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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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