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The Headlamp HL2000 has indicated use in the following situations:

There is a requirement for illuminating a surgical field. .

· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The provided text is a 510(k) clearance letter from the FDA for a device named "HeadLamp, HL2000". This document focuses on the regulatory clearance process and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document explicitly states:

• It is a review of the 510(k) notification and a determination of substantial equivalence.
• It refers to "indications for use" as stated in an enclosure (which is not provided in the text).
• It confirms the device can be marketed subject to general controls.

The text does not detail any performance study or the results of such a study.

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The 50 W Metal Halide Illuminator has indicated use in the following situations:

• There is a requirement for illuminating medical headlamps.
• There is a requirement for fiber-optic illumination for endoscopy applications.
• There is a requirement to use video as a visual aid or a method of recording or both.
• There is a requirement for any or all of the above at the same time.

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The provided document [0] is a 510(k) clearance letter from the FDA for a device called "VES 0501. 50 Watt Metal Halide Illuminator." This type of letter confirms substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related details requested in the prompt.

The closest information it provides in terms of device function are the "Indications For Use" listed in document [1], which describe where the device is intended to be used (illuminating medical headlamps, fiber-optic illumination for endoscopy, and with video systems). However, these are not performance metrics or acceptance criteria derived from a study.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text. The document is merely a regulatory clearance, not a technical report or study summary.

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The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

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The provided text is a 510(k) clearance letter from the FDA for a device called "VES 3001-M Complete Video Endoscopic System". This letter primarily addresses the regulatory clearance of the device and does not contain detailed information about acceptance criteria or performance studies as typically requested for AI/ML-driven devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but does not provide specific performance metrics or the studies that would demonstrate them.

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The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

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The provided text is a 510(k) clearance letter from the FDA for a device called "VES 1501-M Video Endoscopic System." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of new clinical efficacy or performance studies with acceptance criteria for the new device itself.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: The letter states the device is substantially equivalent to a predicate, not that it met specific performance criteria from a new study.
2. Sample size used for the test set and the data provenance: No new test set data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. The letter does not mention such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a video endoscopic system, not an AI algorithm.
7. The type of ground truth used: Not applicable as no new study data is presented.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no new training data is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and intended use. It does not typically involve the presentation of new efficacy studies with defined acceptance criteria in the same way a Premarket Approval (PMA) application might.

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The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.

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This document is a 510(k) clearance letter from the FDA for the Angiolaz VES-1Cam device, dated August 4, 1998. It primarily confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.

Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on regulatory approval and states the device's intended use: "The VES-1CAM use is indicated whenever there is a need for the use of video in endoscopic procedure."

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them from the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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The VES 3001/w use is indicated in the following situations:

• Whenever there is a need for head lamp illumination of the fiber-optic type .
• When ever there is a need for a fiber-optic illuminator for an endoscope .
• . When ever there is a need to use video either as a visual aid for as a method of recording or both.
• When ever there is a requirement for any or all of the above at the same . time.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "VES 3001/2 Dual Output Video Illuminator."

This document does not contain the kind of information requested in your prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, ground truth methods, or details about training sets. The letter is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from this text.

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VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.

The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages:

• Longer life (150 hours vs. typically 40 hours).
• Low energy at the light guide end virtually eliminating problems with burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.)
• 3400% color temperature.
• Better utilization of the available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle.
  The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords.
  The fully assembled system meets the current UL544 current leakage requirements.
  The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.

The provided text describes a medical device, the AngioLaz VES 0281-m Video Endoscopic System, but it does not contain a detailed study report with specific acceptance criteria, method sections, or outcome measures that would allow for a comprehensive answer to all points of your request.

The document is a safety and effectiveness summary for a 510(k) premarket notification. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA for this type of submission.

However, I can extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document does not describe a formal "test set" in the way a clinical or technical validation study would. It refers to the device's performance based on its design and comparison to existing technology.
• Data Provenance: Not applicable, as detailed test set data is not presented. The statements are general claims about the device's characteristics and equivalence.

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

• This information is not provided in the document. The submission is a regulatory filing, not a scientific publication detailing a study with expert ground truth.

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

• This information is not provided in the document. No adjudication method for a test set is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a video endoscopic system (hardware), not an AI-powered diagnostic tool. The document predates widespread AI in medical devices (1998).

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

• Not applicable. This device is hardware (a video endoscopic system). It does not involve a standalone algorithm in the sense of AI.

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

• This information is not explicitly stated as a method for establishing the performance claims. The "effectiveness" is stated as being "the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators." This suggests a reliance on generally accepted performance standards for video endoscopy systems rather than a specific ground truth derived from expert consensus or pathology data for a new diagnostic claim.

8. The sample size for the training set

• Not applicable. This submission describes a hardware device, not an algorithm that would require a training set.

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

• Not applicable. As above, this is a hardware device, not an algorithm requiring a training set.

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