XENON LIGHT SOURCE MODEL LS6000 by CONTEC MEDICAL VISION, LTD.

This document is a 510(k) summary for a Xenon Light Source Model LS 6000 and the FDA's response. It is a declaration of substantial equivalence to already marketed devices, not a study proving the device meets specific acceptance criteria in the way a medical AI or diagnostic device would.

Therefore, many of the requested points are not applicable to this type of submission. This 510(k) relies on the existing safety and effectiveness of predicate devices rather than a new standalone study with performance metrics.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices:	The device is substantially equivalent to legally marketed devices such as the Richard Wolf Model 5141 (K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561), and the Linvatec Model 8430.
Design: Designed the same as predicate devices.	"Each Xenon Light Source is designed the same."
Specifications: Meets the same specifications as predicate devices.	"...meets the same specifications..."
Intended Use: Same indication as predicate devices.	"...and its indication is the same."
Technological Characteristics: No significant difference in technological characteristics compared to existing devices.	"There is no significant technological characteristics of the Model LS 6000 compared to existing, legally marketed devices..."
Lamp Wattage (Distinguishing Feature): Uses a 100-Watt Xenon lamp.	"The lamp utilized with the LS 6000 is a 100 Watt lamp." (This is noted as the only difference to predicates, implying meeting other criteria makes this acceptable.)

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

Sample size: N/A. This is a 510(k) submission asserting substantial equivalence based on device characteristics, not a clinical study with a test set of data.
Data provenance: N/A.

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

N/A. Ground truth establishment for a test set is not relevant for this 510(k) submission.

4. Adjudication Method for the Test Set

N/A.

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

N/A. This device is a light source for endoscopy, not an AI or diagnostic tool.

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

N/A. This is not an algorithm.

7. The type of ground truth used

N/A. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices through their prior 510(k) clearances or pre-amendments status.

8. The sample size for the training set

N/A. This is not a machine learning model.

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

N/A.

Summary

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.