Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface, and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixelation. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiberoptic scope designed for one time use.

Supplemental Instruments: Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.

Procedural Kit: The procedural kit contains many sterile items to aid in the procedure.

AI/ML Overview

This 510(k) summary describes a medical device, the InnerVue™ Diagnostic Scope System. However, it explicitly states that clinical testing was not used to establish substantial equivalence to predicate devices. Instead, equivalence was based on similarities in intended use, non-clinical testing, physical characteristics, and geometry.

Therefore, many of the requested criteria regarding acceptance criteria and study details cannot be provided from this document, as a formal study proving the device meets specific acceptance criteria based on clinical performance was not conducted or submitted with this 510(k).

Here's what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics or thresholds. The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device (Davlite Microendoscope, K020310) based on non-clinical aspects.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported since no clinical study was conducted. The device's "performance" is implicitly deemed equivalent to the predicate through its design and intended use similarities.

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

Not applicable. No test set was used for a clinical study to establish performance, as clinical testing was not conducted.

3. 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)

Not applicable. No test set requiring expert ground truth was used for performance evaluation.

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

Not applicable. No test set requiring adjudication was used.

5. 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

Not applicable. This device is an endoscope system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a hardware/software system for viewing, not an algorithm-only diagnostic system. No standalone algorithm performance was assessed for regulatory purposes.

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

Not applicable. No clinical ground truth was established or used for performance validation of this device.

8. The sample size for the training set

Not applicable. This device does not use machine learning in a way that would require a "training set" for performance evaluation in the context of diagnostic accuracy. The software mentioned "enhances the image... to remove fiber optic pixelation," which implies image processing rather than a learnable AI model requiring a training set for diagnostic classification.

9. How the ground truth for the training set was established

Not applicable. No training set for a diagnostic AI was used.

Summary based on the document:

The InnerVue™ Diagnostic Scope System's acceptance was based on substantial equivalence to an existing legally marketed device (Davlite Microendoscope, K020310). This equivalence was established by demonstrating similarities in:

Intended Use: Viewing the interior cavity of the human body through surgical or natural openings.
Non-clinical testing: Not detailed in this summary, but implies bench testing or other engineering evaluations.
Physical characteristics and geometry: Design and form factor comparisons.

Crucially, this device did not undergo clinical testing to establish its performance or meet specific diagnostic acceptance criteria.

Summary

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JUN - 4 2004

BIOMET

510(k) Summary

Applicant/Sponsor:	Arthrotek, Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Kacy Arnold, RN, MBARegulatory Specialist
Proprietary Name:	InnerVue™ Diagnostic Scope System
Common Name:	Diagnostic Endoscope
Classification Name:	Endoscope

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Davlite Microendoscope, K020310 .

Device Description:

The InnerVue™ Diagnostic Scope System consists of 5 main parts; the hardware, the software, the scope, the instrumentation and the procedural kit.

Hardware:

The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface, and a storage drawer.

Software:

The software enhances the image from the scope to remove fiber optic pixelation. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope:

A rigid fiberoptic scope designed for one time use.

Supplemental Instruments:

Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.

MAILING ADDRESS - MAILENG ADDRESS
Wasaw, IN 46581-0587 - 1587 - 19 - 30- - 36 - Bell Drives.
Wasaw, IN 46581-0587 - 15-87 - 1 - - Warsaw, IN - 06583

10-587 - 10-46581-0587 - 1 - FAX

SHIPPING ADDRESS Warsaw, IN 16582

()FFICIC ) /s / 1 . 2(s / (s(s 34) 1574267 8137 8137 8137 878 878 878 87 87 87 87 157 113 41 41 41 41 41 11 41 11 41 11 41 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 158

. E MAHI. Diomet@biomet con

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Procedural Kit:

The procedural kit contains many sterile items to aid in the procedure.

Indications for Use: This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.

Intended Use: Single use (disposable) scope.

Summary of Technologies: The InnerVue™ Diagnostic Scope System technological characteristics are similar to predicate devices.

Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, Non-offinour Footing, busical characteristics and geometry between the InnerVue™ Diagnostic Scope System and Davlite Microendoscope (K020310)

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 4 2004

Ms. Kacy Arnold, RN, MBA Arthrotek, Inc. 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K040604

R0400 F
Trade/Device Name: InnerVue™ Diagnostic Scope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 5, 2004 Received: March 8, 2004

Dear Ms. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) it stgms J the Medical Device Amendments, or to commerce phor to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costience Act (71ct) that to neview, subject to the general controls provisions of the Act. The r our may, merelore, mains of the Act include requirements for annual registration, listing of general controls proficions a ractice, 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 If your device is classified (600 worrols. Existing major regulations affecting your device can may be subject to such additional resultations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease oe advised that i Dri brisantes or our device complies with other requirements of the Act that I DA has made a actor manalations administered by other Federal agencies. You must of ally it cacal statutes and registments, including, but not limited to: registration and listing (21 Compry will an the Fiel 310ccases and 01); good manufacturing practice requirements as set CTN i at 807), adocing (21 OF R Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kacy Arnold, RN, MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manothing of substantial equivalence of your device to a legally premarket notification. The PDA midnig of bassantal experience 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 If you desire specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Complanes as (sot notification" (21CFR Part 807.97). You may obtain Misbraining by reference to premainters so premainter the Act from the Division of Small other general informational 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 vours,

Sincerery, yours,

Mark A. Millerson

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

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Indications for Use

510(k) Number (if known):

KOAD604 ______________________________________________________________________________________________________________________________________________________________________

Device Name:

InnerVue™ Diagnostic Scope System

Indications For Use:

This device is to be used by a trained physician for viewing the interior cavity of the human body this device a surgical or natural opening.

Prescription Use X AND/OR Over-The-Counter Use _______

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

for

Mule

Concurrence of

Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K040604
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Page 1 of 1

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.