Search Results

The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.

The Neuroblade System is comprised of three components: Neuroblade, Neuropad and Cart. The Neuroblade is a hand-held, sterile neuroendoscope with lighting and camera at its distal end. The camera images are displayed on the Neuropad via a connecting cable that extends from the proximal end of the Neuroblade. It has integrated irrigation and aspiration functions. The distal bipolar electrode allows the application of RF energy from a third-party radiofrequency (RF) generator for coagulation of bleeding vessels in the neuro space. A cutting window on the side of distal end is for the removal of blood clots. The Neuroblade System, like other neuroendoscopes, is advanced into the brain through a burr hole created in the patient's skull. The tip of the Neuroblade is advanced under visualization via the illuminated camera image transmitted from the distal tip of the Neuroblade to the Neuropad. The Neuroblade has irrigation and vacuum tubing (2.0 m) that allows for connection to a third party saline infusion bag and a vacuum waste bucket, respectively. The waste bucket is connected to a vacuum regulator which is attached to the hospital's vacuum system. The bipolar electrode is incorporated into the distal tip of the Neuroblade and has a bipolar plug (20 cm) on the proximal end that allows for connection to a third-party bipolar cord. The proximal end of that bipolar cord connects to the RF Generator. An RF Generator and bipolar cord are common accessories in the operating room. The Neuroblade has a working channel that will facilitate the introduction of flexible endoscopic surgical devices (≤1.7 mm outer diameter) into the surgical site. That same working channel will also facilitate irrigation of the target site and is the channel that supports the aspiration of fluid and tissues. The Neuropad can be installed onto the Cart and adjusted by the user for height and tilt. The Neuropad allows the user to input patient data, control some aspects of the image, and record the case.

I am sorry, but the provided text does not contain the specific acceptance criteria for the device, nor the detailed results of a study that proves the device meets those criteria in a format that would allow me to populate the requested table directly. The document primarily describes the device, compares it to predicate devices, and lists various tests performed (biocompatibility, electrical safety, bench testing, an animal study, etc.) with a "Pass" result, but without specifying the quantitative or qualitative acceptance criteria for each of those tests or linking them to a comprehensive performance evaluation in the way requested.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: While tests are listed, the specific criteria for "Pass" are not detailed, nor are numerical or descriptive performance metrics provided for each criterion.
2. Sample size used for the test set and data provenance: A general animal study is mentioned, but specific sample sizes for particular performance tests are not given.
3. Number of experts used to establish ground truth and their qualifications: Not explicitly stated for any specific test.
4. Adjudication method: Not discussed.
5. MRMC comparative effectiveness study: No mention of such a study or effect sizes of human reader improvement with AI. The device is a neuroendoscopy system, not an AI-assisted diagnostic tool.
6. Standalone performance: The tests are generally standalone device performance evaluations, but the specific metrics are not provided as requested.
7. Type of ground truth: For the animal study, necropsy and histopathology were used for confirmation, but for other tests, "ground truth" in the requested sense is not clearly defined.
8. Sample size for the training set: Not applicable as this is not an AI/ML device with a separate training set.
9. How ground truth for the training set was established: Not applicable.

The document mainly focuses on proving substantial equivalence to predicate devices through various engineering and safety tests, rather than presenting a clinical performance study with detailed acceptance criteria and results.

Ask a specific question about this device

The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

The ClearPath™ Disposable Introducer is a sterile, single-use, neurological endoscope Introducer, consisting of a Sheath and a Dilator.

A locking mechanism design allows the Dilator to lock into the Sheath and prevent "push back" during insertion into the brain. The Dilator tip is designed to be atraumatic during insertion. The Sheath is graduated in centimeters to assist the surgeon in determining the Introducer insertion depth. The Sheath's transparency is useful for full endoscopic visualization during insertion.

The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.

The provided text is a 510(k) summary for the ClearPath™ Disposable Introducer. It focuses on demonstrating substantial equivalence to a predicate device (MINOP® Disposable Introducer 26F, K142315) rather than providing extensive details about acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML device.

Therefore, many of the requested details, such as AI-specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established, are not available in this document as it pertains to a mechanical medical device, not an AI/ML device.

However, I can extract the available information related to performance and testing from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify a "test set" in the context of data for an algorithmic device. The testing described (biocompatibility, bench testing, transit testing, shelf life) refers to physical device testing, not data-driven performance evaluation. Therefore, sample sizes for data-driven testing and data provenance are not applicable or provided.

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

• This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth from a test set of data.

4. Adjudication method for the test set:

• This information is not applicable for the same reasons as point 3.

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:

• This information is not applicable as the ClearPath™ Disposable Introducer is a physical medical device, not an AI-assisted device.

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

• This information is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

• For the performance aspects mentioned (biocompatibility, bench testing, transit testing, shelf life), the "ground truth" would be established by pre-defined engineering specifications, international standards (ISO 10993, ASTM D4169), and validated laboratory testing procedures. There is no "expert consensus" or "pathology" in the context of data for this type of device.

8. The sample size for the training set:

• This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

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

In summary, the provided FDA 510(k) document is for a conventional medical device (an introducer) and thus does not contain the detailed AI/ML specific information requested in many of the questions. It uses standard engineering and biocompatibility testing to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

Ask a specific question about this device

The Axonpen System is indicated for the illumination of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

The Axonpen System consists of a neuroendoscope (Axonpen) and a monitor (Axonmonitor) to view the image from the distal end of the Axonpen. The Axonpen is a steerable, single-use, neuroendoscope with an integrated camera and LED light source. It has a working channel for third-party tools, irrigation, and aspiration. The distal end is steerable and can be extended. The Axonmonitor is a combination of the Axonbox (firmware) and a third-party tablet for viewing and recording images. It is battery operated.

This document is a 510(k) summary for the Axonpen System, which is a neurological endoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically proving the device meets those acceptance criteria in the way described in the request using clinical performance metrics. The provided information is primarily focused on design, materials, and safety testing to support equivalence.

However, based on the provided text, here's an attempt to extract and infer the requested information, acknowledging that a full clinical study with specific performance acceptance criteria for diagnostic/treatment efficacy is not detailed in this 510(k) summary.

Acceptance Criteria and Study for ClearMind Biomedical's Axonpen System (K201308)

The provided 510(k) summary for the Axonpen System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various bench and biocompatibility tests. It does not detail specific performance acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or clinical outcomes that would typically be found in a clinical study proving a device meets such criteria. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful completion of bench testing to demonstrate functionality and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) summary, specific numerical performance metrics are not explicitly stated as "acceptance criteria" for clinical efficacy. The performance reported primarily relates to safety, functionality, and compliance with standards.

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

The 510(k) summary does not mention a clinical test set with human subjects. The "test set" primarily refers to bench tests and in-vitro studies. Therefore:

• Sample Size for Test Set: Not applicable for a clinical test set. For bench/material tests, specific sample sizes are not provided in this summary.
• Data Provenance: The tests conducted (biocompatibility, electrical safety, aspiration, optical, etc.) are generally laboratory-based studies. The document does not specify country of origin for this testing, nor does it specify "retrospective or prospective" as these are not clinical studies.

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

This information is typically relevant for clinical studies involving expert review of images or interpretations. Since no human-based clinical test set is described, this section is not applicable to the provided document.

4. Adjudication Method for the Test Set

As no clinical test set requiring expert interpretation is detailed, an adjudication method is not applicable.

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

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence based on design, materials, and engineering performance, not on direct comparison of reader performance with and without AI assistance.

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

The Axonpen system includes an integrated camera and display (Axonmonitor) for visualization, implying a human-in-the-loop for interpretation and surgical decisions. There's no indication of an "algorithm-only" standalone performance evaluation in the context of diagnostic or treatment decision-making (e.g., using AI for automated pathology detection).

7. The Type of Ground Truth Used

For the various bench and material tests mentioned:

• Biocompatibility: Ground truth is established by standardized testing methodologies (e.g., cell viability in cytotoxicity, immune response in sensitization) and established regulatory limits defined by ISO standards.
• Aspiration Functionality: Ground truth is the observable outcome of successful aspiration of fluid and clots without damage, assessed by direct observation in bench models.
• Optical Performance: Ground truth for optical quality refers to measurable physical properties related to image quality (e.g., resolution targets, color accuracy charts).

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this document since it doesn't describe a clinical study where such ground truths would be applied to a diagnostic or treatment outcome.

8. The Sample Size for the Training Set

The Axonpen system, as described, does not appear to be an AI/machine learning device that would typically have a "training set" of data in the manner of deep learning algorithms for image analysis. Its functions (illumination, visualization, aspiration) are mechanically and optically driven. Therefore, this is not applicable.

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

Since there is no mention of a training set for an AI/machine learning component, this question is not applicable.

Ask a specific question about this device