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The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.

The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.

The provided document is a 510(k) summary for the Olympus EndoLED. It primarily discusses the device's substantial equivalence to a predicate device and non-clinical testing performed.

The document does NOT contain information about a study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting.

Instead, it focuses on:

• Substantial Equivalence: The primary assertion is that the EndoLED is substantially equivalent to the predicate device (PLS Portable Light Source by OPTIM Inc., K091829) in terms of general design, function, and indications for use.
• Non-Clinical Testing: Risk analysis, reprocessing validation, and software validation were carried out according to established standards (ISO-14971, FDA guidance for reprocessing, and FDA guidance for software in medical devices).
• Compliance with Standards: The device applied standards such as ISO 14971, IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.

Therefore, many of the requested sections about a performance study, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be filled from the provided text because such a study is not described.

Here's a response based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Available in straight and angled versions.
• Utilizes a rechargeable NiMH battery.
• Offers 40 minutes of use at maximum power.
• Features a low battery indicator.
• Houses an integrated cooling element. | These are comparative characteristics, not explicit acceptance criteria with quantitative targets and outcomes. The "acceptance" is based on being substantially equivalent to the predicate, which also offers 40 minutes of use. |
  | Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007. | No specific risk acceptance criteria or outcomes are detailed. Implies risks are acceptable per ISO 14971. |
  | Reprocessing Validation | Carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996." | No specific reprocessing acceptance criteria or outcomes are detailed. Implies reprocessing is validated per FDA guidance. |
  | Software Validation | Performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software is "Minor Level of Concern." | No specific software validation acceptance criteria or outcomes are detailed. Implies software is validated per FDA guidance and deemed low risk. |
  | Electrical Safety & EMC | Applied standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. | Implies the device meets the safety and electromagnetic compatibility requirements of these standards. |
  | Usability | Applied standards: IEC 62366 (Medical devices - Application of usability engineering to medical devices). | Implies the device meets usability requirements of this standard. |

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

• Not applicable. The document describes non-clinical testing and a comparison to a predicate device, not a performance study with a test set of data.

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

• Not applicable. No test set or ground truth establishment by experts for performance evaluation is described.

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

• Not applicable. No test set or adjudication process is described.

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 LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a hardware device (light source); it does not have an "algorithm only" performance. The software is noted as a "Minor Level of Concern," indicating its function is likely related to device control rather than interpretation or diagnosis.

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

• Not applicable. No clinical performance study requiring a specific type of ground truth is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the applied standards (e.g., ISO 14971, IEC 60601 series).

8. The sample size for the training set:

• Not applicable. No machine learning or AI training set is mentioned or relevant for this device.

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

• Not applicable. No machine learning or AI training set is mentioned or relevant for this device.

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The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.

The provided document describes a Special 510(k) submission for a device modification, not a study evaluating AI performance or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and human reader studies is not available in the provided text.

This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Vision Sciences Model ENT-3000 Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED) to its predicate device. The changes relate to an enhanced LED light source, requiring validation of safety and performance for this modification.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a Special 510(k) for a device modification rather than a new AI or diagnostic device, the "acceptance criteria" discussed are primarily related to safety and performance standards for the modified physical device, specifically the light source. The document lists the following validation testing:

Note: The document states that these tests were "included in Design Validation and Verification planning" but does not explicitly provide quantitative results or specific pass/fail values. The overall conclusion states the device has been shown to be "safe and effective for its intended use" based on these tests and comparison to predicate devices, implying these criteria were met.

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

• Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The testing mentioned (light output, operating temperature, electrical safety) would typically involve engineering tests on the physical device itself rather than data sets.

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

• Not applicable / Not provided. As there's no clinical "test set" for diagnostic accuracy, there's no mention of ground truth established by experts.

4. Adjudication Method:

• Not applicable / Not provided. No adjudication method is mentioned as there's no diagnostic accuracy study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not mention any MRMC study or comparative effectiveness study involving human readers, with or without AI assistance. The device is a flexible endoscope, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

• Not applicable / Not provided. Since there's no diagnostic performance study, no ground truth types (pathology, expert consensus, outcomes data) are mentioned. The "ground truth" for this type of submission generally relates to compliance with engineering standards and safety requirements.

8. Sample Size for the Training Set:

• Not applicable / Not provided. There is no "training set" in the context of an AI device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable / Not provided. As there's no training set, this information is not relevant.

Summary of what is available about the study:

The submission is a Special 510(k): Device Modification.
The "study" involved Design Validation and Verification Planning, which included:

• Light output testing
• Operating temperature testing
• Electrical safety testing
• Compliance to 21 CFR 820.30 Design Control requirements
• Internal Risk Analysis procedure

The conclusion stated that "Based on the indications for use, technological characteristics, performance and electrical testing and comparison to predicate devices, the VSI ENT-3000 has been shown to be safe and effective for its intended use." This implies that the device successfully met the internal design validation and verification criteria for the modified components.

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