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510(k) Data Aggregation
(197 days)
The F&P InfoGSM™ is intended for home and clinical use as an accessory for the F&P ICON™ CPAP device. The F&P InfoGSM™ transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible.
The InfoGSM™ is intended for use with F&P Healthcare ICON™ CPAP devices only and should not be connected to any other device.
The InfoGSM is an accessory for use with Fisher & Paykel Healthcare !CON Series CPAP devices to provide wireless compliance monitoring and remote settings update functions. The system consists of the InfoGSM and InfoSmart Web Software.
- InfoGSM is an accessory module that attaches via USB cable to the data output port of Fisher & Paykel Healthcare ICON CPAP devices. Compliance data is transferred from the ICON CPAP and uploaded via wireless modem to a secure database server.
- InfoSmart Web is server database and internet application software for review of compliance data uploaded from the InfoGSM. It includes display, reporting, and data management functions to assist in assessing CPAP usage and effectiveness, and allows for remotely updating ICON CPAP device settings.
The provided document is a 510(k) summary for the Fisher & Paykel Healthcare InfoGSM device. It describes the device, its intended use, and indicates that clinical testing was not required. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a clinical study is not applicable or cannot be extracted directly from this document.
However, I can extract information related to non-clinical testing and the overall conclusion regarding safety and effectiveness.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functional Verification | Software verification procedures to ensure data is transferred, uploaded, and displayed accurately, and that CPAP settings updates are accurately communicated back to the device. | "completion of software verification procedures" which "established correct functionality of the InfoGSM according to requirements." "Hardware testing carried out for the InfoGSM indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective..." |
| Device Performance | Performance testing of the modem and software to ensure data is transferred, uploaded, and displayed accurately, and that CPAP settings updates are accurately communicated back to the device. | "performance testing of the modem and software to ensure data is transferred, uploaded, and displayed accurately, and that CPAP settings updates were accurately communicated back to the device." |
| Electrical Safety | Compliance to IEC 60601 series standards. | "will be completed by accredited laboratories before marketing of the device." "The device will meet specified standard requirements for electrical safety..." |
| Electromagnetic Compatibility (EMC) | Compliance to IEC 60601 series standards. | "will be completed by accredited laboratories before marketing of the device." "The device will meet specified standard requirements for... electromagnetic compatibility..." |
| Environmental Testing | Compliance to IEC 60068 series standards. | "will be completed by accredited laboratories before marketing of the device." "The device will meet specified standard requirements for... environmental performance..." |
| GSM Mobile Device Certification | Compliance to FCC and CTIA PTCRB industry certification requirements. | "will be completed by accredited laboratories before marketing of the device." "The device will meet specified standard requirements for... industry certification requirements for GSM mobile devices..." |
| Equivalence to Predicate | "device functions equivalently to the predicate devices" in terms of: transfer of compliance and efficacy data, microprocessor control and pre-approved RF wireless module, rechargeable internal battery, interface to secure server database, and website review software. | "The system configuration functions equivalently to the predicate devices." "This information indicates that the InfoGSM is equivalent to the predicate devices in terms of device safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Not applicable for clinical data. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the InfoGSM System. The product functionality has been adequately assessed by bench testing as above."
- For non-clinical testing (functional verification, performance testing), sample sizes or data provenance are not specified in the document. These typically involve laboratory testing rather than data sets in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth was established as no clinical testing was deemed necessary. For non-clinical testing, "experts" would likely be the engineering and quality assurance teams conducting the verification and validation, but their specific qualifications are not detailed in this document.
4. Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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. No MRMC study was performed as no clinical testing was required. This device is an accessory for data transmission and remote settings update, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable/Implied. The functional and performance testing described (data transfer, upload, display, settings updates) represents a "standalone" evaluation of the device's technical capabilities without requiring human interpretation of results in a diagnostic sense. The document states this testing "established correct functionality of the InfoGSM according to requirements."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For non-clinical testing: The "ground truth" was established by design requirements and specifications, against which the functional and performance testing was measured. For example, the ground truth for data transfer accuracy would be the raw data from the CPAP device, and the ground truth for settings updates would be the intended settings change. For compliance standards (IEC, FCC, CTIA PTCRB), the ground truth is adherence to the specific criteria defined in those standards.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its functionality is based on established communication protocols and software logic.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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