(616 days)
The Minolta Pulsox-3 and Pulsox-3i are the devices 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, pulmonary dysfunction or who need sleep study.
The Minolta Pulsox-3 and Pulsox-3i are the devices 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, pulmonary dysfunction or who need sleep study. 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 text is a 510(k) summary for the Minolta PULSOX-3 and PULSOX-3i pulse oximeters, filed in 2000. These summaries are designed to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical studies with acceptance criteria as would be found in a full efficacy study.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Function, design, and construction similar to pre-1976 devices and existing marketed devices. | "similar in function, design and construction to other products which were in the market place prior to May 28, 1976." "similar to several other products currently being marketed in the United States including the legally marketed predicate device..." |
| Compliance with Published Literature: Performance in line with established pulse oximeter standards. | "The testing results are also in compliance with those in published literature for pulse oximeters." |
| Safety and Effectiveness: Demonstrate the device is safe and effective. | "The testing conducted demonstrates that the Minolta PULSOX-3 and PULSOX-3i are safe and effective." |
| Measurement Principle: Determination of SpO2 non-invasively, based on pulsatile blood flow, using two wavelengths of light. | "Minolta PULSOX-3 and PULSOX-3i are the devices for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients..." "The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow." |
| Definition of SpO2: Consistent with ISO 9919:1992. | "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." |
Important Note: The provided text does not specify quantitative acceptance criteria (e.g., "accuracy within X% of a reference standard") or specific performance metrics (e.g., mean absolute difference). Instead, it makes broad statements of equivalence and compliance. This is typical for 510(k) summaries which focus on demonstrating "substantial equivalence" rather than presenting detailed clinical trial results with specific numerical acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It only generally states "The testing conducted demonstrates..." without providing details on how that testing was performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a pulse oximeter, ground truth often involves co-oximetry, which is a laboratory blood gas analysis, rather than expert interpretation of images. However, the text does not elaborate on the specific ground truth method used.
4. Adjudication Method for the Test Set
The document does not provide any information on an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to the provided document. The Minolta PULSOX-3 and PULSOX-3i are pulse oximeters, which are direct measurement devices, not AI-assisted diagnostic tools that involve human readers interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is also not directly applicable in the context of this device. A pulse oximeter is inherently a standalone device that provides a numerical reading. Its "performance" refers to how accurately it measures SpO2 compared to a reference standard, not its performance in an AI-algorithm sense. The summary implies the device's standalone performance was evaluated against the predicate and published literature, but no specific study details are provided.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For pulse oximeters, the gold standard for SpO2 is often arterial blood gas analysis with co-oximetry. However, the summary does not detail the methods used for "testing." It implies comparison to the predicate device, which would involve comparing sensor readings, but the exact ground truth for the accuracy of those readings is not specified.
8. The Sample Size for the Training Set
The document does not specify any sample size for a training set. This is not an AI/machine learning device, so the concept of a "training set" as it relates to AI model development is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/machine learning model and therefore does not have a "training set" in that context.
§ 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).