(124 days)
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
The device is to measure the heart rate with photoelectric measurement techniques. It is to be connected with a desktop PC or laptop PC. It is operated with a mouse or a keyboard of PC which is used to enter the patient information as well as to operate the system and review the resulting analysis.
The provided 510(k) summary for the Max Pulse System by Medicore Co., Ltd. indicates that no clinical data was needed for its clearance. Therefore, a study demonstrating the device meets acceptance criteria, as one might expect for a clinically validated device, is not present in this document. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.
Here's an analysis based on the information provided, outlining what is and isn't available regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Max Pulse System) |
|---|---|---|
| Intended Use | Measures pulse waveform; SpO2 and heart rate by photoelectric plethysmograph | Measures pulse waveform; SpO2 and heart rate by photoelectric plethysmograph |
| Intended Users | Professional use only | Professional use only |
| Mode | Non invasive | Non invasive |
| Heart Rate Range | 30-230 bpm | 30-240 bpm |
| Accuracy (SpO2 sensor) | ±2% (implicitly for predicate, stated for Max Pulse) | Accuracy ±2% (for MD-10 finger type reusable sensor) |
| Safety Features | Compliant with applicable safety standards | Compliant with applicable safety standards |
| Environmental Conditions (Operation) | Not specified in product labeling | Temperature 10-35°C; Relative humidity 20-95%RH; Atmospheric Pressure 700-1060hPa |
| Environmental Conditions (Storage) | Not specified in product labeling | -20 |
| Overall Performance | Substantially equivalent to predicate | Functions are substantially equivalent to the predicate. Meets the same safety and performance standards as the predicate. |
Missing Information Regarding Acceptance Criteria and Performance:
- Specific, quantifiable acceptance criteria for metrics like heart rate accuracy, pulse waveform fidelity, or SpO2 measurement accuracy (beyond the sensor's stated ±2%) are not detailed. The submission relies on claiming substantial equivalence to the predicate device, K023238 (McPulse by Meridian Co. Ltd.), which means the acceptance criteria are implicitly met if the device performs comparably to the predicate.
- The document does not provide a "study that proves the device meets the acceptance criteria" in terms of clinical trials or performance assessments with specific endpoints. Instead, it states that "The device has completed performance testing showing that the functions are substantially equivalent to the predicate." The details of this performance testing (e.g., methodology, sample size, results against specific thresholds) are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document explicitly states, "Clinical data is not needed for Max Pulse system or for most devices cleared by the 510(k) process." Therefore, there is no test set in the sense of patient data for a clinical study. The "performance testing" mentioned is non-clinical. The document does not specify the sample size or provenance of data used for this non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: Since no clinical data was required and no clinical "test set" was used, there were no experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: As no clinical test set requiring expert ground truth was utilized, no adjudication method was employed.
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:
- No: This is not an AI-assisted device, and no MRMC study was performed. The device is a direct measurement tool (plethysmograph) for heart rate and SpO2.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (Implicit, for technical performance): The device is a standalone measurement system. The "performance testing" mentioned, though not detailed, would likely assess the device's technical capabilities (e.g., accuracy of heart rate detection, signal quality) independent of human interpretation or assistance, comparing them to the predicate's technical specifications. However, the exact nature and results of this "standalone" technical performance testing are not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided for clinical ground truth: For a device measuring heart rate and SpO2, if clinical studies were done, ground truth would typically come from highly accurate reference devices (e.g., ECG for heart rate, co-oximetry for SpO2). However, as stated, no clinical data was required or submitted. For the non-clinical performance testing, the ground truth would have been based on established technical standards and the performance of the predicate device.
8. The sample size for the training set:
- Not Applicable / Not Provided: The Max Pulse System is not described as an AI/ML device that requires a "training set." It is a hardware device based on photoelectric measurement techniques.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: No training set was used for this type of device.
In summary:
The Max Pulse System gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (McPulse by Meridian Co. Ltd.) based on non-clinical performance testing and adherence to applicable safety and performance standards. The submission explicitly states that clinical data was not needed. Therefore, the detailed aspects of clinical studies, such as specific acceptance criteria derived from patient outcomes, sample sizes for clinical test sets, expert ground truth, or adjudication methods, are not present in this 510(k) summary. The "acceptance criteria" are effectively defined by the predicate device's established performance and the general regulatory requirements for this class of device.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).