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The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set. is intended for iniection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."

The AMC System is comprised of the AMC and its Extension Line sets. The AMC is a rigid cannula comprised of two independent channels. The fluid lumens are protected inside a 25cm rigid ceramic cannula. which transitions (steps-down) to a micro-tip. The micro-tip has two independent outlets at the tip that face sideways, designed to prevent plugging during insertion into the brain. The proximal end of the rigid cannula consists of a Y-connector with standard female luers that allow connection to each independent channel. AMC Extension Line Sets with standard male/female luers must be used with the AMC to connect the AMC to an infusion pump. The AMC must be used with a support structure (e.g. a stereotactic quide) to provide support and control during insertion. A safety-sheath, as with the predicate, and depth-stop, for user convenience, are provided on the AMC for this purpose.

This document is a 510(k) premarket notification for the Alcyone MEMS Cannula (AMC) System, aiming to demonstrate its substantial equivalence to a predicate device. It is a regulatory submission, not a study report per se, and as such, it focuses on demonstrating equivalence rather than establishing novel acceptance criteria or conducting a traditional clinical study with defined endpoints for performance metrics like sensitivity/specificity.

Therefore, many of the requested categories (acceptance criteria performance, sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not directly applicable or explicitly stated in the context of an AI/ML-driven device evaluation. This document is for a medical device (cannula) and its evaluation is based on engineering and preclinical testing.

However, I can extract information related to the device's characteristics and the tests performed to demonstrate its safety and performance equivalence to a predicate device. I will adapt the requested table and sections to best fit the available information.

1. Table of Acceptance Criteria (as implied by equivalence to predicate) and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., specific clinical performance thresholds like sensitivity/specificity for a diagnostic AI). Instead, it demonstrates that the AMC System's performance characteristics are equivalent to or meet the requirements for its intended use, similar to the predicate device. The "acceptance criteria" are implied by successful completion of various engineering, biocompatibility, and functional tests, and by demonstrating substantial equivalence to the predicate.

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

The document describes several test sets for different types of evaluations, which are primarily engineering and preclinical tests, not clinical performance studies for an AI/ML device.

• AMC System Performance (Leak, Infusion, Aspiration, Patency, Pull-off): Sample sizes are not explicitly stated for individual bench tests but are typically based on engineering validation standards.
• AMC Brain Insertion, Removal, Lateral Shift Testing: Sample sizes for this mechanical testing are not explicitly stated.
• AMC Tip Compression, Pull-out Testing: Sample sizes are not explicitly stated.
• Magnetic Resonance (MR) Safe Testing: Sample sizes for this are not explicitly stated but generally involve testing representative samples.
• Cytarabine Infusion Compatibility: Sample sizes are not explicitly stated.
• Transit Testing (Packaging): Sample sizes are not explicitly stated but would be based on ISTA-2A standards.
• Accelerated Aging: Protocol defines methods and materials; sample size not explicitly stated.
• Biocompatibility: Sample sizes for in vitro and in vivo biocompatibility tests are not explicitly stated but are conducted according to ISO 10993 standards.
• Sterilization Validation: Sample sizes for radiation sterilization validation are not explicitly stated but are determined by ANSI/AAMI/ISO 11137-2.
• LAL Validation: Sample sizes are not explicitly stated but are determined by USP guidance.
• Animal Testing (Design Validation and Performance Evaluation):
  • Concept-development phase: N=7 Juvenile Yorkshire Pigs (Acute Study).
  • Design-freeze phase: N=4 Juvenile Yorkshire Pigs (Acute Study).
  • Comparative study vs. Predicate: N=4 acute animals, N=6 survival animals (survival for 4-weeks post infusion).
• Human Factors and Usability Testing: N=16 Users with repeat uses totaling 28 uses.

Data Provenance: The document does not specify the country of origin for the data for most tests, but they are generally performed in a laboratory setting or by contract research organizations (CROs) adhering to international standards (e.g., ISO, USP, FDA guidance). The animal studies used "Juvenile Yorkshire Pigs." All non-human testing is retrospective from the perspective of the 510(k) submission date.

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

This question is largely irrelevant for a device like a ventricular cannula, where "ground truth" is typically established by engineering specifications, physical measurements, and biological responses rather than expert consensus on interpretive data (which is common for AI/ML diagnostic tools).

• Bench and Animal Tests: The "ground truth" or performance standards are established by predefined design requirements, applicable international and national standards (e.g., ISO, USP, FDA guidance), and the performance characteristics of the legally marketed predicate device. This involves engineering and scientific experts, but not in the qualitative assessment sense of a radiologist for image interpretation.
• Human Factors and Usability Testing: Involved N=16 "Users," who would be qualified to interact with the device in a simulated clinical setting. Their feedback on ease of use and adherence to instructions serves as "ground truth" for usability. Specific qualifications (e.g., years of experience as a neurosurgeon or nurse) are not detailed but are implied to be relevant clinical users.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used when subjective expert interpretation is involved in establishing ground truth, such as in reading medical images. This process is not applicable to the engineering, biocompatibility, and functional testing described for the Alcyone MEMS Cannula (AMC) System. The "ground truth" (or compliance) is determined by objective measurements against predefined specifications and regulatory standards.

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. The Alcyone MEMS Cannula (AMC) System is a physical medical device (cannula), not an AI-driven software or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device. It does not have an algorithm that performs standalone. Its function is to be used by a human healthcare professional for injecting or removing fluids.

7. The Type of Ground Truth Used

For the Alcyone MEMS Cannula (AMC) System, the "ground truth" varies by the type of test:

• Technical/Engineering Tests (Leak, Flow, Mechanical Safety): Ground truth is based on established engineering specifications, physical measurements, performance data from the predicate device, and compliance with relevant industry standards (e.g., pressure ratings, flow rates, material stresses).
• Biocompatibility: Ground truth is based on compliance with ISO 10993 standards and the biological response of materials. This involves specific test methods (e.g., cytotoxicity assays, animal toxicity studies) with predefined acceptance criteria for biological safety.
• Sterility and Endotoxin: Ground truth for sterility is a Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11137-2. Ground truth for endotoxin is an endotoxin level < 2.15 EU/device per USP guidance.
• MR Safety: Ground truth is defined by the device being "MR Safe" according to FDA guidance, demonstrated by specific magnetic field interaction tests.
• Animal Testing: Ground truth is derived from the device meeting predefined functional specifications, observed performance in a biological system (e.g., insertion depth, channel function, occlusion, backflow), and qualitative/quantitative comparison to the predicate device in the animal model.
• Human Factors/Usability: Ground truth is based on user feedback and observations of ease of use, adherence to instructions, and overall safety during simulated use by relevant clinical personnel.

8. The Sample Size for the Training Set

This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device; it does not involve machine learning or an "algorithm" with a "training set." Its design and performance are based on engineering principles, material science, and preclinical testing, not on data training.

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

This question is not applicable, as there is no "training set" for this physical medical device.

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