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The Bard X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard X-Force™ Nephrostomy catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a band which corresponds with the distal end of the balloon's working length to radiopaque facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is a 510(k) summary for a medical device (X-Force™ N30 Nephrostomy Balloon Dilation Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, general design, and fundamental scientific technology. It states: "The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted." However, it does not provide the details of these performance specifications or the results of those verification and validation activities.

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The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

The provided document K051316 is a 510(k) Pre-Market Notification for the Bard® X-Force™ Nephrostomy Balloon Dilation Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. As such, the document focuses on demonstrating substantial equivalence rather than conducting a de novo study with acceptance criteria for a novel device.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) submission.

Here's an breakdown of what can be extracted based on the provided text:

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

• Not Applicable: This 510(k) submission does not present specific acceptance criteria with quantifiable metrics that need to be met by the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through performance testing. The "reported device performance" is summarized as having "the same scientific technology as the predicate device" and that "appropriate testing to determine substantial equivalence was completed."

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

• Not Applicable: The document describes "appropriate testing to determine substantial equivalence," which includes "testing to accompany Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This implies physical and functional testing of the catheter itself (e.g., burst pressure, durability, etc.) rather than a clinical study involving patient data or a "test set" of cases. Therefore, concepts like sample size for a test set, country of origin, retrospective/prospective data provenance are not relevant for this type of submission.

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)

• Not Applicable: As there is no clinical "test set" in the sense of patient data requiring expert interpretation, the establishment of ground truth by clinical experts is not relevant to this submission. The "ground truth" for this device would be its physical and mechanical properties meeting engineering specifications.

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

• Not Applicable: Given the absence of a clinical test set requiring human interpretation, adjudication methods are not relevant.

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 device is a physical medical instrument (a nephrostomy balloon dilation catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of AI assistance is entirely irrelevant.

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

• Not Applicable: As stated above, this is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not Applicable for clinical ground truth: The "ground truth" for this device's performance would be engineering specifications and standards described in the referenced "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)". This would involve physical and mechanical testing to ensure the balloon inflates correctly, the catheter has appropriate strength and flexibility, and other functional parameters are met. Clinical outcomes data or pathology are not used to establish ground truth for this type of device in a 510(k) submission.

8. The sample size for the training set

• Not Applicable: "Training set" is a concept related to machine learning and AI. This device is a physical catheter, so there is no training set.

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

• Not Applicable: As there is no training set, this question is not relevant.

Summary based on the document:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter received 510(k) clearance based on substantial equivalence to the Cook® Ultraxx™ Nephrostomy Balloon Catheter. The primary evidence presented involved "appropriate testing to determine substantial equivalence" in accordance with the "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This guidance would outline the specific physical and mechanical tests required to demonstrate that the device performs as intended and is as safe and effective as the predicate device. However, the document does not contain the detailed results of these tests or specific acceptance criteria, as is typical for the publicly available 510(k) summary.

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