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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 Libertís™ Shunt Catheter includes a ventricular and distal (peritoneal) drainage catheter that are used as part of a cerebrospinal fluid (CSF) shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system. The ventricular catheter diverts excess CSF from the ventricles of the brain through the valve. After passing through the valve, the excess CSF is drained through the distal catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters have Endexo® polymer, a surface modifying macromolecule, blended into their base silicone. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. The Libertís™ Shunt Catheter has been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have ink markings on the silicone tubing to aid in positioning of the catheter.

The catheters are packaged with two accessories, a stylet and a right-angle adapter. The stylet is used to help introduce the ventricular catheter into the brain's ventricles. The right-angle adapter is used to fixate the ventricular catheter to the cranium.

This document is a 510(k) clearance letter for a medical device, specifically a shunt catheter. It does not describe an AI medical device or software. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility testing, rather than performance studies of an AI algorithm.

However, I can provide the acceptance criteria and performance information that is present in the document, which pertains to the physical and biological characteristics of the shunt catheter.

Acceptance Criteria and Device Performance (for the physical device, not an AI algorithm):

Since the provided document is for a medical device (shunt catheter) and not an AI/software device, the questions related to AI-specific criteria (e.g., sample size for test/training sets of AI, expert adjudication, MRMC studies, standalone algorithm performance, type of ground truth for AI) are not applicable.

The acceptance criteria here refer to the performance of the physical device as demonstrated through various bench and biocompatibility tests. The document states that all tests were "Pass," implying that the device met the pre-defined acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify general "sample sizes" in terms of patient data or typical "test sets" as one would for an AI model. Instead, it refers to "production equivalent devices" used for the various bench and biocompatibility tests. The specific number of devices or replicates for each test is not detailed.
• Data Provenance: The data is generated from laboratory studies and bench testing performed on the physical device. This is not clinical patient data. The provenance for this type of testing is typically the manufacturer's internal testing facilities or contract labs. No country of origin for data or retrospective/prospective nature is applicable as this is not patient data.

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

• Not applicable. This pertains to an AI/software device. The "ground truth" for a physical device is established by objective measurements and standardized test methods, not expert consensus on data interpretation.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Not applicable. This pertains to an AI/software device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not applicable. This pertains to an AI/software device evaluating human reader performance.

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

• No, not applicable. This pertains to an AI algorithm; the device is a physical shunt catheter.

7. The Type of Ground Truth Used

• For the performance bench tests and biocompatibility tests, the "ground truth" is defined by established international (ISO, ASTM) and FDA-recognized consensus standards, as well as pre-defined internal test methods and specifications. For instance, a "Pass" for biocompatibility means the device met the criteria specified in the relevant ISO 10993 standards. For thrombogenicity, the ground truth was a statistically significant reduction in thrombus deposition compared to the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This pertains to an AI/software device. No training set is involved for validating a physical medical device.

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

• Not applicable. This pertains to an AI/software device.

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The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document is a 510(k) clearance letter from the FDA for a medical device (Codman Libertís™ EVD Catheter). It describes the device, its intended use, a comparison to a predicate device, and summaries of nonclinical testing.

However, the question asks for details related to acceptance criteria and studies that prove a device meets acceptance criteria, specifically those typically associated with AI/software medical devices. This document does not describe an AI/software medical device; it describes a physical medical device (a catheter for draining CSF). Therefore, much of the information requested in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) study," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of device and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, and sterilization validation, which are standard for physical medical devices.

Here's an attempt to answer the applicable parts of your request based on the provided text, and explicitly state where information is not available or not applicable.

Description of Acceptance Criteria and Proving Device Meets Criteria

The Codman Libertís™ EVD Catheter is a physical medical device. Its acceptance criteria are primarily demonstrated through a battery of nonclinical performance bench tests, biocompatibility testing, and sterilization validation, to show that it is substantially equivalent to a legally marketed predicate device. The performance criteria are generally considered a "Pass" or "Fail" based on established standards and internal methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria values but rather states a "Pass" or "Fail" for each test. The acceptance criterion for each test is implicitly that the device performs as expected according to the specified standard or internal method.

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

The document states, "All testing was performed on production equivalent devices." However, it does not specify the sample size for any of the individual bench tests.

Data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the traditional sense for these bench tests, which are conducted in a laboratory setting to evaluate physical properties and performance characteristics.

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

This concept is not applicable to this type of medical device (physical catheter). "Ground truth" in this context would refer to established engineering standards, material specifications, and validated test methods, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

This concept is not applicable to this type of medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers (e.g., radiologists) to resolve disagreements in interpretation, which is not relevant for bench testing of a physical device.

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

No MRMC comparative effectiveness study was done, as this is a physical medical device (catheter), not an AI/software device. Therefore, this question is not applicable.

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

This concept is not applicable since the device is a physical catheter, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests of this physical device consists of:

• Established industry standards (e.g., ASTM F647, ISO 7197, ASTM F2503, ISO 10993-1, ASTM F1980, ISO 11607-1).
• Internal predefined functional and mechanical specifications.
• Validated laboratory methods for chemical content, antimicrobial efficacy (Zone of Inhibition), and sterility assurance (SAL 10-6).
• Usability requirements for the Summative Usability Study.

8. The sample size for the training set

This concept is not applicable as this is a physical medical device, not an AI/software device that would involve a "training set."

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

This concept is not applicable for the same reason as above.

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The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is indicated for use in the ICU or Operating Room (OR) environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays ICP Waveform
• Displays Mean ICP numeric
• Displays the historic mean pressure as a trend
• Displays trend statistics (Pressure Time Dosage (PTD), time above threshold, boxplot, histogram)
• Stores 14-days' worth of mean ICP values
• Stores 24 hours of pressure waveform
• Can capture and store screen-shots
• Can download various data to a USB device for printing or analysis
• Real-time data streaming of mean ICP and waveform via USB connection
• Connect to external patient monitor

The CereLink ICP Monitor can be transported with the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with a CereLink ICP Extension Cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.

The provided text describes a 510(k) premarket notification for a medical device, the CereLink ICP Monitor and CereLink ICP Extension Cable, which are intended for intracranial pressure monitoring. The document outlines acceptance criteria and performance testing for these devices, particularly focusing on modifications made to the extension cable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to "the CereLink Systems" being exposed to the electrical stress setup. It does not provide a specific number for the sample size (e.g., number of devices or test units) used in these tests.
The data provenance is from bench testing as explicitly stated ("Performance Bench Test Results"). This indicates controlled laboratory conditions. There is no mention of country of origin for the data, and the nature of the tests (bench) makes the retrospective/prospective distinction less relevant in the typical clinical study sense. However, the tests are for design verification and validation, implying they were conducted prospectively to assess the new design.

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

Not applicable. This submission pertains to a hardware device (ICP monitor and cable) and its electrical and mechanical performance, not an AI/software device that requires human expert review to establish ground truth for image or diagnostic interpretation. The testing relies on established engineering and medical device standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI/software device requiring subjective interpretation or adjudication by experts. The tests are objective performance evaluations against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is a hardware ICP monitor and cable, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical characteristics of the monitor and cable. The tests described (ICP Drift, Out-of-Range Failure, Electrical Safety, etc.) are essentially "standalone" performance evaluations of the device itself.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on engineering specifications and internationally recognized standards (e.g., ISO, IEC). For the specific "Out-of-Range Failure Test," the ground truth for "failure" is when the device enters the out-of-range state, and the "recovery" is when it exits that state within a specified time, which are objective, measurable outcomes in a controlled "electrical stress setup" designed to reproduce these failures.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this hardware device.

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The Bactiseal Catheters are indicated 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 Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.

Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:

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

Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."

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

• Sample Size for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
• Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted are not mentioned.

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. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.

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

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring adjudication.

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 is not an AI/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.

8. The sample size for the training set

• Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid. The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains barium sulfate for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document, K233448, is an FDA 510(k) clearance letter for the Integra LifeSciences Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set. Based on the content of this letter, the device in question is a physical medical device (catheter) and not an AI/software device.

Therefore, the request for information related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics (such as multi-reader multi-case studies, ground truth establishment for training/test sets, sample sizes for image data, and expert adjudication), is not applicable to this document.

The document describes the changes made to an existing device (Bactiseal EVD Catheter Sets) as:

• Labeling changes: Updating MRI labeling to state MR Safe and administrative updates/harmonized symbols.
• New supplier for clindamycin hydrochloride: The antimicrobial impregnated into the catheter.

The studies mentioned are non-clinical (bench testing and engineering analysis) to demonstrate equivalence to the predicate device despite these changes.

Here's a summary of the relevant "acceptance criteria" and "study that proves the device meets the acceptance criteria" as described in the document for this non-AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of units tested, but it refers to "production equivalent devices" for performance testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer.

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

• Not applicable. This pertains to an AI/software device requiring human expert annotation/ground truth. For this catheter, the "ground truth" is adherence to established industry standards (USP) and internal test methods for drug performance and other material characteristics.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical data review for AI/software devices. Testing was based on established laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not applicable. This type of study is for evaluating observer performance with and without AI assistance for clinical interpretations. The current device is a physical catheter, not an AI diagnostic tool.

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

• No, not applicable. This applies to AI/software performance.

7. The Type of Ground Truth Used:

• For drug equivalency and effectiveness: USP standards and monograph, internal test methods.
• For biocompatibility: Assessment against known materials and established literature/standards.
• For physical characteristics: Engineering analysis and comparison to predicate device specifications.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML product.

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

• Not applicable. There is no "training set" or need for ground truth establishment in this context.

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The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.

The provided document is a 510(k) summary for the Certas Plus Programmable Valves, which are medical devices used for the management of hydrocephalus. This specific document outlines the regulatory review of a proposed modification to an already legally marketed device.

The document does not describe a study that proves the device meets clinical acceptance criteria in the way typically seen for novel medical imaging or diagnostic AI devices. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices after minor modifications (material changes and dimensional/tolerance changes). Therefore, much of the requested information regarding clinical study design, ground truth establishment, expert adjudication, or MRMC studies will not be present in this type of submission.

Here's a breakdown based on the information available and what is not applicable given the nature of the submission:

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

The acceptance criteria and performance are reported for bench and biocompatibility testing, not clinical performance in patients.

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

• Test set sample size: Not explicitly stated in terms of number of devices. The document mentions "production equivalent devices" were used for testing, implying multiple units were tested for each performance and biocompatibility assessment. Specific quantities are not provided, as this is a summary.
• Data provenance: Not applicable in the context of clinical patient data. The data comes from laboratory bench tests and biocompatibility studies on the device itself.

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

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies involving the interpretation of medical images or diagnostic outputs by human experts. This submission focuses on the physical and functional properties of an implantable device through bench and biocompatibility testing. The "ground truth" for these tests would be the established scientific and engineering principles and the predefined pass/fail criteria of the specified ASTM/ISO standards.

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

This information is not applicable as there are no human interpretations or diagnostic outcomes to adjudicate. Test results are objective (e.g., chemical analysis, physical measurements, functional outputs).

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 is not applicable. MRMC studies are used for evaluating diagnostic AI tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to assess the AI's impact on their performance. The Certas Plus Programmable Valves are an implantable device, not a diagnostic AI tool.

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

This is not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the performance and biocompatibility testing is based on:

• Standardized test methods: Adherence to established ASTM, ISO, and USP standards for device function, material properties, and biological safety.
• Predefined pass/fail criteria: Each test has specific criteria that the device must meet to be deemed compliant.

8. The sample size for the training set:

This is not applicable. This is a physical medical device, not an AI model or algorithm that requires a training set.

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

This is not applicable for the same reason as above.

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The Codman Hakim Precision Fixed Pressure Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman Hakim® Precision Fixed Pressure and Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Hakim Precision Valve or Hakim Programmable Valve, to another body cavity where it is a subsequently absorbed. Both the Codman Hakim Precision Fixed Pressure and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Hakim Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman Hakim Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman Hakim Programmable Valves can be adjusted to 18 different opening pressure settings.

The provided text describes a 510(k) premarket notification for Hakim Programmable Valves and Hakim Precision Fixed Pressure Valves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance against specific targets.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not explicitly stated in the provided document. The submission is for minor changes (material and dimensional) to an existing device, and relies on bench testing and an equivalency assessment.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the given FDA letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's clinical performance. Instead, it demonstrates that the device passed a series of performance and biocompatibility tests, indicating compliance with established standards. The acceptance criteria for the tests are implied by the "Pass" outcome, meaning they met the requirements of the specified standards (e.g., ISO 7197, ASTM F1980).

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

• Sample Size: Not specified for each individual test. The document states "All testing was performed on production equivalent devices," implying a sufficient number of units to conduct the referenced tests, but the exact count is not given.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing is described as "performance bench test results" and "biocompatibility testing results," indicating lab-based testing rather than patient data. These appear to be prospective tests conducted for the submission.

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

• Not Applicable. This submission does not involve clinical studies requiring expert ground truth for a test set. The tests are bench and biocompatibility studies against established standards.

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

• Not Applicable. As there are no clinical trials or interpretations of complex data like medical images by multiple experts, no adjudication method is cited.

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

• No. An MRMC study was not conducted and is not relevant to this device submission, which involves physical CSF shunting devices, not AI-assisted reading.

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

• Not Applicable. This is a medical device, not a software algorithm.

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

• The "ground truth" for the tests performed is the compliance with the specified international and national standards (e.g., ISO 7197, ASTM F1980, ISO 10993 series, USP). The "Pass" outcome indicates the device met the objective criteria defined within these standards.

8. The sample size for the training set

• Not Applicable. This refers to a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays ICP Waveform .
• Displays Mean ICP numeric .
• Displays the historic mean pressure as a trend .
• Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram)
• Stores 14-days' worth of mean ICP values .
• . Stores 24 hours of pressure waveform
• Can capture and store screen-shots 9
• . Can download various data to a USB device for printing or analysis
• Real-time data streaming of mean ICP and waveform via USB connection .
• Connect to external patient monitor .

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).

Let's break down the information provided to answer your request.

Based on the provided document, the CereLink ICP Monitor is a device that interfaces with pressure transducers and monitors intracranial pressure. The submission to the FDA (K210993) is for modifications to an existing CereLink ICP Monitor (predicate K183406), not for a brand new device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the original, already cleared device.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

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

Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implied to be the successful demonstration that the modifications do not introduce new safety or effectiveness concerns and that the device continues to perform as intended and substantially equivalent to its predicate. The document doesn't list specific quantitative acceptance criteria for clinical performance in the way one might expect for a novel diagnostic algorithm. Instead, it focuses on various engineering and design-related tests to confirm the changes are benign or improvements.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device like the CereLink ICP Monitor, which is a physiological measurement and monitoring device, the "test set" and "ground truth" are interpreted differently than for, say, an AI-powered diagnostic imaging tool.

• Test Set/Sample Size: The document refers to various bench tests including "ICP Drift Test," "Common Mode Noise and Leakage Current Power Supply Test," "13 Day Simulated Environment Validation Test," etc. These are engineering validation tests, not clinical studies with patient data in the traditional sense of a "test set." The sample sizes would refer to the number of devices or components tested, but this specific detail is not provided in a summarized form.
• Data Provenance: Not applicable in the context of clinical data for performance validation. The testing seems to be internal engineering verification and validation.
• Experts/Ground Truth/Adjudication Method/MRMC/Standalone Performance: These concepts are largely not applicable here. The CereLink ICP Monitor is not an AI-driven diagnostic device that relies on expert interpretation or establishing a ground truth for diagnostic accuracy (like identifying a lesion on an image). It's a device that measures and displays physiological parameters. The "ground truth" in this context would be the actual physical/electrical properties that the device is designed to measure and the expected behavior under various conditions (e.g., drift, noise, safety limits). The study's focus is on validating the device's performance against these engineering and safety standards, not on its diagnostic accuracy based on expert consensus.

The document explicitly states:

• "No clinical studies were required."
• "Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing."
• "The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device."
• "The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device."
• "No animal studies were required."

This indicates that the "study" primarily consisted of bench testing and engineering verification and validation to confirm that the technical modifications (power supply, internal components, software updates, etc.) did not compromise the device's ability to accurately measure ICP, maintain electrical safety, and function reliably.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as the CereLink ICP Monitor is not described as an AI/machine learning device that requires a training set. The modifications described are hardware and software updates to an existing physiological monitoring device, not the development of a predictive algorithm using a "training set."

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