(281 days)
The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.
The Minolta PULSOX-2, is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
The provided document is a 510(k) summary for the Minolta PULSOX-2, a pulse oximeter. It states that the device is substantially equivalent to a predicate device (Minolta PULSOX-3) and highlights its function and intended use. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study details, and ground truth establishment.
A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance metrics in the way you've outlined for AI/ML device validation.
Therefore, I cannot populate the table or answer most of your detailed questions from the provided text. The document states "Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective." but does not provide the specifics of that testing.
Here's what can be inferred or explicitly stated from the document, along with what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Missing: Specific numerical performance metrics (e.g., accuracy, precision, bias) for SpO2 measurement, often expressed against a reference method (e.g., co-oximetry). | General Statement: "Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3." Also, "Testing results are also in compliance with those in published literature for pulse oximeters." |
| Missing: Defined thresholds for equivalence or non-inferiority to the predicate device or a recognized standard (e.g., ISO 80601-2-61). | Missing: Specific numerical results to demonstrate this compliance/equivalence. |
2. Sample size used for the test set and the data provenance:
- Missing from document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Missing from document. For pulse oximeters, the "ground truth" for SpO2 accuracy is typically established by arterial blood gas analysis using a co-oximeter, not by expert review of images or interpretations. The document does not describe such a study.
4. Adjudication method for the test set:
- Not applicable / Missing from document. As the ground truth isn't established by expert review, an adjudication method isn't relevant in this context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No indication of an MRMC study. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret data, rather than a standalone physiological monitor like a pulse oximeter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. A pulse oximeter is a standalone device that provides a measurement (SpO2 and pulse rate) without human interpretation affecting the output. The performance assessment would be of the device's accuracy against a reference standard. However, the details of this assessment are missing from the provided text.
7. The type of ground truth used:
- Not explicitly stated, but typically for pulse oximeters, the ground truth is established using arterial blood gas analysis with a co-oximeter. The document states: "The Minolta PULSOX-2 is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction." This implies direct measurement validation, but the details are not provided.
8. The sample size for the training set:
- Not applicable / Missing from document. Pulse oximeters are typically based on optical principles and calibration rather than being "trained" in the machine learning sense. Any calibration data or parameter optimization would not be typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable / Missing from document. (See above point for rationale).
In summary, the provided 510(k) document is a regulatory submission for a basic medical device (a pulse oximeter) that relies on demonstrating substantial equivalence to an existing device and compliance with general performance expectations for its category. It does not contain the detailed study design, acceptance criteria, or performance data that would be expected for a complex AI/ML device requiring rigorous clinical validation with specific metrics and ground truth establishment by experts.
§ 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).