(385 days)
Avidhrt Sense is a handheld spot-checking measurement device, indicated to do the following:
• Non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician).
Avidhrt Sense SpO2 is intended for use in adult patients in the home environment. The Avidhrt Sense SpO2 is not for continuous monitoring, use during motion or for patients with low perfusion. The Avidhrt Sense SpO2 is not intended for pediatric use.
Avidhrt Sense SpO2 is a handheld spot-checking measurement device designed for non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is used in conjunction Avidhrt Sense SpO2 smart phone app that displays the SpO2.
Here’s a breakdown of the acceptance criteria and study proving device performance for the Avidhrt Sense SpO2, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Avidhrt Sense SpO2) |
|---|---|
| SpO2 Accuracy (Arms) per ISO 80601-2-61 | |
| - SaO2 Range: 70-80% | 2.44% Arms |
| - SaO2 Range: 80-90% | 1.49% Arms |
| - SaO2 Range: 90-100% | 1.43% Arms |
| - SaO2 Range: 70-100% | 1.82% Arms |
| Low Perfusion Rejection | Evaluated and addressed by performance testing. |
| Electrical Safety | Complies per IEC 60601-1 and IEC 60601-1-11. |
| Electromagnetic Compatibility (EMC) | Complies per IEC 60601-1-2 and wireless coexistence testing per ANSI C63.27. |
| Biocompatibility | Complies per ISO 10993-1. |
Note: The document states "satisfied the prespecified performance criteria" for the Arms values, indicating these reported values are within the acceptable limits.
Study Details Proving Device Meets Acceptance Criteria
1. Sample Size for the Test Set and Data Provenance:
- Sample Size: 12 healthy volunteer subjects.
- Data Provenance: The study was a "controlled hypoxia or desaturation study," which is typically a prospective, controlled clinical study conducted in a specialized lab environment. The country of origin is not explicitly stated in the provided text.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not explicitly stated in the provided text. For a controlled hypoxia study, the "ground truth" (arterial oxygen saturation, SaO2) is established by directly measuring blood gas samples using a co-oximeter, which is considered the gold standard. The experts involved would typically be medical professionals (e.g., physicians, nurses, lab technicians) trained in arterial blood draws and blood gas analysis.
3. Adjudication Method for the Test Set:
- Not applicable in the traditional sense for this type of study. Ground truth (SaO2) is directly measured from arterial blood samples. The document mentions "Two arterial blood samples were then obtained, approximately 30 seconds apart," which indicates a method to confirm stability, but not an adjudication of human-interpreted results.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This type of study (comparative effectiveness of human readers with/without AI assistance) is relevant for AI-powered diagnostic imaging devices. The Avidhrt Sense SpO2 is a direct measurement device, and the clinical study focuses on its accuracy against a gold standard (arterial blood gas analysis) rather than improving human interpretation of complex data.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical study performed (controlled hypoxia study) is a standalone performance assessment of the device's SpO2 measurement accuracy without human interpretation as part of the primary outcome. The device's output (SpO2 readings) was directly compared against the ground truth.
6. The Type of Ground Truth Used:
- Expert Consensus/Pathology/Outcomes Data: Not used in this context.
- Direct Measurement from Arterial Blood Samples: The ground truth for SpO2 accuracy was established by obtaining arterial blood samples and analyzing them for oxyhemoglobin saturation (SaO2) at controlled, stable levels of induced hypoxia. This is considered the reference standard for oximeter accuracy studies (often referred to as co-oximetry).
7. The Sample Size for the Training Set:
- The document does not mention a separate "training set" or its sample size. For traditional medical devices like oximeters, the manufacturing and design process relies on known physiological principles and validated components rather than machine learning models that require distinct training data. If any internal optimization or calibration used patient data, it is not specified as a "training set" in the context of machine learning.
8. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no dedicated "training set" (in the machine learning sense) is described or needed for this type of device according to the provided text. The accuracy validation is performed on a discrete test set against a clearly defined gold standard.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).