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AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.

AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.

The provided text is a 510(k) summary for the AlphaXenon Light, a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices, not on presenting novel clinical study data with acceptance criteria for device performance as would be expected for a new technology or diagnostic AI.

Therefore, the document does not contain information on:

• Acceptance criteria for device performance (beyond substantial equivalence to predicates).
• A "study that proves the device meets the acceptance criteria" in the sense of clinical performance or accuracy study.
• Sample sizes for test sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

The document primarily focuses on demonstrating that the AlphaXenon Light is substantially equivalent to legally marketed predicate devices.

Here's what the document does state regarding its compliance and equivalence:

1. Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices already on the market. The reported "performance" is that the device is "similar in design, technology and intended use" and raises "no new questions of safety and effectiveness."

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

Not applicable. This is a light source, not a diagnostic AI or imaging device requiring a test set for performance evaluation in the usual sense. The submission likely relies on engineering and bench testing to demonstrate functionality and safety, but these details are not provided in this summary.

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

Not applicable for this type of device and submission.

4. Adjudication method for the test set:

Not applicable.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. This is a light source, its "ground truth" relates to functional specifications and safety, not diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

In summary, this 510(k) summary is for a basic medical device (light source) where the primary regulatory hurdle is demonstrating substantial equivalence to existing, legally marketed devices. It does not involve complex clinical performance studies or AI evaluation metrics as outlined in your request.

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The KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.

The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.

The provided text describes a 510(k) summary for the Karl Storz Xenon-100 SCB Light Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is a regulatory pathway in the US that avoids the need for extensive clinical trials by showing a new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a clinical performance study with AI (like multi-reader multi-case studies, standalone performance, ground truth, sample sizes, etc.) is not present in the provided document.

Here's why and what information is available:

• No acceptance criteria or study results for device performance are listed. The document states: "The minor differences between the Karl Storz Xenon-100 SCB Light Source and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This implies that extensive comparative performance testing (as would be done for a novel AI device) was not required for this 510(k) submission.
• The focus is on "Substantial Equivalence." The entire submission hinges on demonstrating that the new device is functionally similar to an already approved device.
• The device is a "Light Source unit," not an AI-powered diagnostic or therapeutic device. The nature of the device (a light source for endoscopes) does not typically require the types of performance studies involving human readers, ground truth establishment, or AI algorithms as outlined in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, deep learning studies, multi-reader multi-case studies, and ground truth in the way you've requested, as this information is not part of this 510(k) submission document.

However, based on the document, I can provide the following relevant details about the submission process:

• Device Name: Xenon-100 SCB Light Source
• Intended Use: For use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons. It features remote control, central operation, central display, automatic initial setting, and interlocking operation to the Karl Storz SCB Control Computer.
• Regulatory Pathway: 510(k) Premarket Notification, demonstrating Substantial Equivalence to a predicate device.
• Predicate Device: A legally marketed device with similar basic features and intended uses, but not explicitly named in the provided text.
• Date Submitted: September 30, 2008
• Date Received by FDA: October 1, 2008
• FDA Clearance Date: December 18, 2008

To reiterate, the provided document does not contain the specific information you've asked for regarding acceptance criteria, study design, datasets, or AI performance because it's a 510(k) for a light source, not an AI-enabled device requiring such validation studies.

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The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.

The provided text is a 510(k) summary for the ConMed Linvatec 300W Xenon Light Source. It does not contain any information about acceptance criteria, study data, or performance metrics for an AI/ML device or any device that would be subject to such detailed performance studies.

The document describes a conventional medical device (a light source for endoscopic procedures) and establishes its substantial equivalence to previously marketed devices (predicates). Therefore, I cannot fulfill the request to provide information about acceptance criteria, study details, and performance metrics as if it were an AI/ML device.

Here's why and what information is available in the document:

Why the requested information cannot be provided from this text:

• Nature of the Device: The device is a "ConMed Linvatec 300W Xenon Light Source," which is a light-generating device used during endoscopic procedures. It is not an AI/ML diagnostic or prognostic tool.
• Regulatory Pathway: The submission is a 510(k) for substantial equivalence to predicate devices, not a de novo or PMA submission that would typically require extensive clinical performance studies to establish safety and effectiveness for a novel AI/ML application.
• Content: The document focuses on device description, intended use, and comparison to predicates based on design, technology, and intended use, rather than specific performance metrics against an established ground truth.

Information that is available (and relevant to the prompt, if it were an AI/ML device):

1. Acceptance Criteria and Reported Device Performance:

   • NO INFORMATION PROVIDED. For a traditional medical device like a light source, acceptance criteria typically relate to functional performance (e.g., light intensity, color temperature, safety features, durability) based on internal testing and compliance with recognized standards, not clinical performance metrics like sensitivity or specificity. No such performance data or acceptance criteria are detailed in this 510(k) summary.

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

   • NO INFORMATION PROVIDED. There's no test set described for evaluating performance in the context of AI/ML or even clinical performance. The focus is on substantial equivalence.

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

   • NO INFORMATION PROVIDED. Ground truth establishment is not relevant for this type of device and regulatory submission.

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

   • NO INFORMATION PROVIDED. Not applicable.

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:

   • NO INFORMATION PROVIDED. Not applicable. This device does not involve human readers interpreting data with or without AI assistance.

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

   • NO INFORMATION PROVIDED. Not applicable.

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

   • NO INFORMATION PROVIDED. Not applicable.

8. The sample size for the training set:

   • NO INFORMATION PROVIDED. Not applicable. There's no AI/ML algorithm involved that would require a training set.

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

   • NO INFORMATION PROVIDED. Not applicable.

Summary of Device in the Provided Text:

• Device Name: ConMed Linvatec 300W Xenon Light Source
• Intended Use: To be used with an endoscope to provide illumination during endoscopic procedures.
• Regulatory Class: Class II
• Predicate Devices:
  • Linvatec Corporation Xenon 300W Light Source (K031994)
  • Karl Storz Endoscopy Xenon 300W Light Source (K962595)
• Substantial Equivalence: Claimed based on similar design, technology, and intended use to the predicate devices, with "minor differences" that "raise no new questions of safety and effectiveness."

In conclusion, the provided text describes a conventional medical device applying for 510(k) clearance via substantial equivalence, and therefore does not contain the detailed performance study information typically associated with AI/ML devices.

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The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.

Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.

The provided 510(k) summary (K040949) for the ViaDuct Miniscope and Accessories does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices, rather than a submission detailing performance against predefined metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be provided. The document does not specify any quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or biopsy. The submission focuses on demonstrating substantial equivalence in terms of intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. The document states, "All necessary testing was or will be performed on the ViaDuct Miniscope and Accessories to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." However, it does not detail any specific test sets, sample sizes, or data provenance from studies designed to prove clinical performance. This typically refers to bench testing, biocompatibility, sterilization, and sometimes animal studies, but not necessarily human clinical trials for diagnostic performance in the way AI/ML devices often do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be provided. No clinical test set involving expert ground truth determination is described in this document.

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

• Cannot be provided. As no clinical test set is detailed, no adjudication method is mentioned.

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

• Cannot be provided. This document predates the common practice of extensive AI/ML efficacy studies and does not describe any MRMC studies comparing human readers with and without AI assistance. The device is purely an imaging and biopsy tool, not an AI-powered diagnostic algorithm.

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

• Cannot be provided. This device is a manual, physical instrument (fiberscope, biopsy forceps) and does not involve an algorithm with standalone performance.

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

• Cannot be provided. No specific ground truth type is mentioned for a performance study. For a device like this, "ground truth" might refer to the successful retrieval of tissue biopsies or direct visual confirmation of anatomical structures, but this is not detailed in the context of a performance study proving diagnostic accuracy.

8. The sample size for the training set

• Cannot be provided. This refers to a physical device, not an AI algorithm, so there is no "training set."

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

• Cannot be provided. As there is no training set for an algorithm, this question is not applicable.

Summary of Device and Regulatory Context from the Document:

• Device Name: ViaDuct Miniscope and Accessories
• Device Description: Semi-rigid fiberscope with an irrigating outer sheath/introducer, capable of passing a biopsy needle, and an inner grasping sheath/tube functioning as forceps for soft tissue biopsy.
• Intended Use: For use by a physician for viewing an interior cavity of the human body (via natural opening or incision) and for grasping soft tissue for biopsy. It is for diagnostic purposes only and not therapeutic use.
• Regulatory Pathway: 510(k) Pre-market Notification, seeking substantial equivalence.
• Predicate Devices: Acueity (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope (K011189) and Acueity ViaDuct Microendoscope and Accessories (K983527).
• Substantial Equivalence Claim: Based on similar intended use, principles of operation, anatomical site for viewing and sampling, safety characteristics, and physical characteristics compared to predicate devices.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.

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The Medi Pack is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures.

The KSEA Medi Pack is a compact video camera system consisting of a camera control unit, a cold light source, a documentation module, a 6.4-inch high performance LCD video monitor, a keyboard, and a camera head.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for test sets.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This document is a 510(k) summary for the KSEA Medipack, Model 20042020. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It describes "Indications for Use" and "Device Description" but does not contain detailed information about specific performance acceptance criteria, clinical studies, or the methodologies used to establish ground truth or evaluate the device's accuracy in a way that would allow me to answer the questions posed. The document states that "minor differences between the Karl Storz Medi Pack and the predicate devices raise no new issues of safety and effectiveness," which is a common approach in 510(k) submissions, relying on the safety and effectiveness of the predicate device rather than presenting new detailed studies for the new device.

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The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

The Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The Linvatec 300W Xenon Light Source is capable of interfacing with the ConMed I.S. Operating Room Control System to allow an alternate means for user control.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec 300W Xenon Light Source. This document describes a medical device submission seeking substantial equivalence to predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training data cannot be extracted from this document as it does not contain such information.

The document states: "The differences between the Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new questions of safety and effectiveness." This indicates that the regulatory review focused on the similarity to already approved devices, rather than requiring a detailed performance study against new acceptance criteria.

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The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The Endoscopic Light Source XL180/L3 uses a 180 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 6000 °K and the lamp life is approximately 500 hours.

The provided text describes a 510(k) premarket notification for an Endoscopic Light Source XL180/L3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics through clinical trials. Therefore, the information requested about acceptance criteria for device performance, sample sizes, expert ground truth adjudication, MRMC studies, and standalone algorithm performance is not applicable to this document.

The document focuses on the device's compliance with established industry standards as evidence of safety and effectiveness, rather than specific performance metrics against a clinical ground truth.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "study" described is compliance testing against safety and electromagnetic compatibility standards, not a clinical performance study using a "test set" in the context of AI/diagnostic device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence) is not relevant for this type of submission focused on safety and technical standards compliance.

4. Adjudication method for the test set: Not applicable.

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 is a light source, not a diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used: For the purposes of this submission, the "ground truth" is defined by the compliance requirements of the specified international and regional standards (IEC 60601-1, IEC 60601-1-2, MDD 93/42/EEC, UL2601-1). This is a technical and regulatory ground truth rather than a clinical one.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of light source device and its regulatory submission focus.

9. How the ground truth for the training set was established: Not applicable.

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The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The Endoscopic Light Source XL300/L5 uses a 300 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 5600 °K and the lamp life is approximately 500 hours.

The provided text describes a 510(k) summary for the Endoscopic Light Source XL300/L5. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for an AI/ML device.

Here's an analysis based on the provided text, highlighting the absence of information typically requested for AI/ML device studies:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this device are primarily regulatory and safety standards, and performance is evaluated based on its similarity to a legally marketed predicate device. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be typical for an AI/ML diagnostic device.

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

This information is not applicable/not provided in the document. The submission is a 510(k) summary for an endoscopic light source, which is a hardware device. It does not involve a "test set" of patient data for AI model evaluation. The demonstration of substantial equivalence is based on technical specifications and compliance with standards.

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

This information is not applicable/not provided. As there is no "test set" of patient data, there's no need for experts to establish ground truth for an AI model.

4. Adjudication Method for the Test Set

This information is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This information is not applicable/not provided. MRMC studies are relevant for evaluating the impact of AI assistance on human readers, which is not the subject of this 510(k) submission for a light source.

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

This information is not applicable/not provided. This device is a hardware component (a light source), not an AI algorithm.

7. The type of ground truth used.

This information is not applicable/not provided.

8. The sample size for the training set.

This information is not applicable/not provided.

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

This information is not applicable/not provided.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described in the document is a demonstration of substantial equivalence to a predicate device and a commitment to comply with relevant safety and performance standards.

• Predicate Device: Karl Storz Xenon 300 Light Source for Non-Flash Applications (K962595).
• Methodology: The manufacturer states that the Endoscopic Light Source XL300/L5 is "similar in design and technological characteristics" to the predicate device. Both devices are intended to provide illumination for endoscopic procedures using a 300W Xenon lamp. The manufacturer asserts that the "differences... are minor and raise no new questions of safety and effectiveness."
• Performance Data: The device "will comply" with international safety standards (IEC 60601-1, IEC 60601-1-2), will "conform" to the Medical Device Directive 93/42/EEC, and "will meet the requirements" of UL2601-1. This indicates adherence to established electrical, electromagnetic compatibility, and medical device safety standards.
• Conclusion: The FDA reviewed the 510(k) submission and determined that the device is substantially equivalent to the legally marketed predicate device, allowing it to proceed to market. This determination is based on the provided technical specifications, intended use, and commitment to compliance with recognized standards, not on a clinical performance study with patient data or an AI algorithm evaluation.

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The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.

The Endoscopic Light Source XL202/L3 uses a 180 W xenon lamp to provide illumination during endoscopic surgery through a fiber optic cable, which is connected to the device. Furthermore, the light source can be equipped with an additional 150 W halogen lamp for diagnostic applications in endoscopy. The 150 W halogen lamp also function as a backup up lamp to avoid interrupting a procedure in case of a malfunction of the xenon lamp. The color temperature of the xenon lamp and halogen lamp is approximately 6000 % and 3400 % respectively, the lamp life approximately 500 hours and 50 h respectively.

The provided text is for a 510(k) summary for an Endoscopic Light Source. This type of document is for a medical device that provides illumination and is not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies and performance will not be applicable.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance Study for Endoscopic Light Source XL202/L3

The 510(k) summary for the Endoscopic Light Source XL202/L3 does not describe a study involving specific acceptance criteria and performance metrics in the way one would for an AI/ML algorithm or a new diagnostic device requiring clinical performance evaluation. Instead, the "performance data" section focuses on compliance with established electrical safety and general medical device standards, and the demonstration of "substantial equivalence" to predicate devices.

The underlying principle for the approval of this device is substantial equivalence, meaning it performs as safely and effectively as other legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This information is not applicable as the document describes a traditional medical device (light source) without a test set of data in the context of an AI/ML or diagnostic performance study. The "testing" referred to is compliance testing against established engineering and safety standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. Ground truth is not established in the clinical or diagnostic sense for a light source. Device functionality is assessed against engineering specifications and safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method.

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

This information is not applicable. The device is an endoscopic light source, not a diagnostic or AI-assisted interpretation tool. Therefore, a study to measure human reader improvement with or without AI assistance is irrelevant.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable. This is a hardware device (light source), not an algorithm.

7. Type of Ground Truth Used:

This information is not applicable in the context of clinical or diagnostic ground truth. For this type of device, the "ground truth" is defined by compliance with established engineering standards (e.g., light output specifications, electrical safety parameters) and the device's ability to perform its intended function (providing illumination) as reliably as predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a hardware medical device like a light source.

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

This information is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The provided 510(k) summary focuses on demonstrating that the Endoscopic Light Source XL202/L3 meets safety and performance standards equivalent to existing, legally marketed predicate devices through compliance testing and comparison of technical specifications. It is not an AI/ML-driven device or a device requiring a clinical performance study with a test set, ground truth, or expert adjudication.

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The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required

The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables and fiberoptic headsets. The Designs for Vision Daylite Light Sources are supplied with headsets that were first placed into service prior to 1976 and are preamendment devices. The Designs for Vision headsets have been marketed since the early 1970's with a long history of safe use in the surgical suite. The headsets are either coaxial, bifurcated, or focusable designs. The light source includes a universal chuck for fiberoptic cable attachment. The universal chuck accepts various sizes of light cables. The XeNon Light sources provide either 180-watt or 300-watt power output and contain a continuous illumination level adjustment which provides 6000°K color temperature light.

The provided document K013880 is a 510(k) summary for the Designs for Vision, Inc. Daylite XeNon Light Sources. This document is a premarket notification for a medical device and describes its substantial equivalence to predicate devices, focusing on regulatory compliance rather than extensive clinical performance studies.

Therefore, many of the requested details about acceptance criteria, detailed study design, and ground truth establishment are not typically found in such a regulatory submission. A 510(k) primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device.

Based on the provided text, here is the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating electrical safety characteristics and substantial equivalence to predicate devices.

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

The document states "Testing has been performed which demonstrates the electrical safety characteristics." However, it does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set. This type of detail is usually found in detailed test reports, not the 510(k) summary itself. The testing mentioned would likely involve a limited number of manufactured units to verify electrical safety standards rather than a clinical trial with patient data.

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

Not applicable. This device is a light source, not a diagnostic or AI-driven decision support system that requires expert-established ground truth from clinical cases. The "testing" referred to is against engineering and safety standards (e.g., electrical safety), not medical interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the testing relates to electrical safety and compliance with existing standards for medical devices, there would not be an "adjudication method" in the sense of resolving discrepancies in expert interpretation of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI algorithms where human reader performance is being evaluated or augmented. The Daylite XeNon Light Source is an illumination device.

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

Not applicable. This is a hardware medical device (a light source), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device would be its adherence to established electrical safety standards and its functional specifications (e.g., power output, color temperature, continuous illumination adjustment) as compared to its own design specifications and general medical device requirements. These are engineering and performance specifications, not clinical outcomes or expert consensus on medical findings.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware light source, not a machine learning model or AI system that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it in this context.

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