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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target

Here's an analysis of the provided text regarding the superDimension/Bronchus device, focusing on acceptance criteria and study details.

Based solely on the provided text, there is very limited information about specific acceptance criteria or a detailed clinical study demonstrating the device meets those criteria. The submission is a 510(k) summary, which often provides high-level information.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The document states that the device meets these criteria rather than defining specific thresholds or metrics for the criteria (e.g., "guiding accuracy must be within X mm"). This is common in 510(k) summaries which declare substantial equivalence rather than presenting detailed performance specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the clinical evaluation (test set), nor does it break down the number of animal subjects. It only states "animal tests" and "a clinical evaluation."
• Data Provenance: The document doesn't specify the country of origin for the clinical data. It does state that superDimension Ltd. is located in Herzliya, Israel, which might imply the study was conducted there, but this is not explicitly stated for the clinical evaluation. It also doesn't explicitly state if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• The adjudication method is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• There is no mention of an MRMC comparative effectiveness study in the provided text.
• Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from this document.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• The device's intended use is to "aid the physician in guiding endoscopic tools," implying a human-in-the-loop system. The document does not describe any "standalone" performance evaluation of the algorithm without human intervention. Its stated purpose is as a guidance tool, not an autonomous diagnostic or procedural tool.

7. The Type of Ground Truth Used

• The document does not explicitly state the type of ground truth used for its "clinical evaluation" or "animal tests." Given the device's function as a guidance system for the tracheobronchial tree, potential ground truths could include:
  • Direct visualization/localization: Confirmation of tool tip position relative to the target using a reference standard (e.g., fluoroscopy, repeat CT scan with markers, direct visual confirmation if accessible).
  • Pathology/Biopsy results: If the guidance was for biopsy, the success of reaching a lesion later confirmed by pathology might be an indirect measure.
  • Expert Consensus: Clinical assessment by experienced bronchoscopists regarding the accuracy and ease of guidance.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This is a pre-market submission for a device, not a detailed paper about algorithm development. It's likely that the product integrates software and algorithms, but the specifics of their development and training are not disclosed here.

9. How the Ground Truth for the Training Set Was Established

• Since there's no mention of a training set or its sample size, there's also no information on how its ground truth was established.

Summary of Missing Information:

This 510(k) summary provides a high-level overview focused on establishing substantial equivalence. It lacks the granular detail about clinical study design, specific performance metrics, ground truth establishment, or expert involvement that would typically be found in a detailed clinical report or peer-reviewed publication. The "Performance Data" section indicates that tests were done and standards met, but not the specifics of how these were measured or the quantitative results beyond a general conclusion of safety and effectiveness.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for upper airways and tracheobronchial tree.

This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.

The provided text is a 510(k) summary for the Olympus BF Type UM40 Ultrasonic Bronchofiberscope. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval. It mentions the intended use, device description, and technological characteristics, but it does not delve into performance metrics, test sets, ground truth establishment, or statistical analyses typically found in a study proving acceptance criteria.

Therefore, I cannot populate the requested table or sections regarding acceptance criteria and study details based on the provided text. The document is a regulatory submission for market clearance, not a scientific study report.

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The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer. UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.

This document is a 510(k) Summary for the OLYMPUS UM-S30-25R ULTRASONIC PROBE and associated ancillary equipment for bronchial use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly addressed in this type of regulatory submission. The document emphasizes non-clinical tests for design and material compliance to established standards, which are a different kind of "acceptance criteria."

Here's an analysis based on the provided document:

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

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

This information is not provided in the 510(k) summary. The document refers to non-clinical tests (e.g., for electrical safety, EMC, material compatibility) rather than a clinical "test set" with 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 information is not provided as there is no mention of a formal clinical test set or ground truth establishment by experts in this document.

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

This information is not provided as there is no mention of a formal clinical test set or adjudication process in this document.

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

An MRMC comparative effectiveness study is not mentioned in this 510(k) summary. This document is for an ultrasonic probe, not an AI-powered diagnostic device.

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

A standalone performance study for an algorithm is not applicable and not mentioned in this document, as the device is an ultrasonic probe and not an algorithm.

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

This information is not provided as there is no mention of a formal clinical test set or ground truth in this document. The "ground truth" for this type of submission largely resides in meeting prescribed engineering and safety standards, as well as demonstrating equivalence to previously cleared devices.

8. The sample size for the training set

This information is not applicable as this document describes a physical medical device (ultrasonic probe), not a machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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