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The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.

The CRE™ Pulmonary Balloon Dilatation Catheter is used to access the airway tree via a bronchoscope for the purpose of dilating strictures. It consists of an inflatable balloon on a catheter shaft with lumens for inflation and passage of a guidewire.

The provided text describes a medical device, the CRE™ Pulmonary Balloon Dilatation Catheter, and its 510(k) submission for clearance. However, the document does not contain specific acceptance criteria, detailed information about a study proving the device meets those criteria, or the other requested details such as sample sizes, expert qualifications, or ground truth establishment.

The document states:

• "In-Vitro Testing has been performed and all full devices met the required specifications for the completed tests."
• "A summary of the test results has been provided for Kink Resistance, Scope Insertion, Scope Removal, Inflation Time and Deflation Time."

This indicates that performance testing was conducted, and the device met its internal specifications, but these specifications themselves are not presented as "acceptance criteria" in the format requested. The document is a 510(k) summary, which typically provides an overview rather than granular study details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The specific criteria values and detailed performance metrics are not included.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is in-vitro testing, not expert-adjudicated clinical data.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not mentioned and unlikely for this type of device and submission.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: For in-vitro testing, the "ground truth" would be the predetermined engineering specifications or physical measurements, which are not detailed here. No clinical ground truth (pathology, outcomes) is reported.
8. Sample size for the training set: Not applicable as this is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable for the same reason.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K023337) based on the modification of catheter shaft working length and adherence to manufacturing specifications via in-vitro testing. It does not provide the detailed study information you requested for an AI/algorithm-based device or a clinical outcome study.

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The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.

The CRE™ Pulmonary Balloon Dilatation Catheter is used to access the airway tree via a bronchoscope for the purpose of dilating strictures. It consists of an inflatable balloon on a catheter shaft with lumens for inflation and guidewire.

The provided text describes a 510(k) premarket notification for the "CRE™ Pulmonary Balloon Dilatation Catheter." This filing aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with an AI component.

Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI performance is not applicable or cannot be extracted from this document, as this is a traditional medical device submission (a physical device, not a software/AI device).

The document states: "Boston Scientific Corporation has demonstrated that the CRE™ Pulmonary Balloon Dilatation Catheter is substantially equivalent to the currently marketed CRE™ Balloon Dilatation Catheter." This conclusion is based on "a thorough comparison of the descriptive characteristics between the proposed devices and the predicate devices show equivalence."

Key Findings from the document:

• Device Type: The device is a physical medical instrument: "an inflatable balloon on a catheter shaft with lumens for inflation and guidewire."
• Purpose of Submission: The 510(k) submission aims to show "substantial equivalence" of the new CRE™ Pulmonary Balloon Dilatation Catheter to a predicate device (the currently marketed CRE™ Balloon Dilatation Catheter). This is a common regulatory pathway for devices that are similar to existing ones.
• Method of Equivalence: Equivalence was demonstrated through a "thorough comparison of the descriptive characteristics." This implies engineering and design comparisons, not necessarily a clinical study with new performance metrics.
• No AI or Software Component: There is no mention of any AI, software, or algorithm in the description of the device or the justification for its equivalence.
• Acceptance Criteria and Device Performance: Since this is a substantial equivalence claim based on descriptive characteristics, there are no specific performance acceptance criteria or a study proving the device meets them in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, accuracy). The acceptance criterion is "substantial equivalence" to the predicate device.

Therefore, the table and other requested information fields are largely inapplicable to this specific document.

Here is an attempt to populate the table and sections based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a physical device submission demonstrating substantial equivalence to a predicate device via descriptive characteristics, not through a clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method is described.

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

• Not Applicable. This is a physical device without an AI component. No MRMC study was conducted.

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

• Not Applicable. This is a physical device without an algorithm.

7. The type of ground truth used

• Not Applicable. No ground truth in the context of AI/software performance is used. The "ground truth" for this submission is the established performance and safety profile of the predicate device, to which the new device is compared descriptively.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML model requiring a training set.

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

• Not Applicable. This is a physical device, not an AI/ML model requiring a training set.

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