The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding the OsteoMed Pinnacle Driver. This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or a medical imaging system that would typically have acceptance criteria focused on diagnostic performance (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria and performance data presented here are related to the safety and functionality of a mechanical medical device (a surgical drill/driver). Therefore, I cannot extract the information required for questions 2, 3, 4, 5, 6, 7, 8, and 9 as they are specific to AI/ML driven diagnostic/imaging devices.

I can, however, provide the table of acceptance criteria and reported device performance from the provided text, focused on the mechanical and electrical aspects of the device.

1. Table of Acceptance Criteria and the Reported Device Performance

Test	Acceptance Criteria (Implied from Test Method Summary & Results)	Reported Device Performance
Design Verification Testing (DVT)	The device must perform as intended (drilling pilot holes, seating screws, removing screws) over repeated cycles.	The cycle was repeated 99 times, and the subject device performed as intended after the 99 cycles.
Screw Characterization	Data on torque and seat value for various screw lengths and diameters must be retrievable and suitable as input for torque-limiting software.	The data collected was used as an input into the torque limiting software.
Sterilization Validation	A Sterility Assurance Level (SAL) of 10^-6 must be achieved per AAMI TIR12:2010 using defined sterilization parameters.	Having met the predetermined acceptance criteria, the method outlined on the IFU was validated as an effective means of sterilizing the subject device.
Reprocessing (Cleaning) Validation	Automatic cleaning must be validated as effective based on AAMI TIR 30, following FDA Guidance "Reprocessing Medical Devices..."	Automatic cleaning was validated as an effective means of cleaning the subject device.
Packaging & Shipping Validation	Packaging must fully contain and protect the device from normal shipping hazards, and the device must function as intended after shipment.	The packaging fully contained and protected the device from exposure to normal shipping hazards and the device functioned as intended after shipment.
Battery Safety Testing	The device must comply with requirements in IEC 60086-4 (ed.3) and the Sixth Revised Edition of Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria.	The subject devices comply with requirements in the applicable standards.
Biocompatibility	The device materials must be considered non-toxic and biocompatible as per FDA Blue Book Memorandum #G95-1.	The subject devices are considered non-toxic and biocompatible.
Electrical Safety and EMC Testing	The device must comply with requirements in IEC 60601-1, IEC 60086-4, and ES60601-1 standards.	Subject device complies with requirements in the applicable standards.
Software Verification and Validation	Software documentation and testing must confirm a "minor" level of concern as per FDA Guidance for Software in Medical Devices.	Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern as documented in this submission.

Information not available from the provided text for an AI/ML diagnostic device:

Sample sizes used for the test set and the data provenance: Not applicable to this type of device (mechanical/electrical, not AI/ML diagnostic).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device involves functional tests, not expert interpretation of medical images/data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 does not describe an AI-assisted diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering specifications and functional performance.
The sample size for the training set: Not applicable. This document is not describing a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 19, 2017

OsteoMed Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, TX 75001

Re: K162542

Trade/Device Name: OsteoMed Pinnacle Driver 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: February 14, 2017 Received: April 18, 2017

Dear Kathryn Jayne:

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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, Michael J. Hoffmann -S

for

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) K162542

Device Name PINNACLE Driver

Indications for Use (Describe)

The PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The word is in blue, and the letters are slightly slanted to the right. There is a blue swoosh above the word and a gray swoosh below the word.

510(k) SUMMARY

I. SUBMITTER

OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA

Phone: 972-677-4766 Fax: 800-390-2620 Email: kjayne@osteomed.com

Contact Person: Kathryn A. Jayne Date Prepared: May 12, 2017

II. DEVICE

Name of the Device: PINNACLE Driver Common or Usual Name: Battery-operated drill/driver Classification Name: Drill, Bone, Powered Regulation: 882.4310 Regulatory Class: II Product Code: HBE Classification Panel: Neurology

III. PREDICATE DEVICE

The OsteoMed "B" Power System, K933101, is the primary predicate. The OsteoMed OsteoPower System, K971692, is the reference predicate.

IV. DEVICE DESCRIPTION

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word is in blue, and there is a gray oval around the word. The logo is simple and modern.

INDICATIONS FOR USE V.

The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with cranial surgical procedures.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements as demonstrated below.

	Subject Device—OsteoMed PINNACLEDriver & Accessories	Primary Predicate—OsteoMed “B” PowerSystem & Accessories	Reference Predicate—OsteoMed OsteoPowerSystem & Accessories
510(k)	Pending	K933101	K971692
Regulation No.	882.4310	872.4120	872.4120
Product Code	HBE	KIJ	KMW
Device Class	II	Unclassified	II
Regulatory Panel	Neurology	Dental	Dental
Indications forUse	The PINNACLE Driver isintended for drivingscrews and for drillinginto bone, in conjunctionwith cranial surgicalprocedures.	The OsteoMed “B” PowerHandpiece System isintended for drilling andcutting bone and teeth andfor driving pins, screws,and/or wires into bone fordental, craniofacial,orthognathic, mandibular,hand, foot, wrist, orextremity reconstructionsurgical procedures.	The OsteoPower Systemand Accessories areindicated for drilling orcutting bone or teeth, andfor driving screws and/orpins and wires into bone,in conjunction withdental, craniofacial,craniotomies,orthognathic, spinal,mandibular, hand, foot,wrist, and extremityreconstruction surgicalprocedures.
Power Source	Battery operated(Lithium, single patientuse)	Battery operated(rechargeable NiCadbattery)	AC/DC External powersupply
Material	--Handpiece andbattery—Aluminum,PEEK, brass, medicalgrade stainless steel,silicone	--Handpiece andbattery—stainless steel,aluminum, brass, silver,medical grade plastics,fiber reinforced ceramics	--Handpiece only—stainless steel or carbide--Cutting portion of thedrills or burrs—stainlesssteel, carbide, diamond, orfiber reinforced ceramic
	Subject Device—OsteoMed PINNACLEDriver & Accessories	Primary Predicate—OsteoMed “B” PowerSystem & Accessories	Reference Predicate—OsteoMed OsteoPowerSystem & Accessories
	--accessories—medicalgrade stainless steel,aluminum	--accessories—medicalgrade stainless steel orcarbide	--Accessories—stainlesssteel, aluminum, ormedical grade plastics
Speed	2,000 RPM forward275 RPM reverse	120-1800 RPM	608-70,000 RPM
Battery	Disposable, lithium,single use, sterile battery(gamma)	Rechargeable NickelCadmium battery	NA
Modes	DrillDrive	DrillDrive	Speed ranges SAFETY,100%, 75%, 50%, 25%,and Di (12.5%) ofmaximum speed
ActivationButtons	1 Forward button1 Reverse button	1 Forward button1 Reverse button	1 Forward button1 Reverse button
InsertionMaterial	Bone	Bone	Bone
Screwsizes/insertion	1.2mm, 1.6mm, 2.0mm	1.6mm, 2.0mm	1.2mm, 1.6mm, 2.0mm
Collet	Pull-back collet	Pull-back collet	Twist collet
Accessories	Hex Shank drill bits, HexShank driver stems,sterilization trays, rigidsterilization container	Round burrs, oval burrs,twist drills, wire passtwist drills, side cuttingburs, and end-cuttingdrills, saw blades, K-wires and pins, screwdrivers, burr racks, bladecontainers, sterilizationtrays, battery charger	Round burrs, oval burrs,twist drills, wire passtwist drills, side cuttingburrs, end-cutting drills,saws, motor units,modules, footswitches,screw drivers
Sterilization ofre-usable devices	Pre-vacuum steam(wrapped)—Hand pieceonly--Min. Temp: 132° C(270°F)--Full Cycle Time: 4minutes--Min Dry Time: 30minutesPre-vacuum steam (rigidcontainer)—1-Driver Case & 2-DriverCase--Min. Temp: 132° C(270°F)--Full Cycle Time: 4minutes--Min Dry Time: 30minutes	Pre-vacuum Hi Vac(wrapped or unwrapped)Temp: 270-270 °FExposure Time: 4 minDry Time: min 8 min270 °F Gravity(wrapped on tray)Temp: 270-270 °FExposure Time: 35 minDry Time: min 8 min	Pre-vacuum steam(wrapped)Temp: 132° C (270°F)Dwell Time: 10 minutesDry Time: 70 minutes
	Subject Device—OsteoMed PINNACLEDriver & Accessories	Primary Predicate—OsteoMed “B” PowerSystem & Accessories	Reference Predicate—OsteoMed OsteoPowerSystem & Accessories
ParameterControlTechnology	Software	Non-programmable,discrete digital and analoglogic	Non-programmable,discrete digital and analoglogic
Software/safetyfeatures	-Senses torque to preventover-torquing & strippingof screws	NA	Motor unit control switchto temporarily disable theElectric Drive

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Image /page/5/Picture/0 description: The image shows the OsteoMed logo. The logo is in blue and white, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent a medical company.

OsteoMed PINNACLE Driver Submission K162542

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Image /page/6/Picture/0 description: The image shows the Osteomed logo. The logo is in blue and gray, with the word "Osteomed" in bold, blue letters. The logo is surrounded by a gray and blue swoosh design. The logo is simple and modern, and it is likely used to represent a medical company.

OsteoMed PINNACLE Driver Submission K162542

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1.

Cytotoxicity
Sensitization
Irritation ●
Systemic toxicity
Subchronic toxicity ●
Genotoxicity ●
Implantation
Pyrogen testing ●

The device and associated accessories are considered tissue/bone/dentin contacting for a duration of less than 24 hours. However, OsteoMed conducted a biocompatibility evaluation of the exposed material of the driver as worst case. based on an implant device due to the close proximity to the patient. The sterilization trays and rigid containers are considered non-patient contacting.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60086-4 standards for safety and the ES60601-1 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern as documented in this submission.

Bench Testing

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Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a stylized font. The logo is surrounded by a blue and gray oval shape. The logo is simple and modern, and it is likely used to represent the company's brand.

The following bench testing was conducted:

Simulated Use/Design Verification Testing (DVT) ●
Sterilization Validation
. Reprocessing Validation
. Shipping Validation
. Battery Safety Testing
Electrical Safety and Electromagnetic Compatibility .

Animal Study

No animal studies were needed to demonstrate substantial equivalence to the declared predicate.

Clinical Studies

No clinical studies were needed to demonstrate substantial equivalence to the declared predicate.

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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent the company's brand.

Testing Summary
Test	Test Method Summary	Results
Design VerificationTesting (DVT)	Conducted on subject devices withsoftware and powered by single usebatteries. The driver was switchedto drill mode and a drill bit wasused to drill a pilot hole. The modewas switched back to drive modeand a driver stem was used to fullyseat a specified screw. Still in drivemode, the driver was used toremove screws.	The cycle was repeated99 times and the subjectdevice performed asintended after the 99cycles.
ScrewCharacterization	Released screws of various lengthand diameter were used with thesubject device. A torque analyzerwas used to retrieve the data afterthe screw was seated or strippingnoted. Torque and seat value wasthen calculated.	The data collected wasused as an input into thetorque limiting software.
SterilizationValidation	Sterilization validation wasconducted on subject devices perusing overkill sterilization methodvalidating an SAL of 10-6 perAAMI TIR12:2010. The validationwas conducted using thesterilization parameters defined inIFU. The validation was conductedon individually wrapped driversand the driver and accessoriesplaced inside an organizational trayinside a rigid container.	Having met thepredetermined acceptancecriteria, the methodoutlined on the IFU wasvalidated as an effectivemeans of sterilizing thesubject device.
Reprocessing(Cleaning)Validation	Automatic Cleaning Conducted onsubject devices in worst caseconfiguration based on FDAGuidance document "ReprocessingMedical Devices in Health CareSettings: Validation Methods andLabeling" issued March 17, 2015.Worst case cleaning processing(minimum durations for thecleaning steps as defined in theIFU). Acceptance criteria wasbased on AAMI TIR 30.	Automatic cleaning wasvalidated as an effectivemeans of cleaning thesubject device.
Test	Test Method Summary	Results
Packaging &Shipping Validation	Shipping validation was conductedon subject devices using ASTMD4169 after environmentalconditioning per ASTM D4332-14.	The packaging fullycontained and protectedthe device from exposureto normal shippinghazards and the devicefunctioned as intendedafter shipment.
Battery SafetyTesting	Conducted on subject devices perIEC 60086-4 (ed.3) and SixthRevised Edition ofRecommendations on the Transportof Dangerous Goods, Manual ofTests and Criteria.	The subject devicescomply with requirementsin the applicablestandards.
Biocompatibility	The biocompatibility evaluation forthe subject device was conductedin accordance with the FDA BlueBook Memorandum #G95-1.	The subject devices areconsidered non-toxic andbiocompatible.
Electrical Safetyand EMC Testing	Conducted on subject device perIEC 60601-1, IEC 60086-4, andES60601-1	Subject device complieswith requirements in theapplicable standards.

T C 45

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Image /page/9/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in bold letters. The word "OSTEO" is in blue, and the word "MED" is in gray. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern.

VIII. CONCLUSIONS

The basis of substantial equivalence for the device is based on similarities in indications for use, material, function, performance, design, technology, sterilizations, and operating principles. The non-clinical data support the substantial equivalence of the device and the verification and validation demonstrate that the device should perform as intended in the specified use conditions.

(End of Summary)

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).