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LD-Oxi system is intended for use:

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.

To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.

To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability.

The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.

The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).

The device is intended use in licensed practitioner's office

This device is no intended to be used at home, in hospital or out-of-hospital transport

The device is not intended use in support life and not for continuously monitoring

The system will be use by practitioner.

The LD-Oxi System is a programmable electro medical system (PEMS) including:

2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe

2 Software installed on a computer

Description of the features

Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude (photoplethysmography).
Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature).
Mathematical analysis of the Heart Rate Variability (HRV feature).

The provided document does not contain full details of a specific study proving the device meets acceptance criteria, specifically not in the format of a typical clinical validation study with detailed performance metrics, sample sizes, and expert ground truth establishment.

However, based on the information provided in the 510(k) Summary for the LD-Oxi System (K160956), here's what can be inferred and pieced together regarding acceptance criteria and performance, as well as the types of studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to a predicate device (Electro Sensor Oxi K102442) rather than defining explicit acceptance criteria with numerical targets. For performance, it largely relies on the general equivalence to the predicate and standard compliance. The specifications table (page 4) compares the LD-Oxi with the predicate (ESO) for various parameters.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly mention "test sets" or provide details on sample sizes for clinical performance evaluation. The "Performances and Effectiveness" section (page 7) lists general tests, but no specific human subject data or sample sizes for these tests are provided.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "Peer reviews for the photoelectrical plethysmography mathematical analysis" and "Peer review reference for the heart rate variability mathematical analysis." However, it does not specify the number or qualifications of these experts.

4. Adjudication Method

No adjudication method is mentioned for any "test set" or peer review process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study comparing human readers with and without AI assistance is mentioned. The device's primary function is as a monitor and analyzer, not as an AI-assisted diagnostic tool for human readers. The mathematical analyses (PP and HRV) are explicitly stated "ARE NOT intended use for diagnosis."

6. Standalone Performance Study

The document refers to the following for performance and effectiveness:

• Calibration tests (simulator oximeter): This implies standalone testing of the oximeter's core functionality against known standards.
• Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database): This indicates standalone testing of the software algorithms (including PP and HRV analysis) using a recognized physiological database. This could be considered a form of standalone performance evaluation for the algorithmic components.
• Peer reviews: As mentioned above, these are qualitative assessments of the mathematical analysis.

7. Type of Ground Truth Used

• For the core oximeter function (SpO2% and pulse rate), the ground truth for calibration would likely come from simulator oximeter standards.
• For the software algorithms (PP and HRV), the mention of the MIT-BIH database suggests that the ground truth for these analyses would be derived from the expert-annotated physiological data contained within that database. (The MIT-BIH Arrhythmia Database, for example, is known for its expert annotations of ECG signals, which can be related to HR and HRV).

8. Sample Size for Training Set

The document does not specify a separate "training set" or its sample size. The description of the device and its validation focuses on direct measurement, software verification against existing databases, and established principles of oximetry and physiological analysis, rather than a machine learning model that requires a distinct training phase.

9. How Ground Truth for Training Set was Established

Since a "training set" as commonly understood in machine learning is not explicitly detailed, the method for establishing its ground truth is also not described. If the device uses algorithms developed using physiological databases like MIT-BIH, then the ground truth for those underlying algorithms would have been established by the experts who curated and annotated those databases.

In summary:

The LD-Oxi System's acceptance criteria and proven performance rely heavily on demonstrating substantial equivalence to a predicate device (ESO) and compliance with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-61). Performance claims are supported by calibration tests using simulators and software verification using data from established databases like MIT-BIH, implying a form of standalone algorithmic testing. Detailed clinical trial data with specific sample sizes, expert qualifications, or adjudication methods for new data collection are not provided in this 510(k) summary, as the nature of the modifications and the intended use (monitoring and analysis, not diagnosis from AI) did not necessitate such extensive studies for this particular submission.

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The M-50 Series SpO2 Sensor is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment.

The M-50A, M-50E and M-50G SpO2 Sensor is intended for adult patients in hospitals, hospital-type facilities, and home environments.

The M-50B and M-50H SpO2 Sensor is intended for pediatric patients in hospitals, hospital-type facilities, and home environments.

The M-50C SpO2 Sensor is intended for adult, pediatric, infant and neonatal patients in hospitals, hospital-type facilities, and home environments.

The applicant sensor M-50 Series SpO2 Sensors measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.

The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].

SpO2 = [HbO2]/([Hb+[HbO2]]

Those sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.

The model M-50A and M-50B sensors are the accessory of legally marketed device MD300I ( K072825 ).

All of the sensors included in applicant M-50 Series SpO2 sensors have the identical materials , electro-optical components and basic technical specification.

The model M-50A,M-50B and M-50E sensor use the same configuration manner as the finger clip. All the clip sensors ( M-50A, M-50E) composed by two sorts of material, the enclosure's material of the sensor is ABS, and the material of another part which contact with patient skin, we call that " silica gel cushion", is Medical Silicon

The model M-50C use a sort of configuration manner as binding manner. The M-50C just have single material as the Medical Silicon.

The model M-50G and M-50H use the same configuration manner as the fingertip. Because of the fingertip sensor just have single material as the Medical Silicon, so they are soft.

The applicant sensors are not for implant. Those sensors are not sterile and do not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological product.

The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted.

The device is not software-driven.

A11 the information about the device performance was according to the FDA guidance.

The Clinical Test Report following ISO 9919:2005, Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted.

• Acceptance Criteria and Reported Device Performance:

The provided document describes the M-50 Series SpO2 Sensor as being substantially equivalent to a predicate device (MD300I, K072825). The acceptance criteria for the M-50 Series SpO2 Sensor models are not explicitly described with numerical thresholds in the provided text. However, the document states:

• "The Clinical Test Report following ISO 9919:2005, Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted."
• "The result of neonate clinical trial is meet the requirements of FDA Pulse Oximeter Guidance."

This implies that the device performance was measured and found to comply with the performance standards outlined in ISO 9919:2005 and FDA Pulse Oximeter Guidance. Without direct access to these reports or the specific guidance documents, the precise numerical acceptance criteria and reported performance cannot be extracted.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

• Sample size used for the test set and the data provenance:

The document mentions "Clinical Test Report following ISO 9919:2005" and "neonate clinical trial." However, the exact sample sizes for these test sets are not specified in the provided text.
The data provenance is also not explicitly stated beyond the mention of "Clinical Test Report" and "neonate clinical trial." It is not clear if the studies were retrospective or prospective, or the country of origin of the data.

• 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.

• Adjudication method for the test set:

This information is not provided in the given text.

• 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:

The device described is an SpO2 sensor, which non-invasively measures arterial oxygen saturation. It is a standalone medical device and not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

Yes, a standalone study was done. The document states, "AII the information about the device performance was according to the FDA guidance. The Clinical Test Report following ISO 9919:2005, Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted." This refers to performance testing of the device itself, which operates as an algorithm calculating SpO2 values without direct human intervention in the calculation process. Additionally, a "neonate clinical trial" was conducted to demonstrate safety and effectiveness for neonate use of the M-50C sensor.

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

For pulse oximetry, the ground truth for arterial oxygen saturation is typically established through co-oximetry of arterial blood samples. While the document doesn't explicitly state "co-oximetry," clinical trials for pulse oximeters following ISO 9919:2005 commonly use arterial blood gas analysis with co-oximetry as the reference standard to establish ground truth for SpO2 measurements. The phrase "Clinical Test Report following ISO 9919:2005" implies the use of such accepted methods for ground truth establishment.

• The sample size for the training set:

This information is not provided in the given text. The device's operation is based on a "validated calibration table" and an "algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value," rather than a continuously learning AI model with a distinct "training set" in the modern machine learning sense. The calibration table would have been developed using a set of data, but this is not referred to as a "training set."

• How the ground truth for the training set was established:

As mentioned above, the device uses a "validated calibration table" rather than a training set for a machine learning model. The method for establishing the ground truth for this calibration table is not explicitly detailed in the provided text, but it would typically involve
comparing the device's optical absorbance ratio measurements against arterial blood gas co-oximetry readings from various subjects with different oxygen saturation levels.

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The MD300W wrist oximeter 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 Wrist Pulse Oximeter MD300W is a wrist-worn device, which can display %SpO2, pulse rate value and vertical bar graph pulse amplitude,

The applicant device consists of sensor, signal amplify unit, CPU, data display unit, data transmit unit, storage and power unit.

The wrist 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 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 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 applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 1 AAA alkaline batteries.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device or sensor are not sterile and the sensor does not need sterilization and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Pulse Oximeter MD300W:

Please note: The provided text is a 510(k) Summary for a medical device. These summaries typically contain a high-level overview and refer to more detailed reports (like clinical test reports) in their appendices. Therefore, some detailed information might not be explicitly stated in this summary but would be found in the referenced documents.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated for the clinical test. The summary mentions "adult and pediatric patient," but the number of subjects is not provided.
   • Data Provenance: Clinical tests were "conducted in Wulanchabu City Center Hospital" and "Laboratory of Beijing Friendship Hospital." This suggests the data is prospective clinical trial data 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 explicitly provided in the 510(k) summary. For pulse oximetry clinical studies, ground truth is typically established using a co-oximeter measuring arterial blood gas samples, not expert consensus in the traditional sense of image interpretation.

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

   • This information is not applicable to a pulse oximetry accuracy study where ground truth is established through instrumental measurement (co-oximetry) rather than expert review. There's no "adjudication" necessary for the primary outcome.

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. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

   • Yes, a standalone performance assessment was done. The clinical test assesses the accuracy of the device itself (algorithm and hardware) against a reference standard without human interpretation. The summary states: "The Clinical Test reports following ISO 9919:2005... are conducted in Wulanchabu City Center Hospital provided in Attachment IV Clinical Test Reports."

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

   • The ground truth for pulse oximeter accuracy studies is typically established by arterial blood gas analysis using a co-oximeter. While not explicitly named in the summary, conformance to ISO 9919:2005 (which specifies requirements for in vivo clinical testing) implies this method. ISO 9919:2005 requires comparing the device's SpO2 readings to simultaneously drawn arterial blood samples analyzed by a laboratory co-oximeter.

7. The sample size for the training set:

   • This information is not applicable/not provided. Pulse oximeters of this type, especially from this era (2008), typically rely on established physiological models and calibration rather than machine learning "training sets" in the modern AI sense. While internal calibration data would be used, it's not a "training set" for an algorithm that learns from data.

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

   • As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the context of this device's type and the information presented. The device's underlying principles are based on the Beer-Lambert law and physiological light absorption, not a learned AI model.

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