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This Handheld Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.

The Handheld Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Handheld 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 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 Handheld Pulse Oximeter is powered by 3 AA batteries. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The Handheld Pulse Oximeter is compatible with S0010B-S sensor. The device is a spot-check Handheld Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

The provided text describes the 510(k) summary for a Handheld Pulse Oximeter (WIT-S100, WIT-S300) and its substantial equivalence determination. The document primarily focuses on non-clinical and clinical performance data to support the device's accuracy and safety.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for a pulse oximeter revolve around its accuracy in measuring functional oxygen saturation (SpO2) and pulse rate (PR). The standards cited provide these.

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The Handheld Pulse Oximeter is intended for measuring the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.

This SP-20 Handheld Pulse Oximeter is an integrated product with a modular design. It simultaneously measures physiological parameters by integrated modules and corresponding accessories. The measurement results are displayed, stored and transferred by the central processing unit. The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.

Here's an analysis of the acceptance criteria and study information for the Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter, SP-20 based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices and adherence to various safety and performance standards rather than explicitly stating numerical acceptance criteria for SpO2 and Pulse Rate accuracy with corresponding numerical performance results. However, it does state compliance with the general requirements of the standards.

Based on the information, the primary performance standard for the pulse oximeter function is:

Important Note for SpO2 and Pulse Rate: While ISO 80601-2-61 covers the particular requirements for pulse oximeter equipment, the document does not explicitly state the specific accuracy (e.g., Arms value) or bias results for SpO2 or Pulse Rate as acceptance criteria or reported performance results. It only states general compliance with the standard. Typically, pulse oximeter standards define specific accuracy requirements (e.g., Arms ≤ 3% for SpO2 between 70-100%). It's implied that the device meets these within the standard, but the specific numbers are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Twelve (12) subjects.
• Data Provenance: The subjects consisted of volunteers (3 women and 9 men) with no known illnesses and no anemia. They represented a mixture of ethnic backgrounds with skin colors ranging from light to dark, and ages from 22 to 38. A total of 24 samples were obtained per subject.
• Study Type: This appears to be a prospective clinical testing for performance validation. The location of the test is not explicitly stated as a country, but it says "Data was recorded by Bickler-Ye Lab and provided for analysis," which might hint at a US-based lab given Dr. Jeffrey Bickler's affiliation with UCSF.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the clinical testing in the traditional sense of consensus reading for diagnostic imaging. Instead, for pulse oximetry, the "ground truth" for oxygen saturation is typically established through direct arterial blood gas analysis, a recognized clinical standard. However, this document does not explicitly state how ground truth for SpO2 was established in the clinical test. It states "Testing validated the submitted device was effective in determining SPO2."

4. Adjudication Method for the Test Set

Not applicable in the context of this pulse oximeter performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers are interpreting images or data and their disagreements need to be resolved. For pulse oximetry, the comparison is usually against a physiological standard (e.g., co-oximetry).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not done. The study described is a clinical validation of the device's accuracy in measuring SpO2 and pulse rate, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the described "Clinical testing" focuses on the device's performance in measuring SpO2. This is a standalone performance test of the device (algorithm/sensor system) without human interpretation in the loop. The device directly provides numerical readings (SpO2, Pulse Rate).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the method for establishing ground truth for SpO2 in the clinical trial. For pulse oximeters, the accepted gold standard for SpO2 is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from an arterial blood sample. While the document mentions "Testing validated the submitted device was effective in determining SPO2," it doesn't detail the comparison method.

8. The Sample Size for the Training Set

No information about a training set is provided. This device is a pulse oximeter, not an AI/ML-driven diagnostic algorithm that typically requires a separate training set. Its principle of operation is based on optoelectronics and signal processing, which doesn't usually involve a "training phase" in the same way an AI model does.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set for an AI/ML algorithm is not relevant to this type of device based on the provided information.

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The MD300M122/MD300M222/MD300M322 handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

The applicant device MD300M122 Handheld Pulse Oximeter is integrated with Bluetooth® technology allowing the user to transfer measurement data any time and anywhere. The oximeter is designed with the measurement, storage, review, visible and audible alarms and data transmission function. The MD300M122 Handheld Pulse Oximeter works by applying a external 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 light. The applicant device of MD300M122 Handheld Pulse Oximeter is the handheld equipment, which mainly function are measurement, display, alarm, data storage & replay etc.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, K111494, focuses on the substantial equivalence of the Handheld Pulse Oximeter Model: MD300M122, MD300M222, MD300M322 to a predicate device, rather than explicitly stating acceptance criteria in a table format with specific performance metrics. However, it does imply acceptance criteria through its adherence to standards and the results of its clinical testing.

The primary acceptance criteria are derived from the applicable standard, ISO 9919:2005 Annex EE, which specifically addresses pulse oximeter accuracy. The study aimed to demonstrate compliance with the "specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter."

Here's a table based on the implicit criteria and the reported outcome:

Study Details

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

   • Sample Size: Not explicitly stated. The document indicates that "The Clinical Tests following ISO 9919:2005, Annex EE.2 are conducted," and that "Procedures of testing required in EE.2 are adopted." ISO 9919:2005 Annex EE.2 typically outlines methodologies for clinical evaluation of pulse oximeter accuracy, which involves human subject testing over a range of oxygen saturation levels. The specific number of subjects and measurements within that framework is not detailed in this submission.
   • Data Provenance: The study was conducted in a clinical lab in Beijing, China, specifically at the "Beijing Military General Hospital." The study is prospective in nature, as it is clinical testing for the purpose of demonstrating device performance and gaining regulatory clearance.

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

   • The document refers to a "Golden Standard" Co-Oximeter for ground truth. This implies a gold standard instrument rather than expert consensus on subjective data. Therefore, the concept of "experts establishing ground truth" in the traditional sense of image interpretation or diagnosis is not directly applicable here. The accuracy of the Co-Oximeter itself is assumed to be established and validated. The individuals operating the Co-Oximeter and conducting the study would be trained clinical professionals, but their specific number and qualifications as "experts establishing ground truth" are not detailed.

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

   • As the ground truth is established by an objective "Golden Standard" Co-Oximeter measurement, an adjudication method for reconciling differing human expert interpretations is not relevant or described. The comparison is between the device's SpO2 and PR readings and the Co-Oximeter's readings.

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 conducted. This device is a standalone pulse oximeter for measuring SpO2 and pulse rate. It does not involve human "readers" interpreting data or an AI component designed to assist human interpretation.

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

   • Yes, the performance evaluation described, which compares the device's measurements directly against a "Golden Standard" Co-Oximeter, represents a standalone performance assessment of the oximeter's algorithm and sensing capabilities. There is no human-in-the-loop component in the accuracy validation described.

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

   • The ground truth used was continuous physiological measurement from a "Golden Standard" Co-Oximeter. This is an objective, instrumental measurement considered highly accurate for blood oxygen saturation.

7. The sample size for the training set:

   • The document does not provide information on a training set. Pulse oximeters typically rely on established physiological principles and sensor technology rather than machine learning algorithms that require extensive training data. If any internal algorithm optimization occurred during development, details about its data would not typically be included in a 510(k) summary focused on validation.

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

   • As no training set is described for an algorithm in the machine learning sense, this question is not applicable based on the provided text. The device's design is based on established scientific principles of light absorption by oxygenated and deoxygenated hemoglobin.

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M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.

The proposed device is a handheld device, which can display %SpO2, waveform, pulse rate value, pulse amplitude bar indication. It consists of detector and emitter LED, OLED display module, CPU, driving circuit, power supply circuit and battery. In addition, it has alarming function including physical parameter alarming and technical alarming. The physical alarming limit can be set by user. The modifications to M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List on the next page.

The provided document is a 510(k) summary for the M800 Handheld Pulse Oximeter, which is a modification of the M700 Handheld Pulse Oximeter. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed information about a study to prove acceptance criteria for a new AI or diagnostic device.

Pulse oximeters are typically evaluated based on specific performance criteria related to the accuracy of SpO2 and pulse rate measurements. However, the provided text does not contain the detailed results of such a study. It only states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region."

Therefore, based on the provided text, I cannot complete the requested tables and sections as they pertain to a detailed study proving device meets acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement with AI. The document primarily highlights design modifications and claims substantial equivalence.

Information NOT present in the provided text:

• A table of specific acceptance criteria for SpO2 and pulse rate accuracy (e.g., A_rms values, bias, precision) and the reported device performance against these criteria.
• Sample size used for a test set to evaluate accuracy.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI.
• If a standalone (algorithm only) performance study was done.
• Type of ground truth used (e.g., arterial blood gas analysis for SpO2 accuracy).
• Sample size for a training set (as this is not an AI/ML device in the context of typical training sets).
• How ground truth for a training set was established.

The document is a 510(k) summary for a pulse oximeter, and these types of devices traditionally undergo verification and validation testing to ensure accuracy and compliance with standards (e.g., ISO 80601-2-61 for pulse oximeter basic safety and essential performance). However, the specific details of these tests and their results against quantitative acceptance criteria are not presented in this summary.

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The MD300A/MD300K2/MD300M handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

Handheld Pulse Oximeter Model MD300A/ MD300K2/ MD300M

This document is a 510(k) premarket notification letter for a Handheld Pulse Oximeter and does not contain the detailed study information required to fill out the table and answer all the questions. The letter confirms that the device is substantially equivalent to legally marketed predicate devices but does not include the actual performance data, acceptance criteria, or study design details.

Therefore, I cannot provide the requested information from the given text. The relevant sections like "Acceptance criteria and the study that proves the device meets the acceptance criteria" are not present.

The document only states the "Regulation Number: 21 CFR 870.2700" and "Regulation Name: Oscillometer" which would generally dictate the standards and required performance for such a device, but the specific acceptance criteria and study proving compliance are not detailed here.

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