(28 days)
The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.
The Radial Jaw 14 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use devices. The Radial Jaw'14 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
The provided text does not describe a study involving a device that uses artificial intelligence (AI) or machine learning.
Instead, the document is a 510(k) summary for a medical device called the "Radial Jaw™ 4 Pulmonary Biopsy Forceps." This device is a sterile, single-use instrument designed to collect tissue endoscopically for histologic evaluation. The submission specifically focuses on a modified handle design compared to a previously cleared predicate device.
The "Performance Data" section explicitly states: "Bench Testing has been performed on the proposed Radial Jaw™ 4 Pulmonary Biopsy Forceps to demonstrate that the modified handle design met the required specifications for the completed tests." This indicates traditional engineering bench testing, not a clinical study involving human readers, AI algorithms, or the kind of acceptance criteria typically associated with AI device performance.
Therefore, I cannot provide the requested information regarding:
- Table of acceptance criteria and reported device performance (in the context of AI)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth (in the context of AI)
- Sample size for the training set
- How ground truth for the training set was established
The document details a regulatory submission for a conventional medical instrument where "performance data" refers to its mechanical and functional specifications.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.