivalence of a modified physical medical device (Kiva® VCF Treatment System with 5 loops) to a previously cleared version (4 loops). The "study" described is a series of non-clinical, benchtop, and simulated-use tests to ensure the modified device maintains the same safety and performance characteristics as its predicate. It is not related to software, AI, or diagnostic image analysis.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

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

Benvenue Medical, Inc. % Ms. Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K141141

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: May 16, 2014 Received: May 19, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

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 STATEMENT 4.

510(k) Number (if known): K141141

Device Name: Kiva® VCF Treatment System

Indications for Use:

Prescription Use __ X AND/OR (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(K) SUMMARY

510(k) Owner:

Barbara S. Lindsay Vice President, Clinical, Regulatory and Quality Affairs BENVENUE MEDICAL, INC 3052 Bunker Hill Lane, Suite120 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:	June 18, 2014
Device Trade Name:	Kiva® VCF Treatment System
Common Name:	Cement, bone, vertebroplasty
Classification Name:	Polymethylmethacrylate (PMMA) Bone Cement (21 CFR888.3027)
Device Product Code:	NDN. LOD

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Predicate Device: Kiva® VCF Treatment System, K132817

Device Description:

Statement of Intended Use:

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.

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Summary of Similarities and Differences in Technological Characteristics Between Subject and Predicate Devices:

The modified Kiva® VCF Treatment System has no change to the indications or intended use, no change to the materials or methods of manufacturing and no change to the manner in which the user operates the device or the principles of operation. The only difference is that the modified device allows the user to deliver a maximum of 5 loops of the implant as opposed to 4 loops.

The clinical risks for delivering an implant which has a maximum of 5 loops (15mm maximum height) are equivalent to those for a 4 loop implant (12mm height) as demonstrated by bench and deployment performance testing.

Nonclinical Performance Data:

The performance of the original 4 loop system was evaluated in testing per ASTM F2077-11 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F1877-05 (Standard Practice for Characterization of Particles) in both static and dynamic testing for a worst-case scenario of 4 loops of implant with no PMMA cement present.

This testing was repeated for the 5 loop system in the equivalent worst case configuration with all 5 loops of implant and no cement present. The test results confirmed that the 5 loop system met all of the pre-defined criteria. Thus, the modified system met the same biomechanical performance criteria as the original the 4 loop system.

The performance of the delivery system was evaluated to confirm that all required performance specifications are still met with the modification that permits 5 loops of Kiva Implant. The deployment performance was evaluated in a predefined simulated clinical-use protocol using a total of 30 units in which the Kiva Implant was deployed in human cadaveric spines and into a 7.5 PCF urethane foam analogs of osteoporotic bone. The testing results confirmed that the 5 loop system meets all of the pre-defined criteria. Thus, the modified implant met the same deployment performance criteria as the original 4 loop system.

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Conclusion:

The nonclinical tests demonstrate that modified device is as safe, as effective and performs as well as the predicate device.

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.”