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The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments.

Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature.

According to the clinical situation, users choose the appropriate Pressio® catheters:

• Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring.

• Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring.

• Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application.

The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor:

• Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring
• Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring.
• Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.

The Pressio® 2 ICP Monitoring System is composed of a monitor (PSO-4000) with accessories and implantable catheters. The PSO-4000 monitor is an electromedical device designed for monitoring patient's intracranial pressure and temperature via catheters implanted in parenchyma (PSO-PBT and PSO-PTT) or in ventricles with drainage of cerebrospinal fluid (PSO-VTT). Previously marketed Pressio® kits (K062584) are also available on the Pressio® 2 ICP Monitor and allows monitoring of intracranial pressure via catheters implanted in parenchyma (PSO-PB and PSO-PT) or in ventricles (PSO-VT) with also drainage of cerebrospinal fluid.

The Pressio® 2 ICP Monitor can also be connected to a patient monitor via a compatible monitor connection cable. This connection is not necessary for Pressio® 2 Intracranial Pressure Monitor functioning. The Pressio® 2 Monitor can also extract data to external computer via a USB cable. The Pressio® 2 ICP Monitoring System is sold as a kit containing a Pressio® 2 ICP Monitor (PSO-4000), a power supply cable (PSO-AC), a catheter extension cable (PSO-EC30).

The provided text is a 510(k) Premarket Notification from the FDA for the SOPHYSA SA Pressio® 2 ICP Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo approval. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, test set details, ground truth establishment, expert adjudication, MRMC studies, and training set information is not present in this document.

However, based on the non-clinical testing section and comparative tables, we can extract some information related to the device's conformance to standards, which implicitly defines some "acceptance criteria" through compliance.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical performance targets and actual device performance results in the way one would see for a de novo submission focusing on clinical accuracy. Instead, it refers to conformance to established medical device standards as the primary means of demonstrating performance and safety, thereby implicitly defining acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) submission, primarily relying on non-clinical testing (bench testing, component analysis, and conformance to standards) to demonstrate substantial equivalence, rather than new clinical trials with patient test sets. Therefore, details about a "test set" in the context of clinical data (like patient numbers, retrospective/prospective nature, or country of origin) are not included. The performance testing mentioned (e.g., "Placement in subdural space - Pressure Measurement") would refer to bench or simulated testing, not a clinical patient sample size.

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)

Not applicable, as this is a non-clinical submission relying on engineering/bench testing and conformance to standards, not human expertise for ground truth in image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no mention of a human-read test set or adjudication process.

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 device is an ICP monitoring system, not an AI-assisted diagnostic tool for human readers/interpreters.

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

This refers to the device's intrinsic ability to measure ICP and temperature as designed. The entire non-clinical testing described (conformance to standards for electrical safety, EMC, software, biological evaluation, etc.) is essentially evaluation of the device's standalone performance against defined engineering and safety benchmarks. The performance claim "No alteration of pressure measured with a Pressio® catheter when inserted in a subdural space" is a direct standalone performance assessment.

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

The "ground truth" for the device's performance is established by engineering specifications, physical measurements/calibrations, and compliance with recognized industry standards (e.g., ISO, IEC, AAMI) for medical device safety, performance, and functionality. For example, the ground truth for pressure measurement accuracy would be established by calibrated pressure sensors and established metrology.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable.

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The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

Polaris Pressure Adiustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit

This document is a letter from the FDA regarding the 510(k) premarket notification for the "Polaris Pressure Adjustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain any information regarding the acceptance criteria, device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or how ground truth was established. It focuses solely on the FDA's decision regarding the 510(k) submission and the regulatory classification of the device.

Therefore, I cannot provide the requested table and study details based on the provided text.

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The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid CSF).

The SiphonX® Gravitational Anti-sibhon Device is a siphon requlating accessory device used in the treatment of hydrocephalus. SiphonX® Gravitational Anti-siphon Device is an implantable, single-use device. The SiphonX® Gravitational Anti-siphon Device consists of a plastic housing with integral inflow and outflow channels that are separated by a conical valve seat. The housing contains a weight ball that rests upon a smaller, orifice-sealing ball. The device contains two silicone seals. Gravitational effect is provided by a weight ball which pushes on the valve sealing ball, under the effect of gravity, as the device transitions from a horizontal to a vertical position. The cerebrospinal fluid (CSF) flows in through the inlet connector, past the orifice-sealing ball and flows out by way of the outlet connector when the fluid pressure is greater than the sum of the pressure exerted by the weight ball and the operating pressure of the valve. When the SiphonX® Gravitational Anti-siphon Device is in a horizontal position, no resistance to the flow is provided by the weight ball and orifice-sealing ball thereby allowing CSF to flow freely as regulated by the upstream shunt. On the contrary, when the SiphonX® Gravitational Antisiphon Device is in a vertical position, maximum CSF resistance is applied as the weight ball presses on the orifice-sealing ball. The CSF is directed towards the orifice-sealing ball creating an opposing force to that which is generated by the weight ball. Upon sufficient CSF flow and combined valve pressure and Gravitational Anti-siphon Device pressure, CSF is able to push up the orifice-sealing ball and weight ball and flow through the outlet channel and connector. The device will be distributed by itself or in combination with the Polaris® and Sophy® Pressure Adiustable valves and valve kits.

The provided document is a 510(k) summary for the SiphonX® Gravitational Anti-siphon Device. It describes the device, its intended use, and the testing conducted to demonstrate its safety and efficacy.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that functional tests were conducted, but it does not explicitly state specific acceptance criteria values or detailed reported device performance metrics in a readily quantifiable format within this summary. It broadly states that:

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

The document states: "The SiphonX® Gravitational Anti-siphon Device was subjected to laboratory testing to demonstrate device safety and efficacy."

• Sample Size for Test Set: Not explicitly stated. The text refers to "laboratory testing" and "functional tests" but does not provide the number of devices or units tested.
• Data Provenance: The testing appears to be prospective laboratory testing conducted by the manufacturer, Sophysa SA, located in France. The standards referenced (ISO/FDIS 7197:2006(E) and ASTM F 647) are international and US national standards, respectively, suggesting universally applicable test methods rather than specific country-of-origin patient data.

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

This information is not provided in the document. The testing described is functional and biological testing against standards, not a clinical study involving expert interpretation of patient data. Therefore, the concept of "ground truth established by experts" as typically understood in studies involving images or diagnoses (e.g., radiologists) does not apply here.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the testing conducted was functional and biological laboratory testing against predefined standards, there would be no need for an adjudication method as seen in clinical studies with human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted according to this 510(k) summary. The document describes laboratory testing, not a clinical study involving human readers or patient cases to assess the improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a mechanical medical device (a shunt accessory), not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used

The ground truth for the functional and biocompatibility testing was established by international and national standards (ISO/FDIS 7197:2006(E), ASTM F 647, and ISO 10993-1). The device's performance was compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. The SiphonX® Gravitational Anti-siphon Device is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The device design would have been developed through engineering processes, but not "trained" on data.

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

This information is not applicable/provided for the same reason as point 8.

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The Polaris® Adjustable Pressure Valves are indicated to drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Polaris® Adjustable Pressure Valve is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball- in-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart.

The basic settings of the Polaris® Valve Models SPV, SPVA, and SPVB are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40-50 mm Hz0 increments (decrements) in three operating ranges, low pressure (LP =30 mm Hz0), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).

The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂0; adjustments to intermediate pressures are made manually in 30-40 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H₂0; adjustments to intermediate pressures are made manually in 50-80 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H-0; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements).

The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

The provided text describes specific verification and validation testing for the Polaris® Adjustable Pressure Valves related to their MRI compatibility, rather than a clinical study evaluating the device's functional performance in treating hydrocephalus. Therefore, some of the requested information, such as effect size of human readers improving with AI, sample size for training sets, or number of experts for ground truth, is not applicable or available in the given text.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance for MRI Compatibility

The acceptance criteria are implicitly met if the test results "supported the MRI labeling statements for exposure of the Polaris Adjustable Pressure Valves to a 3-Tesla MRI environment." The specific quantitative thresholds for these criteria are not detailed in the provided text.

Study Details:

1. Sample size used for the test set and the data provenance: Not specified. The testing was conducted on "Polaris Adjustable Pressure Valves," implying a physical sample of devices, but the exact number or how they were selected is not provided. No patient data (retrospective or prospective) was used for this specific testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this engineering verification study would be based on validated physical measurements and performance standards, not expert clinical interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was a technical verification and validation study, not a clinical study involving adjudication of clinical findings.

4. 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 study focuses on the device's physical compatibility with MRI, not AI assistance for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

6. The type of ground truth used: For magnetic field interactions, heating, and artifacts, the ground truth would be based on established engineering standards and validated measurement techniques (e.g., temperature probes for heating, specific protocols for artifact assessment). For the functional aspects, the ground truth would be the device's functional specifications (e.g., pressure settings) before and after MRI exposure, measured using calibrated equipment.

7. The sample size for the training set: Not applicable. This is a physical device testing, not a machine learning study requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.

The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.

The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.

The Pressio® ICP Monitoring System (PSO-3000) is an electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter implanted in the parenchyma (PSO-PB or PSO-PT) or in the ventricles (PSO-VT). The Pressio® ICP Monitoring System is sold as a kit containing a Pressio® ICP Monitor (PSO-3000), a Power Supply Cable (PSO-AC) and the Catheter Extension Cable (PSO-EC20).

The Pressio® ICP Monitor can be connected to a patient monitor via a compatible monitor connection cable (PSO-MCxx). This permits medical staff to display intracranial pressure curves on the patient monitor. This connection is not necessary for Pressio™ Intracranial Pressure Monitor functioning. The calibration of patient monitor is performed via a host monitor calibration key on Pressio™ Intracranial Pressure Monitor.

The Pressio® ICP Monitoring System is composed of the following:

• Pressio® ICP Monitor (PSO-3000)
• Pressio® ICP Catheters: there are three available types of implantable . catheters:
  • Catheter implanted in ventricles via tunnelling (PSO-VT) .
  • Catheter implanted in parenchyma via tunnelling (PSO-PT) .
  • Catheter implanted in parenchyma via a bolt (PSO-PB) .
• . Pressio® Serial Transmitter Model (PSO-TX00)
• . Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00)
• Catheter Extension Cable (PSO-EC20) .
• Monitor Connexion Cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references
• Power Supply Cable (PSO-AC) .
• Pressio® Pole Clamp (PSO-CL) .
• . Pressio® Disposable Hand Drill (PSO-DR)

The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets specific performance criteria.

Instead, this document is a 510(k) summary for the Pressio® ICP Monitoring system, submitted to the FDA in 2007 for premarket notification. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing general safety and performance testing.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document mentions "extensive performance testing" and compliance with standards like ISO 10993, IEC 60601-1, and UL 2601, but it does not specify any quantitative or qualitative acceptance criteria (e.g., accuracy, precision, drift limits for ICP measurements).
• No Specific Study Details: While "extensive performance testing" is mentioned, no specific study design, methodology, or results (beyond general statements of safety and suitability) are provided. There's no information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement.
• No mention of AI/ML components: The device described is an "electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter." There is no indication of any Artificial Intelligence or Machine Learning (AI/ML) components in its design or function. Therefore, questions related to AI-specific studies (e.g., MRMC studies, standalone performance, training sets) are not applicable.

Summary of what can be extracted related to testing:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not specified in the document.
   • Reported Device Performance: The document generally states that "Results of the testing showed that the catheter designs are safe for their intended uses" and that the system components "underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601." It also mentions "Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used... are safe for its intended use." No quantitative performance data (e.g., accuracy, reliability) is provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.

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): Not applicable, as no specific clinical or diagnostic test set with ground truth established by experts is described. Testing appears to be primarily engineering performance and safety focused.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, as the device does not employ AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device does not employ an algorithm in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. The ground truth for functional tests would likely be established by a reference standard or validated measurement device for parameters like pressure, temperature, etc., which is not detailed here.

8. The sample size for the training set: Not applicable, as the device does not employ AI/ML that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as the device does not employ AI/ML.

In conclusion, the provided 510(k) summary gives an overview of the device and its general testing for safety and substantial equivalence but lacks the specific details regarding acceptance criteria and performance study outcomes that would be required to answer your questions comprehensively.

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To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ballin-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drroinage is directed to the abdominal cavity or to the right atrium of the heart.

The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂O; adjustments to intermediate pressures are made manually in 30 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H2O; adjustments to intermediate pressures are made manually in 50-70 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H2O; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements).

The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

This application (K042481) for the Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is a 510(k) Special Summary and does not contain the detailed study information needed to answer all aspects of your request. This type of submission relies on substantial equivalence to a previously cleared device (predicate device K031097), often meaning that extensive new studies are not required if the new device has only minor changes from the predicate.

However, based on the provided text, I can infer some information and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a table of acceptance criteria or specific reported device performance metrics for the Polaris® SPV-140, SPV-300, SPV-400 system. The submission states that the device is "substantially equivalent to the SOPHYSA Sophy® Polaris® SPV Valve (K031097) previously cleared and currently marketed" in terms of "intended use, materials, biocompatibility, design, performance, function, and operating characteristics." This implies that the performance is expected to be the same as the predicate device, but no specific performance data for this particular submission is presented.

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

The provided text does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) Special Summary where the focus is on demonstrating substantial equivalence to a predicate, rather than presenting new clinical study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention any experts being used to establish ground truth for a test set. As no new clinical study data is presented, this information would not be part of this submission.

4. Adjudication Method

The provided text does not describe any adjudication method. This is because no new clinical study data requiring adjudication is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention any MRMC comparative effectiveness study. This type of study would typically be performed for new, more complex diagnostic or AI-driven devices, which is not the case for this hydrocephalus shunt.

6. Standalone (Algorithm Only) Performance Study

The device described is a physical medical device (a pressure adjustable valve), not an algorithm or AI system. Therefore, a "standalone algorithm performance study" is not applicable and not mentioned in the document.

7. Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) is not directly applicable in the context of this 510(k) submission for a physical device. The "truth" here revolves around the device's physical and functional characteristics being equivalent to a known, safe, and effective predicate device.

8. Sample Size for the Training Set

The provided text does not describe a training set or its sample size. This device is a physical product, not a machine learning model that would require a training set.

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

As no training set is applicable, the establishment of ground truth for a training set is not relevant to this submission.

Summary of Device and Evidence Presented:

The Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is an implantable device used to treat hydrocephalus by draining cerebrospinal fluid. It is designed to maintain constant intraventricular pressure and is transcutaneously adjustable. The key feature highlighted is a self-locking rotor-shuttle micro-magnet system that prevents accidental pressure setting changes by unidirectional magnetic fields (like domestic magnets or MRI).

The study that "proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to the predicate device, the SOPHYSA Sophy® Polaris® SPV Valve (K031097). This means that the FDA has determined that the new device is as safe and effective as the predicate based on comparisons of:

• Intended Use: Both devices are for draining CSF for hydrocephalus management.
• Materials: Implied to be the same or similar, leading to similar biocompatibility.
• Biocompatibility: Assumed to be equivalent due to similar materials.
• Design: The new models are variations of the predicate.
• Performance: Expected to be equivalent to the predicate.
• Function: Operates in the same manner as the predicate.
• Operating Characteristics: Similar pressure ranges, adjustment increments, and mechanism for pressure setting.

The provided document does not contain new experimental data or clinical trials for the K042481 submission itself, but rather references the predicate device (K031097) as the basis for its safety and effectiveness.

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To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Polaris® Pressure Adjustable Valve is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® Valve are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40 mm Hy0 increments (decrements) in three operating ranges, low pressure (LP = 30 mm H20), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).

The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized

The provided text describes the Polaris® Pressure Adjustable Valve, a device for treating hydrocephalus, and its substantial equivalence to a predicate device. However, the document does not contain information about specific acceptance criteria, a study demonstrating the device meets those criteria, or quantitative performance metrics.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified.
• Data provenance: Not specified. The document refers to the predicate device (Sophy® SM8 Valve, K013488) but doesn't detail any specific clinical or performance testing data for the Polaris® valve itself in the context of a new study to establish performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new performance study with a test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set:

• Not applicable. No new performance study with a test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study is mentioned.

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

• Not applicable. This device is a mechanical shunt, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new performance study with ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which implies the predicate's established performance serves as the benchmark.

8. The sample size for the training set:

• Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.

In summary: The provided document is a 510(k) summary for a medical device (a hydrocephalus shunt). Its purpose is to demonstrate that the new device (Polaris® Pressure Adjustable Valve) is "substantially equivalent" to an already legally marketed device (Sophy® SM8 Valve). This regulatory pathway typically relies on comparison of design, materials, and intended use, rather than extensive new clinical performance studies with specific acceptance criteria and ground truth, as would be expected for novel devices or AI algorithms. The document explicitly states the basis for substantial equivalence is "biocompatibility, Industry, and operating characteristics" to the predicate device.

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To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Sophy® Pressure Adjustable Valve System SM8 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat deign, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SM8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 30 mm H20 to 200 mm H20, as follows: 30 = Low, 110 = Medium (intermediate 50, 70, 90) and 200 = High (intermediate 140, 170).

The principle of the Sophy® Pressure Adjustable Valve System SM8, nearly identical to that of its predicate Sophy@SU8 FDA cleared hydrocephalus valve (K992465), is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted noninvasively by using a adjustment magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For manual pressure setting, a specific adjustment kit is necessary, including a compass, magnet, and pressure selector.

The Sophy® Pressure Adjustable Valve System SM8 is a miniaturized version of the predicate Sophy®SU8 (K992465), with a nearly 50% volume reduction and an approximately 45% weight reduction.

This document is a 510(k) summary for the Sophy® SM8 Pressure Adjustable Valve System. It seeks to demonstrate substantial equivalence to a previously cleared device, the SOPHYSA Sophy® SU8 (K992465), rather than providing a study proving a device meets specific acceptance criteria based on novel performance metrics.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.

The document outlines:

• Device Identification: Sophy® Pressure Adjustable Valve System, Model SM8, a hydrocephalus shunt.
• Predicate Device: SOPHYSA Sophy® SU8 (K992465).
• Device Description: An implantable device for treating hydrocephalus by shunting CSF. It features 8 adjustable pressure settings (30 to 200 mm H2O) adjusted non-invasively by a magnetic rotor, similar in principle to the predicate device but miniaturized (50% volume reduction, 45% weight reduction).
• Substantial Equivalence: Claimed based on "intended use, materials, design, performance, function, and operating characteristics" to the predicate Sophy®SU8 (K992465).
• Indications for Use: To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

To directly answer your prompt based on the provided text, the requested information elements are not present. The 510(k) process for this device relies on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against new acceptance criteria.

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To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Sophy® Pressure Adjustable Valve System SU8 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat design, and the valve is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SU8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 50 mm H20 to 170 mm, as follows: 50 = Low, 110 = Medium (intermediate 65,80,95), and 170 = High (intermediate 130, 150). The principle of the Sophy® Adiustable Valve System SU8, identical to that of several existing FDA cleared hydrocephalus valves, is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted non-invasively by using a programming magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For pressure setting, a specific programming kit is necessary, including a compass, magnet, and pressure selector.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

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

• Sample Size for Clinical Study (Test Set): 43 consecutive patients (25 pediatric, 18 adults)
• Data Provenance: The study was a retrospective clinical study. The document does not specify the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth for Test Set & Qualifications:
This information is not provided in the given text. The text only states that a "retrospective clinical study" was conducted and "results indicated that the Sophy® Pressure-Adjustable Valve System SU8 performs as well as, and is safe and effective as currently marketed hydrocephalus shunts." There's no mention of specific experts establishing ground truth for individual cases within this study.

4. Adjudication Method for the Test Set:
The adjudication method is not specified in the provided text.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not explicitly described as being performed in the provided text. The clinical study was a direct patient outcome study, not a study comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This is not applicable as the device described is a physical medical device (hydrocephalus shunt), not an AI-driven algorithm. The testing described focuses on the device's physical and clinical performance.

7. Type of Ground Truth Used:
The ground truth for the clinical study was based on patient outcomes/clinical performance data over a follow-up period (1 year follow-up in 93% of patients, 2 year follow-up in 59%). The comparison was made against the performance of "currently marketed hydrocephalus shunts."

8. Sample Size for the Training Set:
This is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set. The performance testing was based on engineering and clinical evaluations.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as above (physical medical device, no training set).

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