Search Results

The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.

The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is infrared-red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The devices are normally applied to adult, adolescent, child and infant in hospital and home environments.

The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

The provided document describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CG11/MD300CG51 and its substantial equivalence to a predicate device (MD300CB3).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a detailed comparison table between the proposed devices (MD300CG11/MD300CG51) and the predicate device (MD300CB3). This table essentially serves as the acceptance criteria for the proposed device, demonstrating that its performance characteristics are substantially equivalent to the legally marketed predicate.

Key takeaway on acceptance criteria and performance: The acceptance criteria are implicitly defined by the specifications of the predicate device (MD300CB3). The reported performance shows that the proposed devices (MD300CG11/MD300CG51) meet or are substantially equivalent to these criteria. Minor differences in display type, direction, and SpO2 display/measurement range (99% vs 100%) are noted, but these are considered not to affect the substantial equivalence for regulatory purposes.

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

The document explicitly states: "Clinical Test: The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2."

Therefore, no clinical test set was used for the demonstration of substantial equivalence given the product's classification and similarity to the predicate. The device's performance was evaluated through non-clinical testing. The provenance of any underlying test data from these non-clinical tests is not specified, but the applicant company is based in China.

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)

Since no clinical test set was used, there were no experts required to establish ground truth from clinical data. The accuracy claims for SpO2 and PR are based on engineering performance tests against established standards.

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

No adjudication method was used for clinical data as no clinical test set was deemed necessary.

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

This is not applicable. The device is a standalone medical device (Fingertip Pulse Oximeter) and does not involve AI assistance for human readers or interpretation of medical images.

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

Yes, the device's performance was evaluated as a standalone product. The non-clinical tests described (SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test, Performance Test after Disinfection, Shelf-life Test) evaluate the device's intrinsic performance against established standards like ISO 80601-2-61.

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

For the non-clinical performance tests, the "ground truth" is defined by the calibrated reference measurements and standards outlined in ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment. This standard specifies a method for evaluating pulse oximeter accuracy against a co-oximeter or other reference method under controlled hypoxia conditions. The document mentions that performance tests were conducted "in accordance with ISO 80601-2-61."

8. The sample size for the training set

This is not applicable. The Fingertip Pulse Oximeter is a hardware device that directly measures and displays physiological parameters. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

Principle of the oximeter is as follows:

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization.

The device is for prescription.

The device does not contain drug or biological products.

The device is software-driven and software validation is provided in Section XI Software.

The provided document details the 510(k) submission for the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CN310. It establishes the substantial equivalence of the proposed device to a predicate device (MD300C29-H) and outlines the testing conducted to support this claim.

Here's a breakdown of the requested information:

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

The document provides performance specifications for SpO2 and Pulse Rate accuracy. Since this is a 510(k) submission primarily focused on substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the new device performs at least as well as the predicate device and meets recognized standards. The reported device performance is listed as identical to the predicate device in terms of these accuracy specifications.

2. Sample size used for the test set and the data provenance

The document mentions "SpO2 and PR accuracy Test" and references ISO 80601-2-61. This standard outlines requirements for clinical testing with human subjects. However, the specific sample size used for the test set is NOT explicitly stated in this document.
The data provenance is implied to be prospective clinical data for the SpO2 and PR accuracy testing, as it states "We have also conducted other performance test including SpO2 and PR Accuracy Test... Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s]". Clinical testing for pulse oximeters involves human subjects whose oxygen saturation is varied, and measurements from the device are compared to reference measurements. The country of origin for the data is not specified, but the manufacturer is based in Beijing, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For a pulse oximeter, the "ground truth" for SpO2 accuracy is typically established by simultaneously measuring arterial oxygen saturation (SaO2) from blood samples analyzed by a co-oximeter, while the subject is varying oxygen levels. It does not involve human experts in the typical sense of radiologists reviewing images. Instead, it relies on highly precise laboratory equipment and trained medical staff for blood sampling and co-oximetry. The document does not specify the number or qualifications of clinicians/technicians involved in conducting such a study.

4. Adjudication method for the test set

Not applicable in the typical sense of expert adjudication for diagnostic imaging or subjective assessments. The "ground truth" for SpO2 and PR accuracy is derived from objective, quantitative measurements (co-oximetry for SaO2 and ECG for heart rate) compared against the device's readings. Discrepancies would be analyzed statistically, not through an adjudication process among experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or required for this type of device (a pulse oximeter). MRMC studies are typically used for diagnostic devices that involve human interpretation of complex data (e.g., medical images), often in the context of Artificial Intelligence (AI) assistance. This device is a direct measurement tool.

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

This refers to the inherent performance of the device's algorithms for calculating SpO2 and Pulse Rate. The "SpO2 and PR Accuracy Test" performed according to ISO 80601-2-61 serves as the standalone performance evaluation. This test directly assesses the device's ability to accurately measure SpO2 and PR against a known reference, without human interpretation influencing the measurement itself.

7. The type of ground truth used

The ground truth used for the SpO2 and PR accuracy testing is implicitly reference measurements from established medical standards. For SpO2, this means arterial blood gas analysis using a co-oximeter (measuring SaO2). For pulse rate, it would typically involve an independent, highly accurate heart rate measurement method, such as an electrocardiogram (ECG). This falls under the category of objective physiological measurements rather than expert consensus or pathology.

8. The sample size for the training set

The document describes the device itself and its testing for regulatory approval. It does not mention any "training set" because this device is a traditional medical measurement device, not an AI/machine learning algorithm that requires a training set. Its algorithms are based on established biophysical principles of light absorption by blood.

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

As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

The applicant device of Fingertip Pulse Oximeter MD300C is a fingertip device, which can display % SpO2, pulse rate value. The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. The Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in fingersensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastele is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries. The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization since it is not sterile. The device is not for prescription. The device does contain drug or biological products.

Here's an analysis of the acceptance criteria and study information for the Fingertip Pulse Oximeter MD300C, based on the provided text:

Acceptance Criteria and Device Performance

The submission states that the device's accuracy is in compliance with the requirements of ISO 9919:2005. While specific numerical acceptance criteria (e.g., accuracy percentages or ranges for SpO2 and pulse rate) are not explicitly enumerated in the provided text, the overall statement of compliance implies that the device met the performance standards outlined in ISO 9919:2005.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of patients or data points included in the "Clinical Test reports."
   • Data Provenance: The clinical tests were "conducted in Beijing Friendship Hospital and Wulanchabu City Center Hospital." This indicates the data is prospective and originated from China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the given text. For pulse oximeters, ground truth is typically established using a co-oximeter in a controlled desaturation study, not by human experts adjudicating readings.

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

   • This information is not provided. Given the nature of pulse oximetry accuracy studies, a human adjudication method like 2+1 or 3+1 would not be applicable for establishing the ground truth of SpO2 and pulse rate. The ground truth (reference SpO2) comes from a reference device (co-oximeter).

4. 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, an MRMC comparative effectiveness study was not done. The device is a standalone medical device (pulse oximeter) that provides direct measurements of SpO2 and pulse rate. It does not involve "human readers" interpreting input or an "AI" component assisting interpretation in the way a diagnostic imaging AI might.

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

   • Yes, a standalone study was done. The "Clinical Test reports following ISO 9919:2005" represent the standalone performance of the device without human interpretation or intervention in the measurement process itself, other than proper device application. The device directly outputs SpO2 and pulse rate.

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

   • While not explicitly stated in the provided text, for pulse oximeters, the ground truth for accuracy studies (like those following ISO 9919:2005) is typically established by simultaneously measuring arterial blood oxygen saturation using a co-oximeter from an arterial blood sample, taken during controlled desaturation studies. This is the standard reference method.

7. The sample size for the training set:

   • Not applicable / Not provided. The device described is a pulse oximeter which uses established physiological principles and signal processing to derive SpO2 and pulse rate. It is not an AI/machine learning model that typically requires a distinct training set in the conventional sense. Its "algorithm" is based on the Beer-Lambert law and signal analysis of light absorption.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As mentioned above, this device does not appear to utilize a machine learning model requiring a training set with established ground truth.

Ask a specific question about this device