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The Alivio Ventricular Catheter and Flusher System) is for use in the treatment of patients with hydrocephalus, as components of a shunt system when draining of cerebrospinal fluid (CSF) is indicated. The Alivio Flusher may be used by a qualified clinician as a tool to facilitate a non-invasive retrograde fluid flush of the Alivio Ventricular Catheter to unblock inlet holes or open its relief membrane to restore or increase CSF flow in a non-flowing shunt. The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions.

The Alivio System, consisting of the Alivio Flusher and Alivio Ventricular Catheter, is an implantable component of a CSF Shunt System used in the treatment of patients with Hydrocephalus. The Ventricular Catheter is implanted in the ventricle and connected distally to the Flusher, which is in turn connected to a commercially available flow regulating valve (not provided as part of the Alivio System).

Similar to manual pumping of a flow requlating valve or performing an invasive shunt tap via the flow regulating valve; the Alivio Flusher, a fluid reservoir, may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush to the Alivio Ventricular Catheter to unblock occluded, proximal inlet holes. If the inlet holes are not able to be unblocked, the retrograde fluid flush will open the relief membrane of the Alivio Ventricular Catheter, creating a new fluid pathway to restore or increase CSF flow in a non-flowing shunt with occluded inlet holes. Once the relief membrane has been used to restore flow in a non-flowing shunt, subsequent retrograde fluid flushing of the Alivio Ventricular Catheter with the Alivio Flusher may not be sufficient to reopen the relief membrane, which may become occluded similar to proximal catheter inlet holes.

After flushing the device, standard methods of care should be used to determine that the reservoir is refilled prior to flushing a second time. Similar to commercially available reservoirs used in shunt systems, refilling of the Flusher reservoir can be confirmed by palpation of the dome. Repeated flushing of the device with an empty reservoir may not be effective. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the Alivio System.

The Alivio Flusher does not requlate flow of the shunt system. A flow requlating shunt valve is not provided with the Alivio System. During passive fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. The Alivio System is compatible and has been tested with the Integra Contour-Flex™ Valve. The Alivio System is designed to be compatible with all commercially available flow requlating valves with standard inlet connectors, similar to the integra "Contour-Flex"" Valve.

The Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device for treating hydrocephalus. The FDA document K172006 provides information on the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with recognized standards and successful completion of various tests, with results deemed suitable for the intended use and substantially equivalent to predicate devices. Specific quantitative acceptance criteria are not explicitly detailed for all tests in the provided text, but the reported performance consistently states that the criteria were met.

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

• Biocompatibility, Packaging, Sterilization, Pyrogenicity, Shelf Life, Pressure Leak/Flow, Durability, Break Strength, Tensile Strength, Pressure Handling, Cartridge Performance, Catheter Bond Pressure, Flusher Reliability, MR Safety, System Imaging, Occlusion Flushing Performance: These were bench and laboratory studies. Specific sample sizes for each bench test are not provided, but generally, these involve sufficient samples to establish statistical validity for the test method. The data provenance is from preclinical (laboratory/bench) testing.
• Comparative Performance Testing in Animals:
  • Pilot animal study 1: N=1 (evaluated at acute timepoint). Provenance: Preclinical animal study.
  • Pilot animal study 2: N=2 (evaluated at subacute and acute timepoints). Provenance: Preclinical animal study.
  • Pilot animal study 3: N=2 (evaluated at acute timepoints). Provenance: Preclinical animal study.
  • Animal study 4: N=11 (evaluated at subacute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
  • Animal study 5: N=6 (evaluated at acute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
• Usability and Human Factors Testing: The number of users (experts) involved was 24 neurosurgeons. Provenance: Simulated clinical use model, which is a form of preclinical testing.
• Alivio Flusher Clinical Study: N=4 patients. Provenance: Clinical study (registered as NCT02651337).

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

• Usability and Human Factors Testing: 24 neurosurgeons (intended users) of varying experience. Their specific years of experience are not mentioned, but their role as "neurosurgeons" implies significant medical expertise relevant to the device's application.
• Alivio Flusher Clinical Study: The "users" in the clinical study performed the primary steps and their ability to do so was assessed. While not explicitly stated as "ground truth establishment," their successful use contributed to the device's functional safety assessment and efficacy. The study involved clinicians, overseen by a physician for patient care.

4. Adjudication Method for the Test Set

This document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple experts. For the usability study, it indicates that the "24 neurosurgeons (intended users) of varying experience" evaluated the device, implying a consensus or aggregated assessment rather than a specific adjudication protocol. For the clinical study, the outcome was based on the "criteria for success outlined in the protocol."

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, nor is there any AI component mentioned in the context of human reader improvement. The device (Alivio System) is a physical medical device (catheter and flusher system), not an AI-based diagnostic or assistive software.

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

This question is not applicable as the Alivio System is a physical medical device, not an algorithm or AI solution. The performance tests evaluate the device's physical and functional characteristics.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable in the same way to this physical medical device. Instead, the studies rely on:

• Compliance with recognized standards: For most preclinical tests (e.g., ISO, ASTM), the "ground truth" is adherence to established engineering and material performance specifications.
• Histopathology analysis: In animal studies, histological analysis of tissue provided objective data for safety comparisons.
• Comparative performance data: Comparison against predicate devices' known performance characteristics.
• Clinical outcomes data: For the small clinical study, the "criteria for success outlined in the protocol" served as the evaluation metric for the device's functional safety and ability to restore/increase CSF flow.
• User feedback/observational data: From the usability study involving neurosurgeons.

8. The sample size for the training set

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set.

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

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set or its associated ground truth establishment.

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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.

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