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HAKIM™ Precision Valve System: The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System: The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
SiphonGuard™ CSF Control Device: The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart. 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 erect position.

The devices that are the subject of this Special 510(k): Device Modification are identical to their respective predicate predecessors, with the exception of one material component. The proposed alternative epoxy is the single difference in the devices.

The provided text is a 510(k) summary for a medical device modification, specifically regarding the CODMAN HAKIM™ Precision, Programmable, Micro Programmable Valve Systems and the SiphonGuard™ CSF Control Device. The core of this submission is a material change (alternate epoxy) to existing devices.

Therefore, the study performed is not a typical performance study comparing a device's diagnostic or therapeutic efficacy against a ground truth. Instead, it focuses on demonstrating that the new material does not negatively impact the device's established performance.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria here are implicitly that the modified devices (with the new epoxy) demonstrate equivalence to the predicate devices in terms of performance and safety, as assessed through bench and biocompatibility testing. The "reported device performance" is the statement that these tests were performed and were "appropriate... to support the device for its intended use," which signifies that the modifications meet the safety and effectiveness requirements.

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

The document does not specify the sample size for the test set used in the bench and biocompatibility testing. The data provenance is not explicitly stated. Given that it's a 510(k) submission for a material modification, these would typically be retrospective tests conducted by the manufacturer in a laboratory setting (bench testing) and possibly with in vitro or animal studies for biocompatibility, rather than human clinical trials with geographical data provenance.

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

Not applicable. For a material change and bench/biocompatibility testing, the "ground truth" is typically defined by established engineering specifications, material science standards, and biocompatibility guidelines. These are assessed by engineers, material scientists, and toxicologists, rather than medical experts establishing a diagnostic ground truth. The document does not specify the number or qualifications of these experts.

4. Adjudication Method for the Test Set

Not applicable. This type of submission does not involve adjudication of expert readings or diagnoses. The "adjudication" would be internal technical review and approval by the manufacturer's quality and regulatory teams to ensure the test results meet the defined criteria, followed by FDA review of the submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, with and without AI assistance, to assess the AI's impact on diagnostic accuracy. This submission concerns a material change in existing Shunt Systems and a CSF Control Device, which are implantable mechanical devices.

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

Not applicable. There is no algorithm or AI component in these mechanical devices.

7. The Type of Ground Truth Used

The ground truth for this type of submission (material change) would be based on:

• Engineering specifications and performance standards: Ensuring the modified device meets predefined mechanical, flow, and durability specifications.
• Biocompatibility standards: Demonstrating that the new epoxy material is non-toxic and compatible with the human body as per recognized international standards (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

Not applicable. There is no AI model involved that requires a training set.

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

Not applicable. As there is no AI model, there is no training set or associated ground truth.

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The HAKIM Micro Programmable (HMP) Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

The HMP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve opening pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's ruby ball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The opening pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.

Acceptance Criteria and Study for the HAKIM Micro Programmable Valve System

The provided text describes the HAKIM Micro Programmable Valve System, its intended use, and a comparison to a predicate device, but it does not explicitly state specific acceptance criteria or details of a comprehensive study that demonstrates the device meets those criteria.

Instead, the submission states: "Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt. Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt."

This indicates that the "study" was primarily focused on demonstrating substantial equivalence to an existing predicate device (CODMAN HAKIM Micro Precision Valve System, K973774) rather than meeting predefined, quantitative acceptance criteria. The FDA's 510(k) clearance process often relies on this substantial equivalence model.

Therefore, many of the requested details regarding specific acceptance criteria, sample sizes, ground truth establishment, and expert involvement are not available in the provided document.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The document refers to "Performance testing" but does not quantify the number of devices or scenarios tested.
• Data Provenance: Not specified. Given it's a 510(k) submission from a US company, it's highly likely the testing was conducted in a controlled lab environment, potentially within the US. The type of testing (e.g., in-vitro bench testing, animal models) is not detailed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of a medical device, it's likely that engineers, medical professionals, and quality assurance personnel were involved, but their specific roles in "ground truth" establishment (beyond verifying device function) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The testing described appears to be objective performance evaluation (e.g., pressure measurements, flow rates) rather than subjective interpretation requiring adjudication among experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or implied. This type of study is more common for diagnostic imaging or interpretation tasks, not for the direct functional performance of a mechanical implantable device like a shunt.

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

• Standalone Performance: This concept doesn't directly apply here as it's a mechanical device, not an algorithm. The "device performance" described would inherently be standalone from human intervention once implanted and programmed, focused on its physical function of regulating CSF pressure. There's no AI or algorithmic component described in its operation.

7. The Type of Ground Truth Used

• Ground Truth Type: For a mechanical device like this, the "ground truth" would be established through objective physical measurements and engineering specifications. This would involve:
  • Bench Testing: Measuring actual pressure regulation, flow rates, and programmability against design specifications.
  • Functional Equivalence: Demonstrating that its performance parameters (e.g., pressure range, stability) are comparable to the predicate device.
  • Material Compatibility/Biocompatibility: (Implied for an implantable device, though not detailed in the summary).

8. The Sample Size for the Training Set

• Sample Size (Training Set): This concept is not applicable as the HAKIM Micro Programmable Valve System is a mechanical device, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its "design" and "manufacturing" would be based on engineering principles and iterative development, not data-driven training.

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

• Ground Truth Establishment (Training Set): As mentioned above, this is not applicable for this type of device. The "ground truth" during development would be the engineering specifications, performance targets, and safety requirements derived from medical understanding of hydrocephalus and prior shunt designs.

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