Search Results

The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source:

• Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery.
• The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.

The provided text describes the Myriad SPECTRA Light Source, an accessory for fluorescent visualization of grade III or IV gliomas during neurosurgery. The submission focuses on demonstrating substantial equivalence to a predicate device (Leica FL400) through performance testing.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists various tests conducted and states that the device "Passed" them or that the results were "acceptable" compared to the predicate. The "acceptance criteria" are implied by the nature of the tests and the "Passed" results.

For the purpose of this summary, I will infer the acceptance criteria from the context of "Passed" or "acceptable when compared to the predicate device" results.

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

The document provides very limited information regarding sample sizes for human-involved testing:

• Usability/Comparison Study: This study involved a usability/comparison study where users "consistently and accurately rank[ed] the level of fluorescence." No specific sample size (number of users or cases) is mentioned.
• Data Provenance: The document does not specify the country of origin of the data or whether any human user studies were retrospective or prospective. Given the nature of a 510(k) submission for a light source, most of the "testing" described is non-clinical (electrical, mechanical, optical properties) rather than clinical.

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)

This information is not provided in the document. For the usability/comparison study where users ranked the level of fluorescence, there is no mention of experts establishing a "ground truth" for the fluorescence levels themselves, nor are the qualifications of the users participating in this study mentioned. The study focused on the user's ability to consistently and accurately rank the level of fluorescence, implying a comparison rather than an absolute ground truth establishment.

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

This information is not provided in the document.

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

• MRMC Study: There is no mention of an MRMC comparative effectiveness study in the provided text.
• AI Assistance: The device described, Myriad SPECTRA Light Source, is a light source for surgical visualization, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The usability/comparison study simply assessed the user's ability to rank fluorescence levels when using the device with a compatible surgical microscope, comparing it implicitly to the predicate.

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

The Myriad SPECTRA Light Source is a hardware device (a light source) used in conjunction with a surgical microscope and a fluorophore for human visualization. It is not an algorithm, and therefore, a "standalone algorithm only" performance study is not applicable and was not done.

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

For the non-clinical performance tests (illumination characteristics, general performance, environmental, electrical safety, etc.), the "ground truth" is based on established engineering specifications, industry standards (e.g., IEC/UL/EN 60601-1, ISO 10993), and comparisons to the predicate device's measured characteristics.

For the usability/comparison study, the "ground truth" for fluorescence levels is not explicitly defined as expert consensus or pathology. The study assesses the user's ability to consistently and accurately rank fluorescence, implying that the relative levels of fluorescence in the tested scenarios served as a de facto ground truth for comparative purposes.

8. The sample size for the training set

The device is a hardware light source, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable to this device.

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

As the device does not involve a training set for machine learning, this question is not applicable.

Ask a specific question about this device

The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, percutaneous, and open. Applications include those when access to the is limited, such as Neurosurgical/ Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following:

• Primary/Secondary Brain Tumors
• Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation/CH)
• Intraventricular Tumors/Cysts
  The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue.
  The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.

The NICO Myriad NOVUS is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The handpiece is capable of precise tissue shaving and rapid tissue debulking.
The NICO Automated Preservation System™ is a group of accessories for collection and preservation of resected tissue, it is comprised of three parts:

• Specimen Collector with filter element which collects tissue;
• Specimen Infusion Valve (SIV) which provides the desired biological environment;
• Specimen Preserver which provides the desired thermal condition
  For standard handpieces, the Myriad-LX™ high intensity light source, handpiece sleeve, and illumination fiber combine to deliver illumination to the surgical field to aid in visualization.

The provided text describes the NICO Myriad NOVUS device and its substantial equivalence to a predicate device (NICO Myriad cleared under K182340). However, it does not contain details about specific acceptance criteria, reported device performance metrics with quantitative values, or a study design involving test sets, expert ground truth, adjudication methods, or comparative effectiveness studies (MRMC or standalone AI performance).

The document primarily focuses on:

• Device Description: What the NICO Myriad NOVUS is, its components, and its intended use (resection and removal of soft tissue and fluids).
• Comparison to Predicate: Highlighting the similarities and differences, specifically mentioning the addition of illumination and a console software update as key changes.
• Nonclinical Testing: Listing various tests performed to demonstrate compliance with design and performance requirements and support substantial equivalence. These tests are largely related to engineering, material science, and software validation, not clinical performance metrics in terms of accuracy or efficacy for specific diagnostic or prognostic tasks.

Therefore, I cannot provide the requested information from the given text. The text does not detail an AI/ML-driven medical device evaluation study as outlined in your request.

Ask a specific question about this device

The NICO Myriad™ is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.

Specific neurosurgical indications may include diseases such as the following:

• Primary/Secondary Brain Tumors
• Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation)
• Intraventricular Tumors/Cysts

The Myriad is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.

The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS is comprised of three parts:

• Specimen Collector with filter element which collects tissue;
• Specimen Infusion Valve (SIV) which provides the desired biological environment;
• Specimen Preserver which provides the desired thermal condition

The provided text describes a 510(k) premarket notification for the NICO Myriad device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with predefined metrics.

Therefore, the document does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them in the context of an AI/ML medical device. Specifically:

• Acceptance Criteria Table and Reported Performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, AUC) for the device. Instead, it focuses on demonstrating that design changes do not raise new questions of safety or effectiveness compared to the predicate device.
• Sample Size and Data Provenance (Test Set): This information is not applicable as there is no mention of a clinical "test set" being used to evaluate performance against specific metrics like an AI/ML model would require. The testing described is primarily non-clinical (e.g., biocompatibility, longevity, IEC 60601-1 testing).
• Number of Experts and Qualifications (Ground Truth): Not applicable, as there's no mention of expert-established ground truth for a test set.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Study: Not applicable. This type of study is common for evaluating the impact of AI on human reader performance, which isn't the focus of this 510(k) summary.
• Standalone Performance: Not applicable. The NICO Myriad is an electrosurgical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable. The device is not an AI/ML model.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of what is in the document:

The document outlines the NICO Myriad's substantial equivalence to a predicate device (K161307). The new submission (K182340) addresses changes such as:

• New contract manufacturer
• Design enhancements/process improvements (e.g., electronic components, bonding methods, adhesives)
• Capital equipment changes
• Packaging changes
• Additional handpiece offering (11 ga x 13 cm Pre-Bent handpiece)
• Labeling updates

The non-clinical testing performed to support substantial equivalence includes:

• Biocompatibility per ISO 10993-1
• Longevity Testing
• Specification Review & Dimensional Analysis
• Usability & Design Validation
• IEC 60601-1 Testing
• Sterility Testing
• Packaging Stability and Performance
• Product Stability
• Various Process Validations

The conclusion is that these changes "do not raise new questions of safety or effectiveness," indicating that the device "is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad." This is the typical standard for a 510(k) clearance, which differs significantly from the type of performance evaluation required for AI/ML-based medical devices.

Ask a specific question about this device

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:

• Primary/Secondary Brain Tumors
• · Vascular Abnormalities/Malformations
  · Intraventricular Tumors/Cysts

The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.

The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.

The provided text focuses on the 510(k) premarket notification for the NICO BrainPath device, specifically for an updated version (K172433) compared to a predicate device (K150378). This is a submission for device substantial equivalence, not a study proving the device meets acceptance criteria in terms of diagnostic performance or clinical outcomes for an AI/algorithm-based medical device.

Therefore, many of the requested criteria regarding AI/ML device performance evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this document.

However, I can extract the acceptance criteria and "performance" findings relevant to a medical device's physical and functional properties, as presented in this 510(k) submission.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):

The document describes non-clinical testing performed to demonstrate that modifications to the NICO BrainPath still meet applicable design and performance requirements and support substantial equivalence to the predicate device. The "acceptance criteria" can be inferred as the expected "Pass" or "Non-cytotoxic," "Non-sensitizer," "Non-irritant" results for the respective tests.

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

• Sample Size: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of devices tested for biocompatibility, number of packaging units, etc.). It generally states "All" devices/components were subjected to relevant tests.
• Data Provenance: The data provenance is internal to NICO Corporation's testing and validation processes. The document does not mention the country of origin of "data" in a patient/clinical sense, as this is laboratory/engineering testing. It is retrospective in the sense that the testing was conducted prior to the 510(k) submission to demonstrate compliance.

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

• This question is not applicable to the data presented. The document describes laboratory and engineering tests (e.g., biocompatibility, sterilization, simulated use, packaging). "Ground truth" in the context of expert consensus (like for image interpretation in AI) is not relevant here. Compliance with established standards (e.g., ASTM, ISO standards for biocompatibility) would be the "ground truth."

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

• This question is not applicable to the data presented. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretative variability exists. For engineering tests, results are typically objective Pass/Fail or numerical measurements against defined 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:

• This question is not applicable. This device is a physical surgical tool (self-retaining retractor), not an AI/ML-based diagnostic or assistive software that interacts with human "readers" or interpreters.

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

• This question is not applicable. This device is a physical surgical tool, not an algorithm or software.

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

• The "ground truth" for the non-clinical tests is adherence to established engineering specifications, validated test methodologies, and recognized industry standards (e.g., for biocompatibility, sterility, packaging integrity). For example, a "Pass" for sterility validation means the device met the acceptance criteria for a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product, and its design is based on engineering principles and previous versions (predicate device).

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

• This question is not applicable. As there is no training set for an AI/ML algorithm, this concept does not apply. The "ground truth" for the device's design and manufacturing is established through defined product specifications, design control processes, and compliance with quality system regulations (e.g., 21 CFR Part 820).

Ask a specific question about this device

The NICO Myriad™ is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.

Specific neurosurgical indications may include diseases such as the following:

• · Primary/Secondary Brain Tumors
• · Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation)
• · Intraventricular Tumors/Cysts

The Myriad is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.

In addition to the system and handpiece accessories or replacement parts, this submission also covers the Tissue Preservation System (TPS). The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS is comprised of three parts:

• Specimen Collector with filter element which collects tissue;
• Specimen Infusion Valve (SIV) which provides the desired biological environment;
• Specimen Preserver which provides the desired thermal condition ●

These TPS accessories can be arranged in a multitude of ways depending on the desired setup. Refer the handpiece IFU for additional details. The following tables outline the system, components, accessories, and various handpieces sizes.

The NICO Myriad™ is a powered instrument for resection and removal of soft tissue and fluids. The provided text, a 510(k) summary for the device, does not explicitly define acceptance criteria in a quantitative manner for specific performance metrics. Instead, the study aims to demonstrate substantial equivalence to predicate devices through a combination of non-clinical testing and clinical review, asserting that the device is at least as safe and effective.

Here's an analysis of the provided information:

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

As stated, explicit quantitative acceptance criteria are not provided in the document. The acceptance is determined by "Passed" outcomes for various non-clinical tests and a "Clinical Review" that supports its intended use.

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

• Non-Clinical Testing: The document does not specify exact sample sizes for each non-clinical test. The tests are general verification, life cycle, and environmental tests, likely conducted on a sufficient number of units to demonstrate compliance.

• Clinical Review (Case Reports):

  • Sample Size: 1205 case reports for Myriad alone, and 617 case reports for Myriad used in conjunction with NICO BrainPath (totaling 1822 case reports).
  • Data Provenance: The document does not explicitly state the country of origin. It mentions "physician feedback on some of their cases in the form of case reports," which suggests these are real-world clinical data. Given the address of NICO Corporation in Indianapolis, Indiana, USA, it's plausible a significant portion, if not all, of these reports originate from the US.
  • Retrospective/Prospective: The description "NICO obtains physician feedback on some of their cases in the form of case reports" suggests these are retrospective reports of cases that have already occurred.

• Clinical Review (Literature Citations):

  • Sample Size: 33 journal citations and 12 posters/abstracts were provided. These represent over 500 clinical uses of the Myriad.
  • Data Provenance: Not specified, but likely from various international and domestic sources, as journal articles are often widely published.
  • Retrospective/Prospective: Journal articles and abstracts can include both retrospective and prospective study designs.

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)

For the non-clinical tests, the "experts" would be the engineers, technicians, and quality control personnel performing and evaluating the tests according to established standards. Their specific number and qualifications are not detailed.

For the clinical review, the "ground truth" for the case reports would be the clinical outcomes and observations made by the treating physicians. The "experts" are the physicians who submitted the case reports and the authors of the peer-reviewed articles. Their specific number and qualifications (e.g., years of experience, specialty) are not provided in the summary, other than being implied as current clinical users or researchers in neurosurgery and related fields.

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

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either the non-clinical or clinical review sections.

• Non-Clinical: Testing results are typically evaluated against pre-defined specifications by the testing personnel and reviewed by quality management.
• Clinical Review: The "ground truth" is derived from individual physician case reports and published literature, which are generally accepted as reported by the authors/clinicians, without an explicit multi-expert adjudication mentioned in this summary. The purpose of this section is to corroborate usage patterns, not to establish a new ground truth for specific diagnoses.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any AI component in this device submission. The NICO Myriad is a surgical instrument, not an AI-powered diagnostic or assistive tool.

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

Not applicable, as the NICO Myriad is a physical surgical instrument and not an algorithm.

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

• Non-Clinical Testing: The "ground truth" for these tests is based on established engineering and safety standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. Performance is measured against these standards and specifications.
• Clinical Review: The "ground truth" for the clinical review is based on:
  • Outcomes Data/Physician Observation: from the 1822 case reports, describing the use of the device and its clinical context.
  • Published Clinical Literature: (33 citations, 12 abstracts) serving as evidence of existing medical understanding and practice regarding the use of such devices for specific conditions. This supports the claim that the expanded indications are a "subset" of previously cleared general uses.

8. The sample size for the training set

Not applicable, as this is a surgical device and not an AI/machine learning model that requires a training set.

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

Not applicable.

Ask a specific question about this device

The NICO TRIOwand is a disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.

The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field.

This submission covers a single configuration of the device:

• . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°)
  The direct patient contacting materials consist of PEBA and stainless steel. The indirect contacting materials are PVC, TPV, polycarbonate, ABS, PC/ABS, silicone, and glue.

This document describes the NICO TRIOwand, an electrosurgical cutting and coagulation device. The provided text is a 510(k) summary for clearance of a modified version of the device (K162075), comparing it to a previously cleared predicate device (K150993).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device. The performance is assessed by repeating nonclinical tests to ensure the modified device (K162075) meets applicable design and performance requirements, as compared to the predicate (K150993).

The "acceptance criteria" are implied to be that the modified device's performance in these nonclinical tests is equivalent to or better than the predicate device and does not raise new questions of safety or effectiveness.

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

The document does not specify the sample sizes used for the nonclinical tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor does it detail the country of origin. However, given that these are nonclinical laboratory tests conducted for a 510(k) submission, they are typically performed in a controlled laboratory environment.

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 and not provided in the document. The tests performed are nonclinical and involve laboratory measurements and comparisons to established standards (e.g., ISO 10993-1) or predicate device performance, not human expert interpretation of data to establish a ground truth as typically seen in in vivo or clinical studies.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. The listed studies are nonclinical performance tests.

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

There is no MRMC comparative effectiveness study mentioned. The device is an electrosurgical tool, and the studies performed are nonclinical engineering and safety tests, not related to AI or image interpretation by human readers.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.

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

The concept of "ground truth" as it applies to clinical diagnosis or image interpretation is not directly applicable here. For the nonclinical tests:

• Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993-1) and the results of laboratory tests (e.g., observing cell viability, skin reactions).
• Tensile Testing, Irrigation/Flush Drip Measurement, Longevity Testing, Shelf Life, Product Stability, Specification Review: Ground truth is defined by engineering specifications, control samples (predicate device), and established physical/chemical testing methodologies. Performance is compared to these predetermined standards or to the predicate performance.
• Usability/Human Factors Analysis: Ground truth for usability typically involves identifying potential use errors or difficulties based on user interaction protocols and expert review, aiming to ensure safe and effective operation.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable as there is no training set for this device.

Ask a specific question about this device

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:

• Primary/Secondary Brain Tumors
• Vascular Abnormalities/Malformations
• Intraventricular Tumors/Cysts

The NICO BrainPath and Accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.

The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm surgical corridor to the lesion or abnormality.

The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).

This document is a 510(k) premarket notification for the NICO® BrainPath® and Accessories, a medical device for neurosurgery. It does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy in the context of an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NICO Brain Port, K120691) through non-clinical testing.

Therefore, many of the requested elements for an AI/ML powered medical device study are not applicable or cannot be extracted from this document, as this is a traditional medical device submission.

Here's a breakdown of the available information based on your request, with an emphasis on what is present in the document and what is not:

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

The document provides a table of "Non-Clinical Testing" with "Result/Conclusion". These are the acceptance criteria and performance for a traditional medical device, not an AI/ML powered one.

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. This document describes non-clinical engineering and biocompatibility testing for a surgical device, not a study involving patient data or test sets in the context of AI/ML.

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. Ground truth, in the context of diagnostic accuracy, is not established in this type of submission. The "ground truth" for the non-clinical tests is based on established engineering standards and validated methods (e.g., ISO standards for biocompatibility, cleaning validation protocols).

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

• Not Applicable. No adjudication method is described as this is not a study assessing diagnostic performance.

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 device is a surgical instrument, not an AI-powered diagnostic tool. The document states that the BrainPath "facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy." This indicates it can be used with other technologies, some of which may be software-based, but BrainPath itself is not an AI/ML device, and no MRMC study on its comparative effectiveness with AI assistance is mentioned.

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

• No. A standalone algorithm performance study was not done. The device is a physical surgical tool and does not operate as an algorithm.

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

• The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, such as:
  • Biocompatibility standards: (e.g., ISO 10993 for Cytotoxicity, Sensitization, Irritation).
  • Sterilization validation methods: (e.g., for steam autoclaving, gas plasma, gamma irradiation).
  • Mechanical and functional specifications: (e.g., ability to interface with other instruments, packaging integrity).
  • These are not "expert consensus" or "pathology" in the clinical sense, but rather adherence to predefined and validated test methodologies and acceptance limits.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned as this is not an AI/ML device.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

In summary: This document is a 510(k) submission for a physical surgical device, the NICO® BrainPath®, demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not pertain to the development or validation of an AI/ML powered medical device, and thus, most of the requested information regarding AI/ML study design and criteria is not present.

Ask a specific question about this device

Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.

The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field.

This submission covers a single configuration of the device:

• . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°)
  The direct patient contacting materials consist of PEBAX® and stainless steel. The indirect contacting materials are Tygon®, polycarbonate, ABS, PC/ABS, silicone, and Dymax glue.

This document describes the NICO TRIOwand, an electrosurgical device. The information provided heavily focuses on regulatory aspects, comparisons to predicate devices, and a list of nonclinical tests performed. It does not contain the specific acceptance criteria or detailed results of a study that prove the device meets these criteria in the format requested.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert involvement, or ground truth as this information is not present in the provided text.

The document states that "The following tests were performed and demonstrate that the subject device met applicable design and performance requirements, and supports a determination of substantial equivalence." However, it only lists the types of tests, not the detailed acceptance criteria for each test or the specific results that satisfied those criteria.

For example, it lists "Ex-Vivo Animal Study for Comparison to Predicates" but does not provide details on the study design, sample size, or results. Similarly, "Design Validation/Simulated Use" is mentioned, but without any specifics on the validation metrics or outcomes.

In summary, the provided text lacks the detailed scientific study results and acceptance criteria breakdown necessary to complete the requested table and answer many of the specific questions.

Ask a specific question about this device

To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).

The provided document is a 510(k) Summary for the NICO Brain Port device, which is a medical device for neurosurgery. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing.

However, this document does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because such clinical study information is not present in the provided text.

The closest information related to testing and validation is found under the "Summary of Non-Clinical Testing/Statement of Equivalence" section:

Summary of Non-Clinical Testing (as described in the document):

The document states that "Multiple tests concerning product functionality, biocompatibility, packaging and sterilization have been performed to ensure that the Brain Port device is as safe and as effective as the predicate device."

Specific tests included:

• Radiation sterilization validation on sterile components.
• Cleaning method and sterilization validation of reusable components.
• Packaging drop testing.
• Simulated shipping, aging, and environmental stress testing.
• In Vitro Cytotoxicity testing.
• Irritation and Delayed-Type Hypersensitivity biocompatibility testing.
• General functional, mechanical, dimensional, and performance testing against pre-determined specifications.
• Simulated use testing consisting of inserting the Brain Port into a medium representative of brain tissue.

Ground Truth Used: The ground truth for this non-clinical testing would be the pre-determined specifications for the device's functionality, mechanical properties, dimensions, and performance, as well as established standards for biocompatibility, sterility, and packaging integrity. For simulated use, the "medium representative of brain tissue" served as the test environment.

Sample Sizes: The document does not specify sample sizes for any of these non-clinical tests.

Data Provenance: This is non-clinical, in-vitro, and simulated data, not human patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.

Expert Involvement: The document does not mention the number or qualifications of experts used to establish ground truth or conduct these non-clinical tests, beyond the general statement of "pre-determined specifications."

Adjudication Method: Not applicable to the described non-clinical testing.

MRMC Comparative Effectiveness Study: Not performed or mentioned in the document.

Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is inherent to its design and how it is used by a human surgeon.

Training Set: Not applicable to a physical medical device. The "training" for such a device comes from engineering design, material science, and prior knowledge of similar predicate devices.

In summary, the provided text details a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, rather than a clinical study with acceptance criteria for device performance in human subjects.

Ask a specific question about this device