(91 days)
The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
This submission includes two additional configurations of the Codman Certas Plus Programmable Valve: Certas Plus Inline Small and Certas Plus Right Angle. The Codman Certas Plus Programmable Valves are sterile, single use, implantable devices 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 a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth (8) 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 postimplantation by using the Codman Certas Tool Kit.
The provided document is a 510(k) premarket notification for a medical device, specifically the Codman Certas Plus Programmable Valve. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through an AI-based study or a multi-reader, multi-case (MRMC) comparative effectiveness study. The document primarily focuses on bench testing (Verification Testing) and simulated use (Validation Testing) to establish that the modified versions of the device perform equivalently to the predicate.
Therefore, many of the questions related to AI-specific study design (like ground truth establishment, expert consensus, MRMC studies, training/test set sizes, and specific performance metrics like AUC, sensitivity, specificity for diagnostic AI) are not applicable to this document.
However, I can extract information related to the physical device's performance, acceptance criteria for those tests, and the general approach to validating the device's functionality.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance for Codman Certas Plus Programmable Valve
The device is a non-AI, physical medical device (a CSF shunt) and therefore the typical "acceptance criteria" and "study" described in an AI context (e.g., AUC, sensitivity, specificity, MRMC studies) are not present. Instead, the document describes design verification and validation activities against established standards and internal criteria to demonstrate substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document states that "All samples in design verification testing met predefined acceptance criteria" and "test results demonstrated that the acceptance criteria were met." However, the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. The results are reported as "PASS."
| Test Category | Test Method Summary | Reported Device Performance/Result |
|---|---|---|
| Verification Testing | ||
| Shunt Safety and Performance Testing | Testing per ISO 7197:2009 standard, including: | |
| • 4.2. Radiopacity | ||
| • 4.3. Biocompatibility | ||
| • 4.4. Resistance to leakage | ||
| • 4.5. Control of the implanted shunt | ||
| • 4.6. Pressure-flow characteristics | ||
| • 4.7. Identification of shunts in vivo | ||
| • 4.8. Ability to withstand overpressure | ||
| • 4.9. Dynamic breaking strength | ||
| • 4.10. Behavior under MR imaging conditions | ||
| • 4.11. Bursting pressure | ||
| • 5.1.1. Reflux performance | ||
| • 8.2.d. Method for puncture and indication of how often puncturing is possible | PASS | |
| Shelf Life Study | Testing per ISO 7197:2009 standard for shunt safety and performance following accelerated aging. Clauses related to mechanical performance of the valve were tested to specifically stress the valve's silicone housings. | PASS |
| Sterilization | Testing per ISO 17665-1: 2006 and ISO 17665-2: 2009 for sterilization, moist heat. | |
| • Confirm assembly process does not create a higher risk of bioburden. | ||
| • Test ability of Certas Plus Inline valve sterilization cycle to sterilize the subject devices. | ||
| • Natural Product Resistance Test | ||
| • Microbial Challenge | PASS | |
| Transit Testing | ISO 11067-1: 2009 and ISO11607-2: 2006: Packaging for Terminally Sterilized Medical Devices. Confirm that unit box and double blister prevents damage to the product in normal conditions of transit, handling, and storage in accordance with ISTA 3A (Vibration, drop, and environmental conditioning). | PASS; Cosmetic defects observed on unit box with no effect on packaging or valve performance. |
| Valve Fixation Testing | Confirm that silicone strength of Certas Plus Inline Small valve suture flange is no worse than the predicate device. Test compatibility of bone screw fixation with Certas Plus Right Angle valve per ISO 7197:2009 method of Dynamic Breaking Strength. | PASS |
| Valve Flexibility Testing | Measure force to flex subject devices to known curvature compared to predicate device. | PASS; Certas Plus Inline Small valve is more flexible and Certas Plus Right Angle valve is equivalent to predicate device. |
| Adjustment and Indication Testing | Verify ability to use Codman Certas toolkits to adjust and indicate a valve. | PASS |
| Validation Testing | ||
| System Safety Study (Simulated Post-Implantation Use) | Clinicians evaluated the maximum acceptable rate for false positives and maximum success rate for completing a full procedure. Testing conducted on a simulated head model with variable valve orientation. | PASS |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each verification and validation test. It generally refers to "all samples" meeting criteria. This is typical for 510(k) summaries where the detailed test protocols and sample sizes are provided in the full submission, but not always summarized in this public document.
Data provenance: The testing was conducted by Integra LifeSciences Production Corp. (manufacturer/applicant). The document doesn't explicitly state the country of origin of the data in terms of patient source, as this is bench and simulation testing, not clinical data from patients. The testing is retrospective in the sense that it's performed on manufactured devices, not derived from real-time patient observations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a physical device like a shunt, "ground truth" generally refers to the known physical properties and performance specifications, established through engineering and quality control benchmarks, and adherence to international standards (e.g., ISO). For the "System Safety Study" (validation), "clinicians" were involved, but their number and specific qualifications are not detailed. Their role was to evaluate the device in simulated use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation of data, typically in diagnostic imaging or AI performance assessment. For physical device performance, reconciliation/adjudication is typically handled by senior engineers or quality assurance personnel reviewing failed tests, not by a formal multi-reader 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 is a physical medical device, not an AI diagnostic or assistance system. The "System Safety Study" involved clinicians but was a usability/performance study in a simulated environment, not an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The device functions mechanically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Adherence to international standards (e.g., ISO 7197:2009, ISO 17665-1: 2006, ISO 17665-2: 2009, ISO 11067-1: 2009, ISO11607-2: 2006, ISTA 3A).
- Predefined engineering specifications and performance characteristics (e.g., pressure-flow characteristics, strength, sterilization effectiveness).
- Comparison to the performance of the legally marketed predicate device (K152152) and reference device (K053107) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).