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Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a MRI and/or CT imaging.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Trajectory Guide Biopsy Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria & Performance: The document only lists the device's trade/device name, regulation number, regulatory class, product code, and indications for use. It does not provide specific performance metrics (e.g., accuracy, precision, success rates) or the numerical acceptance criteria for those metrics.
• Study Details: There is no mention of any specific study conducted to validate the device's performance. All the requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance is absent.
• Purpose of Document: This is a regulatory clearance letter, not a scientific study report or a summary of performance data. Its purpose is to officially state that the device can be marketed in the U.S. because it's deemed "substantially equivalent" to existing devices, implying that detailed performance data was submitted separately in the 510(k) application, but it's not present in this letter.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) submission document or a summary of the performance studies conducted by Image-Guided Neurologics, Inc. for the Navigus Trajectory Guide Biopsy Kit.

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Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

This device is identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc Sheathless IAB-04230S predicate.

This 510(k) summary (K963865) describes a substantial equivalence claim for an intra-aortic balloon catheter, the Arrow 8Fr - 30cc Narrowflex™ Sheathless Intra-Aortic Balloon Catheter. The document focuses on comparing its characteristics to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria with numeric thresholds, a specific study with a sample size, expert involvement for ground truth, or MRMC studies, are not present in the provided text. The submission relies on "nonclinical test results showing comparable performance" to established predicate devices.

Here's an attempt to answer based on the provided information, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The nonclinical test results included in the submission showing comparable performance to the predicate devices are as follows." This indicates that the "study" was a set of nonclinical tests designed to demonstrate equivalence to the predicate devices across the listed characteristics. The submission focuses on substantial equivalence to existing legally marketed devices (K961358 for both listed predicates) rather than establishing new, independent performance thresholds.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: Not specified in the provided text. The document only mentions "nonclinical test results."
• Data Provenance: Not specified. Given it's a nonclinical bench test, typical provenance details like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical study. It's safe to assume these were internal laboratory tests conducted by Arrow International.

3. Number of Experts and Qualifications:

• Not applicable. This was a nonclinical engineering/performance test, not a study requiring expert readers for ground truth establishment.

4. Adjudication Method:

• Not applicable for a nonclinical test of this nature.

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

• No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is typically for evaluating diagnostic imaging or similar devices where human interpretation is a key component.

6. Standalone Performance Study (Algorithm Only):

• Yes, in a sense, the "nonclinical test results" are a form of standalone performance evaluation for the device itself. However, it's not an "algorithm only" study as there's no algorithm involved. It's a physical device being tested without human-in-the-loop performance being a primary measure, but rather intrinsic device performance characteristics.

7. Type of Ground Truth Used:

• For the nonclinical tests, the "ground truth" would likely be engineering specifications, established physical limits, or direct comparative measurements against the predicate devices using calibrated instruments and standardized test methods. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

• Not applicable. This is a medical device, not an AI/machine learning algorithm, so there is no "training set."

9. How Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for an AI/machine learning algorithm.

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The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty

The provided 510(k) summary for the Datascope Percor STAT-DL® 9.5Fr. & 10.5 Fr. Intra-Aortic Balloon (IAB) does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/ML device.

This document describes a medical device from 1997, which predates the widespread use of AI/ML in medical devices and the regulatory frameworks associated with them. The criteria for demonstrating safety and effectiveness at that time were different.

Here's an analysis based on the provided text, highlighting the absence of the requested AI/ML specific information:

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

The document does not provide a table of acceptance criteria nor specific performance metrics in the way a modern AI/ML device submission would. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions comparably to the predicates.

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

• Test Set Sample Size: Not applicable. There was no "test set" in the context of an AI/ML model for this submission. The "tests" mentioned are in-vitro physical/mechanical tests.
• Data Provenance: Not applicable for an AI/ML test set. The in-vitro tests would have been conducted in a lab setting.

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. This device is not an AI/ML diagnostic or prognostic tool that relies on expert consensus for ground truth. Its safety and effectiveness are established through engineering design, material science, and mechanical testing, comparing it to existing, approved devices.

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

Not applicable. There was no expert adjudication process for this type of device submission.

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 not an AI/ML device designed to assist human readers.

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

Not applicable. This is a physical medical device (an intra-aortic balloon), not an algorithm.

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

Not applicable. For this device, "ground truth" would relate to the physical and chemical properties of the device components and its functional operation when tested in vitro, compared against specifications or performance of predicate devices.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no training set.

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

Not applicable. There is no AI/ML model, and therefore no training set or ground truth establishment for it.

Summary of the Study and Conclusion from the Document:

The "study" presented is a demonstration of substantial equivalence (through non-clinical tests) to legally marketed predicate devices.

• Non-Clinical Tests: In-vitro tests were conducted to demonstrate that the functionality and performance characteristics of the new device (Datascope Percor STAT-DL® 9.5Fr. & 10.5Fr. IAB) are comparable to the currently marketed predicate devices. The differences in material grade and chemical composition were analyzed and demonstrated not to affect safety or efficacy.
• Clinical Tests: The document explicitly states, "There has been no clinical evaluation of the new device in the U.S." This further emphasizes that the approval was based on non-clinical data and substantial equivalence.
• Conclusion: Based on the information from the in-vitro tests and comparison to predicate devices, Datascope's Percor STAT-DL® 9.5Fr. & 10.5Fr. IABs were considered substantially equivalent to Datascope's currently marketed IABs. This substantial equivalence is the "proof" that the device met the (implied) regulatory acceptance criteria for market clearance in 1997.

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