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 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

Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

AI/ML Overview

The provided text is a 510(k) Summary for the Medtronic POWEREASE™ System. It discusses the device's substantial equivalence to a predicate device, IPC™ POWEREASE™ SYSTEM (K111520), and outlines some performance data. However, it explicitly states that no new testing was performed for the subject devices, and instead relies on a "confirmatory validation" to ensure minor modifications do not introduce new safety or effectiveness issues.

Therefore, the document does not report on a study that establishes acceptance criteria and demonstrates that the device meets those criteria through new performance testing. Instead, it asserts substantial equivalence based on the device being identical to the predicate in key aspects.

Given this, I cannot fully answer all parts of your request as there isn't a detailed study report with new acceptance criteria and performance data in the provided document. I will fill in what can be inferred from the text.

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

Based on the provided text, no specific quantitative acceptance criteria or new device performance metrics are presented for the subject device. The document states that the subject instruments are "identical to the predicate devices in terms of fundamental technology, intended use and indications for use." The "confirmatory validation" is not described with numerical acceptance criteria or performance results.

Acceptance Criteria	Reported Device Performance
Material Composition: Adherence to standards for surgical instruments.	• Manufactured from identical materials as the predicate devices. • Materials meet ASTM F899 (Standard Specification for Wrought Stainless Steels for Surgical Instruments).
Biocompatibility: Safe for limited contact.	• Classified as communicating devices with Tissue/Bone/Dentin (<24h external contact). • Materials have a long history of safe and effective use in predicate spinal implants. • Biocompatibility testing for the subject device was not required as materials are identical to predicate devices.
Functional Equivalence: No new safety or effectiveness issues introduced by minor modifications.	• A "confirmatory validation" was conducted to ensure minor modifications do not introduce new issues of safety and effectiveness and that devices function as intended. • No new testing was performed for the subject devices.

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

The document explicitly states: "Non-clinical mechanical testing was not performed for the subject instruments." Therefore, there is no test set sample size mentioned in relation to new performance data. The "confirmatory validation" is not described in a way that suggests a test set or specific data provenance.

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, as no new clinical or performance testing requiring expert ground truth establishment for a test set was performed or reported.

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

Not applicable, as no new clinical or performance testing with a test set was performed or reported.

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. The device is a powered surgical system, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a powered surgical system, not an algorithm.

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

Not applicable, as no new clinical or performance testing requiring ground truth was performed or reported for the subject device. The claim of substantial equivalence is based on the known performance and safety history of the predicate device with identical materials and technology.

8. The sample size for the training set

Not applicable, as this is a medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 4, 2018

Medtronic Sofamor Danek USA, Inc. Ankit Shah Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K182436

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 Dated: September 6, 2018 Received: September 7, 2018

Dear Ankit Shah:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Matthew C. Krueger -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name POWEREASETM System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY MEDTRONIC Sofamor Danek POWEREASE™ System September 2018

I. Submitter	Medtronic Sofamor Danek, USA Inc.
	1800 Pyramid Place
	Memphis, Tennessee 38132
	Telephone: (901)396-3133
	Fax: (901) 346-9738
Contact:	Ankit K. Shah
	Principal Regulatory Affairs Specialist
	Phone: (901) 344-1272
Date Prepared:	September 4, 2018
II. Device
Name of Device:	POWEREASE™ System
Classification Names:	Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310)
	Manual cranial drills, burrs, trephines, and their accessories (21 CFR 882.4300)
Class:	Class II
Product Code:	HBE, HBG
III. Predicate Devices:
	Primary Predicate:
	• IPC™ POWEREASE™ SYSTEM, K111520 (S.E. 10/26/2011)
	Reference Device:
	• CD HORIZON™ Spinal System, K162379 (S.E. 11/16/2016)

The predicates have not been subject to a design related recall.

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IV. Description:

Indications for Use: V.

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.

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.

Comparison of Technological Characteristics with the Predicate Devices: VI.

The subject working ends for use with the POWEREASE™ System have the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared predicate IPC™ POWEREASE™ SYSTEM, K111520 (S.E. 10/26/2011).

VII. Performance Data:

The following information is provided in support of substantial equivalence.

Biocompatibility

The subject working ends for use with the POWEREASE™ System are limited contact (<24h) external and will be classified as communicating devices with Tissue/Bone/Dentin, according to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices

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Part 1: Evaluation and Testing". The subject instruments are manufactured from identical materials as the predicate devices, in accordance with the following standards:

ASTM F899: Standard Specification for Wrought Stainless Steels for Surgical Instruments
The mateials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants and biocompatibility testing is not required.

Mechanical Testing

Non-clinical mechanical testing was not performed for the subject intrsuments. The subject instruments are identical to the predicate devices in terms of fundamental technology, intended use and indications for use. A confirmatory validation was conducted to ensure that the minor modifications being introduced do not introduce new issues of safety and effectiveness and the devices function as intended. There is no new testing perfomed for the subject devices.

Conclusion: VIII.

A risk analysis was completed, and the modified subject instruments do not introduce a new worst case. Based on the supporting information provided in this pre-market notification, the subject POWEREASE™ System is substantially equivalent to the predicate IPC™ POWEREASE™ SYSTEM, K111520 (S.E. 10/26/2011).

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).