The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.

Device Description

The Acu-Cut Vertebral Augmentation System consists of:

the Acu-Cut Cutting Instrument .
. 2 Cannulas
1 Tri-Point Tip Trocar .
1 Bevel Tip Trocar ●
1 Hand Drill ●
· 5 Cement Delivery Tubes with Plungers
· A previously FDA cleared bone cement.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Acu-Cut Vertebral Augmentation System:

Summary of Acceptance Criteria and Device Performance:

The provided 510(k) summary for the Acu-Cut Vertebral Augmentation System (K113452) primarily focuses on demonstrating substantial equivalence to a predicate device. While it lists various tests performed, it does not explicitly state specific numerical acceptance criteria (e.g., "torque shall be greater than X Nm") or corresponding reported quantitative performance values for each test. Instead, it broadly states that "The testing demonstrated that the System conforms to its design specifications" and "In all instances, the Acu-Cut System functioned as intended." This approach is common in 510(k) submissions where substantial equivalence is the primary pathway.

However, based on the general descriptions of the tests, we can infer the types of acceptance criteria being met. The performance data section describes comprehensive bench and clinical testing.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Bench Testing (Acu-Cut Cutting Instrument):
- Cutting torque in osteoporotic vertebrae and sawbones meets design specifications (e.g., sufficient torque to cut bone).	System conforms to design specifications; functioned as intended.
- Tensile strength of Cutting Instrument band meets design specifications (e.g., band does not break under expected tension).	System conforms to design specifications; functioned as intended.
- Cutting Instrument flex cable weld strength meets design specifications (e.g., welds are secure).	System conforms to design specifications; functioned as intended.
Bench Testing (Trocars, Cannulas, Hand Drills, Cement Delivery Devices):
- Insertion testing demonstrates safe and effective insertion.	System conforms to design specifications; functioned as intended.
- Trocar Handle Strength Testing shows adequate handle integrity.	System conforms to design specifications; functioned as intended.
- Torque and Tensile Strength Testing (of components) meets design specifications for robust use.	System conforms to design specifications; functioned as intended.
- Cement Delivery Instrument Testing demonstrates effective and controlled cement delivery.	System conforms to design specifications; functioned as intended.
- Removal Force Testing shows instruments can be removed appropriately.	System conforms to design specifications; functioned as intended.
Other Testing:
- Sterilization Validation confirms sterility.	Validated.
- Packaging and Shipping Validations ensure product integrity.	Validated.
- Biocompatibility Testing confirms material safety.	Pass.
- Clinical Testing (Ascendx VCF Repair System IDE study) demonstrates safety and effectiveness in human subjects.	Implicitly demonstrated safety and effectiveness for its intended use (no specific outcomes or metrics provided in 510(k) summary).
- Accelerated and Real Time Aging Testing confirms shelf-life and stability.	Pass.
Overall Mechanical Withstand:	Demonstrated ability to mechanically withstand insertion and deployment within a vertebral body.
Functionality:	Functioned as intended in all instances.

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

Sample Size for Bench Testing: Not explicitly stated for each test (e.g., how many osteoporotic vertebrae or sawbones were used for torque testing).
Sample Size for Clinical Testing: The summary mentions "Clinical Testing Ascendx VCF Repair System IDE study," but does not provide the sample size used in this study.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The mention of an "IDE study" implies a prospective clinical trial conducted under an Investigational Device Exemption.

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

Not Applicable / Not Provided: The nature of the bench and clinical tests described does not typically involve "experts" establishing a ground truth in the way it would for an AI- radiology study. Bench tests rely on engineering measurements and standards. Clinical studies involve patient outcomes and clinician assessments (e.g., surgeons performing the procedure), but no specific number or qualification of "experts" for ground truth establishment is given in this context.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: Adjudication is generally relevant for studies where observer variability or interpretation of findings is key (e.g., interpreting medical images). For a device like the Acu-Cut system, performance is assessed through mechanical tests and clinical outcomes, not typically requiring adjudication in the common sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: The provided documentation is for a physical medical device (vertebral augmentation system), not a diagnostic artificial intelligence product. Therefore, an MRMC study is not relevant to this submission.

6. Standalone Performance:

Yes (for bench testing): The bench tests described (cutting torque, tensile strength, insertion testing, etc.) represent the standalone performance of the device components.
Yes (for clinical performance): The clinical testing of the "Acu-Cut System" inherently evaluates its standalone performance in human subjects, although specific metrics are not detailed in this summary.

7. Type of Ground Truth Used:

Bench Testing: Engineering measurements, adherence to design specifications, material properties, and functional performance (e.g., successful cutting, no breakage, correct cement delivery).
Clinical Testing: Patient outcomes, functional assessments, and clinician observations regarding the safety and effectiveness of the device in treating vertebral compression fractures. The summary does not specify particular outcome measures.

8. Sample Size for the Training Set:

Not Applicable: This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.

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

Not Applicable: As stated above, this is not an AI/ML device, so there is no training set or ground truth establishment method for one.

Summary

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K113452
PAGE 1 of 2

510(k) SUMMARY for K113452

Ascendx Spine, Inc.'s Acu-Cut Vertebral Augmentation System FEB 17 2012

Submitter

Ascendx Spine, Inc. 7079 University Blvd Winter Park FL 32792

Phone: (321) 280-4800 Facsimile: (321) 280-4801 Contact Person: Teresa Cherry Date Prepared: July 16, 2012 (12/15ed)

Name of Device

Acu-Cut Vertebral Augmentation System

Classification Name

Vertebroplasty, Cement, Bone

Predicate Devices

Medtronic USA, Inc.'s Arcuate Vertebral Augmentation System (K070527)

Intended Use / Indications for Use

Technological Characteristics

The Acu-Cut Vertebral Augmentation System consists of:

the Acu-Cut Cutting Instrument .
. 2 Cannulas
1 Tri-Point Tip Trocar .
1 Bevel Tip Trocar ●
1 Hand Drill ●

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Page 2 of 2

· 5 Cement Delivery Tubes with Plungers
· A previously FDA cleared bone cement.

Performance Data

Comprehensive bench and clinical testing of the Acu-Cut Vertebral Augmentation System was conducted. Testing included:

Bench testing for the Acu-Cut Cutting Instrument .
- Cutting torque testing in osteoporotic vertebrae and sawbones o
- Tensile strength testing of Cutting Instrument band o
- Cutting Instrument flex cable weld strength testing o
Bench testing for the Trocars, Cannulas, Hand Drills and Cement Delivery ● Devices
- o Insertion testing
- Trocar Handle Strength Testing 0
- Torque and Tensile Strength Testing O
- Cement Delivery Instrument Testing O
- o Removal Force Testing
Sterilization Validation ●
Packaging and Shipping Validations .
Biocompatibility Testing ●
Clinical Testing Ascendx VCF Repair System IDE study ●
Accelerated and Real Time Aging Testing .

The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Acu-Cut System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Acu-Cut System functioned as intended.

Substantial Equivalence

The Acu-Cut Vertebral Augmentation System is substantially equivalent to the predicate device. The Acu-Cut Vertebral Augmentation System has the same intended uses and indications as the predicate Arcuate Vertebral Augmentation System. Both systems include a cutting device that is used to create a cavity by cutting cancellous bone within the vertebral body. Both systems include Class I instruments for gaining access to the vertebral body and for delivering previously cleared bone cement. The technological characteristics and principles of operation of the Acu-Cut System are also similar to the predicate. The minor technological differences between the Acu-Cut Vertebral Augmentation System and its predicate device, e.g., with respect to dimensions, etc., raise no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the body, wings, and tail feathers.

Public Health Service

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

FEB 17 2012

Ascendx Spine, Incorporated % Hogan LovellsUS LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K113452

Trade/Device Name: Acu-Cut Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, KIH Dated: November 21, 2011 Received: November 21, 2011

Dear Ms. Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and enough the Medical Device Amendments, or to connineres phot to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increasing market the act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: OD10 : 0010 : abeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (300 acree, insisting major regulations affecting your device can be may be subject to additions, 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 that IDA has made a accornmancir in administered by other Federal agencies. You must or any rederal statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the For 8 requirements (1); medical device reporting (reporting of medical CrK Fall 607), laocing (21 OFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Janice M. Hogan

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 n you active spothio ad 1100 corpor JDA/Centers Offices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Somer 10. BOTTess and ing by reference to premarket notification" (21CFR Part note the 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 I ou may 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,

Eind Keith

~ 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 (if known):

K113452

Device Name: Acu-Cut Vertebral Augmentation System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-(Division Sign-Sign-Sical, Orthopedic, and Restorative Devices

510(k) Number

Page I of i

18 ·

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.”