(30 days)
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:
- 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.
- 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.
- 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.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is for evaluating human performance with and without AI assistance.
- Standalone (algorithm only) performance: Not applicable, as this is a physical surgical access port, not an algorithm.
- 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.
- Sample size for the training set: Not applicable, as there's no AI model being trained.
- 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.
§ 874.4720 Mediastinoscope and accessories.
(a)
Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.