(206 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.
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.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| No major deformation under mechanical load | No major deformation under worst-case mechanical load conditions |
| No breakage of device parts | No breakage of other parts of the device (specifically fiber optic bundles) |
| Fiber optic bundles don't pull apart | Fiber optic bundles don't pull apart under normal conditions of use |
| Illumination quality verified | Illumination quality verified following mechanical tests and simulated use testing |
| Biocompatibility | Studies performed in accordance with ISO 10993-1:2009 for a limited contact duration device |
| Sterility Assurance Level | Sterilized to an SAL of 1x10^-6 using ethylene oxide (validated EO cycle) |
| Sterile packaging integrity | Maintained a sterile barrier over time in shelf life testing |
| Product functionality maintained | Functionality maintained in shelf life testing |
| Withstand distribution conditions | Adequately withstood ISTA 2A distribution standards for packaging |
| Appropriate incision size | Established appropriate incision size through cadaver testing |
| Forces on tissue during insertion/extraction | Evaluated forces during insertion/extraction in cadaver testing, demonstrated device does not break or is not damaged |
| Safe light output | Spectral irradiance was "considerably less" than standard light source, indicating safe use |
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.
§ 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.