(121 days)
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle. Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters. Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet. The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.
The provided text is a 510(k) summary for the Serpex Medical, Inc. Compass Steerable Needle. It outlines the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, it does not describe a study that proves the device meets specific acceptance criteria in terms of AI model performance, diagnostic accuracy, or clinical effectiveness as typically seen for AI/ML-enabled devices.
Instead, the "acceptance criteria" and "study" described in the document refer to standard medical device verification and validation activities for a new physical medical device (a steerable biopsy needle), focusing on its engineering performance, safety, and functionality. This includes:
- Bench Testing: Mechanical and functional performance of the device.
- Validation Testing: Simulated use conditions, including human cadaver testing for clinical performance.
- Human Factors Usability: Assessment of user interface and potential use errors.
- Biocompatibility: Evaluation of material safety in contact with human tissue.
- Sterilization: Validation of the sterilization process.
Therefore, I cannot extract the information required for an AI/ML-driven device's acceptance criteria and study proving it meets them. The prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to the content of this 510(k) summary.
In summary, the provided document details the regulatory clearance process for a physical medical device (a steerable biopsy needle), not an AI/ML diagnostic or assistive device. Consequently, it does not contain the information requested regarding AI model performance, expert adjudication, or MRMC studies.
§ 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.