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The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.

The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea. delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.

This document is an FDA 510(k) summary for the EXALT Model B Single-Use Bronchoscope. It states that the proposed device is identical to its predicate device (EXALT Model B Single-Use Bronchoscope, K211030). The purpose of the Special 510(k) was only to revise the specifications for insertion tube stiffness. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device, which largely means showing that the new device has the same technological characteristics and indications for use as the predicate.

Here's a breakdown of why the requested information cannot be fully provided based on the given document:

• Acceptance Criteria and Reported Device Performance: This document states the device is identical to the predicate and only revised a specification for insertion tube stiffness. It does not provide performance metrics or acceptance criteria for clinical outcomes or device effectiveness.
• Study That Proves the Device Meets Acceptance Criteria: No such study is described for the proposed device. The only "testing" mentioned was on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish insertion tube stiffness in commercial use, which informed the revised specifications for the EXALT Model B.
• Absence of specific information regarding clinical trials or performance studies for the EXALT Model B: The document explicitly states, "Performance testing was not required to establish a finding of substantial equivalence between the proposed device and the predicate device, since the device is unchanged."

Therefore, it is not possible to fill in the requested table or answer the specific questions about clinical performance, test sets, ground truth, experts, or MRMC studies based solely on this 510(k) summary.

Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided document):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical "test set" for performance evaluation of the EXALT Model B is described.
2. 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): Not applicable, as no such test set or ground truth establishment is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable; this is a bronchoscope, not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance/testing:

• The proposed EXALT Model B Single-Use Bronchoscope is identical to its predicate device (K211030).
• The "special" nature of this 510(k) is to revise the specifications for insertion tube stiffness for the Slim, Regular, and Large sizes.
• Performance testing was NOT required to establish substantial equivalence for the EXALT Model B because it is "unchanged" from the predicate, except for the stiffness specification.
• "Performance testing was conducted on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish the insertion tube stiffness seen in commercial use." This testing informed the new specifications for the EXALT Model B.

In essence, this FDA letter and summary confirm that the EXALT Model B is substantially equivalent to a previously cleared device, and the specific change addressed (insertion tube stiffness specifications) was supported by testing performed on the original predicate device, not the EXALT Model B itself as a new performance study.

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EXALT Model B Single-Use Bronchoscope:
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.

EXALT Monitor:
The EXALT Monitor is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observations.

The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea, delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.

The EXALT Monitor is an electronic device that:

• Receives video signals from a Boston Scientific single-use endoscope,
• Processes the video signals,
• Displays image on integrated display
• Outputs video images to a secondary video monitor when connected to AC mains,
• Outputs electrical signal(s) that interface with external image capture systems, and
• Saves and exports procedure images and videos.

The EXALT Monitor also controls the light transmitted by the tip of the single-use endoscope to illuminate the area of interest within the anatomy. Buttons on the Monitor touch screen enable the user to control the brightness level of the light.

The provided text pertains to a 510(k) premarket notification for the Boston Scientific EXALT Model B Single-Use Bronchoscope and EXALT Monitor. This document is a regulatory submission for a medical device and describes its equivalence to predicate devices, focusing on design, physical characteristics, and basic performance parameters.

Based on the provided text, the device is a bronchoscope and monitor system, not an AI/ML-enabled diagnostic device. Therefore, the standard acceptance criteria and study design elements typically associated with AI/ML devices (like sensitivity, specificity, AUC, ground truth establishment by experts, MRMC studies, or training/test set sample sizes for AI models) are not present in this document.

The "study" described in the document is a series of non-clinical, bench performance tests to demonstrate substantial equivalence to predicate devices, rather than a clinical trial or AI model validation study.

Here's an analysis based solely on the provided information, framed to address your query about acceptance criteria and study to the best extent possible given the document's nature:

Acceptance Criteria and Device Performance (Based on provided text)

The document outlines performance testing to establish substantial equivalence to predicate devices. The "acceptance criteria" are implied to be that the subject device's performance characteristics are equivalent or superior to the predicate device's, or fall within similar operational parameters.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• For characteristics like "Field of View" or "Max Resolution," the acceptance criterion is implied to be "at least as good as the predicate" or "within a clinically acceptable range similar to the predicate."
• For physical dimensions (e.g., Insertion Tube Outer Diameter, Monitor Dimensions, Weight), the acceptance criterion is implied to be "comparable to the predicate" such that it does not raise new questions of safety or effectiveness.
• For "Suction Rate," the document explicitly states "equivalent or superior."
• For "Contrast control" on the monitor, the subject device does not have it, while the predicate does. This is presented as a difference but not as a failure to meet acceptance criteria, likely because it was deemed not to affect substantial equivalence for the intended use.
• For "Battery Life," the subject device's 1.5 hours is less than the predicate's 3 hours. This is also a difference but not framed as a failure.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a "test set sample size" in the context of an AI/ML model. The evaluation described is "performance testing (bench)" on the physical devices. It would involve a sample of the manufactured bronchoscope and monitor units. The exact number of units tested is not stated.
• Data Provenance: Not applicable in the context of clinical/image data for an AI/ML device. The testing is bench-based, likely performed in the manufacturer's labs.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This device is a bronchoscope and monitor, not an AI/ML diagnostic tool. There is no human image interpretation "ground truth" involved in the substantial equivalence testing described. The "ground truth" for these tests would be objective measurements of physical and performance parameters (e.g., measuring diameter, resolution charts, light meters, suction flow rates).

4. Adjudication Method

• Not applicable. There's no subjective interpretation or annotation process requiring adjudication for this type of device and testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC study was not conducted. This type of study is relevant for AI/ML-assisted diagnostic tools where human reader performance is being evaluated with and without AI assistance. This document describes a medical device (bronchoscope hardware) and its performance validation through bench testing, not an AI algorithm.

6. Standalone Performance (Algorithm Only)

• Not applicable. There is no AI algorithm being evaluated for standalone performance. The document describes the performance of a physical device system (bronchoscope and monitor).

7. Type of Ground Truth Used

• The "ground truth" for the performance tests described (e.g., field of view, resolution, suction rate) is based on objective physical measurements and engineering specifications obtained through bench testing, often against industry standards (e.g., ISO 8600 series). It is not clinical "expert consensus, pathology, or outcomes data."

8. Sample Size for Training Set

• Not applicable. This document does not describe the development or training of an AI/ML model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no AI/ML model, there is no training set and no associated ground truth establishment process in the context of medical image analysis.

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