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

The Codman Certas Plus Programmable Valve is a sterile, single use, implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The Codman Certas Plus Programmable Valve is a pressure-regulating valve utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve.

The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide for a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve "virtually off" without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed post-implantation by using the Codman Certas Tool Kit, which employs magnetic force to select one of the 8 settings.

The provided text describes a 510(k) premarket notification for the Codman Certas Plus Programmable Valve, where the manufacturer is seeking to expand its indications for use to include ventriculo-atrial (VA) shunting. The key focus of the submission is to demonstrate substantial equivalence to a predicate device for this expanded use.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: The document does not specify the exact sample sizes used for reflux testing or shelf-life testing.
• Data Provenance: The data comes from internal testing conducted by Codman, the device manufacturer. It is prospective testing, performed specifically to support this 510(k) submission for expanded indications. The country of origin of the data is not explicitly stated, but the submitter is Codman & Shurtleff, Inc., based in Raynham, MA, USA, and Medos International SARL in Le Locle, Switzerland.

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

• No external experts were used to establish ground truth for the bench testing. The "ground truth" for these tests is defined by the international standards (ISO and ASTM) and internal company specifications for performance.

4. Adjudication Method for the Test Set

• No adjudication method is described as the testing performed was objective bench testing against pre-defined standards.

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

• No MRMC comparative effectiveness study was done. This filing is for a physical medical device (a programmable valve) and not an AI/imaging diagnostic device.

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

• Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• For bench testing, the ground truth is defined by international consensus standards (ISO 7197:2009, ASTM F647:1994 (R2006)) and internal company specifications that ensure the device meets predefined performance characteristics (e.g., reflux limits, shelf life stability).
• For biocompatibility, the ground truth is based on regulatory and scientific standards (ISO 10993-1, ISO 10993-4) and FDA guidance, often relying on established material safety data.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set. The device itself is the product under review.

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

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

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