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

The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

The Certas Programmable Valve System is designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular pressure and drainage of CSF. The Therapy Management System allows the user to non-invasively adiust the opening pressure setting before and after implant.

The Certas Programmable Valve is available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters as well as accessories needed to facilitate placement and use of the valve.

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

The Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

The provided text describes a 510(k) submission for the CODMAN CERTAS Programmable Valve System and CODMAN CERTAS Therapy Management System, focusing on demonstrating substantial equivalence to a predicate device after extending its shelf life from 1 year to 5 years.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by "no change" and "maintained" functionality. The performance data demonstrates that these criteria were met.

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

The document does not explicitly state the sample size for the stability testing (both packaging and product). It refers to "packaging stability study" and "product stability testing" without providing specific numbers of units tested.

• Sample Size: Not explicitly stated.
• Data Provenance: The studies were conducted by the manufacturer, Medos International Sarl, as part of their regulatory submission. The context suggests these were prospective tests designed specifically to demonstrate the extended shelf life. The country of origin of the data is not specified beyond the company's location (Switzerland/US branch).

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

This type of information is not applicable (N/A) to this device submission. This submission concerns a physical medical device (a valve system) and its mechanical/functional performance after aging, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is the physical measurement of performance parameters (e.g., seal strength, pressure-flow, leak, reflux) against established engineering standards (EN ISO 7197:2009).

4. Adjudication Method for the Test Set

This is N/A for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used for expert reviews in image analysis or clinical assessments where there might be inter-observer variability. For objective physical device testing, the results are measured against defined performance specifications.

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 N/A. This submission is for a physical medical device (hydrocephalus shunt valve) for which MRMC comparative effectiveness studies with or without AI assistance are not relevant. This type of study is typically performed for AI-powered diagnostic tools or image analysis software.

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

This is N/A. The device is a physical valve system and a programming system, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this testing is based on:

• Objective physical measurements: Assessing parameters like seal strength, adjustment/indication capability, pressure-flow characteristics, and leak/reflux.
• Engineering Standards: Conformance to recognized international standards like EN ISO 7197:2009 for hydrocephalus shunts. The "ground truth" is that the device must continue to meet these functional and safety specifications after accelerated aging.

8. The Sample Size for the Training Set

This is N/A. This device is not an AI/machine learning product, so there is no "training set" in the context of data-driven model development. The product development likely involved engineering design and testing, but not a data-based training set.

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

This is N/A for the same reasons as point 8.

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The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

The Certas Programmable Valve System is designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular pressure and drainage of CSF. The Therapy Management System allows the user to non-invasively adjust the opening pressure setting before and after implant. The Certas Programmable Valve will be available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters. The Certas Programmable Valve includes the same legally marketed accessories that are available with the Hakim Programmable Valve. The Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position. The BACTISEAL catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Codman Certas Programmable Valve System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes pre-clinical testing for the Codman Certas Programmable Valve System. While it doesn't explicitly state quantitative "acceptance criteria" values in a table, it lists the types of tests performed and the general outcome.

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

The document does not provide specific sample sizes for the pre-clinical tests or details on the provenance of data (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench or laboratory-based, as is common for pre-clinical performance evaluations of medical devices.

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

The document does not mention the use of experts to establish a "ground truth" for the test set. The tests described are primarily objective, quantitative engineering and materials tests (e.g., pressure-flow, strength, MRI compatibility, biocompatibility, sterility) rather than clinical evaluations requiring expert interpretation of outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective pre-clinical evaluations, not interpretive clinical assessments that would require an adjudication method.

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

No. The document describes pre-clinical (bench) testing to demonstrate substantial equivalence based on performance characteristics, materials, and principles of operation. It does not mention any clinical studies, MRMC studies, or human reader performance evaluations.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical medical implant and associated management system, not an AI algorithm. The performance evaluation is for the physical device itself.

7. Type of Ground Truth Used

The "ground truth" for the pre-clinical tests would be the established scientific and engineering standards and methodologies defined by the cited ISO and ASTM standards. For example, for sterility, the ground truth is a sterility assurance level of 10^-6^. For MRI compatibility, the ground truth is the criteria defined by ASTM F2503 for "MR Conditional."

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" of the device itself refers to its design and manufacturing processes based on engineering principles and regulatory standards.

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

Not applicable. As above, this is a physical medical device, not an AI/ML algorithm. The "ground truth" for its development would be based on established engineering principles, material science, and prior knowledge from predicate devices and relevant standards.

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