(175 days)
The Electronic Reading Instrument is intended to locate and read the operating pressure of a Polaris valve. It is specifically designed to be combined with the Locator from a compatible Polaris Adjustment Kit (PAK2).
The Polaris® valve electronic reading instrument (PAK3-ERI) is intended to non-invasively locate and read the operating pressure of a Polaris® valve before and after implantation in the treatment of hydrocephalus. It should be inserted into the PAK2-LI locator tool (identical to the locator tool part as in the predicate device cleared via K141227) in order to read the valve's pressure position.
The provided text describes a 510(k) submission for the "Polaris Valve Electronic Reading Instrument." However, it does not include detailed information regarding the acceptance criteria of a study that proves the device meets specific performance metrics. Instead, it focuses on the equivalence to a predicate device and summarizes non-clinical testing.
Therefore, many of the requested items cannot be directly extracted from the provided text. I will provide what can be inferred or stated from the document, and indicate where information is not provided.
Device Description:
The Polaris Valve Electronic Reading Instrument (PAK3-ERI) is intended to non-invasively locate and read the operating pressure of a Polaris® valve, particularly when combined with the Locator from a compatible Polaris® Adjustment Kit (PAK2). It uses an indicator light to measure the valve's magnetic field and display the valve pressure position.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in this document. The document states that "Performance testing included design verification tests, software tests, electrical safety test, EMC safety test, simulated use test, use life test and transit test," but it does not specify the acceptance criteria for these tests nor the reported numerical performance of the device against those criteria. This is typically found in a separate detailed test report.
2. Sample Size Used for the Test Set and Data Provenance
Not provided regarding performance testing. For the "simulated use test" and "use life test," the sample size of valves or test subjects is not specified. The data provenance (country of origin, retrospective/prospective) for these tests is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. This device is an "Electronic Reading Instrument" that reads the physical operating pressure of a valve. The "ground truth" for its function would likely be established by comparing its readings to known, precisely set pressures of the valves, not by human expert interpretation of images or clinical data. Therefore, expert consensus in the typical sense (e.g., radiologists interpreting images) is not relevant for establishing ground truth for the device's primary function.
4. Adjudication Method for the Test Set
Not applicable for this type of device. Adjudication methods like "2+1" or "3+1" are typically used when there is subjective interpretation involved, such as in image reading or clinical diagnosis. For an instrument that reads a physical property (valve pressure), the "ground truth" would be objective measurements or pre-set values, not subject to adjudication by multiple human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, not performed and not applicable. An MRMC study is relevant for AI/imaging devices where human readers interpret medical images. This device is an electronic reading instrument for a physical valve, not an image analysis or diagnostic aid requiring human interpretation of complex medical imagery. The document states a comparison to a predicate device (PAK2-RI vs. PAK3-ERI), but this is a technical equivalence comparison, not an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Likely yes, as this is an instrument. The device's primary function is to read the operating pressure. Performance tests (e.g., accuracy of pressure reading) would inherently be "standalone" in this context, meaning the instrument's reading accuracy would be assessed against a known standard. However, the specific details or results of these standalone tests are not provided. The text mentions "simulated use test," which would evaluate the device's function directly.
7. The Type of Ground Truth Used
Inferred to be objective physical measurements/settings. For an instrument designed to "read the operating pressure of a Polaris valve," the ground truth would be the actual, precisely known operating pressure of the test valves, established by a calibrated reference method or by setting the valves to known pressures. This is based on the device's function as a measurement tool.
8. The Sample Size for the Training Set
Not applicable to this type of device/submission. This is an electronic measurement instrument, not an AI/machine learning device that requires a "training set" in the typical sense (e.g., for image recognition or predictive models). The "software tests" mentioned would refer to verification and validation of the embedded software's functionality, not training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable to this type of device/submission. As there's no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here.
§ 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).