The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.

Device Description

The Primado2 consists of the Control Unit, the Foot Control (optional) and various handpieces for use with specific motors. Available Motors include Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has handpieces or attachments specific to that series. Burs, drills, blades (saws), and rasps are available for use with specific handpieces / attachments. Handpieces and attachments are available for cranial surgery, trephination, oral surgery, and craniotomy. Sagittal, reciprocating, and oscillation saw blades are available, including for intra oral use.

The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.

The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.

AI/ML Overview

The provided text describes a surgical system, the "Primado2 Total Surgical System," and its performance testing. However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The document is a 510(k) summary for a medical device submission to the FDA, focusing on substantial equivalence to predicate devices and compliance with safety and electrical standards.

Here's an analysis based on the information provided and what is missing:

The device is the Primado2 Total Surgical System. Its intended use is "for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures."

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Compliance to internal functional specifications (including software)	Demonstrated that the device is safe and effective.
Compliance to FDA Guidance for Software Contained in Medical Devices (verification/validation, traceability to software requirements and risk hazards)	Documentation provided; testing confirmed compliance.
Compliance to relevant voluntary safety standards (IEC 60601-1, IEC 60601-1-2) for Electrical safety and Electromagnetic Compatibility	Testing confirmed compliance.
Compliance to applicable standards for biocompatibility and sterilization	Evaluations and validations performed to demonstrate compliance.
Substantial equivalence to predicate devices (K083112, K040369, K040300, K081475, K053526)	Stated that the device is substantially equivalent based on similarities in primary intended use, principles of operation, functional design, and established medical use.

Note: The document does not report specific quantitative performance metrics for the device's surgical capabilities beyond general statements of "safe and effective" and compliance with standards. There are no sensitivity, specificity, or accuracy figures typical of diagnostic or AI-driven devices.

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

This information is not provided in the document. The testing described is verification/validation to internal specifications, software requirements, and safety standards, rather than a clinical trial with a "test set" of patient data.

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)

This information is not provided. The device is a surgical system, and the reported testing is about its functional, electrical, and safety performance, not about assessing clinical outcomes against expert-established ground truth in a diagnostic context.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

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

This information is not provided. An MRMC study is not relevant for this type of device (a surgical tool) and the type of performance testing described. The device is not an AI-driven assistive tool for readers.

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

This information is not provided and is not applicable. This device is a surgical system, requiring human operation, not a standalone algorithm.

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

This information is not provided and largely not applicable in the context of the reported performance testing. The "ground truth" for the device's performance appears to be its ability to meet engineering specifications, safety standards, and functional requirements. For example, for "electrical safety," the ground truth would be conformance to IEC 60601-1.

The sample size for the training set

This information is not provided. The device is not described as involving machine learning or AI that would require a "training set."

How the ground truth for the training set was established

This information is not provided and is not applicable, as there is no mention of a "training set" or AI/machine learning components in the device description.

Summary

{0}------------------------------------------------

132264

5. 510(k) SUMMARY

DEC 1 7 2013

Comments of the comments of the
Submitter:	Nakanishi, Inc.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666
Contact Person:	Ms. Diane RutherfordSubmissions Manager, Ken Block ConsultingTEL: 972-480-9554FAX: 972-767-4325rutherford@kenblockconsulting.com
Date Prepared:	July 12, 2013 Revised December 17, 2013
Trade Name:	Primado2 Total Surgical System
Common Name:	Electrical Surgical System
Classification Name:	HBC	882.4360	Motor, Drill, Electric, Cranial
SecondaryClassification Name:	ERL	874.4250	Drill, Surgical, ENT (Electric or Pneumatic), IncludingHandpiece
Additional ProductCodes forAccessories:	DZIDZJERLGEYHBCHBEHWEGFFEQJ	872.4120872.4120874.4250878.4820882.4360882.4310878.4820878.4820874.4140* 510(k) Exempt	Class 2Class 2Class 2Class 1Class 2Class 2Class 1Class 1Class 1	Drill, Bone, PoweredDriver, Wire, and Bone Drill, ManualDrill, Surgical, ENT (Electric or Pneumatic),Including HandpieceSurgical instrument motors and accessories/ attachmentsMotor, Drill, Electric, CranialDrills, Burs, Trephines & Accessories (Simple,Powered), cranialInstrument, Surgical, Orthopedic, AC-PoweredMotor and Accessory/AttachmentBur, Surgical, General & Plastic surgeryBur, Ear, nose and throat
Predicate Device:	K083112 - Nakanishi Primado Surgical DrillK040369 - Stryker COREK040300 - Stryker COREK081475 - Medtronic IPCK053526 - Aesculap microspeed™ uni
Device Description:	The Primado2 consists of the Control Unit, the Foot Control (optional)and various handpieces for use with specific motors. Available Motors includeSlim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series hashandpieces or attachments specific to that series. Burs, drills, blades (saws), andrasps are available for use with specific handpieces / attachments. Handpieces andattachments are available for cranial surgery, trephination, oral surgery, andcraniotomy. Sagittal, reciprocating, and oscillation saw blades are available,including for intra oral use.

Image /page/0/Picture/4 description: The image shows a black and white drawing of a bird. The bird is in mid-flight, with its wings spread out. The bird's body is long and slender, and its tail is long and pointed. The bird's head is small and round, and its beak is short and sharp. The bird is flying over a body of water.

Section 5: Page 1 of 2

{1}------------------------------------------------

K132264

510(k) SUMMARY (continued)

Device Description: (continued)

The Primado 2 is an AC-electrically powered total surgical system that is intended Statement of for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, Intended Use: bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial / Maxillofacial), ENT, Endoscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.
As with the predicate devices referenced above, the Primado2 is an AC-electrically Summary of powered software driven total surgical system that powers and controls the Technological functions of compatible motor attachments. The software allows for the control of Characteristics: the device features such as brightness, volume, speed control, rotational direction, irrigation control, priming control, footswitch control and confirmation, and configuration settings. The proposed device shares technological characteristics with the predicate devices. The proposed device also has some differences in technological characteristics from those of the predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device.
Tests were performed on the Primado2 including verification/validation testing Performance to internal functional specifications (including software) which demonstrated Testing: that the device is safe and effective. Documentation was provided demonstrating compliance of the Primado2 to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, verification/validation plus traceability of of including results verification/validation tests to software requirements and software risk hazards. Testing confirmed that the Primado2 complies with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility and sterilization.
Nakanishi, Inc. considers the Primado2 to be substantially equivalent to the Conclusion: predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

Image /page/1/Picture/9 description: The image shows a black and white drawing of a bird in flight. The bird has a long, pointed beak and outstretched wings. The bird's body is detailed with lines to show the feathers. The background is plain, with some text at the bottom of the image.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

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

Nakanishi Incorporated c/o Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Dr., Suite 280 Richardson, Texas 75080

December 17, 2013

Re: K132264

Trade/Device Name: Primado2 Total Surgical System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC Additional Product Codes: ERL, HBE, HWE Dated: November 6, 2013 Received: November 7, 2013

Dear Ms. Rutherford:

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. Ilisting 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

{3}------------------------------------------------

Page 2 - Ms. Diane Rutherford

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

2011 - 12 - 1 - - 1 - - 1 - - - -

510(k) Number: K132264

Device Name: Primado2 Total Surgical System

Indications for Use:

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

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Neil R Oge 2013.12.16 # 2 -05'00'

(Division Sign-off)for BSA Division of Surgical Devices K132264 :510(k) Number:

Page 1 of 1

Page 6 of 333

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).