(104 days)
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.
The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals
The provided 510(k) summary for the PM-50 Pulse Oximeter does not include specific acceptance criteria or details of a study that quantifies device performance against those criteria.
The submission focuses primarily on demonstrating substantial equivalence to a legally marketed predicate device (K052693 PM-50 Pulse Oximeter) through modifications involving the addition of new SpO2 probes.
Here's an analysis based on the information provided, highlighting what is present and what is missing based on your requested information:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document states that "Laboratory testing and clinical study was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications and was substantially equivalent to predicate device." However, no specific performance metrics, acceptance criteria, or quantitative results from these tests are included in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The summary mentions "clinical study" but offers no details about the sample size (number of patients, number of readings), data provenance, or study design (retrospective or prospective).
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 applicable/Not provided. For a pulse oximeter, the "ground truth" for oxygen saturation is typically established by arterial blood gas analysis, not by expert interpretation of images. The document does not describe how ground truth was established, beyond implying standard clinical methods would be used in a "clinical study."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple experts assess the same case. This is not relevant for a pulse oximeter's core function of measuring physiological parameters.
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. An MRMC study is relevant for AI systems that assist human readers in interpreting complex medical data (like imaging studies). The PM-50 Pulse Oximeter is a standalone measurement device, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone algorithm/device. Its performance is measured directly, not in conjunction with human interpretation for its primary function. The "clinical study" mentioned would assess the device's accuracy in measuring SpO2 and pulse rate. However, the details of how this standalone performance was measured and quantified are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but typically a gold standard like arterial blood gas analysis. For pulse oximeters, the accepted gold standard for determining actual oxygen saturation (SpO2) is typically arterial blood gas (ABG) analysis. The document only vaguely refers to a "clinical study" without detailing the ground truth methodology.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physiological measurement device, not an AI/machine learning model that undergoes a "training" phase with a dataset in the conventional sense. Its "training" would be more akin to calibration and design optimization based on engineering principles and physiological models.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/ML development pipeline.
Summary of what the document does state regarding validation:
- Testing Conducted: "Laboratory testing and clinical study was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications and was substantially equivalent to predicate device."
- Quality Assurance Measures:
- Risk Analysis
- Environmental Testing
- Function and Performance Testing
- Clinical Study
- Conclusion: "The conclusions drawn from clinical and laboratory testing of the PM-50 Pulse Oximeter demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the PM-50 Pulse Oximeter numbered K#052693."
In essence, the 510(k) summary asserts that testing was performed and concluded substantial equivalence, but it does not provide the specific data, acceptance criteria, or detailed methodologies typically sought when evaluating device performance against established clinical metrics. This level of detail is often found in the full 510(k) submission, not necessarily in the brief summary provided for public access. The core claim here is one of "substantial equivalence" based on similar technology and unspecified testing results matching a predicate device.
§ 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).