The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery.

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

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

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

Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, 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 bonv pvramid). 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 aesthetic surgery.

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

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.

Device Description

The XPS® 3000 System consists of power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps and cannulae.

This submission expands the device's indications for use in brain tumor removal from the current acoustic neuroma, tympanoplasty and vestibular neurectomy to include such tumors as meningiomas, craniopharyngiomas, pilocytic astrocytomas, some oligodendrogliomas and gangliogliomas, colloid cysts, choroid plexus papillomas, hemangioblastomas and some pineal region tumors such as teratomas, pinealocytomas.

AI/ML Overview

The provided text describes a 510(k) submission for the Medtronic Xomed XPS® 3000 System, which is an electrical surgical shaver and microresector. This submission primarily focuses on expanding the device's indications for use, particularly in brain tumor removal and other surgical procedures.

However, the document is a regulatory submission for a surgical device with expanded indications, not a study describing acceptance criteria and device performance based on a rigorous statistical analysis for an AI or diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the format you've requested (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because this type of information is not present in the provided 510(k) summary.

The 510(k) process for this type of surgical tool typically relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials with detailed performance metrics like sensitivity, specificity, or reader improvement, which are common for diagnostic or AI-driven devices.

Here's a breakdown of why the requested information cannot be found:

Acceptance Criteria and Reported Device Performance (Table): Not applicable in this context. The document describes the intended use and indications for use of a surgical device but does not present specific quantitative performance metrics (e.g., accuracy, precision) that would be evaluated against acceptance criteria in a study. The "performance" for a surgical shaver relates to its physical characteristics, safety, and ability to cut tissue, which are likely demonstrated through preclinical testing (e.g., bench testing for cutting efficiency, material biocompatibility) and comparison to existing predicate devices, not typically in a clinical study with reported numerical outcomes.
Sample Size and Data Provenance (Test Set): Not mentioned. There is no reporting of a "test set" in the context of evaluating a diagnostic or AI device's performance.
Number and Qualifications of Experts for Ground Truth: Not applicable. Ground truth, in the context of diagnostic or AI studies, involves experts labeling data. For a surgical device, "ground truth" would relate to its physical properties and surgical efficacy, which are established through engineering design, material science, and established surgical practices.
Adjudication Method: Not applicable. There's no diagnostic output to adjudicate.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. This type of study assesses the impact of a diagnostic tool on human reader performance, which is not relevant for a surgical shaver.
Standalone Performance: Not applicable. The device is a surgical tool used by a human surgeon, not an algorithm performing a task independently.
Type of Ground Truth Used: Not applicable in the same sense as for diagnostic AI. The "truth" for this device is its safe and effective function in surgery, benchmarked against existing devices.
Sample Size for Training Set: Not applicable. This device is not an AI algorithm that undergoes a training phase with a dataset.
How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided document is a regulatory filing for a physical medical device (a surgical shaver), focusing on its intended use and indications, and demonstrating substantial equivalence to previously cleared devices. It is not a scientific publication detailing a study to demonstrate performance against specific quantitative metrics typically associated with AI or diagnostic device evaluation.

Summary

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K073255

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510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR XPS® 3000 System (with expanded indication)

MAR 2 4 2008

Medtronic Xomed, Inc 510(k) Owner 6743 Southpoint Drive North Jacksonville. Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX)

Contact Name David Guzek Senior Regulatory Affairs Specialist Medtronic Xomed, Inc

Date Summary Prepared March 20, 2008

XPS® 3000 System Proprietary Name

Common Name Electrical surgical shavers, electrical microresectors, mastoid drills, microdrill, ENT drills, handpieces and cutting blades, rasps and burs

Drill, Surgical, ENT (Electric or pneumatic) Classification Name including handpiece (21 CFR 874.4250 and 874.4140, Product Codes 77ERL and 77EQJ. Class II and I)

Marketed device claiming equivalence to

Medtronic Xomed XPS® System, 510(k), K041523 Medtronic Xomed XPS® System, 510(k), K041413 Medtronic Xomed XPS® System, 510(k), K002224

Device Description

The XPS® 3000 System consists of power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps and cannulae.

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K073255

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Intended Use

The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery.

Indications for Use

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

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

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K073255

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INDICATIONS FOR USE (con't)

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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 consists of a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2008

Medtronic, Inc. % Mr. David Guzek Senior Regulatory Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K073255

Trade/Device Name: XPS® 3000 System (with expanded indication) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: II Product Code: ERL, EQJ Dated: February 19, 2008 Received: February 20, 2008

Dear Mr. Guzek:

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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Page 2 – Mr. David Guzek

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 device 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 at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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INDICATIONS FOR USE KOJ 325

510(k) Number (if known): K073255

Device Name: XPS® 3000 System (with expanded indication)

Indications for Use:

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

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, 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 aesthetic surgery.

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

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Prescription Use × (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)

Souther
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number*K073255*

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.