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This document is a 510(k) summary for a medical device, specifically a Xenon Light Source, and not a study describing acceptance criteria and device performance. Therefore, it does not contain the information requested in the prompt.

The document primarily focuses on establishing "substantial equivalence" of the Xenon Light Source Models LS 6035/LS 6180 to already legally marketed devices. This is a regulatory pathway to market medical devices in the United States, indicating that the new device is as safe and effective as a predicate device.

Here's why the requested information cannot be extracted:

Acceptance Criteria and Reported Device Performance: This document states that the new models "meet the same specifications" as the equivalent devices, but it does not list those specifications (acceptance criteria) or present any test results showing how the new devices performed against them.
Study Details: There is no mention of a study to prove the device meets acceptance criteria. The 510(k) process for this type of device often relies on demonstrating similarity to existing devices rather than extensive new clinical trials or performance studies that generate quantified performance metrics.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set, and Ground Truth for Training Set: None of these details are present because the document is not an efficacy or performance study report. It's a regulatory submission to demonstrate equivalence.

In summary, the provided text is a 510(k) summary for a Xenon Light Source, which is a regulatory document, not a scientific study report describing device performance against specific acceptance criteria.

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K Number

K981804

Device Name

XENON LIGHT SOURCE MODEL LS6000

Manufacturer

CONTEC MEDICAL VISION, LTD.

Date Cleared

1998-07-24

(64 days)

Product Code

GCT

Regulation Number

876.1500

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

K944821,K944607,K954561

Predicate For

K982962

Intended Use

The Xenon Light Source Model LS6000 is designed to supply light for endoscopic diagnostic observation and surgical procedures.

Device Description

The Model LS 6000 is an electronic light source using a 100Watt Xenon lamp, to provide light for endoscopic procedures.

AI/ML Overview

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.

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