(262 days)
The Prosurg's Neo-Bronchoscope™ - Digital Video Bronchoscopy System -Rigid & Flexible (which includes Digital Video Bronchoscope, Single view (Volto Sheath) is intended for use for use for use for use for use for use for use for use for use for use for use for use for use for examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices and accessories.
The Single Use Digital Video Bronchoscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB Connector at the proximal end. The distal end of the Bronchoscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The NeoFlex™ - Bronchoscope , Flexible Video Bronchoscope device with an Articulating Tip is designed with built-in fluid suction / irrigation and working channel for Micro Instrument delivery.
The Neo- Bronchoscope ™ Video Bronchoscopy System consists of four main components:
- (a) Digital Video Bronchoscope (Rigid / Flexible) with CMOS Sensor & Built-in LEDs / Fiber optic.
- (b) Single Use. Rigid Diagnostic / Operating Outer Sheath with Suction / Irrigation / Instrument channel and a separate, dedicated channel for video Bronchoscope insertion. Or a flexible Bronchoscope with suction / Irrigation & Instrument channel with Articulating tip deflection.
- (c ) )Laptop /Tablet computer with windows Operating System, Video Module and Video processing Software. (Commercially Available, Not supplied by Prosurg, Inc)
- (d) USB 2.0 / HD / S-Video Connecting Cables. (Commercially Available, Not supplied by Prosurg, Inc)
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Neo-Bronchoscope Digital Video Bronchoscopy System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily describes bench testing performed to demonstrate safety and effectiveness, rather than specific performance metrics against pre-defined acceptance criteria with numerical targets. It lists the types of tests conducted.
| Acceptance Criteria Category | Reported Device Performance / Test Conducted |
|---|---|
| Physical Performance | Dimensional Measurements (Outer Diameter, Working Length), Field of View (in air), Image Resolution (Number of Pixels), Direction of View |
| Electrical / Optical | LED Brightness, Voltage & Current measurement, USB Connection compatibility with Laptop / Tablet / Monitor |
| Mechanical (Flexible) | Tip Deflection Control Mechanism (flex) & Angle of Tip deflection |
| Safety | Electrical Safety Test (IEC 601-1), Electromagnetic Compatibility (IEC 601-1-2), Thermal (Heat) Temperature at the Distal Tip (LED), Maximum Safe amount of Suction (Vacuum) testing |
| Material / Process | Product Labeling & IFU Requirements & Accuracy, Packaging Integrity & Sterility Assurance Test, Accelerated Aging Test (one Year), Sterilization Assurance Level (ISO 11135-1:2007), ETO Residual Levels (ISO 10993-7:2008), Biocompatibility (ISO 10993-1:2009) |
Missing Information: The document states that these tests were "completed to demonstrate safety & effectiveness," but it does not provide the specific acceptance criteria (e.g., "Field of View must be > X degrees") nor the quantitative results from these tests. It only lists the types of tests performed.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Prosurg has conducted performance testing (Bench Evaluation - As per FDA Guidance Document) of Neo- Bronchoscope™ device." This indicates that the testing was performed on physical devices in a laboratory setting.
- Sample Size: The document does not specify the sample size of devices used for the bench tests.
- Data Provenance: The data provenance is from bench testing conducted by Prosurg, Inc. The document does not mention human subject data, therefore, the concepts of "country of origin of the data," "retrospective or prospective" do not apply in the context of this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study described is a series of bench tests on the device's physical and functional properties, not a clinical study involving diagnosis or interpretation by experts. Therefore, no ground truth established by experts is mentioned in this context.
4. Adjudication Method for the Test Set:
This information is not applicable as the described study is a series of bench tests and does not involve human interpretation or adjudication.
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:
This information is not applicable. The document describes the premarket notification for a bronchoscope, which is a medical device for direct visualization. There is no mention of AI or human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an endoscope, which is directly operated by a human. It does not involve any algorithms functioning in a standalone capacity (without human-in-the-loop performance) that would be assessed.
7. The Type of Ground Truth Used:
As noted above, the study involved bench testing of device specifications and safety parameters. The "ground truth" for such tests would be the engineering specifications and regulatory standards (e.g., IEC 601-1, ISO 11135-1, ISO 10993-7, ISO 10993-1) that the device must meet.
8. The Sample Size for the Training Set:
This information is not applicable. The document describes the premarket notification for a medical device that does not appear to involve machine learning or AI, and therefore would not have a "training set" in the computational sense. The "training" here refers to the manufacturing and design process.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8.
§ 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.