The provided text is a 510(k) summary for the "5 Star Medical Endoscope," which received market clearance in 1997. This document details the description of the device and its intended use, rather than a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in this type of regulatory submission.

However, I can extract the following relevant information based on the typical content of such documents and the provided text:

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

This information is not provided in the 510(k) summary. 510(k) submissions typically demonstrate "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in a formal clinical study report contained within the summary.

Here's an illustrative table based on general expectations for an endoscope, but the values are hypothetical as they are not in the document:

Acceptance Criteria (Hypothetical)	Reported Device Performance (Not in Document)
Image Resolution	Demonstrated clear visualization of anatomical structures
Illumination (Light Output)	Sufficient illumination of the surgical field
Working Channel Patency	Accessories pass smoothly through the working channel
Deflection Range and Control	Full, smooth deflection as designed
Biocompatibility	In compliance with ISO 10993 (implied by regulatory review)
Cleaning and Sterilization	Effective sterilization without device degradation

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not mentioned. 510(k) summaries do not typically detail the sample size of a specific test set for performance evaluation in the way a clinical study report would. The "test set" in the context of a 510(k) is often the comparison to the predicate device's established performance, or bench testing, not a clinical trial with a defined patient sample.
Data Provenance: Not mentioned. Given the nature of a 510(k) for substantial equivalence, the "data" would likely refer to bench testing or possibly a review of existing literature on similar devices, rather than a specific clinical study with identified geographical origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not mentioned. In a 510(k) for an endoscope, "ground truth" as established by experts for a test set typically refers to clinical accuracy studies. This document does not describe such a study. Device safety and efficacy are primarily established through technical specifications, bench testing, and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

Not applicable/Not mentioned. No specific adjudication method is described as there is no mention of a clinical test set requiring expert consensus.

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. The device is a traditional endoscope, not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this product.

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

Not applicable. The device is a traditional endoscope; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used:

Not applicable/Not explicitly stated in the context of clinical performance. For an endoscope, "ground truth" for its intended use (direct visualization and diagnostic/therapeutic procedures) would be the actual pathology or clinical outcome confirmed by other means (e.g., biopsy, follow-up, surgical findings). The 510(k) relies on the known performance and safety profiles of the predicate device and the design specifications of the new device to demonstrate substantial equivalence, rather than needing to establish "ground truth" for a diagnostic accuracy claim from a novel algorithm.

8. The sample size for the training set:

Not applicable/Not mentioned. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. No training set exists.

Summary of available information from the document:

Device Name: 5 Star Medical Endoscope
Predicate Device: Saratoga Modular Miniature Endoscope System
Description: A system including rigid mini ureteroscopes, deflecting tip scopes of various lengths and diameters, an optical handle with magnifying optics, fiber optic cables, adapters, and light sources.
Intended Use/Indications For Use: Direct Visualization of B.I. - B.U. System (likely referring to Biliary, Intestinal, and Bladder, Ureteral systems based on the description of use in common bile duct, liver, pancreatic duct, urethra, bladder, ureters, kidney, and colon), using additional accessories to perform various diagnostic and therapeutic procedures.
Regulatory Clearance: Received 510(k) clearance (K963354) on September 8, 1997, based on substantial equivalence to the predicate device.
Regulatory Class: Class II
Product Codes: 78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG

Summary

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

ﺎﻧﻴﺔ

ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

510 (k) Summary for 5 Star Medical, Inc.

K963354

Pin I

DEVICE NAME

5 Star Medical Endoscope

SEP - 8 1997

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Saratoga Modular Miniature Endoscope System

DESCRIPTION OF DEVICE

A description of the endoscopes' components is as follows:

Optical Catheters

A rigid mini ureteroscope provides for examination of the lower third of the ureter. Channels are provided for irrigation and instrumentation.

The deflecting tip scopes are available in various lengths (30 to 200 cm) and outer diameters (1.6 to 4.0mm) for visualization and diagnosis of the urethra , bladder(of children), ureters (of adults) and kidney. They can also be used to directly visualize and diagnose conditions in the common bile duct, liver and pancreatic duct. The exploration of the colon can also be accomplished by passing the 5 Star Medical endoscopes through the operating channel of a standard colonoscope. They are available with a working channel, fiberoptic cable connection and device for deflection. Manipulation at the proximal end of the flexible scope activates the deflection of the distal tip.

Optical Handle

The optical handle consists of an eye piece, a barrel and a scope connection. The handle incorporates magnifying optics which can be adjusted for focus with the focusing ring.

Fiber Optic Cables, Adapters and Light Sources

The fiber optic cables consist of a bundle of non-coherent glass fibers. The fiber optic bundle is sheathed. The light source end of the cable is configured to fit various light sources currently available in distribution (e.g. Wolf, Olympus, Storz ACMI and Pentax). The instrument end of the cable is finished with a female ACMI type connector. Light sources which are in common use are compatible with the 5 Star Medical Endoscope. Diagnostic and photo light sources are effective and safe to use with this system. The adapters which are available for use with the fiber optic cable provide for connection to light sources built by Wolf. Olympus, Storz, ACMI and Pentax.

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

Image /page/1/Picture/0 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 often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Beverly J. Stewart President 5 Star Medical, Inc. 4767 Wren Court Charlottesville, Virginia 22911

8 1997 Re: K963354 5 Star Medical Endoscope Dated: June 1, 1997 Received: June 13, 1997 Regulatory class: II 21 CFR 8876.1500 Product codes: 78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG

Dear Ms. Stewart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yittg diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Page of 4

510(k) Number (if known): K 96 33 5 Y Device Name: dosco

Indications For Use:

ﻳ

Direct Visualization of B.I. - B.U. System

using additional accessories to perform

various diagnostic and therapeutic procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Relev 72 Aith (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number . 'rescription Use OR Per 21 CFR 801.109) Over-The-Counter Use

(Optional Formal 1-2-96)

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.