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The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only)

The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.

The provided text is a 510(k) summary for the IRIS-XP device, which is a thermal based imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device (MEDITHERM MED2000) rather than presenting a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the IRIS-XP to its predicate device." This means that a clinical study designed to prove the device meets acceptance criteria as typically understood for performance metrics (like sensitivity, specificity, accuracy against a ground truth) was not performed.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, or image quality against a predefined benchmark for a diagnostic task). Instead, it relies on demonstrating that its technical characteristics (specifications) are substantially equivalent to a predicate device.

The closest to "acceptance criteria" and "reported performance" are the technical specifications compared in Table 1 (page 6-7). The implicit acceptance criterion for this submission is that its technical specifications and indications for use are similar enough to the predicate device to not raise new questions of safety or effectiveness.

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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

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.

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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 a photoelectric plethysmograph with is used to estimate blood flow in a region of the body using photoelectric measurement techniques

The provided text is a 510(k) summary for the SA3000P System, a photoelectric plethysmograph. It does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the comprehensive study that proves the device meets them.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document broadly states:

Missing Information: The specific quantitative acceptance criteria for parameters like accuracy of pulse waveform, heart rate measurement, safety, or specific performance standards are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: This information is not provided in the 510(k) summary. The summary mentions "performance testing showing that The functions are substantially equivalent to the predicate," but no details about the test set, sample size, or data provenance are included.

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)

Missing Information: This information is not provided. The summary does not describe how ground truth was established or if any experts were involved in a blinded assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: No adjudication method is mentioned in the provided text.

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

Missing Information: The device described is a photoelectric plethysmograph, which measures physiological parameters like pulse waveform and heart rate. It is not an AI-assisted diagnostic imaging device that would typically involve human readers or MRMC studies for comparative effectiveness of AI vs. human performance. Therefore, an MRMC study is highly unlikely to have been conducted for this type of device. The document does not mention any AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing Information: As this device is a plethysmograph (a measurement device), its performance would inherently be "standalone" in terms of its ability to measure pulse waveform and heart rate. However, the details of how this "standalone performance" was assessed (e.g., against a gold standard reference device) are not provided. The document focuses on equivalence to a predicate, not necessarily absolute accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing Information: The type of ground truth used for performance validation is not specified. For a plethysmograph, ground truth would typically be established by a reference method or a gold standard device for pulse waveform and heart rate measurement.

8. The sample size for the training set

Missing Information: This device does not appear to involve machine learning, therefore, there would not be a "training set" in the context of AI/ML models. The summary focuses on hardware performance and equivalence.

9. How the ground truth for the training set was established

Missing Information: Not applicable, as there is no indication of a machine learning component requiring a training set.

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