(311 days)
The Loop System is intended for adult patients in the home environment for passive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
The Loop System measures and records:
- arterial oxygen saturation (SpO2)
- heart rate (HR)
- respiration rate (RR)
All of these measurements are made when no motion is detected by the System.
The Loop System device does not provide physiological alarms
The Loop System is a prescription-only medical device indicated for use by adult patients in the home environment for passive, non-invasive, intermittent data collection of resting (i.e., no motion) physiological parameters. The data is derived from reflectance-based photoplethysmogram (PPG) signals from the patient's wrist, collected by Light Emitting Diodes (LEDs) of varying wavelengths and photodiodes sensitive to said wavelengths embedded in the Loop Band. An accelerometer incorporated in the Loop Band determines when the patient is at rest by constantly monitoring the activity level of the patient. The data is recorded during those resting periods. Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server.
Patients wear the Loop Band on their wrist for periods of up to 24 hours. Patients will then have to charge the Loop Band with a Loop Charging Station provided to them as part of the Loop System. During charging, the data is uploaded to the Spry Server.
The Loop band can independently analyze and display resting heart rate and arterial oxygen saturation (SpO2). The data must be downloaded and analyzed by the Spry Server to determine respiration rate.
All physiological measurements collected by the Loop System are reported on a comma separated value (CSV) file as a time-stamped series. The CSV can then be remotely accessed through a web interface for review and analysis by a clinician.
The provided text focuses on the 510(k) summary for the Spry Health Loop System, comparing it to a predicate device. It briefly mentions clinical studies but does not provide detailed acceptance criteria or study results in the format requested. Therefore, the answers will be based on the limited information available and will highlight what is missing.
Here's an attempt to answer based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria and their corresponding reported device performance values are mostly stated in comparison to the predicate device or standards. The document identifies acceptance criteria through compliance with ISO standards and FDA guidelines.
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Loop System) |
|---|---|---|
| Respiration Rate | 3 RPM ARMS | 3 RPM ARMS |
| SpO2 | 2% ARMS (predicate) | 3% ARMS, no motion |
| Heart Rate (HR) | 3 BPM ARMS, no motion | 3 BPM ARMS, no motion |
| Respiration Rate Range | 4 - 70 RPM (predicate) | 4 - 40 RPM |
| SpO2 Range | 70 - 100% | 70 - 100% |
| Heart Rate Range | 25 - 240 BPM (predicate) | 25 - 250 BPM |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, ISO 80601-2-61, ISO 10993-1 |
Note: For SpO2, the Loop System's 3% ARMS performance compared to the predicate's 2% ARMS is stated to still comply with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters (2013). The document rationalizes the reduced respiration rate range as "not clinically differentiating in a retrospective monitoring context" and the SpO2 accuracy as still complying with relevant standards and guidance.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size:
- Respiration Rate Study: 12 healthy adult subjects
- Pulse Oximetry Study: 12 healthy adult subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies conducted specifically for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth. It refers to:
- "Gold standard monitoring procedure" for respiration rate.
- "Gold standard, arterial blood gas analysis" for pulse oximetry.
It does not mention human expert interpretation as the ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method as the ground truth was established using "gold standard" medical procedures (e.g., arterial blood gas analysis) rather than expert consensus on subjective interpretations.
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
No MRMC study was mentioned. The device measures physiological parameters automatically; it does not appear to be an AI-assisted diagnostic tool that would involve human readers improving their performance. The purpose is "passive, intermittent data collection" for remote review by a clinician, implying the data is presented to the clinician, but the study described is about the accuracy of the device's measurements themselves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical studies described appear to be standalone performance assessments of the device's ability to accurately measure physiological parameters (SpO2, HR, RR) against a "gold standard." The device collects data "when no motion is detected," and the data is then processed by internal algorithms to derive the measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Respiration Rate: "gold standard monitoring procedure" (details not provided).
- SpO2: "gold standard, arterial blood gas analysis" (a direct physiological measurement).
8. The sample size for the training set
The document does not mention details about a training set since this is a 510(k) submission primarily focused on demonstrating substantial equivalence and performance of a measurement device, not an AI/ML model that typically requires a distinct training and test set. While the device uses "data processing algorithms," there is no explicit mention of an "AI/ML training set" in the context of this document.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" and its ground truth establishment are not discussed in this 510(k) summary.
§ 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).