The ARTISAN™ Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or titanium mesh in bony defects of oral maxillofacial anatomy.

The ARTISAN™ Space Maintenance System is intended for temporary use in oral maxillofacial surgical reconstruction and dental regeneration procedures for maintaining space during bone grafting procedures and to support soft tissue until bone formation.

Device Description

The ARTISAN™ Space Maintenance System is a comprehensive, allinclusive system which contains a variety of implants designed to temporarily reconstruct bony deficiencies common to the oral cavity that are not intrinsic to the stability of the bony structure. Bony deficiencies may be naturally occurring osseous defects, surgically created osseous defects, or osseous defects created from traumatic injury to the bone.

The ARTISAN™ Space Maintenance System includes a selection of Socket Preservation screws which are designed to aid in extraction socket grafting while simultaneously supporting the original gingival margins and papilla. The system contains a porous titanium mesh (with only one size of 76mm x 44mm x 0.2mm), titanium allov mesh fixation screws (with sizes of 1.2mm or major diameters x 4mm or 6mm or 10mm or 10mm or 12mm or 14mm lengths, and with sizes of 1.4mm maior diameters x 3mm or 5mm or 7mm lengths), titanium allov tenting screws (with sizes of 1.2mm or 1.4mm major diameters x 8mm or 10mm or 12mm or 14mm lengths x 5mm head diameter), and titanium allov socket preservation screws (with sizes of 1.2mm or 1.4mm major diameters x 14mm or 18mm or 20mm lengths x 3/4mm or 4/5mm or 5/6mm head diameters). When used as indicated, this system provides a semi-protected space to stabilize, support, and protect bone graft (autograff, autograft extenders, allograft, and bone void fillers) by minimizing soft-tissue collapse into the graft recipient site.

AI/ML Overview

The provided document is a 510(k) summary for the ARTISAN™ Space Maintenance System, primarily focused on obtaining appropriate MRI labeling. It details the device, its predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence and MRI safety. However, this document does not describe a clinical study that proves the device meets acceptance criteria in the context of human performance or comparative effectiveness with AI.

Instead, the "acceptance criteria" here refer to proving substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance by the FDA. The "study" that proves the device meets these criteria is a series of non-clinical (bench) tests and analyses, not a human-in-the-loop clinical trial.

Therefore, many of the requested sections about human studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable based on the provided text.

Here's a breakdown of the available information:

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

Acceptance Criteria (Demonstration of Substantial Equivalence and MRI Safety)	Reported Device Performance
Substantial Equivalence (Mechanical/Material Properties):
- Design similarity to predicate devices	The ARTISAN™ Space Maintenance System has the "same design" as its respective predicate devices.
- Material similarity to predicate devices	The ARTISAN™ Space Maintenance System has the "same materials" as its respective predicate devices.
- Physical properties similarity to predicate devices	The ARTISAN™ Space Maintenance System has the "same physical properties" as its respective predicate devices.
- Performance in Static Axial Pullout Testing (ASTM F543-02)	Tests were performed "in accordance with ASTM F543-02". Results support substantial equivalence, though specific numerical results are not provided in this summary.
- Performance in Static Subsidence Testing (no industry standard)	Tests were performed. Results support substantial equivalence.
- Performance in Static Cantilever Bending Testing (no industry standard)	Tests were performed. Results support substantial equivalence.
- Performance in Static "Removal Torque" and "Torque to Failure" testing (ASTM F543-02)	Tests were performed "in accordance with ASTM F543-02". Results support substantial equivalence.
MRI Safety and Labeling:
- Magnetic Field Interaction Evaluation at 3-Tesla (ASTM F2052-06)	Evaluation performed "at 3-Tesla (ASTM F2052-06)". Results demonstrated MR-Conditional classification.
- Qualitative Torque Assessment (ASTM F2213-06)	Assessment performed. Results demonstrated MR-Conditional classification.
- MRI related Heating Assessment at 1.5-Tesla and 3-Tesla (ASTM F2182-11)	Assessment performed "at 1.5-Tesla and 3-Tesla (ASTM F2182-11)". Results demonstrated MR-Conditional classification.
- Artifact Assessment at 3-Tesla (ASTM F2119-07)	Assessment performed "at 3-Tesla (ASTM F2119-07)". Results demonstrated MR-Conditional classification.
Overall Conclusion:	The ARTISAN™ Space Maintenance System is substantially equivalent to its predicate devices and can be classified as MR-Conditional in 1.5 and 3 Tesla environments.

2. Sample size used for the test set and the data provenance

This document describes non-clinical (bench) testing, not human subject testing. Therefore, "sample size" refers to the number of device units tested. The document does not specify the exact number of units tested for each non-clinical test. Data provenance is internal laboratory testing by Medtronic Sofamor Danek.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench study. "Ground truth" was established based on engineering standards (ASTM) and the physical properties and performance of the devices themselves, measured with scientific instruments.

4. Adjudication method for the test set

Not applicable. This was a non-clinical bench study.

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. This document describes a 510(k) submission for substantial equivalence and MRI labeling, based on non-clinical testing. It does not involve AI or human readers evaluating medical cases.

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

Not applicable. This device is a physical medical implant, not an algorithm or software. The "standalone" performance here refers to the device's physical and MRI characteristics, which were assessed independently in bench tests.

7. The type of ground truth used

For the substantial equivalence tests (mechanical properties), the "ground truth" was derived from the performance of the predicate devices and established engineering standards (e.g., ASTM F543-02). For MRI safety tests, the "ground truth" was based on specified MRI safety criteria and standards (e.g., ASTM F2052-06, F2213-06, F2182-11, F2119-07).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in this non-clinical bench testing context for a physical medical device.

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

Not applicable, as there is no training set for this type of non-clinical device testing.

Summary

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ARTISAN™ Space Maintenance System 510(k) Summarv

MAY 3 0 2012

Below is the 510(k) summary submitted to the FDA containing information per Code of Federal Requlations, Title 21, Part 807.92: This 510(K) is submitted for one reason: to provide appropriate MRI labeling for the subject devices, while also providing MRI technologists with a method of concluding whether an MRI scan can be performed on the device and specific instructions on how to perform the scan.

Submitter Information 1.
Medtronic Sofamor Danek Sponsor: 1800 Pyramid Place Memphis. TN 38132

Contact Person: Lin Wu, Regulatory Affairs Specialist lin.wu@medtronic.com (901) 396-3133

Date Prepared: April 18, 2012

1. Device Name
  Proprietary Trade Name: ARTISAN™ Space Maintenance System Common/Usual Names:

Classification Name: Bone Plate (Regulation Number 21 CFR 872.4760) JEY, DZE Product Code:

lll. Predicate Devices

ARCHITEX™ Space Maintenance System (K100779 SE 12/13/2010, and K110259 SE 04/13/2011)

IV. Device Description

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may be naturally occurring osseous defects, surgically created osseous defects, or osseous defects created from traumatic injury to the bone.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and medical grade cobaltchromium-molybdenum allov may be used together.

Technological Characteristics

The ARTISAN™ Space Maintenance System has the same design, same materials, and physical properties as their respective predicate devices, and is substantially equivalent to their predicate devices.

V. Indications for Use

The ARTISAN™ Space Maintenance System is intended for temporary use in oral maxillofacial surqical reconstruction and dental reqeneration procedures for maintaining space during bone grafting procedures and to support soft tissue until bone formation.

The ARTISAN™ Space Maintenance System has the same indications for use as their respective predicate devices.

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VI. General discussion of the non-clinical tests submitted

For a determination of substantial equivalence, the following analyses and bench performance tests were performed on Subject Devices and Predicate Devices: h

Analysis of Dimensional and Material Features
Static Axial Pullout Testing in accordance with ASTM F543-02: A
Static Subsidence Testing (to date there are no industry standards); >
A Static Cantilever Bending Testing (to date there are no industry standards):
Static "Removal Torque" and "Torque to Failure" testing in accordance A with ASTM F543-02

For a determination of MRI labeling and safety information, the following analyses and bench tests were performed on the Subject Devices:

Magnetic Field Interaction Evaluation at 3-Tesla (ASTM F2052-06)
Qualitative Torque Assessment (ASTM F2213-06) >
MRI related Heating Assessment at 1.5-Resla and 3-Tesla (ASTM F2182-11)
Artifact Assessment at 3-Tesla (ASTM F2119-07)

VII. Conclusions drawn from the non-clinical Tests

Results of the MRI testing have demonstrated that the ARTISAN™ Space Maintenance System can be classified as MR-Conditional in 1.5 and 3 Tesla environments.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is black and appears to be printed on a white background. The text is centered horizontally in the image.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Mr. Lin Wu Regulatory Affairs Specialist Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132

MAY 3 0 2012

Re: K120271

Trade/Device Name: ARTISAN™ SPACE MAINTENANCE SYSTEM Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZE Dated: May 24, 2012 Received: May 24, 2012

Dear Mr. Wu: -

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.

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Page 2 - Mr. Wu

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,

Anthony D. Owens

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ARTISAN™ SPACE MAINTENANCE SYSTEM

INDICATIONS FOR USE:

The ARTISAN™ Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or titanium mesh in bony defects of oral maxillofacial anatomy.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Russer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120627

Page 1 of 1

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.