(271 days)
The OxiWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear.
The OxiWear System is an ear pulse oximeter that non-invasively measures and displays patient blood oxygen saturation (SpO2) and Pulse Rate for spot-checking and/or continuous data collection. The OxiWear System is intended to be used with well or poorly perfused patients of all skin types in both motion conditions. The system is intended for use in clinical and home environments for adult (22+) and adolescent (12-21) patients of all skin types who are well or poorly perfused, and can safely wear the oximeter device on the helix of the OxilVear System can be used with patients that are in both motion and stationary conditions.
The OxilVear System contains the OxilVear Wearable, and the OxiMear Mobile Application. The OxiMear Wearable is a wireless, reusable, non-invasive ear pulse oximeter that is intended to measure SpO2 and Pulse Rate based on the amount of transmitted, reflected light through the ear. The OxiWear Wearable is powered by an internal rechargeable lithium ion battery, and attaches directly to the ear. The OxilVear Wearable is intended to be recharged by the OxiWear Charger, which is a rechargeable portable charger,
The OxiMear Wearable is designed to be used with the OxiMeation which receives data from the OxiMear Wearable via Bluetooth connection to the user's smart phone. The OxiMear Mobile Application acts as a historical trending, live data monitoring, and text alert application is intended to be used alongside the OxiWear Wearable during daily use, as well as a data repository to refer back to previous reports containing information about the patient, pulse rate, patient contacts, and more, to present to a physician or caregiver for review.
The document describes the OxiWear system, an ear pulse oximeter, and its claim of substantial equivalence to predicate devices (Nonin Medical, Inc. Models 8100Q2, 8101Q2, and 8102Q2; and Masimo Corporation's Rad-G Pulse Oximeter). The acceptance criteria are primarily defined by the performance specifications for SpO2 and Pulse Rate accuracy, and the studies conducted to prove these metrics are largely non-clinical bench and simulator tests, complemented by clinical testing for SpO2 and Pulse Rate accuracy under no motion and motion conditions.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate table but compares the subject device's (OxiWear) performance specifications against those of the predicate and reference devices. These comparisons implicitly define the performance targets for acceptance.
| Characteristic | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (OxiWear) |
|---|---|---|
| SpO2 Measurement Range | 70-100% | 70-100% |
| SpO2 Accuracy, no motion | Predicate: ± 3% (ARMS); Reference: Adults/Pediatrics/Infants: ± 2% (ARMS) | ± 3.5% (ARMS) |
| SpO2 Accuracy, motion | Reference: ± 3% (ARMS) | ± 3.5% (ARMS) |
| SpO2 Accuracy, low perfusion | Predicate: ± 2% (ARMS); Reference: Adults/Pediatrics/Infants: ± 2% (ARMS) | ± 3.5% (ARMS) |
| Pulse Rate Measurement Range | Predicate & Reference: 25-240 BPM | 20-240 BPM |
| Pulse Rate Accuracy, no motion | Predicate & Reference: ± 3 BPM (ARMS) | ± 3 BPM (ARMS) |
| Pulse Rate Accuracy, motion | Reference: ± 5 BPM (ARMS) | ± 5 BPM (ARMS) |
| Pulse Rate Accuracy, low perfusion | Predicate & Reference: ± 3 BPM (ARMS) | ± 3 BPM (ARMS) |
Note: For SpO2 accuracy, OxiWear's reported accuracy (± 3.5% ARMS) is slightly less precise than either predicate's specified accuracy (± 3% or ± 2% ARMS). However, the document concludes that "OxiWear has a level of accuracy comparable to an industry standard pulse oximeter," implying this difference was deemed acceptable within the context of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document specifies "clinical testing" but does not provide specific sample sizes for the SpO2 and Pulse Rate accuracy studies.
- Test Set Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The document states that "SpO2 validation under normal perfusion conditions was conducted under controlled laboratory conditions evaluating the OxiWear system against a cooximeter." "Motion SpO2 testing was conducted in subjects wearing the OxiWear device while on a treadmill."
- It doesn't specify the country of origin.
- The studies appear to be prospective clinical testing (as subjects wore the device and were evaluated).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a co-oximeter in a controlled desaturation study, not necessarily by human experts.
4. Adjudication Method for the Test Set
Not applicable/not provided. For technical performance metrics like SpO2 and Pulse Rate accuracy, ground truth is typically established by reference devices (e.g., co-oximeters) or a simulator, not through human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not conducted. This type of study is more common for diagnostic imaging AI where human readers interpret cases with and without AI assistance. The OxiWear is a sensor device measuring vital signs directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes. The described clinical testing for SpO2 and Pulse Rate accuracy, where the OxiWear device's measurements are compared against a reference (co-oximeter or reference pulse oximeter), represents a standalone performance evaluation of the device's algorithmic and sensor capabilities.
7. The Type of Ground Truth Used
- Objective Measurement from Reference Devices:
- For SpO2 accuracy (no motion): A co-oximeter was used as the ground truth reference in controlled laboratory conditions.
- For SpO2 and Pulse Rate accuracy (motion): A reference pulse oximeter was used as the ground truth.
- For Low Perfusion Testing and No Motion Pulse Rate Testing: Simulators were used to establish controlled conditions, and comparisons were made against "an industry standard pulse oximeter."
8. The Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning or AI model development. The OxiWear device appears to be a traditional pulse oximeter, not an AI-driven diagnostic device that would require such training sets. If there are internal signal processing algorithms that might have been "trained," this information is not disclosed in the provided FDA submission summary.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/ML model is explicitly mentioned or relevant based on the description of the device as a traditional oximeter.
§ 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).