(228 days)
The Nonin Model 3100 WristOx™ Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.
The Nonin Model 3100 WristOx is a small, wrist worn pulse oximeter. It uses an electro-optical sensor to noninvasively measure, display and store functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. The WristOx stores up to 33 hours of SpO2 and pulse rate data. Stored patient data may be downloaded to any data management software system using the nonproprictary communication protocol . Nonin's data management software system (nVISION™) is available as an accessory, but is not required to use the memory feature.
The provided text is a 510(k) summary for the Nonin Model 3100 WristOx Pulse Oximeter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about the acceptance criteria or a study that explicitly proves the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods.
The document states:
"The Nonin Model 3100 WristOx has undergone Functional and Safety Testing: both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device."
While it mentions "clinical testing," it does not provide the specifics requested in your prompt. Therefore, I cannot fill in the table or answer most of your detailed questions based on the provided text.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be inferred/answered from the text:
- Device Name: WristOx Pulse Oximeter, Model 3100
- Predicate Device: Model 2500 PalmSat® Hand Held Pulse Oximeter (K002690)
- Type of Study (General): Functional and safety testing, including clinical testing, to demonstrate substantial equivalence.
- Ground Truth for Substantial Equivalence: Comparison to a legally marketed predicate device (Model 2500 PalmSat® Hand Held Pulse Oximeter).
- Regulation Number/Name/Class: Regulation Number: 870.2700, Regulation Name: Oximeter, Regulatory Class: II.
- Application Type: 510(k) premarket notification.
What cannot be answered from the provided text:
- Specific Acceptance Criteria: The document does not list quantitative acceptance criteria (e.g., accuracy +/- X%, precision Y%).
- Reported Device Performance: No specific performance metrics (e.g., SpO2 accuracy, pulse rate accuracy) are reported.
- Sample size used for the test set: Not mentioned.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. The device is an oximeter, not an AI-assisted diagnostic tool, so an MRMC study in the context of human reader improvement with AI is unlikely to be relevant here.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable as it's not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed beyond general clinical testing.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the clinical testing, the standard for oximeters usually involves comparing to a co-oximeter in an induced hypoxia study, but this is not specified in the provided text. The primary "ground truth" for the 510(k) summary is the predicate device's performance.
- The sample size for the training set: Not applicable/not mentioned, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable/not mentioned.
Summary Table (with inferred/unavailable information):
| Feature/Criterion | Acceptance Criteria (as per document) | Reported Device Performance (as per document) |
|---|---|---|
| Substantial Equivalence | Device is substantially equivalent to predicate device (Model 2500 PalmSat® Hand Held Pulse Oximeter, K002690). | The device was determined by the FDA to be substantially equivalent to the predicate device. |
| Functional Characteristics | Appropriate functional characteristics. (Specifics not provided) | Achieved "appropriate functional characteristics" to demonstrate substantial equivalence. (Specifics not provided) |
| Safety Testing | Expected to be safe. (Specifics not provided) | Underwent safety testing to demonstrate substantial equivalence. (Specifics not provided) |
| SpO2 Accuracy | Not specified in text (Typically +/- 2% or 3% for medical oximeters within a certain range, compared to co-oximetry). | Not reported in text |
| Pulse Rate Accuracy | Not specified in text (Typically +/- 1 to 3 bpm or % compared to ECG). | Not reported in text |
| Memory Function | Similar to predicate device. | Stores up to 33 hours of SpO2 and pulse rate data; similar to predicate. |
| Indications for Use | Measuring, displaying, and storing functional SpO2 and pulse rate; for adult and pediatric patients; in hospitals, medical facilities, ambulatory, subacute, and sleep study environments. | Meets stated indications for use. |
Since the requested detailed information regarding specific study metrics, sample sizes, and expert details is not present in the provided document, I cannot complete those sections. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of clinical study results. A full 510(k) submission might contain such details, but they are not in this 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).