The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic Surgical Procedures.

Device Description

The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.

AI/ML Overview

This 510(k) summary (K081277) describes the Electric Drill System (XPS 4000 System, Midas Rex Legend Drill System, Integrated Power Console (IPC)) from Medtronic Xomed, Inc. This submission is for a surgical device, and as such, the acceptance criteria and study information provided are related to demonstrating substantial equivalence for engineering performance and intended use, rather than diagnostic accuracy metrics typically found for AI/ML devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted to address your specific points where applicable:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance thresholds (e.g., sensitivity, specificity, or error rates) as would be typical for AI/ML diagnostic devices. Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied to be that the new device performs equivalently or comparably to the predicate devices in terms of its intended use and functional characteristics.

The table below summarizes the characteristics compared between the new device and the predicate devices, effectively serving as the "performance" report for demonstrating this equivalence.

Table 1: Acceptance Criteria (Implied Equivalence) and Reported Device Performance

Characteristic	Implied Acceptance Criteria (Equivalent to Predicate)	New Device Performance (XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console)	Predicate Device 1 Performance (Medtronic Xomed XPS 3000 Electric System)	Predicate Device 2 Performance (Medtronic Powered Surgical Solutions (MPSS) Electric System)	Predicate Device 3 Performance (Linvatec Advantage Drive Electric System)
Indications for Use	Must be substantially equivalent or broader while maintaining safety and effectiveness.	Incision/cutting, removal, drilling, sawing of soft and hard tissue/bone in Head & Neck/ENT, Oral/Maxillofacial, Plastic/Reconstructive/Aesthetic Surgical Procedures.	Incision/removal of soft & hard tissue/bone in general otorhinolaryngology, head & neck, and otoneurological surgery. ( 詳細な適応症は別のセクションで記載)	Neurosurgical, Spine, Orthopedic Surgery, General Surgery, ENT, Maxillofacial, Craniofacial.	Cutting of soft tissue and bone in Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otlaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.
Handpieces Compatibility	Must be compatible with relevant handpiece types for intended use.	Drills, Microdebriders, Saws	Drills, Microdebriders	Drills	Drills, Microdebriders, Saws
Pumps used for	Must perform necessary pump functions (irrigation, cooling, etc.).	Irrigation, Motor Cooling, Scope Cleaning	Irrigation, Motor Cooling	Irrigation	Irrigation, Motor Cooling
Stim Guard Capable	Presence or absence of this safety feature.	Yes	Yes	No	No
Provided Sterile	Sterilization status.	No	No	No	No
Foot control	Presence of foot control.	Yes	Yes	Yes	Yes
Tubing sets	Presence of tubing sets.	Yes	Yes	Yes	Yes
Blade/bur/drill bit	Compatibility with relevant accessories.	Yes	Yes	Yes	Yes
Irrigation Remote	Presence or absence of irrigation remote.	Yes	No	No	Unknown
External Software Upgradable	Presence or absence of this feature.	Yes	No	No	No
Patient Contact (console/handpiece)	Whether console/handpiece contacts patient.	No	No	No	No
Patient Contact (tubing set (fluid path))	Whether tubing set (fluid path) contacts patient.	Yes	Yes	Yes	Yes
Patient Contact (blade/bur/drill bit)	Whether blade/bur/drill bit contacts patient.	Yes	Yes	Yes	Yes

Here's an assessment for the specific points you requested:

A table of acceptance criteria and the reported device performance
- See the table above. The "acceptance criteria" is implicit in demonstrating substantial equivalence to the predicate devices across the listed characteristics. The "reported device performance" is the description of the new device's features and capabilities, which are directly compared to the predicates.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a submission for a mechanical/electrical surgical device, not an AI/ML diagnostic device that relies on a "test set" of data. The "study" here is a demonstration of substantial equivalence through comparison of specifications, intended use, and likely bench testing (though detailed results of bench testing are not explicitly in this summary). There is no "data" in the sense of patient-derived images or clinical measurements that would require a sample size, provenance, or retrospective/prospective classification.
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)
- N/A. As explained above, there is no "ground truth" test set of clinical data for this type of device. The ground truth for a surgical drill system would be its functional performance against engineering specifications and its safety profile, which are assessed through engineering tests, risk analyses, and comparison to predicate devices, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring expert adjudication is relevant for this device.
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
- N/A. This is not an AI-assisted diagnostic device, so an MRMC study is not applicable. The device is a surgical tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical surgical device, not an algorithm. Its performance is inherent in its mechanical and electrical function under human control.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a surgical drill system, the "ground truth" (or basis for verification and validation) is related to its engineering specifications, safety standards compliance, and functional performance in simulated and (potentially) animal/cadaveric models. This would include criteria like:
  - Motor speed consistency and torque output.
  - Thermal management (to prevent tissue damage).
  - Vibration levels.
  - Noise levels.
  - Sterilization efficacy for reusable components.
  - Biocompatibility of patient-contacting materials.
  - Electrical safety.
  - Mechanical integrity and durability.
- The "study" cited in the 510(k) is primarily a comparison to predicate devices to demonstrate substantial equivalence based on these functional and safety attributes, leading to the regulatory clearance.
The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established
- N/A. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

In summary, the provided document is a 510(k) summary for a Class II surgical device (electric drill/saw system). The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, and functional performance, rather than the statistical performance metrics and data sets common in AI/ML device submissions.

Summary

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K081277

510(k) Summary

510(k) Owner	SEP - 5 2008Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX)
Contact Name	Antoine KouchakjySenior Regulatory Affairs SpecialistMedtronic Xomed, Inc
Date Summary Prepared	April 15, 2008
Proprietary Name	Electric Surgical Drill / Saw System(XPS 4000 System, Midas Rex Legend Drill System,Integrated Power Console (IPC))
Common Name(s)	· Drill, Surgical, ENT (electric or pneumatic) includinghandpiece (ERL)· Saw, Powered, and Accessories (HAB)· Saw, Surgical, ENT (Electric or Pneumatic) (EWQ)
Classification Name(s)	· Ear, nose, and throat electric or pneumatic surgical drill(21 CFR 874.4250, Product Code ERL, Class II)· Surgical instrument motors and accessories/attachments(21 CFR 878.4820, Product Code HAB, Class I)· Ear, nose, and throat manual surgical instrument(21 CFR 874.4420, Product Code EWO, Class I)

Marketed device claiming equivalence to

The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523).

Device Description

Intended Use / Indications for use

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Characteristic	NEW DEVICE(XPS 4000)(Legend EHS System)(Integrated Power Console)	Medtronic XomedXPS 3000Electric System(K002224, K010666,K010677, K011321,K041413, K041523,K073255)	Medtronic PoweredSurgical Solutions(MPSS)Electric System(K935567, K012453,K012456, K012457)	LinvatecAdvantage DriveElectric System(K002523)
Indications for use	The Electric Drill System isindicated for the incision / cutting,removal, drilling, and sawing ofsoft and hard tissue and bone inHead & Neck / ENT (Otologic,Neurologic, Neurotologic, Sinus,Rhinologic, Nasopharyngeal /Laryngeal), Oral / Maxillofacial,and Plastic / Reconstructive /Aesthetic Surgical Procedures.	See Next Page	NeurosurgicalSpineOrthopedic SurgeryGeneral SurgeryENTMaxillofacialCraniofacial	The device functions as a poweredinstrument system consisting ofhandpieces to perform cutting of softtissue and bone. The fields of applicationinclude Arthroscopic, Foot, Hand, MedialSternotomy, Neurosurgical, Orthopedic,Otlaryngological, Oral / Maxillofacial,Plastic / Reconstructive, and Spinalsurgical procedures.
HandpiecesCompatibility	DrillsMicrodebridersSaws	DrillsMicrodebriders	Drills	DrillsMicrodebridersSaws
Pumps used for	IrrigationMotor CoolingScope Cleaning	IrrigationMotor Cooling	Irrigation	IrrigationMotor Cooling
Stim Guard Capable	Yes	Yes	No	No
Provided Sterile	No	No	No	No
Console/handpiece	No	No	No	No
Foot control	Yes	Yes	Yes	Yes
Tubing sets	Yes	Yes	Yes	Yes
Blade/bur/drill bit	Yes	Yes	Yes	Yes
Irrigation Remote	Yes	No	No	No
Patient Contact	No	No	No	No
Console/handpiece	No	No	No	No
Foot control	No	No	No	No
Tubing set (fluid path)	Yes	Yes	Yes	Yes
Blade/bur/drill bit	Yes	Yes	Yes	Yes
Irrigation Remote	No	No	No	Unknown
External SoftwareUpgradable	Yes	No	No	No

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XPS 3000 System 510k's

Intended Usc

The XPS 3000 system is intended for the incision and removal of soft and hard tissue or bonc in general otorhinolaryngology, head and neck, and otoneurological surgery.

Indications for use

Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apcx cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of car tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectorny, frontal sinus trephination and irrigation, frontal sinus drill out, cndoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphcnoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectorny, tonsillotomy and removal of endobronchial lesions.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or acsthetic surgery.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired .

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Image /page/3/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 stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K081277 Medtronic Xomed, Inc. c/o Antoine Kouchakjy 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980

SEP - 5 2008

Re: K081277

Trade/Device Name: Electric Drill System [XPS 4000, Midas Rex EHS System, Integrated Power console] Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: July 18, 2009 Received: July 21, 2008

Dear Mr. Kouchakiy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your levice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance and its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Mahina B. Egleston, MD

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K081277 510(k) Number (if known):

Device Namc: Electric Drill System [XPS4000, Midas Rex EHS system, Integrated Power Console (IPC)]

Indications for Use:

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorue bohu

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K081277

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.