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510(k) Data Aggregation
(111 days)
The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.
TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals.
TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System.
The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C.
Here's a breakdown of the acceptance criteria and the study details for the TipTraQ (TTQ001) device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents the performance results directly without explicitly stating the "acceptance criteria" as a separate, quantified threshold. However, for the SpO2 validation, it states "met the predefined acceptance criteria <3.5". For the sleep validation study, it mentions "met all the predetermined acceptance criteria (set by prior studies and reference literatures)," implying these are the results shown in the table.
| Measure | Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|---|
| SpO2 Accuracy | Arms (Artificial Root Mean Square) | < 3.5% (stated) | 1.41% (Overall) |
| SpO2 Range 70-100% | N/A (implied by meeting overall Arms) | 1.41 | |
| SpO2 Range 60-70% | N/A | 1.55 | |
| SpO2 Range 70-80% | N/A | 1.7 | |
| SpO2 Range 80-90% | N/A | 1.35 | |
| SpO2 Range 90-100% | N/A | 1.11 | |
| Pulse Rate (PR) Accuracy | Arms (Artificial Root Mean Square) | N/A | 1.64 |
| PR Range | N/A | 56-118 bpm | |
| Total Sleep Time | Pearson Correlation Coefficient (PCC) | N/A | 0.786 |
| Epoch-wise Sleep Stage (Wake) | Sensitivity | N/A | 0.655 |
| Specificity | N/A | 0.901 | |
| Accuracy | N/A | 0.837 | |
| Epoch-wise Sleep Stage (REM) | Sensitivity | N/A | 0.713 |
| Specificity | N/A | 0.930 | |
| Accuracy | N/A | 0.905 | |
| Epoch-wise Sleep Stage (NREM) | Sensitivity | N/A | 0.824 |
| Specificity | N/A | 0.738 | |
| AHI based on 1a rule | Overall Accuracy | N/A | 0.791 |
| AHI cutoff 5 sensitivity | N/A | 0.868 | |
| AHI cutoff 5 specificity | N/A | 0.741 | |
| AHI cutoff 15 sensitivity | N/A | 0.876 | |
| AHI cutoff 15 specificity | N/A | 0.755 | |
| AHI cutoff 30 sensitivity | N/A | 0.806 | |
| AHI cutoff 30 specificity | N/A | 0.905 | |
| AHI based on 1b rule | AHI cutoff 5 sensitivity | N/A | 0.924 |
| AHI cutoff 5 specificity | N/A | 0.801 | |
| AHI cutoff 15 sensitivity | N/A | 0.909 | |
| AHI cutoff 15 specificity | N/A | 0.908 | |
| AHI cutoff 30 sensitivity | N/A | 1.000 | |
| AHI cutoff 30 specificity | N/A | 0.933 |
2. Sample Size and Data Provenance for the Test Set
- SpO2 Validation Study:
- Sample Size: 12 subjects
- Data Provenance: University of California San Francisco (UCSF) - implies prospective study data from the US.
- Sleep Validation Study:
- Sample Size: 147 qualified samples
- Data Provenance: Duke University Hospital - implies prospective study data from the US.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for either the SpO2 validation study or the sleep validation study.
- SpO2 Validation: The ground truth was established by "reference arterial blood gas sampling," which is a clinical standard, not an expert panel.
- Sleep Validation: The ground truth was established by "the gold standard in-lab polysomnography (PSG)." PSG scoring typically involves trained sleep technologists and often review by a board-certified sleep physician, but the number and qualifications of these individuals are not specified in the document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for either the SpO2 validation study or the sleep validation study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance is present in the document. The studies described are standalone performance validations against a gold standard.
6. Standalone Performance Study (Algorithm Only)
Yes, standalone performance studies were done. Both the SpO2 validation study and the sleep validation study describe the TipTraQ device's performance (which includes its algorithm, "TipTraQ Algorithm System") compared to a "gold standard" or reference method, without human-in-the-loop assessment as part of the primary performance metrics. The stated "TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals," clearly indicates an algorithm-only evaluation for these parameters.
7. Type of Ground Truth Used
- SpO2 Validation Study: "Reference arterial blood gas sampling." (Clinical standard measurement)
- Sleep Validation Study: "Gold standard in-lab polysomnography (PSG)." (Clinical standard physiological monitoring and expert scoring)
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set used for the TipTraQ Algorithm System.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set was established. It only describes the validation studies.
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