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The MGB LAPORT sterile Trocars for Endoscopic surgery are intended to establish a path of entry for endoscopic abdominal, for use during general, instruments gynaecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "LAPORT / Trocar for laparoscopic procedures." It indicates that the device has been found substantially equivalent to predicate devices.

However, this document does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the 510(k) submission itself, or in supplementary documents describing the performance testing.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document primarily focuses on:

• Device identification: LAPORT / Trocar for laparoscopic procedures, K092584.
• Regulatory classification: Class II, Product Code GCJ, Regulation Number 21 CFR 876.1500 (Endoscope and accessories).
• Substantial equivalence determination: The FDA concluded the device is substantially equivalent to legally marketed predicate devices.
• Indications For Use: To establish a path of entry for endoscopic abdominal, general, gynecological, and thoracic minimally invasive procedures.
• General regulatory requirements.

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The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for:

• -General surgery
• Abdominal surgery - .
• Gynecological surgery -
• Thoracic minimally invasive procedures. -

The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.

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I am sorry, but the provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to MGB Endoskopische Geräte GmbH Berlin regarding their MGB Disposable Retrieval Bag/LAPBAG. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, study methodologies, or ground truth details.

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Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.

The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides 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 is approximately 5600°K and the lamp life is approximately 500 hours.

The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides 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 is approximately 6000°K and the lamp life is approximately 500 hours.

The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides 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 is approximately 3400°K and the lamp life is approximately 50 hours.

The provided text describes a 510(k) premarket notification for an Endoscopic Light Source. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set ground truth cannot be fully extracted from the provided text because it primarily addresses regulatory compliance through substantial equivalence.

Here's why and what information can be gathered:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or image quality scores. Instead, the "acceptance criteria" are implied by the requirement to be "substantially equivalent" to predicate devices. This means the device must perform similarly to widely accepted and commercialized devices.
• Reported Device Performance: The primary "performance data" mentioned is compliance with several international and European standards, indicating safety and general functionality. No specific individual performance metrics are provided that would typically populate such a table for an AI/diagnostic device.

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/Not provided. This is not a clinical study involving a "test set" of patient data. The evaluation is largely based on technical specifications and comparison to existing devices.

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/Not provided. Ground truth for a diagnostic test is not relevant here as this is a medical device for illumination, not for diagnosis based on data interpretation.

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

• Not applicable/Not provided.

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/Not provided. This is an endoscopic light source, not a diagnostic AI tool, so MRMC studies are not relevant.

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

• Not applicable/Not provided. This is a hardware device, not an algorithm. Its "standalone" performance is its ability to produce light according to its specifications.

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

• Not applicable/Not provided in the context of a diagnostic test. The "truth" for this device lies in its technical specifications and compliance with safety and performance standards.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI model that requires a training set.

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

• Not applicable/Not provided. As above, no training set is relevant.

Summary in relation to the provided document:

The provided document is a 510(k) summary, which aims to demonstrate that a new medical device is "substantially equivalent" to existing, legally marketed predicate devices. This regulatory pathway relies on comparing the new device's technological characteristics, intended use, and safety/effectiveness profile to the predicates, rather than conducting new clinical trials to establish novel performance metrics or compare it against a gold standard in a diagnostic context.

The "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence is primarily a technical assessment and comparison to established predicate devices and compliance with relevant international and European standards for medical electrical equipment. No clinical studies involving patient data, expert readers, or AI algorithms were conducted or reported in this summary.

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The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are 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 VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing for both right-handed and left-handed users.

The provided text is a 510(k) summary for an endoscopic camera, not a study report demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.

Here's an analysis based on the available information:

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

This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics in relation to such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance testing against predefined criteria.

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

The document does not describe a clinical or performance study with a test set. The claim of substantial equivalence is based on design and technological characteristics, not on a study with a sample size of patients or images.

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. There is no mention of a test set with ground truth established by experts.

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

Not applicable. No test set or adjudication method 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 endoscopic camera, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a hardware component (endoscopic camera) and does not involve a standalone algorithm.

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

Not applicable. Ground truth is not relevant in the context of demonstrating substantial equivalence for an endoscopic camera in this document.

8. The sample size for the training set:

Not applicable. This document does not describe any machine learning or AI component requiring a training set.

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

Not applicable. As above, there is no training set mentioned.

Summary of what the document does state regarding performance/equivalence:

Acceptance Criteria (Implied by Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the devices (VP-1000C/Med Cam 100 and VP-3000A/Med Cam 300) are "substantially equivalent" to predicate devices already on the market. This means they should pose the "same type of questions about safety and effectiveness" and have "no diminished safety or effectiveness" compared to predicates.

Reported Device Performance (as presented for substantial equivalence):

The document states that the new devices are "similar in design and technological characteristics" to their respective predicate devices (World of Medicine Lemke GmbH's Endoscopic Camera MC404/C3 for VP-1000C and Endoscopic Camera TC804/C4 for VP-3000A).

The key performance claims supporting substantial equivalence are:

• Intended Use: Identical – "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."
• Design: Both are camera systems consisting of a camera control unit (CCU), camera head, objectives, cables, and adapters.
• Functionality: Both take images through standard endoscopes and display them on standard video monitors.
• Differences: Described as "minor and limited to picture quality and handling convenience," implying that these differences do not negatively impact safety or fundamental effectiveness for the intended use.
• Standards Compliance: The devices "will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC." (Note: IEC 60601-1-2 is listed twice; likely a typo in the original text, usually refers to General Requirements for Safety and Essential Performance and Electromagnetic Disturbances).

In essence, the "study" demonstrating the device meets acceptance criteria is a demonstration of substantial equivalence through comparison of design, intended use, and technical specifications with legally marketed predicate devices, rather than a clinical trial or performance study with quantified metrics.

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For use to allow access and observation of body cavities during endoscopic . and/or laproscopic procedures:

• General endoscopic and laparoscopic surgical procedures. .
• Plastic, reconstructive, and aesthetic surgical procedures. .
• Thoracic cavity diagnostic and therapeutic procedures. .
• Athroscopy of body joints during diagnostic and therapeutic procedures. .

The MGB LAPALUX telescope is a laparoscope designed for general, gynecological and plastic surgery. It is similar in design to other telescopes currently available for commercial distribution in the United States.

Here's a breakdown of the acceptance criteria and study information for the MGB LAPALUX® Telescope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states, "Although there are no performance standards established by the FDA for these devices, the MGB LAPALUX telescope has been designed and manufactured to meet the following standards." The basis for clearance is that the device "has no significant differences in design, materials or other technological characteristics compared to the predicate device" and is therefore "substantially equivalent." This implies that by meeting these standards, the device performs equivalently to the predicate and thus meets its "acceptance criteria."

Regarding the study that proves the device meets the acceptance criteria, the provided document does not describe a clinical study with a test set, experts, or ground truth in the way one might expect for a modern AI/ML device.

This submission is a 510(k) Premarket Notification from 1998 for a rigid medical telescope (laparoscope). The primary method of demonstrating safety and effectiveness for such devices at that time, and particularly for this type of device, was Substantial Equivalence (SE) to a legally marketed predicate device.

Let's address the specific points based on a Substantial Equivalence pathway, even if they don't perfectly align with AI/ML study methodologies:

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

• Sample Size: Not applicable. There was no specific "test set" in the context of a clinical study for this 510(k) submission. Substantial equivalence is primarily demonstrated through comparison of design, materials, and intended use with a predicate device.
• Data Provenance: Not applicable for a clinical test set. The "data" here would be the technical specifications and design parameters of the MGB LAPALUX® Telescope and its predicate (Karl Storz Hopkins II rigid autoclavable telescope). The provenance of these specifications is likely the manufacturer's engineering and quality assurance processes in Germany (MGB Endokopische Geräte GmbH Berlin).

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

• Not applicable. As no clinical "test set" was described, no external experts were used to establish ground truth in this manner. The "experts" involved would be the manufacturer's engineers and quality control personnel who ensured the device met the listed DIN and EN standards, and potentially internal medical advisors on device design.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical "test set" requiring an adjudication method.

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 a passive optical instrument (a laparoscope), not an AI-based system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device is a passive optical instrument, not an algorithm, and does not operate standalone in this context (it's observed by a human).

7. The Type of Ground Truth Used

• The "ground truth" in this context is established by compliance with recognized international standards (DIN, EN, EU Directive) and the documented equivalence of specifications and performance to a legally marketed predicate device. This is a technical and regulatory ground truth rather than a clinical ground truth derived from pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device and therefore does not have a "training set."

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

• Not applicable. As no training set exists, no ground truth was established for it.

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