(570 days)
The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.
The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead.
IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate.
The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.
The provided document is a 510(k) summary for the IM2001 Pulse Oximeter. While it describes the device's intended use and substantial equivalence to a predicate device, it does not contain the detailed information required to fill out the requested table and answer all questions related to acceptance criteria and performance studies.
Specifically, the document primarily focuses on regulatory approval and substantial equivalence, not on the technical performance study details like sample sizes, ground truth establishment, or expert adjudication for performance criteria.
Therefore, many of the requested fields will be marked as "Not provided in the document."
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "calculations, validations, and performance testing results" were performed to demonstrate substantial equivalence, but the specific acceptance criteria (e.g., accuracy +/- X%) and the corresponding results are not detailed. | Not explicitly stated in the document. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document.
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
- Not applicable. This is a pulse oximeter, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies general "performance testing" was done to establish substantial equivalence. However, the details of a standalone performance study with specific metrics are not provided. The pulse oximeter itself is a standalone device in operation, but the detailed study proving its accuracy is not described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided in the document. For a pulse oximeter, the ground truth for SpO2 would typically be derived from arterial blood gas analysis (co-oximetry), but this is not stated in the provided text.
8. The sample size for the training set
- Not applicable/Not provided. The document describes a medical device, not a machine learning algorithm that requires a "training set" in the typical sense.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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).