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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 hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems.

The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.

The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.

The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.

The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.

The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.

The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.

The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.

The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.

This submission describes a collection of Central Nervous System Fluid Shunt and Components, including various connectors, reservoirs, and a shunt filter.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on the Magnetic Resonance (MR) safety of the devices. The acceptance criteria are implicit in adhering to established ASTM standards for MR safety. The reported performance demonstrates that the devices meet these standards.

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

• Sample Size: The document does not specify the exact number of units or individual components tested for each ASTM standard. It simply states "Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182." and that "The devices that are made of silicone and plastic were evaluated and determined to be MR Safe". However, given the nature of MR safety testing for medical devices, it typically involves a representative sample of each unique device type, material, and configuration that could potentially interact with the MR environment.
• Data Provenance: The study is a retrospective bench-top study. The data provenance is internal to the manufacturer ("Bench testing was performed..."). There is no indication of country of origin of the data beyond the manufacturer's location (Raynham, MA, USA).

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

This information is not provided in the document. For MR safety testing, ground truth is established by objective measurements based on scientific principles and standardized test methods (ASTM standards) rather than expert consensus. The experts involved would typically be engineers or technicians with expertise in magnetic resonance and materials science who conduct the tests and interpret the results according to the specified ASTM protocols.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., radiology images) and disagreement among readers needs resolution. Here, the "ground truth" is determined by direct physical measurements against established 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:

Not applicable. This submission is for a medical device (hydrocephalus shunt components) and their MR safety, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

The ground truth used is based on objective physical measurements and adherence to internationally recognized ASTM standards for Magnetic Resonance safety (ASTM F 2052, ASTM F 2213, ASTM F 2119, ASTM F 2182, and ASTM F 2503). These standards define acceptable limits for device interaction with MR fields (e.g., heating, force, torque, artifacts).

8. The Sample Size for the Training Set:

Not applicable. This submission describes a physical medical device. There is no concept of a "training set" as would be found in machine learning or AI development. The device design and materials are based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As stated above, there is no training set for a physical medical device like this in the context of MR safety testing. The "ground truth" for the device's characteristics and safety (before testing) is established through its design specifications, material properties, and manufacturing processes, which are then validated through bench testing.

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