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KnightControl is a remote control for use by clinicians to adjust the settings of the GoodKnight 418, GoodKnight 420, GoodKnight 425 and Knightstar 330 devices.

The KnightControl is designed to control the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 devices in hospital, sleep laboratories, or other clinical settings. The KnightControl is powered by AC mains (100 VAC to 240 VAC nominal). The KnightControl is doubleinsulated so that grounding is not required. The KnightControl is set up for use by the clinician according to the instructions provided in the manual. The devices are operated according to the instructions contained in their respective Patient Manual and Clinical Manual. The KnightControl relies on a microprocessor for setting and viewing main control parameters and status of the attached device, and turning features on and off. The microprocessor is also required for getting data of some signals from the devices in order to output these signals to allow these signals to be recorded. The KnightControl is linked via an RS232 serial port to one of the following devices: GoodKnight 418 series, GoodKnight 420 series, GoodKnight 425 series, or Knightstar 330. The KnightControl uses software to recognize the device to which it is connected and automatically adapt its menu to the device. The KnightControl is not for use in life-supporting or life-sustaining situations. The device and it's accessories are not intended for sterile use. The KnightControl is for multiple use. The KnightControl contains no patient contact components. The KnightControl is for use in by physicians, nurses, and sleep lab technicians in a clinical (hospital, sleep laboratory, etc.) environment. The KnightControl does not contain any drugs or biological products as components. The KnightControl is not part of a kit.

Here's an analysis of the provided 510(k) summary for the PURITAN BENNETT KnightControl, extracting the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

The provided 510(k) summary is a high-level overview and does not contain the detailed quantitative acceptance criteria or specific performance metrics that would typically be found in a comprehensive test report. The summary states that tests were performed and passed, but not what the specific pass/fail thresholds were for each test (e.g., specific voltage limits for electrical safety, EMI/EMC radiation levels).

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

• Sample Size: Not specified. The document refers to "testing" but does not give the number of devices or iterations used for any of the performance tests.
• Data Provenance: Not specified. The summary does not provide details on the country of origin or whether the data was retrospective or prospective. Given the nature of a remote control device and the type of tests conducted (functional, electrical, EMC, mechanical, environmental), it's highly likely these were laboratory-based, prospective tests conducted on the manufactured device samples.

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

This information is not applicable to this type of device and study. The KnightControl is a hardware accessory (remote control) for medical devices, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment based on clinical data. The tests focus on engineering performance, safety, and compatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The KnightControl is not an AI-assisted diagnostic or decision-support device. It's a remote control for CPAP machines. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

This information is not applicable. The KnightControl does not contain an algorithm that operates "standalone" in a diagnostic or interpretive sense. Its software controls the associated CPAP devices and processes signals, but it doesn't perform diagnostic functions independently of clinician interaction. Performance testing (functional, electrical, etc.) inherently evaluates the device itself (standalone in an engineering context) but not in the sense of a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be its objective engineering specifications and compliance with recognized standards. For example:

• Functional Ground Truth: Whether the commands sent by the remote control are accurately received and executed by the connected CPAP device, and whether the displayed information is accurate.
• Electrical Safety Ground Truth: Compliance with established electrical safety standards (e.g., leakage current within limits, insulation integrity).
• EMC Ground Truth: Compliance with established electromagnetic compatibility standards (e.g., radiated emissions below limits, immunity to interference).
• Mechanical/Environmental Ground Truth: Ability to withstand specified physical stresses (e.g., vibration, temperature) without functional degradation.

These are verified through direct measurement and observation against pre-defined engineering requirements and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The KnightControl is not a machine learning or AI device that requires a "training set." Its software is traditionally programmed and verified, not trained on data.

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

This information is not applicable for the same reason as point 8.

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