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The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HD Mediastinoscope:

Due to the nature of the device (a physical surgical instrument rather than an AI/software device), the provided document does not contain information typically found in acceptance criteria and studies for AI/ML devices, such as sensitivity, specificity, or AUC.

Based on the provided text, the "acceptance criteria" appear to be related to the device's technical specifications and safety/effectiveness in comparison to predicate devices, rather than specific performance metrics like those for an AI algorithm.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied through the comparison with existing predicate and reference devices and compliance with recognized standards. The "performance" is demonstrated through non-clinical testing, particularly a cadaver test study.

Details of the Study (Non-AI/ML Device)

Since this is a traditional medical device (mediastinoscope) and not an AI/ML device, many of the requested points related to AI/ML studies (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not specified in this 510(k) summary.

However, based on the information provided:

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

   • The primary non-clinical performance test mentioned is a cadaver test study.
   • The sample size (number of cadavers or tests performed) is not specified in the document.
   • The data provenance (country of origin, retrospective/prospective) is not specified.

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

   • The document mentions "a cadaver test study was conducted to demonstrate that the change in spatula design...". It does not specify the use of "experts" to establish a "ground truth" in the way an AI/ML study would (e.g., radiologists labeling images). Instead, the study likely involved technical assessment and observation by qualified personnel (e.g., surgeons, engineers).
   • Not explicitly stated in terms of "ground truth experts" for an AI/ML context.

3. Adjudication method for the test set:

   • Not applicable / Not specified for this type of device and study.

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, an MRMC study was not conducted. This is not an AI-assisted device.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm.

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

   • For the cadaver study, the "ground truth" would likely be the direct observation and technical assessment of the device's performance in a cadaveric model (e.g., ease of introduction, visualization, ability to facilitate instrument use, assessment of tissue damage, etc.) by the study investigators. This is not a "ground truth" in the sense of a diagnostic label for an AI.

7. The sample size for the training set:

   • Not applicable. This device does not use a training set as it is not an AI/ML product.

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

   • Not applicable.

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The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

This document describes the FDA's 510(k) clearance for the Karl Storz HD Mediastinoscope (K202272). The device is intended to aid surgeons in viewing the mediastinum and facilitating the introduction and removal of surgical instruments during ENT endoscopic procedures.

The information provided focuses on the substantial equivalence determination based on non-clinical performance data, rather than a study proving the device meets AI-specific acceptance criteria. Therefore, most of the requested information regarding AI model performance, ground truth establishment, expert review, and clinical study details is not present in the provided text.

Here is a breakdown of what can be extracted and what is not available based on the request:

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

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it states compliance with recognized standards and successful completion of various bench tests.

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

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means there was no clinical test set in the traditional sense for assessing device performance in a human population. All testing was non-clinical bench testing. Therefore, sample size and data provenance (country, retrospective/prospective) related to a clinical test set are not applicable here.

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, as no clinical test set or ground truth in the context of diagnostic interpretation (e.g., for an AI model) was established. The ground truth for bench testing would be metrology standards and physical measurements.

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

Not applicable, as no clinical test set involving human readers or interpretation was performed.

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 mediastinoscope (a physical viewing instrument), not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-only device.

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

For the non-clinical bench testing, the ground truth would be based on established engineering and optical metrology standards, and potentially manufacturer specifications for the device's components. For biocompatibility and reprocessing, the ground truth is compliance with the listed ISO and AAMI standards.

8. The sample size for the training set

Not applicable, as 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, as this is not an AI/ML device.

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The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).

The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.

The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:

• . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
• The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
• . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
• . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
• . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.

Both devices are being used in accordance with their cleared indications for use.

This document is a 510(k) premarket notification for the Aegis Transit System, which is a medical device intended to aid surgeons in visualizing the mediastinum and facilitating surgical instrument introduction and removal. The document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical accuracy or effectiveness.

Instead, this submission focuses on demonstrating substantial equivalence to already cleared predicate devices (Aegis Surgical, Ltd., Illuminated Mediastinal Access Port, K141622 and K160171) based on technological characteristics and design modifications.

Here's why the requested information cannot be provided from this document:

• Type of Device: The Aegis Transit System is a surgical access system (a mediastinoscope and accessories), not a diagnostic AI/ML device that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data. Its "performance" is primarily related to its mechanical and material properties, and its ability to provide access and visualization.
• Nature of Submission: A 510(k) submission generally aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve showing improved clinical outcomes or diagnostic accuracy via large-scale clinical trials in the way an AI/ML diagnostic would.

Therefore, the following points are not applicable or cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for clinical accuracy or present data against such criteria. The "performance data" section states "No new bench testing was required" and refers to prior testing for the predicate devices, focusing on the mechanical and material changes.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" for performance metrics like sensitivity/specificity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this is not an AI/ML diagnostic or image interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there is no AI/ML component.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide concerning "performance" and "acceptance":

The document effectively describes the changes from the predicate devices and argues that these changes do not raise new questions of safety or effectiveness. The "acceptance criteria" here are implied to be the demonstration of substantial equivalence by showing that:

• The intended use is the same (with enhanced examples of procedures).
• The principle of operation is the same.
• Material changes (from industrial grade to medical grade polycarbonate) are considered improvements or equivalent, leveraging prior testing of the handle design.
• The shelf life has been extended from 3 months to 3 years, implying successful shelf-life testing, though details are not provided in this summary.
• Packaging changes are noted.

The crucial statement regarding performance is in section 1.7: "No new bench testing was required for an assessment of substantial equivalence; the bench testing submitted and reviewed under K141622 and K160171 is applicable to the proposed Aegis Transit System." This indicates that the previous predicate devices' performance data (presumably related to mechanical integrity, biocompatibility, sterilization, etc.) formed the basis for accepting the current device's performance, as the changes were deemed not to impact safety or effectiveness. The modification to the small trocar handle incorporated a design cleared under K160171, and thus, previous testing of that handle was deemed sufficient.

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The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.

The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.

Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar.

The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation.

The entire device is disposable, single use and provided pre-sterilized.

The provided text describes a medical device, the "Illuminated Mediastinal Access Port," and its 510(k) submission for substantial equivalence. It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-driven medical device.

The document discusses:

• The device's intended use and technological characteristics.
• The fact that it is a modification to a previously cleared device.
• Performance testing that was performed:
  • A cadaveric usability study was conducted to evaluate dimensional/user interface modifications.
  • Packaging validation and distribution simulation testing were performed.

However, the provided text does NOT include any of the following information relevant to your request about acceptance criteria and a study for an AI-driven device:

1. A table of acceptance criteria and reported device performance: Not present. The document focuses on showing substantial equivalence to a predicate device, not on meeting specific quantitative performance metrics for an AI.
2. Sample size for the test set and data provenance: A cadaveric usability study is mentioned, but details on sample size, specific demographic/physiological characteristics of the cadavers, or whether it was a "test set" in the context of AI validation are absent. Data provenance is not applicable here as it's a physical device study.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as there's no "ground truth" establishment in the AI sense. The cadaveric study evaluated usability by surgeons.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is for evaluating human performance with and without AI assistance.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical surgical access port, not an algorithm.
7. Type of ground truth used: Not applicable. The "performance testing" was for device usability and packaging integrity, not for diagnostic accuracy against a ground truth.
8. Sample size for the training set: Not applicable, as there's no AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for a physical medical device (Illuminated Mediastinal Access Port) and its substantial equivalence to a predicate device, not an AI/algorithm-driven device. Therefore, the specific information requested about acceptance criteria and studies for AI performance is not available in this text.

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The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.

The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.

The Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device includes a blunt trocar for dissecting tissue planes. The open cannula provides for direct visualization of the surgical space and includes small notches at the rim to anchor sutures.

The base of the cannula has fiber optic bundles incorporated that may be connected to a fiber optic light cable and an endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source.

The trocar/cannula access device also includes a handle for connection to a support arm. This allows the mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the mediastinoscope, and to provide stability for the mediastinoscope during operation.

The entire device is disposable, single use and is provided pre-sterilized.

This document is a 510(k) summary for the Illuminated Mediastinal Access Port, which is a medical device intended to aid surgeons in visualizing the mediastinum and facilitating surgical instrument introduction and removal. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed study proving the device meets an explicit set of acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in the provided text. The document primarily describes various performance tests conducted to ensure the device's safety and functionality in comparison to a predicate device.

Here's an attempt to extract relevant information and note what is missing based on your request:

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

The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. Instead, it describes general performance tests and states that the device was ensured to meet certain conditions or functions comparably to the predicate.

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

• Sample Size: Not explicitly stated for any of the individual tests. The document refers to "worst case mechanical load conditions," "normal conditions of use," and "cadaver models," but without specific numbers.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based ("bench" testing), cadaver testing, and potentially internal studies by the manufacturer or a contracted lab. This would typically be considered prospective for the device being tested, but the setting (lab/cadaver) is not a clinical one.

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

• This information is not provided. The term "ground truth" as typically used in AI/diagnostic device studies (e.g., confirmed disease status) is not directly applicable here as this is a surgical access device, not a diagnostic one.
• For assessments like "appropriate incision size" and ability of surgeons to grip the handle, the document mentions "surgeons" in the cadaver models, but does not specify their number, qualifications, or how their observations were formalized into a "ground truth" or acceptance criterion.

4. Adjudication method for the test set

• Not applicable as this is not a diagnostic study requiring adjudication of findings. Performance tests were conducted against technical specifications or functional requirements.

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 a diagnostic device involving human readers or AI.

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

• Not applicable as this is not an AI/algorithm-based device.

7. The type of ground truth used

"Ground truth" in the AI/diagnostic sense is not directly applicable. For this device, the "truth" is based on:

• Engineering specifications/standards: Mechanical load conditions, durability, sterilization standards (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135-2007).
• Functional performance: "No major deformation," "illumination quality verified," "maintain sterile barrier."
• Clinical observation (cadaver): "Appropriate incision size," "forces applied to tissue," surgeon feedback on handle grip. These are observational data points rather than a pre-defined "ground truth."

8. The sample size for the training set

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

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

• Not applicable.

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This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.

Here's a breakdown of the acceptance criteria and study information for the Olympus EndoEYE HD II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present a formal table of acceptance criteria with corresponding performance metrics for the Olympus EndoEYE HD II as one might expect from a detailed clinical or performance study report. Instead, it describes various non-clinical tests and validations performed to demonstrate substantial equivalence to predicate devices.

However, based on the information provided, we can infer the types of acceptance criteria and the confirmation that the device met these criteria through testing.

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

The document describes non-clinical testing for performance, safety, and reprocessing. It does not mention a "test set" in the context of clinical data or human evaluation (e.g., patient images). Therefore:

• Sample Size for Test Set: Not applicable as no clinical test set/data is described. The testing involved physical devices and their components.
• Data Provenance: Not applicable as no clinical data is described. The tests were likely conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) in Germany.

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

This information is not provided in the document. Since the testing described is non-clinical/technical (e.g., resolution, sterilization, durability), the "ground truth" would be established by engineering and quality assurance standards and measurements, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the non-clinical nature of the described testing. Adjudication methods are typically used in studies involving human interpretation of data where consensus among experts is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical performance, not through a comparative clinical study with human readers assessing diagnostic performance.

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

No, a standalone algorithm study is not mentioned. The device is a video laparoscope, a physical instrument for visualization during surgery, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the described non-clinical testing would be based on objective technical specifications, engineering standards, and validated measurement techniques. For example:

• Resolution: Measured against established optical resolution charts/targets.
• Color Correctness: Measured against color calibration standards.
• Sterilization Effectiveness: Demonstrated through biological indicator kill rates and physical/chemical indicators conforming to sterilization standards (e.g., DIN EN ISO 17665-1).
• Durability: Assessed by subjecting devices to a specified number of sterilization cycles and then re-evaluating performance against initial specifications.
• Software Functionality: Verified against software requirements specifications.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for an AI/machine learning algorithm described.

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LTF-Y0009 (3D Laparo-Thoraco Videoscope): This instrument has been designed for use in conjunction with light source, video system centers, 3D Video Mixer, 3D monitor, documentation equipment, hand instruments, and other ancillary equipment for endoscopy and endoscopic surgery within the peritoneal and thoracic cavity.

MAJ-Y0041 (3D Video Mixer): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope and Video System Center for 3D video observation.

XOEV-3D1(Polarized 3D Monitor): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center and 3D Video Mixer for endoscopic diagnosis and video observation.

MAJ-Y0108 (3D glasses): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center, 3D Video Mixer and 3D monitor for 3D video observation.

3D Laparo-Thoraco Videoscope (LTF-Y0009) is a video endoscope used for endoscopy and endoscopic surgery within the peritoneal and thoracic cavity. LTF-Y0009 is basically identical to predicate device 3D Laparoscope, for the same application areas. The 3D video observation of this system is implemented with following process. The captured signals from two CCDs which correspond to left and right eye incorporated in distal end of the subject LTF-Y0009 are transferred to the MAJ-Y0041 via CV-Y0001. CV-Y0001 converts the captured signals into video image signals, and transmits them to the MAJ-Y0041. The MAJ-Y0041 converts the image signals into 3D video signal and transfers it to the XOEV-3D1. On the XOEV-3D1, 3D video image is displayed as passive stereo type which has different polarizing angle in the left and right; therefore, the MAJ-Y0108 is required to obtain 3D video image. The MAJ-Y0108's glasses have polarizing films on them which correspond to their each polarizing angle and it enables 3D observation to the users.

The provided 510(k) summary for the Olympus 3D Laparo-Thoraco Videoscope, Polarized 3D Monitor, and 3D Video Mixer focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally does not include detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment in the way that, for example, a new diagnostic AI device would.

The summary states:
"The LTF-Y0009, XOEV-3D1. MAJ-Y0041 is basically identical to the predicate device in intended use, and similar in specifications except for the optical system of the subject LTF-Y0009." (Section 6)
And in the conclusion:
"When compared to the predicate device, the LTF-Y0009, XQEV-3D1, MAJ-Y0041 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." (Section 7)

Because the device is considered "substantially equivalent" to a legally marketed predicate device, the regulatory pathway relies on demonstrating that the new device does not raise new questions of safety or effectiveness. This is different from proving that a device meets specific performance metrics against a defined acceptance criterion through a dedicated study. Therefore, the information requested in your prompt (acceptance criteria, specific study details like sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not typically part of a 510(k) summary for a device like this.

The key 'proof' that the device meets "acceptance criteria" (in the context of a 510(k)) is the demonstration of substantial equivalence to the predicate device. This is typically achieved through comparisons of technological characteristics, intended use, and safety profiles.

Therefore, many of the specific details you requested are not present in this 510(k) summary. I can, however, extract the information that is available:

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)

This information is not provided in the 510(k) summary. For a 510(k) based on substantial equivalence, specific clinical performance testing with a "test set" in the context of an AI/diagnostic device is not usually required or described in this format. The comparison is primarily against the specifications and performance of the predicate device.

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)

This information is not provided in the 510(k) summary. This type of detail would be relevant for a device making a new diagnostic claim or employing a novel algorithm requiring clinical validation against a ground truth. This is not such a device.

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

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary. This is not an AI-assisted diagnostic device, but rather an imaging system.

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

This information is not applicable/provided in the 510(k) summary. This device is a video endoscope system, not an algorithm.

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

This information is not provided in the 510(k) summary.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The device is not an AI/machine learning model that undergoes a training process in the conventional sense.

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

This information is not applicable/provided in the 510(k) summary, as it does not relate to an AI/machine learning model.

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This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.

The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.

The major difference from the predicate device is only the NBI function added to the subject device.

When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.

The provided text is a 510(k) summary for the Olympus HD EndoEYE, a high-definition digital video laparoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria in the way a clinical trial report would.

Here's an analysis based only on the provided text, as if it were a direct answer to your request. However, it's crucial to understand that this 510(k) summary does not contain the detailed study information you've requested regarding acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone proficiency studies).

The document primarily relies on a comparison of specifications to demonstrate substantial equivalence, implying that if the new device's technical characteristics are similar or improved without introducing new safety/effectiveness concerns compared to legally marketed devices, it meets regulatory requirements.

Based on the provided K090980 510(k) Summary for the HD EndoEYE:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the form of performance thresholds for a study. Instead, it compares the technical specifications of the subject device (HD EndoEYE) to its predicate devices. The "reported device performance" is essentially presented as its specifications, which are deemed acceptable because they are similar or superior to the legally marketed predicate devices without significant changes affecting safety or effectiveness.

Study Proving Acceptance Criteria:

The "study" presented here is a comparison of specifications between the subject device and its predicate devices. The conclusion states: "When compared to the predicate devices, the HD EndoEYE does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that by being substantially equivalent or demonstrating comparable technical performance to already-approved devices, it meets the inherent "acceptance criteria" for regulatory clearance.

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

• The document does not specify a test set sample size or any clinical data provenance (e.g., country of origin, retrospective/prospective study) in the context of device performance testing.
• The review is based on a comparison of technical specifications and an assessment of substantial equivalence.

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

• The document does not mention experts being used to establish ground truth for a test set in the context of a performance study.
• The "ground truth" for this 510(k) submission is the functional equivalence and safety assessment against legally marketed devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set performance study with adjudication is described in the provided text.

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

• No MRMC comparative effectiveness study is mentioned. The document does not describe any human reader studies, either comparing human readers with AI assistance or in general. The device is a laparoscopic imaging system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is an imaging instrument (hardware), not a standalone algorithm. Its performance is assessed through its physical and optical specifications, not an algorithmic output.

7. Type of Ground Truth Used:

• For this 510(k) submission, the "ground truth" is primarily technical specifications and functional characteristics of already legally marketed predicate devices, against which the new device is compared to establish substantial equivalence. No clinical outcome or pathology data is presented for this purpose.

8. Sample Size for the Training Set:

• Not applicable. This document is for a medical device (laparoscope), not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set or AI algorithm is discussed.

Summary of what is not found in the document regarding your request:

The provided 510(k) summary is a regulatory filing for substantial equivalence, not a detailed clinical or performance study report in the traditional sense described by your questions. It focuses on comparing the new device's technical characteristics and intended use to existing predicate devices. Therefore, specific details about acceptance criteria derived from a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment (other than general device specifications), or clinical study methodologies (like MRMC or standalone performance evaluations) are not present in this document.

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