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 provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously 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, which is a submission to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific performance criteria and results.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) is not available in this document.

The document indicates that the purpose of this particular 510(k) application is to "include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248)". This suggests that the substantial equivalence argument relies on the existing clearance of the base system and its components.

Here's a breakdown of what can be extracted and what is missing:

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

Not Available: This document does not present specific performance criteria or a study demonstrating the device meets them. The device is a set of manual instruments for delivering bone cement, and the substantial equivalence is based on its similarity to other legally marketed systems. Performance data related to mechanical properties or clinical outcomes would typically be found in direct studies, which are not detailed here for this 510(k) submission.

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

Not Available: No test set or associated data is described in this summary, as it's a substantial equivalence submission for additional instruments, not a de novo clearance requiring new clinical performance data.

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)

Not Available: No test set or ground truth establishment is mentioned.

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

Not Available: No test set or adjudication process 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

Not Applicable/Not Available: This is a submission for a medical device (surgical instruments and cement delivery system), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not Applicable/Not Available: This is not an algorithm or AI product.

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

Not Available: No ground truth establishment is described.

8. The sample size for the training set

Not Available: No training set is applicable or described.

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

Not Available: No training set or ground truth establishment is applicable or described.

Summary of the 510(k) Content:

Device: ARCUATE™ Vertebral Augmentation System (specifically, additional instruments for a previously cleared system).
Purpose: Percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine for vertebroplasty procedures.
Indication: Treatment of painful pathological fractures of the vertebral body (due to osteoporosis, benign lesions, and/or malignant lesions).
Substantial Equivalence: Demonstrated by comparison to several previously cleared systems and the VISIOPLAST™ Spine Cement (K042415) packaged with the system. The focus is on the device's design and intended use being similar to existing, cleared products.
Regulatory Clearance: K070527 was cleared on May 4, 2007.

To find the missing information (performance criteria, specific study details), one would typically need to review the original 510(k) submission for the predicate devices that established the foundational clearance for vertebroplasty systems and PMMA bone cement, or the full K063248 submission for the ARCUATE™ Vertebral Augmentation System itself, if it contained such data. This specific document K070527 is an amendment for additional instruments, relying on prior clearances.

Summary

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K070527

ARCUATE™ Vertebral Augmentation System 510(k) Summary April 2007

I.	Company:	Medtronic Sofamor Danek USA, Inc.
		1800 Pyramid Place
		Memphis, TN 38132

MAY - 4 2007

Christine Scifert Contact: Group Director, Regulatory Affairs (901) 396-3133
ARCUATE™ Vertebral Augmentation System Proposed Proprietary Trade Name: II. Classification Name: Methyl Methacrylate for Vertebroplasty Orthopedic Cement Delivery System NDN. KIH Product Code: 888.3027 and 888.4200 Regulation No .:

Product Description/Purpose of Application III.

The purpose of this application is to include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248). The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously cleared by the FDA for use in the treatment of painful vertebral compression fractures.

IV. Indications

V. Substantial Equivalence

Documentation was provided which demonstrated the subject ARCUATE™ instruments to be substantially equivalent to previously cleared systems such as the ARCUATE™ Vertebral Augmentation System (K063248, SE 03/13/07, 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 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Cement System (K062424, SE 0914/06). The VISIOPLAST™ Spine Cement packaged with this

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system was cleared by the agency for use in the treatment of painful vertebral compression fractures in K042415, SE 06/09/05.

. . . . . . . .

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AY = 4 7007

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

Re: K070527

Trade/Device Name: ARCUATE™ Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: February 22, 2007 Received: February 23, 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 ass outted in also encreat 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 n your at 110 to 11 also 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.

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Page 2 - Ms. Christine Scifert

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 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 vours.

barbara Buend
TS

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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April - 2007

510(k) Number_

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)

Sebeart BuelsingBaxm

(Division Sign) Division of General, Restorative, and Neurological Devices

510(k) Number K070527

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.”