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The MobiCath Transseptal Needle is used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needles consist of a thin-walled stainless steel cannula bonded to an ergonomic handle and stopcock, and a removable stylet. The cannula is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with an introducer or catheter. The handle is integrated with a pointer to show the orientation of the curve. The two-way stopcock facilitates air aspiration, fluid infusion, blood sampling, and pressure monitoring. The stylet attaches to the proximal end of the needle assembly.

Here's an analysis of the provided text regarding the MobiCath Transseptal Needle, focusing on the acceptance criteria and the study that proves the device meets them.

This document describes a 510(k) submission for a modified medical device, specifically stating "Greatbatch Medical proposes using an alternate stopcock for the MobiCath Trasseptal Needles. The current stopcock has been discontinued by the supplier. A similar stopcock has been tested as a replacement. A few minor design changes are required for the stopcock to interface with the handle components. In addition, a few manufacturing improvements have been proposed." This means the studies are not for a novel device but to demonstrate substantial equivalence of the modified device to a previously cleared predicate device (MobiCath Transseptal Needle K111644).

Therefore, the "acceptance criteria" here are to demonstrate that the changes have not introduced new safety or efficacy issues and that the device performs equivalently to the predicate. The "study" refers to a battery of non-clinical tests.

Acceptance Criteria and Device Performance

The provided document doesn't explicitly list "acceptance criteria" with numerical thresholds in a table format for each test. Instead, it describes a series of tests performed to ensure the modified device (with a new stopcock) maintains the same performance and safety profile as the predicate device. The implied acceptance criterion for each test is that the modified device performs comparably to the predicate or within established engineering specifications for the original device.

Since specific numerical thresholds for acceptance are not provided, the "Reported Device Performance" is generally stated as "risks have been mitigated and that no new safety or efficacy issues were raised," implying successful completion of the tests.

Study Details

1. Sample sizes used for the test set and data provenance:

   • The document does not specify sample sizes for any of the non-clinical tests.
   • The data provenance is not explicitly stated in terms of country of origin, but it is clear these are retrospective tests conducted by Greatbatch Medical to support the 510(k) submission for a device modification. They are lab-based tests, not clinical studies involving patient data.

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

   • This question is not applicable here. These are non-clinical engineering and biological tests conducted in a laboratory setting, not studies involving human interpretation of medical data (like radiology images). "Ground truth" in this context would refer to established engineering specifications or industry standards, which are not set by human experts in the sense implied by the question.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies where multiple readers interpret complex data. These are objective non-clinical tests with predefined pass/fail criteria.

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:

   • This is not applicable. This submission is for a physical medical device (transseptal needle) and does not involve AI, image interpretation, or human readers in an MRMC study.

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

   • This is not applicable. This is not an algorithmic or AI-based device.

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

   • For the non-clinical tests performed, the "ground truth" refers to predefined engineering specifications, material properties standards, and biocompatibility standards. For example, for "Air and liquid leakage," the ground truth is an established standard for permissible leakage, or zero leakage. For "Tensile" testing, it would be a specified tensile strength range.

7. The sample size for the training set:

   • This is not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • This is not applicable. As above, there is no training set for this type of device submission.

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The MobiCath™ Transseptal Needle is used to create the primary puncture in the inter-atrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needle consists of a thin-walled stainless steel cannula which is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with a transseptal catheter or introducer. The proximal end of the needle is bonded to an ergonomic handle with an integrated pointer to show the orientation of the curve section and a two-way stopcock to facilitate air aspiration, fluid infusion, blood sampling, and pressure monitoring. The Transseptal Needle includes a stylet with an over-molded hub designed to attach to the proximal end of the needle assembly.

This is a Premarket Notification (510(k)) for the MobiCath Transseptal Needle, a medical device for creating punctures in the inter-atrial septum. The provided document describes the device, its indications for use, comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, the acceptance criteria are implicit in the performance of the predicate devices and the successful completion of a battery of non-clinical tests. The stated objective is to demonstrate that the device "performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."

The reported device performance is that it "passed all verification specification criteria." This indicates that the device met internal design and functional requirements, which were presumably benchmarked against the predicate devices.

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

• Sample Size: The document does not specify the exact sample size for each bench test conducted. It states "Performance (bench) testing... were performed." For sterilization, shelf life, and biocompatibility, standard protocols according to the cited ISO standards would have been followed, which inherently involve specific sample sizes. However, these are not quantified in the summary.
• Data Provenance: The testing described is pre-clinical bench testing. There is no mention of human subject data, animal data (beyond specific biocompatibility tests like "Rabbit Pyrogen"), or retrospective/prospective clinical data for the performance evaluation. It's all laboratory-based, controlled testing of the physical device.

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

• This question is not applicable in the context of this 510(k) submission. This is a pre-clinical performance study of a physical medical device, not an AI or diagnostic imaging device that requires expert-established ground truth for a test set. The "ground truth" for the performance tests would be the established engineering specifications and industry standards (e.g., ISO, internal design requirements) that the device must meet.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., image interpretation) to resolve discrepancies in ground truth establishment. The tests performed here are objective bench tests with pass/fail criteria based on specifications.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools or image analysis, which this device is not. The MobiCath Transseptal Needle is a physical surgical tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The device is a physical, manually operated transseptal needle and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation in this 510(k) is based on engineering specifications, industry standards (e.g., ISO 11135-1, ISO 10993-1), and the performance characteristics of the predicate devices. The device had to pass "verification specification criteria" in various bench tests. This is a form of "established scientific principles and objective measurements" as ground truth.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

• This question is not applicable as there is no training set.

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