IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Device Description

The POWEREASE™ System Working Ends consists of instruments such as taps, drill bits, screwdrivers, post cutter, set screw break-off tool, reduction nut driver and sleeves. The working ends have a manual alternative. The working ends, listed above, are compatible with the CD HORIZON® SOLERA® and the TSRH® 3Dx Spinal System implants. Of the working ends, only the taps, screwdrivers, drill bits, and sleeves are also compatible with Medtronic's NIM-ECLIPSE® Spinal System.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the Medtronic Sofamor Danek POWEREASE™ System, which is a surgical instrument system. The content describes the device, its intended use, and a comparison to a predicate device.

Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, as is common in 510(k) submissions, rather than presenting a performance study with specific acceptance criteria and detailed results from a clinical or non-clinical trial against those criteria. Therefore, the requested information about acceptance criteria and a study demonstrating performance against them (especially clinical performance metrics like accuracy, sensitivity, specificity, etc.) is largely absent from this particular document.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Reported Device Performance

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

The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., accuracy, sensitivity, precision) that the device must meet, nor does it present a structured report of the device's performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (POWEREASE™ System K111520). The "acceptance" in this context is based on the FDA's determination that the new device does not raise new questions of safety and effectiveness compared to the predicate.

The document states:

"Engineering rationales, based on engineering theoretical analysis, were completed using testing that had been performed on the predicate device."
"The predicate testing was in accordance with IEC 60601 for Medical Electrical Equipment."
"Information and data to support these engineering rationales, as well as surgeon validations and internal verification activities, were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices."

This indicates that the "performance" demonstrated is primarily focused on safety and functional equivalence to the predicate, often through bench testing, materials characterization, and adherence to relevant standards like IEC 60601 for electrical medical equipment (though the specific aspects of IEC 60601 are not detailed, it typically covers electrical safety, electromagnetic compatibility, and basic performance).

Study Details (Based on available information)

Given the nature of a 510(k) summary relying on substantial equivalence, the detailed study information typically associated with AI-driven devices or novel therapies (like sample size, expert ground truth, adjudication) is not present.

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

Not Applicable / Not Provided: The document does not describe a test set or data provenance in the context of clinical performance evaluation (e.g., diagnostic accuracy, outcome prediction). The "testing" referred to is against the predicate device, likely involving bench testing and engineering analysis rather than a clinical dataset with "samples."

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 Applicable / Not Provided: This information is not relevant to this 510(k) submission, which focuses on hardware and mechanical/electrical safety and function, not a clinical diagnostic or AI-driven device requiring expert-labeled ground truth. The submission mentions "surgeon validations," but these are likely qualitative assessments of usability and function rather than establishing ground truth for performance metrics.

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

Not Applicable / Not Provided: No such adjudication method is mentioned or implied, as there is no "test set" in the context of typical AI/diagnostic studies.

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 Provided: The device is a system of powered surgical instruments (drills, taps, drivers). It is not an AI-assisted diagnostic or therapeutic device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

Not Applicable / Not Provided: This device is a surgical instrument and does not have an "algorithm" in the context of AI or standalone diagnostic interpretation. Its function is directly human-controlled or assists a human surgeon.

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

Not Applicable / Not Provided: For this type of mechanical surgical device, "ground truth" would relate to engineering specifications, material properties, mechanical integrity, and functionality, verified through engineering analysis and bench testing, rather than clinical outcome data or expert consensus on a diagnostic interpretation.

8. The sample size for the training set

Not Applicable / Not Provided: There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.

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

Not Applicable / Not Provided: As there is no training set, this question is not applicable.

Summary

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K123270

510(k) SUMMARY MEDTRONIC Sofamor Danek POWEREASE™ System October 2012

JAN 1 1 2013

I. Medtronic Xomed, Inc. (PowerEase) Company: Medtronic Surgical Technologies 6743 Southpoint Drive North Jacksonville, Florida, 32216, USA (904) 296-9600

Medtronic Sofamor Danek, USA Inc. (Working Ends) 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133

Julie Bassett Principal Regulatory Affairs Specialist Telephone: (901) 399-3248 Fax: (901) 346-9738

IPC® System IPC® POWEREASE™ System POWEREASE™ System POWEREASE™ System Working Ends

Powered simple cranial drills, burrs, trephines, and their accessories; Surgical instrument motors and accessories/attachments; Evoked Response Electrical Stimulator

Class II

HBE, HWE, GWF

Product Code:

Class:

V. Description:

The POWEREASE™ System Working Ends consists of instruments such as taps, drill bits, screwdrivers, post cutter, set screw break-off tool, reduction nut driver and sleeves. The working ends have a manual alternative. The working ends, listed above, are compatible with the CD HORIZON® SOLERA® and the TSRH® 3Dx

II. Contact:

III. Proprietary Trade Name:

IV. Common &Classification Names:

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Spinal System implants. Of the working ends, only the taps, screwdrivers, drill bits, and sleeves are also compatible with Medtronic's NIM-ECLIPSE® Spinal System.

VI. Indications for Use:

The IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

Summary of the Technological Characteristics: VII.

The purpose of this application for Premarket Notification is to expand the previously cleared [POWEREASE™ System K111520 (S.E. 10/26/2011)] indications to include placement of not only screws, but rods as well. The indications are changing to include the intended use of the nut reduction driver, as well as, update the indications since screws, posts, and rods may all be "cut" or "placed" during the procedure.

In addition, two modified Taps and a Reduction Nut Driver are being added to the POWEREASETM System.

The instrument modifications detailed in this submission have no impact on the technological characteristic of the existing instruments. The working end Taps are intended for tapping during spinal surgery, including both open and minimally invasive procedures. The working ends are used to facilitate the placement of the

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K123270

rods. Like the predicate POWEREASE™ System instruments, the subject instruments are manufactured from stainless steel.

IX. Discussion of Non-Clinical Testing:

Engineering rationales, based on engineering theoretical analysis, were completed using testing that had been performed on the predicate device. The predicate testing was in accordance with IEC 60601 for Medical Electrical Equipment. Information and data to support these engineering rationales, as well as surgeon validations and internal verification activities, were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.

Conclusion: X. .

Based on the supporting documentation provided in this premarket notification, Medtronic believes the subject devices demonstrate substantial equivalence to the predicate POWEREASE™ System K111520 (S.E. 10/26/2011).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three wavy lines representing the staff and a single line representing the snake.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Medtronic Sofamor Danek USA, Incorporated % Ms. Julie Bassett Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

January 11, 2013

Re: K123270

Trade/Device Name: POWEREASE™ System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBE, HWE, GWF Dated: October 18, 2012 Received: October 19, 2012

Dear Ms. Bassett:

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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Page 2 – Ms. Julie Bassett

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K123270

Device Name: POWEREASE™ System

Indications for Use:

Prescription Use _X (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)

Peter D. Rumm -S

(Division Sign-Off)

Division of Surgical Devices

K123270 510(k) Number_

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).