The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

ethmoidectomy/sphenoethmoidectomy .
polypectomy .
septoplasty and .
procedures such as .
- antrostomy .
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation .
- septal spurs removal .
- trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

adenoidectomy ●
laryngeal lesion de-bulking ●
laryngeal polypectomy .
tracheal procedures ●
. tonsillectomy

Head & Neck procedures would encompass:

. soft tissue shaving
rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
acoustic neuroma removal .

Otology procedures would include:

mastoidectomy .
mastoidotomy .

Device Description

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

AI/ML Overview

The provided text is a 510(k) summary for the Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece. This document is related to a medical device's regulatory review and does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/software device evaluation.

The 510(k) is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way an AI/software device would. The modifications described are about allowing the existing "Diego Powered Dissector and Drill System Handpiece" to integrate with BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri) through an adapter. This likely involves mechanical integration and compatibility, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/software device is not present in this document.

Here's an attempt to answer based on the spirit of the request, highlighting what's missing in the context of your questions, and what can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria for device performance in terms of clinical accuracy or outcome metrics as would be seen for an AI/software device. Instead, the "acceptance criteria" for a 510(k) submission are largely based on demonstrating substantial equivalence to a predicate device, which implies that the modified device will perform as safely and effectively as the predicate.

The document implicitly "reports device performance" by stating its intended use and showing equivalence to predicate devices for navigation. The performance here is in terms of compatibility and retaining the function of the original dissector and drill system while integrating with image guidance.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence for a modified device)	Reported Device Performance (Implied by submission)
Device maintains existing safety and effectiveness.	The Diego™ Powered Dissector Handpiece continues to cut and remove bone and tissue as intended.
Device is compatible with specified predicate Image-Guided Surgery (IGS) Systems.	The modified handpiece accepts the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter, allowing real-time tracking.
Device supports the stated indications for use.	The device's intended use for various ENT, Head & Neck, and otoneurologic procedures remains supported by the original device's performance and now augmented by IGS.

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

Sample Size: Not applicable/Not provided. This 510(k) submission does not describe a clinical performance study that would use a "test set" in the context of an AI/software device evaluation. The assessment is likely based on engineering verification and validation of the mechanical and functional integration with the IGS systems, rather than a statistical sample of patient data.
Data Provenance: Not applicable/Not provided for a clinical "test set."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no mention of a "test set" with expert ground truth in this submission, as it's not an AI/software device undergoing such a performance evaluation. The review for 510(k) is about substantial equivalence based on engineering, bench, and potentially pre-clinical (e.g., cadaveric) testing, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. As no clinical "test set" requiring expert ground truth or adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI-assisted diagnostic or therapeutic guidance system that would typically undergo an MRMC study to show human reader improvement. The device itself is a surgical tool, and the modification enhances its guidance capabilities, but the submission doesn't include an MRMC study comparing surgeon performance with/without the image-guided assistance provided by this specific adapter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a manual surgical tool that is guided by an image-guided surgery system. Its function inherently involves a human operator (the surgeon) and the image navigation system. There is no "algorithm only" component that would perform a task independently. The performance is the combined system's ability to track the instrument accurately.

7. Type of Ground Truth Used:

Not applicable in the context of an AI/software device's performance study. For a mechanical device, "ground truth" would relate to engineering specifications, e.g., the true position of the instrument as measured by highly accurate systems, or the physical dimensions and tolerances of the adapter. However, the submission does not detail these engineering verification methods beyond stating the intent to integrate with image-guided systems.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical surgical instrument; it does not utilize a "training set" for machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for this type of device.

Summary of what the document DOES provide:

Device Description: A modified handpiece for the Diego™ Powered Dissector and Drill System, designed to accept adapters for BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri).
Intended Use: Cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures, with specific examples listed.
Predicate Devices: BrainLAB Kolibri IGS System (K014256) and BrainLAB Vectorvision2 IGS System (K003589). The modification makes the Gyrus ENT device "compatible" with these predicate image-guided systems.
Regulatory Classification: Class II, Stereotaxic instrument (HAW).
510(k) Clearance: The document is the FDA's clearance letter, stating substantial equivalence to predicate devices, thus permitting marketing.

This 510(k) focuses on the mechanical and functional compatibility of a modified surgical instrument with existing image-guided navigation systems, rather than a new AI/software diagnostic or therapeutic device whose performance would be assessed with detailed statistical studies against clinical ground truth.

Summary

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1630343

Food and Druq Administration

January 31, 2003

510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

MAY = 2 2003 510(k) Summary

Submitter's Name:Submitter's Address:Submitter's Telephone Number:	Gyrus ENT LLC2925 Appling Road, Bartlett, TN 38133901.373.0200
Contact Person:	Gregory Sredin
Date Summary Prepared:	January 31, 2003
Proprietary Name:	Diego™ Powered Dissector Handpiecewith Starlink™ Image Guided AdapterMounting Interface
Common Name:	Instrument, Stereotaxic
Classification Name:	Instrument, Stereotaxic
Classification	Class II
Classification Panel:	Neurology
Device Product Code	HAW

Subject Device Description

Applicable 510(k)'s

Manufacturer	Submission Name	FDA Clearance
BrainLAB AG	Kolibri IGS System	K014256
BrainLAB AG	Vectorvision2 IGS System	K003589

Subject Device Intended Use

Sinus applications would embody:

ethmoidectomy/sphenoethmoidectomy .

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

K030343

Food and Drug Administration

January 31, 2003

510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

polypectomy .
septoplasty and .
procedures such as .
- antrostomy .
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation .
- septal spurs removal .
- trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

adenoidectomy ●
laryngeal lesion de-bulking ●
laryngeal polypectomy .
tracheal procedures ●
. tonsillectomy

Head & Neck procedures would encompass:

. soft tissue shaving
rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
acoustic neuroma removal .

Otology procedures would include:

mastoidectomy .
mastoidotomy .

{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 is a circular emblem with the words "HUMAN SERVICES • USA" and "DEPARTMENT OF" arranged around the top and bottom of the circle, respectively. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or progress.

MAY - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory Sredin Senior Regulatory Affairs Specialist Gyrus ENT LLC 2925 Appling Road Bartlett, Tennessee 38133

Re: K030343

Trade/Device Name: Diego™ Powered Dissector Handpiece with Starlink™ Image Guided Adapter Mounting Interface

Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 21, 2003 Received: February 3, 2003

Dear Mr. Sredin:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Gregory Sredin

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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam a. Provost

(W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Food and Drug Administration

January 31, 2003 510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

Ko30343 510(k) Number:

Device Name: Diego™ Powered Dissector and Drill System Handpiece with Image Guided Surgery System Interface,

Indications for Use:

The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

ethmoidectory/sphenoethmoidectorny .
polypectomy ●
septoplasty and .
procedures such as .
antrostomy .
endoscopic DCR ●
frontal sinus drill-out 해
frontal sinus trephination and imgation
septal spurs removal .
. trans-spehnoidal procedures

Nasopharyngeal/laryngeal procedures would comprise:

adenoidectory .
laryngeal lesion de-bulking ●
laryngeal polypectomy ●
tracheal procedures ●
tonsillectomy ●

Otology procedures would include:

mastoidectomy .
mastoidotomy. ●
Head & Neck procedures would encompass:
soft tissue shaving .
rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) ●
removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the . face
acoustic neuroma removal ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K030343

Prescription Use
(Per 21 CFR 801.109) X

Over-the-Counter

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).