(225 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Console & Foot Pedal Packaging Testing | Passed |
| General Verification Testing including review of specifications | Passed |
| Console Life Cycle Testing on functionality following repetitive use | Passed |
| Console Environmental Testing on functionality under environmental extremes | Passed |
| Firmware Unit Plan, Design, & Verification | Passed |
| Handpiece Sterility, Packaging, and Shelf Life Testing | Passed |
| Handpiece Biocompatibility per ISO 10993 (Cyto, Sensi, Irri, Pyro, Hemo) | Passed |
| Simulated Use of system and ability to cut surrogate materials/tissue while using handpieces bent to maximum allowable angle | Passed |
| Endoscope Compatibility on functionality with applicable commercially available endoscopes | Passed |
| Physical Characteristics Verification on material selection, fabrication methods, and multiple bonds/joint/weld evaluations | Passed |
| Handpiece Life Cycle Testing on functionality following repetitive use | Passed |
| Handpiece Environmental Testing on functionality under environmental extremes | Passed |
| Accessories: Replacement Working Channel Adapters Packaging & Shelf Life Testing | Passed |
| Accessories: Specimen Collector and Filter Element Verification including Sterility, Packaging & Shelf Life | Passed |
| Accessories: Bending Tool Verification, including Sterility, Packaging, Shelf Life, and Biocompatibility per ISO 10993 | Passed |
| Accessories: Specimen Infusion Valve Verification including Sterility, Packaging, & Shelf Life Testing | Passed |
| NICO Myriad System Usability | Passed |
| IEC 60601-1 General Electrical Safety Testing | Passed |
| IEC 60601-1-2 EMC Testing | Passed |
| Clinical evidence supporting specific neurosurgical indications as a subset of general use | Supported by case reports and literature review |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.