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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.

Device Description

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.

AI/ML Overview

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.

Test Category	Acceptance Criteria (Implicit from "Test Method Summary")	Reported Device Performance and Conclusions
Biocompatibility	Non-cytotoxic (ISO 10993-5)	Results support that the Alivio System is non-cytotoxic.
	Non-sensitizer (ISO 10993-10)	Results support that the Alivio System is a non-sensitizer.
	Non-irritant (ISO 10993-10)	Results support that the Alivio System is a non-irritant.
	Non-toxic (systemic) (ISO 10993-11)	Results support that the Alivio System is non-toxic.
	Non-pyrogenic (material-mediated) (ISO 10993-11)	Results support that the Alivio System is non-pyrogenic.
	Non-mutagenic (Ames Mutagenicity, ISO 10993-3)	Results support that the Alivio System is non-mutagenic.
	Non-hemolytic (ISO 10993-4)	Results support that the Alivio System is non-hemolytic.
	Non-carcinogenic, non-mutagenic, non-toxic (Exhaustive Chemical Characterization, ISO 10993-18, ISO 10993-17)	Results support that Alivio System is non-carcinogenic, non-mutagenic, and non-toxic.
	Compliance with allowable extract levels (Metals Analysis, ASTM F647)	Results support that the Alivio System is in compliance with the allowable extract levels outlined in Section 5.2 and Appendix X2.5 of ASTM F647.
Packaging	Meets performance for partial simulation (ISTA-2A), detecting gross leaks (ASTM F2096-11), and seal strength (ASTM F88-09).	All testing passed.
Sterilization	Achieves a 10-6 sterility assurance level (SAL) (ANSI/AAMI/ISO 11137-1, -2, -3).	Terminal sterilization validation testing supports a 10-6 SAL.
Pyrogenicity	Endotoxin levels less than 2.15 EU/device (0.06 EU/mL) (ANSI/AAMI ST72:2011).	All units tested met the criteria of less than 2.15 EU/device (0.06 EU/mL).
Shelf Life	Maintains visual/dimensional, surface, particulate, strength, reliability, and system performance at intended shelf life (Accelerated and Real-time Aging).	Results support expiration dating on the labeling, successfully comparing devices at time 0 and the intended shelf life.
Pressure Leak Tests & Pressure Flow Characteristics	Passes pressure leak test; appropriate pressure-flow characteristics as per ASTM F 647-94(2014) Sections A 2.8.1.1 and A2.8.1.2 and ISO 7197:2006 (E) Sections 4.4 and 4.6.	All devices passed the pressure leak test and the appropriate pressure flow characteristic graph is provided in the device labeling.
Durability and System Level Functional Test	Meets acceptance criteria (ASTM F 647-94(2014)).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Flusher and Catheter Dynamic Break Strength Test	Meets acceptance criteria (ISO 7197:2006 (E) Section 4.9). No component rupture or breakage.	All results met acceptance criteria per protocol and applicable standards. During this test, no component ruptured or broke.
Flusher and Catheter Tensile Strength Test	Meets acceptance criteria (ASTM F 647-94(2014)).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Flusher Pressure Handling Test	Meets acceptance criteria (ISO 7197:2006 (E) Section 4.11).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Alivio Cartridge Performance Test	Demonstrates compliance with requirements for cartridge performance (flush pressure).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Catheter Bond Pressure Test	Withstands pressure testing at a minimum of twice the maximum relief membrane opening pressure specification.	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use.
Alivio Flusher Reliability Test	Demonstrates reliable flushing during expected useful life, with no mechanical damage and acceptable pressure/volume output.	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
MR Safety	Complies with FDA guidance to label "MR Safe" in all MR environments (ASTM F647-94(2014), Section 6.1.3).	All implanted Alivio System materials/components comply with the FDA guidance to label "MR Safe" in all MR environments.
Alivio System Imaging	Demonstrates compliance with imaging requirements (ASTM F 647-94(2014) and ISO 7197:2006).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Occlusion Flushing Performance	Ability of retrograde flush to unblock inlet holes in simulated occlusions.	Comparative testing demonstrated that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device. Flushing of the Alivio System was able to restore flow in the ventricular catheter with simulated blocked inlet holes.
Comparative Performance Testing in Animals (Several studies)	Meets functional requirements; no new questions of safety and efficacy; substantially equivalent to predicate (various acute and subacute timepoints, histological analysis).	All results met acceptance criteria and demonstrated that the Alivio System meets its performance criteria. No significant difference of histological analysis of tissue between Alivio System and predicate was found. Testing demonstrated that the Alivio System does not raise any new questions of safety and efficacy and is substantially equivalent to the predicate. (One small animal model was not suitable for comparative testing, but found no histological difference).
Usability and Human Factors Testing	Ease of preparation, implantation, and use for intended use per labeling, in accordance with ANSI/AAMI HE 75, IEC 62366:2007, and FDA Human Factors Draft Guidance.	All acceptance criteria were met and the device performed as expected according to its specifications and in compliance with applicable recognized standards. Minor technological differences do not raise new types of safety and efficacy concerns, evaluated by 24 neurosurgeons.
Alivio Flusher Clinical Study	Functional safety in patients undergoing shunt revision surgery; users able to perform primary steps; no safety issues; increase or restore flow in occluded/sluggish catheters (NCT02651337).	The outcomes on 4 patients treated at the time of submission met the criteria for success outlined in the protocol. All users were able to perform the primary steps needed to use the Alivio Flusher for its intended use and use environment. No safety issues associated with the device were observed. These results demonstrate that the Alivio Flusher could increase or restore flow in occluded or sluggish flowing catheters.

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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