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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.

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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.

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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.

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