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The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.

The provided text describes a 510(k) submission for a device called "SightFix." This submission primarily focuses on establishing substantial equivalence to predicate devices rather than detailing independent performance criteria and an accompanying study with specific acceptance criteria that would typically be found in a primary clinical trial or performance evaluation.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance cannot be directly extracted from the provided text. The document primarily relies on compliance with international and European safety standards for its performance data.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

• Not explicitly stated. The document refers to compliance with standards, which would involve testing, but the specific sample sizes for such tests or the provenance of any performance data are not provided. The strategy is based on substantial equivalence, not a direct clinical performance study.

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

• Not applicable/Not stated. This information would typically be relevant for a clinical performance study with human interpretation (e.g., imaging studies), which is not the primary basis of this 510(k) submission.

3. Adjudication method for the test set:

• Not applicable/Not stated. See point above.

4. 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. This is not an AI-assisted device. The device is an endoscope and holder.

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

• Not applicable. This device is a medical instrument (endoscope and holder), not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing, tested against standards for safety and function, not as a standalone algorithmic performance.

6. The type of ground truth used:

• Compliance with recognized standards and substantial equivalence. The "ground truth" here is that the device meets established safety and sterilization standards and is functionally similar to legally marketed predicate devices, which are presumed safe and effective.

7. The sample size for the training set:

• Not applicable/Not stated. This concept is typically relevant for machine learning algorithms, which this device is not.

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

• Not applicable/Not stated. See point above.

Summary of Approach:

The 510(k) submission for SightFix relies on demonstrating substantial equivalence to existing predicate devices (MGB LAPALUX Telescope, Robotrac™ Retractor Arm, and KSEA Endoscope Holder) in terms of intended use, design, material, and technological characteristics. Additionally, it highlights compliance with relevant international and European safety and sterilization standards. This approach, common for medical devices, means that a detailed, independent clinical study with specific performance acceptance criteria and associated sample sizes, expert ground truth, and comparative effectiveness (as one might see for diagnostics or AI devices) is generally not required or presented in such a submission. The performance is assessed against the established safety and functional profiles of the predicate devices and the relevant standards.

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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 ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.

The ER150/M2 is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery. The monitor accepts and processes composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C signals and NTSC, PAL and SECAM standard video signals. The ER150/M2 is designed with a digital microprocessor and offers an automatic input selection. The received signal is displayed on a 20" screen. The images can be adjusted by the user for color, contrast, hue, brightness, enhanced sharpness and color temperature (6500K or 9300K). Additional output sockets of the ER150/M2 allow the connection to further equipment including a second monitor or recording device.

This 510(k) summary describes a medical video monitor, the ER150/M2, which is an accessory to an endoscope. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for novel acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not applicable or available in the provided text. The device is a monitor, and its "performance" is primarily defined by its ability to display signals effectively, conforming to established standards for medical monitors.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission is for product clearance based on substantial equivalence to a predicate device and compliance with general performance and safety standards, not a clinical study involving a "test set" of patient data. The "test" in this context refers to engineering and quality assurance testing against the listed standards.

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

Not applicable. As this isn't a clinical study, there was no ground truth for a test set established by medical experts in the way that would be done for an AI diagnostic device. The "ground truth" for a medical monitor is its adherence to technical specifications and regulatory standards, which are evaluated through engineering tests and regulatory review.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth requiring adjudication. Compliance with technical standards would be determined by testing procedures outlined within those standards and reviewed by the manufacturer's quality control and ultimately by the FDA.

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 medical monitor, not an AI-powered diagnostic tool. No MRMC study was performed, and there is no AI component described.

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

Not applicable. As described, this is a hardware device (a monitor) with no standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established technical and safety standards for medical monitors (e.g., IEC 60601-1, UL2601-1, 21 C.F.R. § 81020.10) and general device requirements for substantial equivalence. The device's performance is measured against these objective, predefined criteria through engineering and compliance testing. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and development process would involve iterative engineering and testing, but not training data for an algorithm.

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

Not applicable. There is no training set.

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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 Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.

The provided text describes a 510(k) summary for the Endoscopic Camera TC804/C4. It outlines the device's intended use and design but does not contain information regarding specific acceptance criteria, performance data from a study, or details about ground truth establishment or sample sizes as would be expected for an AI/ML device.

The section titled "VIII. Performance Data" states: "The Endoscopic Camera TC804/C4 complies with the International Standard IEC 601-1. IEC 601-1-2. the European Standard EN 55011 and conforms to the Medical Device Directive 93/42 EEC. The device will be tested in accordance with UL2601-1." This indicates compliance with general electrical safety and EMC standards, and a plan for UL testing, but not a study evaluating its "performance" in the context of image quality or diagnostic accuracy, which would be relevant for devices that AI/ML systems typically enhance.

Therefore, I cannot populate the requested table and answer many of the questions because the document does not contain the necessary information about acceptance criteria, specific device performance metrics, study design, ground truth, or expert involvement as outlined in the prompt. The device described appears to be a standard endoscopic camera, not one incorporating AI/ML, and its regulatory submission focuses on substantial equivalence to predicate devices based on design and intended use, rather than detailed performance studies against specific acceptance criteria.

Analysis of Provided Information vs. Requested Details:

1. Table of acceptance criteria and reported device performance: Not available. The document only mentions compliance with general medical device standards (IEC, EN, UL). It does not provide specific performance metrics like resolution, sensitivity, specificity, or image quality against defined acceptance criteria.
2. Sample size for test set and data provenance: Not available. No test set or study validating specific performance claims is described.
3. Number of experts and qualifications for ground truth: Not available. No ground truth establishment is described for a performance study.
4. Adjudication method: Not available.
5. MRMC comparative effectiveness study: Not applicable/not available. The document does not describe an AI-assisted device.
6. Standalone performance study: Not available in the context of AI/ML or image quality metrics.
7. Type of ground truth used: Not available.
8. Sample size for training set: Not applicable/not available. No AI/ML model training is mentioned.
9. How ground truth for training set was established: Not applicable/not available.

In summary, the provided 510(k) summary is for a traditional endoscopic camera, and its "Performance Data" section refers to compliance with safety and electrical standards, not to clinical or image quality performance studies that would typically have acceptance criteria, ground truth, and expert evaluation described.

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The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.

The provided text is a 510(k) summary for the Endoscopic Camera MC404/C3. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis often seen with novel devices or AI/ML-based products.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this document. The document primarily confirms compliance with general safety and performance standards rather than specific clinical performance metrics.

Here's an analysis of what information is available from the provided text:

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

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

Not applicable. The "performance data" section refers to compliance with international and European standards for electrical safety, EMC, and general medical device requirements, not a clinical test set with human or patient data.

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)

Not applicable. This was not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was not a study requiring adjudication of a test set.

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. This is a 2002 submission for an endoscopic camera, not an AI-based device. No MRMC study was performed or mentioned.

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

Not applicable. This is a medical device (endoscopic camera), not an algorithm or AI. Its core function is to provide an image for human interpretation.

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

Not applicable. The performance data relates to compliance with regulatory and safety standards, not diagnostic or clinical accuracy against a ground truth. The substantial equivalence argument relies on the predicate device's established use for "visualization of body cavities," implying that if the new device can also provide adequate visualization, it meets its intended purpose.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The "study" in this context is the submission and review process for substantial equivalence to a predicate device, along with verification of adherence to relevant safety and performance standards.

The primary "proof" that the Endoscopic Camera MC404/C3 meets its acceptance criteria (primarily its intended use as a visualization tool for endoscopic procedures) is based on:

• Substantial Equivalence: The device is deemed substantially equivalent to the Karl Storz Endovision XL Endoscopic Camera System (K974391). The submitter argues that both devices serve the same intended use (visualization of body cavities, hollow organs, and canals during endoscopic procedures when attached to standard endoscopes and displaying images on standard video monitors). The differences are noted as "limited to picture quality and handling convenience," implying these differences do not raise new questions of safety or effectiveness.
• Compliance with Standards: The device's performance is demonstrated through its compliance with recognized international and European standards for medical devices, specifically:
  • IEC 601-1 (general medical electrical equipment safety)
  • IEC 601-1-2 (electromagnetic compatibility for medical electrical equipment)
  • EN 55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
  • Medical Device Directive 93/42/EEC (European regulatory compliance)
  • UL2601-1 (Underwriters Laboratories standard for medical electrical equipment, indicated as "will be tested in accordance with").

This type of submission assumes that if the device is substantially equivalent to a legally marketed predicate and meets fundamental safety and performance standards, it is safe and effective for its stated intended use. Specific clinical performance metrics, reader studies, or AI performance validations were not required for this type of device at the time of this 2002 submission.

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