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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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The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.

The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.

The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).

The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.

The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.

The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.

The provided text is a 510(k) summary for a medical device (Disposable Double Lumen Endobronchial Tube) and focuses on non-clinical performance testing and biocompatibility. It does not describe a study involving an AI algorithm or human readers.

Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, effect size of AI assistance) are not applicable to this document.

The document primarily describes non-clinical performance testing to demonstrate functional and material equivalence to a predicate device.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Non-Clinical)

The submission provides a table of non-clinical performance test items, their reference standards, acceptance criteria, and reported test results.

1. Table of Acceptance Criteria and Reported Device Performance:

Biocompatibility Testing:

The biocompatibility evaluation was conducted based on the device's classification as a surface device in contact with mucosal membrane for limited exposure (

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The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.

Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor.

The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced.

The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.

The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for a Disposable Endobronchial Blocker Tube. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested in your prompt regarding artificial intelligence (AI) device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance is not applicable to this medical device submission.

The "study" described in the document is a series of non-clinical, functional and biocompatibility tests intended to show that the new device performs similarly and safely compared to the predicate device, not necessarily to prove a specific clinical efficacy or diagnostic accuracy.

Here's the breakdown of the information that is available based on your request, with an explanation for the parts that are not applicable:

1. A table of acceptance criteria and the reported device performance

The document states: "Testing datas and results are included in this submission, and demonstrated that the Disposable Endobronchial Blocker Tube meets all the pre-determined testing and acceptance criteria." However, the specific acceptance criteria and the detailed reported Device performance values are not explicitly listed in the provided text. The document lists the types of tests performed:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical tests (e.g., how many blocker tubes were tested for dimensions, cuff seal, etc.), nor does it mention data provenance as it's not a clinical study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" equivalent for a physical device like this is its compliance with engineering specifications and biocompatibility standards, not clinical diagnostic accuracy assessed by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically relevant for clinical studies or AI performance evaluations where human expert consensus is needed.

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 is not applicable. The device is a physical medical instrument, not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission. The submission explicitly states: "Clinical and animal testing were not performed for Disposable Endobronchial Blocker Tube as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Disposable Endobronchial Blocker Tube, did not require clinical and animal studies to support substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as it is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device's performance is adherence to established engineering specifications, performance standards (like ISO 5361:2016 for anesthetic and respiratory equipment), and biocompatibility guidelines (ISO 10993 series).

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" for this physical device.

9. How the ground truth for the training set was established

This is not applicable.

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