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The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area.

It is indicated for diseases of the trachea and bronchi other than contraindications.

The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use.

The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit.

The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device.

The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient.

The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area.
This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc.
This product contains a working channel, which is convenient for use after insertion of endoscopic accessories.
The applied part of this product is the insertion part of the Single-use Bronchoscope.
Single use application of this product minimises the risk of cross-contamination of the patient.

There appears to be a misunderstanding of the provided FDA 510(k) clearance letter. The document details the clearance of a Single-use Flexible Video Bronchoscope and an accompanying Insight Workstation.

Crucially, this document does NOT describe an AI/ML-driven medical device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance. The "Insight Workstation" mentioned is a display unit, not an AI component.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving an AI device meets those criteria, as the provided document pertains to a traditional medical device (a bronchoscope) and makes no mention of AI or machine learning.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho Family) based on:

• Identical indications for use, patient population, and environment of use.
• Similar technological characteristics (flexible scope, working length, illumination, color performance, image/video capture, single-use, EO sterilization, shelf life, packaging).
• Non-clinical performance testing (electrical safety, EMC, optical performance, bending angle, aging, sterile packaging integrity, thermal safety, reliability, usability, chemical properties, photobiological safety, mechanical performance, color performance).
• Biocompatibility testing.

The document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the Single-use Flexible Video Bronchoscope and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This means there are no clinical studies or AI performance studies to discuss within the scope of this FDA clearance letter.

To provide the requested information, a document describing the clearance of an AI/ML-based medical device would be required.

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