The ARCUATE™ 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.

Device Description

The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provide physicians with a means to augment the vertebral body with a mechanical device in order to prepare the site for vertebroplasty. Once the site is prepared, the ARCUATE™ Vertebral Augmentation instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the ARCUATE™ Vertebral Augmentation System kits are packaged with and may only be used with VISIOPLAST™ Spine Cement, which has been cleared by the FDA for use in the treatment of painful vertebral compression fractures.

AI/ML Overview

The provided text is a 510(k) summary for the ARCUATE™ Vertebral Augmentation System and discusses substantial equivalence, not a study evaluating the device's performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

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

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

Cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, not on presenting performance data from a specific study against acceptance criteria.

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

Cannot be answered from the provided text. No specific test set or study data is described.

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)

Cannot be answered from the provided text. No information about ground truth establishment is present.

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

Cannot be answered from the provided text. No adjudication method is described.

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

Cannot be answered from the provided text. This document describes a medical device for vertebral augmentation, not an AI-assisted diagnostic tool or an MRMC study.

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

Cannot be answered from the provided text. This document describes a manual surgical instrument system, not an algorithm.

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

Cannot be answered from the provided text. No ground truth information is provided.

8. The sample size for the training set

Cannot be answered from the provided text. No training set for an algorithm is mentioned.

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

Cannot be answered from the provided text. No training set or ground truth establishment for it is mentioned.

Summary of available information from the input:

Device Name: ARCUATETM Vertebral Augmentation System
Purpose of Application: To market the ARCUATE® Vertebral Augmentation System, which consists of manual instruments to augment the vertebral body with a mechanical device for vertebroplasty, followed by percutaneous delivery of PMMA bone cement (VISIOPLAST™ Spine Cement).
Indications for Use: Treatment of painful pathological fractures of the vertebral body (resulting from osteoporosis, benign lesions, and/or malignant lesions like metastatic cancers and myeloma).
Substantial Equivalence: The system was deemed substantially equivalent to the EQUESTRA™ Fluid Delivery System (K040483), Kit Mendec Spine and Delivery System (K062452), EBI Vertebroplasty System (K060148), and Vertefix™ Vertebroplasty Procedure Set (K042691). The VISIOPLAST™ Spine Cement was cleared under K042415.
Regulatory Classification: Class II, Product Code NDN, KIH, HRX, HXG.
Date of Clearance: March 13, 2007.

The document provided is a regulatory clearance letter based on substantial equivalence, meaning the FDA determined the device performs as intended and is as safe and effective as existing legally marketed devices. It does not contain a detailed performance study against specific acceptance criteria in the way one would find for a novel diagnostic or AI device.

Summary

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ARCUATETM Vertebral Augmentation System 510(k) Summary - K063248 February 2007

l. Company: Medtronic USA, Inc. 1800 Pyramid Place Memphis, TN 38132
- Christine Scifert Contact: Group Director, Regulatory Affairs (901) 396-3133
ARCUATETM Vertebral Augmentation System Proposed Proprietary Trade Name: II. Methyl Methacrylate for Vertebroplasty Classification Name: Orthopedic Cement Delivery System, Tamp, Arthroscope NDN. KIH, HXG and HRX Product Code: 888.3027, 888.4200, 888.4540 and 888.1100 Regulation No .:

Product Description/Purpose of Application III.

The purpose of this application is to notify the FDA of our intent to market the ARCUATE® Vertebral Augmentation System. The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provide physicians with a means to augment the vertebral body with a mechanical device in order to prepare the site for vertebroplasty. Once the site is prepared, the ARCUATE™ Vertebral Augmentation instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the ARCUATE™ Vertebral Augmentation System kits are packaged with and may only be used with VISIOPLAST™ Spine Cement, which has been cleared by the FDA for use in the treatment of painful vertebral compression fractures.

IV. Indications

Substantial Equivalence V.

Documentation was provided which demonstrated the ARCUATE™ Vertebral Augmentation System to be substantially equivalent to previously cleared systems such as the EQUESTRA™ Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/13/06)

MAR 1 3 2007

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and the Vertefix™ Vertebroplasty Procedure Set, Cook Incorporated (K042691, SE 11/08/05). The VISIOPLAST™ Spine Cement packaged with this system was cleared by the agency for use in the treatment of vertebral compression fractures in K042415, SE 06/09/05.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Ms. Christine Scifert Group Director, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

MAR 1 3 2007

Re: K063248

Trade/Device Name: ARCUATE™ Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Methyl Methacrylate for Vertebroplasty Regulatory Class: Class II Product Code: NDN, KIH, HRX, HXG Dated: February 7, 2007 Received: February 8, 2007

Dear Ms. Scifert:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Ms. Christine Scifert

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

fabaebruemp

Mark N. Melkerson, Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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February - 2007

510(k) Number - K063248

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use: The ARCUATE™ 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Powell

(Division Sign-(Division of General, Restorative, Division rological Devices

510(k) Number K063248

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.”