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

Device Description

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 drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is 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 drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in the both in 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 document is a 510(k) premarket notification for a medical device called the "PINNACLE Driver." It describes the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Based on the information provided, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device for diagnostic or prognostic purposes, nor does it refer to a multi-reader multi-case (MRMC) comparative effectiveness study.

The "PINNACLE Driver" is a surgical tool (battery-operated driver/drill for bone, primarily for dental, orthognathic, and mandibular procedures). The "software" mentioned in the document is for torque limiting ("senses torque to prevent over-torquing and stripping of screws") and "bit recognition," not for diagnostic interpretation or image analysis.

Therefore, many of the requested elements (e.g., ground truth, sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of device and its regulatory submission.

However, I can extract the closest applicable information regarding "acceptance criteria" and "performance study" for this mechanical/software-controlled surgical device:

Acceptance Criteria and Device Performance (for a Mechanical/Software-Controlled Surgical Device)

Since this is a mechanical surgical device with integrated software for operational control (torque limiting), the "acceptance criteria" and "performance" are primarily addressed through engineering and safety standards, and bench testing, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated in Document)	Reported Device Performance (Summary from Document)
Biocompatibility	Compliance with FDA Blue Book Memorandum #G95-1 for tissue/bone/dentin contact (<24 hrs).	Evaluation conducted on exposed material as worst-case (implant device proximity). Tests included Cytotoxicity, Sensitization, Irritation, Systemic toxicity. (Implied compliance).
Electrical Safety	Compliance with IEC 60601-1 standards.	The system complies with IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60086-4 and ES60601-1 standards.	The system complies with IEC 60086-4 and ES60601-1.
Software Functionality	Software validation for a "moderate" level of concern, demonstrating proper function of torque sensing and bit recognition.	Software verification and validation testing were conducted, as recommended by FDA's guidance for software in medical devices. (Implied successful validation).
Mechanical Performance	Ability to drive screws and drill into bone as intended; proper functioning of forward/reverse modes, speed ranges, and torque limiting.	"Simulated Use" bench testing was conducted. (Implied successful performance in simulated use).
Sterilization & Reprocessing	Validation of sterilization methods (e.g., pre-vacuum steam) and reprocessing for reusable components.	Sterilization Validation and Reprocessing Validation were conducted. (Implied successful validation).
Shipping Performance	Device integrity maintained during transport.	Shipping Validation was conducted. (Implied successful validation).
Battery Performance	Absence of leak, proper power delivery.	Battery Leak Testing was conducted. (Implied successful testing).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a "sample size" in the context of diagnostic data. Performance was evaluated through bench testing of the device itself (e.g., simulated use, electrical safety tests, sterilization validation). The number of test units or iterations for these engineering tests is not specified in this summary.
Data Provenance: Not applicable as it's not a clinical data study for algorithm development. The "data" refers to the results of engineering tests conducted by the manufacturer, OsteoMed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This pertains to establishing ground truth for diagnostic data. For this device, "ground truth" would be established by engineering specifications, validated test methods, and compliance with recognized standards (e.g., IEC 60601). The "experts" would be the engineers, quality control personnel, and regulatory affairs specialists involved in the device design, manufacturing, and testing process.

4. Adjudication Method for the Test Set

Not applicable. This applies to human review of diagnostic cases. For this device, compliance is determined by successful completion of specified engineering tests and validation protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is specifically for evaluating the impact of AI assistance on human readers in diagnostic tasks. The PINNACLE Driver is a surgical tool, not a diagnostic imaging device.

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

Not applicable in the context of an AI algorithm for diagnostic purposes. The "software" in this device controls mechanical function (torque limiting, bit recognition). Its "standalone performance" is validated through the engineering bench tests (e.g., demonstrating it can limit torque as designed).

7. The Type of Ground Truth Used

Engineering Specifications and Recognized Standards: The "ground truth" for this device's performance is adherence to its design specifications, established engineering tolerances, and compliance with relevant international and national safety and performance standards (e.g., IEC 60601-1 for electrical safety, ISO standards for biocompatibility). For the software component, the ground truth is its ability to correctly execute its programmed functions (e.g., accurately sense torque, correctly identify bits) as per its design requirements and software validation protocols.

8. The Sample Size for the Training Set

Not applicable. This device's software is not based on machine learning that requires a "training set" of data in the typical sense (e.g., medical images). It's software for operational control.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there's no "training set" in the context of AI/ML. The "ground truth" for its simple, rule-based software is defined by its functional specifications and verified through testing.

Summary

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

April 4, 2017

Osteomed Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001

Re: K162544

Trade/Device Name: Osteomed Pinnacle Driver Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: KMW Dated: February 16, 2017 Received: March 9, 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 (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,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162544

Device Name PINNACLE Driver

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)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 blue, bold letters. The logo is surrounded by a blue and gray swoosh design. The blue swoosh is on top, and the gray swoosh is on the bottom.

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: March 29, 2017

II. DEVICE

Name of the Device: PINNACLE Driver Common or Usual Name: Battery-operated drill/driver Classification Name: Drill, Bone, Powered Regulation: 872.4120 Regulatory Class: II Product Code: KMW

III. PREDICATE DEVICE

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

This primary predicate and reference predicate have not been subject to a designrelated recall.

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/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in blue letters. The logo has a blue swoosh above the word and a gray swoosh below the word. The logo is likely for a medical company that specializes in orthopedics.

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

V. INDICATIONS FOR USE

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

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

	Subject Device-	Primary Predicate-	Reference Predicate-
	OsteoMed PINNACLE	OsteoMed "B" Power	OsteoMed OsteoPower
	Driver	System & Accessories	System & Accessories
510(k)	Pending	K933101	K971692
Regulation No.	872.4120	872.4120	872.4120
Product Code	KMW	KIJ	KMW
Device Class	II	Unclassified	II
Regulatory Panel	Dental	Dental	Dental
Indications forUse	The PINNACLE Driver isintended for drivingscrews and for drillinginto bone, in conjunctionwith dental, orthognathic,and mandibular 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	Primary Predicate—OsteoMed “B” PowerSystem & Accessories	Reference Predicate—OsteoMed OsteoPowerSystem & Accessories
		--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 drills, HexShank driver stems,sterilizationorganizational 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	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	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-bit recognition	NA	Motor unit control switchto temporarily disable theElectric Drive

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Image /page/5/Picture/1 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 swoosh design. The blue swoosh is on top and the gray swoosh is on the bottom.

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

The primary predicate device contains non-programmable, discrete digital and analog logic to operate. The subject device contains software to sense torque to prevent over-torquing and stripping of screws. Software validation is located in section 16 of this submission.

The primary predicate and subject devices are similar in basic shape and structure. The main difference between the two devices is the addition of software and the sterilization/reprocessing. The evaluation performed and supporting documentation within this submission demonstrates that the subject is comparable to the predicate device. Whenever possible, testing, located in section 18, was executed using recognized standards to establish product performance.

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

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.

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Image /page/7/Picture/1 description: The image shows the logo for Osteomed. The logo is in blue and gray, with the word "OSTEOMED" in blue, sans-serif font. The logo is surrounded by a gray and blue swoosh design. The swoosh design is gray on the bottom and blue on the top.

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 "moderate" level of concern as documented in this submission.

Bench Testing

The following bench testing was conducted:

Simulated Use
Sterilization Validation
Reprocessing Validation
Shipping Validation ●
o Battery Leak Testing
Electrical Safety and Electromagnetic Compatibility ●

Animal Study

No animals studies were needed to demonstrate substantial equivalence to the predicates.

Clinical Studies

No clinical studies were needed to demonstrate substantial equivalence to the predicates.

CONCLUSIONS VIII.

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 demonstrates substantial equivalence to the declared predicate 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

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.