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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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The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum.

Mediastinoscopy is carried out

• In order to evaluate the operability of patients suffering from bronchial carcinoma which have . already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies.
• For diagnostic clarification of primary and secondary diseases of the mediastinum, when other . examination methods have been unable to provide the nature, and in particular the histological character of the disturbance.
• For the removal of nodes and tumors. .
• For the diagnosis and removal of lymphatic nodes.

Various auxiliary instruments are used in mediastinoscopy:

• The smoke evacuation tube is used to evacuate smoke during HF or laser applications.
• The telescope rinsing tube (optic irriyation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid.
• The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/histological purposes.
• The tumor grasping forceps are used for grasping and manipulating tissue. .
• The micro grasping forceps with HF are used for coagulating small vessels and grasping. .
• The HF coagulation suction devices are used for suction and for coagulation while holding tissue 'out of the way' during endoscopic operations of the larynx in connection with CO, lasers or in mediastinoscopy.
• The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for . coagulation of small lesions.

The Optical Mediastinoscope is a tubular, conical shaped endoscope with a handle and a build-in telescope with fiber illumination which is bent at a 90° angle. The endoscope tube consists of two spreadable spatulas which allow distention of the operative field, and therefore, optimizes vision. The spatulas may be dismounted for easier cleaning.

For efficiency during diagnostic and therapeutic procedures, a variety of accessory instruments are needed, e.g. biopsy and grasping forceps, puncture, suction and coagulation tubes or telescope rinsing tubes

The provided text describes the 510(k) summary for the "Optical Mediastinoscope and Accessories" (K971166). This document is for a medical device that requires premarket notification but does not describe the use of any AI/ML technologies. Therefore, many of the requested fields related to AI/ML performance and studies are not applicable.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission is for a physical medical device (mediastinoscope) and accessories, not an AI/ML algorithm. Performance data described includes mechanical tests and sterilization tests, not a "test set" in the context of an AI/ML model.

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

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/ML model for this device. The performance data relates to physical properties and sterilization effectiveness, assessed through laboratory tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of an AI/ML model that would require an adjudication method. The performance data is based on physical and sterilization testing.

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 submission is for a physical medical device and does not involve AI/ML or human "readers" or "interpreters" in the context of diagnostic imaging.

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

Not applicable. This submission is for a physical medical device and does not involve an AI/ML algorithm.

7. The type of ground truth used

Not applicable. As this is not an AI/ML device, the concept of "ground truth" in this context is not relevant. The performance data stems from mechanical and sterilization testing to demonstrate the device's physical integrity and functionality.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

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

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set" with established ground truth.

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