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The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.

The document provided is a 510(k) Premarket Notification from the FDA for a Pulse Oximeter. It describes the device, its intended use, and a comparison to a predicate device, including non-clinical and clinical data.

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

1. Acceptance Criteria Table and Reported Device Performance

• IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-11 Edition 2.0 2015-01
• ISO 80601-2-61: 2017
  (Statement of compliance, not a numerical performance metric, beyond the clinical accuracy which is detailed elsewhere). Electrical safety explicitly stated: "Conformed to IEC60601-1, IEC 60601-1-11". |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • FS20P: 10 healthy female adult volunteer subjects.
  • FS20C: 13 healthy adult volunteer subjects.
• Data Provenance: The studies involved volunteer subjects, implying prospective data collection. The document does not specify the country of origin of the study data, but the submitting company is based in China, so it is highly likely the studies were conducted there. The subject skin tones (Fitzpatrick 1-6) suggest a diverse population, but this is a characteristic, not a location.

3. Number of Experts and Qualifications for Ground Truth

• The document describes a clinical study for SpO2 accuracy compared to arterial blood CO-Oximetry. This is a direct physiological measurement, implying that no human expert adjudication was used to establish the ground truth for SpO2. The CO-Oximeter itself is the "expert" or gold standard.
• Therefore, the concept of "number of experts" for ground truth establishment, as typically applied to image-based diagnostic AI, is not directly applicable here.

4. Adjudication Method for the Test Set

• None, as the ground truth was established by direct physiological measurement using a CO-Oximeter, which is considered a gold standard for SpO2. No human adjudication process (like 2+1 or 3+1) was necessary or mentioned for the SpO2 values.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance.
• For a pulse oximeter, the device directly measures physiological parameters (SpO2 and PR). The clinical study focused on validating the device's accuracy against a gold standard (arterial blood CO-Oximetry), not on improving human reader performance.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The clinical studies directly measured the device's (i.e., the pulse oximeter's algorithm/measurement system) SpO2 accuracy (ARMS) against a gold standard (arterial blood CO-Oximetry). The reported ARMS values (1.70% for FS20P and 1.71% for FS20C) are metrics of the device's standalone performance.

7. Type of Ground Truth Used

• The ground truth used was outcomes data / physiological measurement, specifically arterial blood CO-Oximetry. This method provides a direct, highly accurate measurement of arterial oxygen saturation, serving as the gold standard for SpO2.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. For a traditional medical device like a pulse oximeter, particularly one based on well-established principles of optical measurement, there isn't typically an "AI training set" in the sense of machine learning. The device's calibration and design would be based on engineering principles and potentially internal validation data, but not typically a labeled "training set" like an AI performs. The studies described are for validation/testing the accuracy of the final device.

9. How Ground Truth for the Training Set Was Established

• This question is not applicable as there is no mention of an "AI training set" or a separate training set in the context of this device's submission. The described clinical studies are for performance validation (test set), not for training an algorithm.

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WS20A is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients(≥10 years old, ≥30kg). It is designed for finger circumference more than 33mm. It is intended for spot-check, continuous data collection, recording and transmitting, not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home.

Pulse Oximeter WS20A is an internally powered pulse oximeter. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission. Place one fingertip into the sensor and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is intended to be applied to adult and pediatric patients in sleep labs, long-term care, hospital and home care environment. The subject device is composed of the following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), TFT display screen and Bluetooth module.

The provided text describes the 510(k) summary for the Hunan Accurate Bio-Medical Technology Co., Ltd.'s Pulse Oximeter (WS20A). While it details the device, its intended use, and comparison to a predicate device, it does not contain a specific table of acceptance criteria with reported device performance in the format of typical medical device performance claims (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Instead, the performance criteria for this pulse oximeter are related to its accuracy in measuring SpO2 and Pulse Rate against a reference standard (CO-Oximetry). The acceptance criteria for pulse oximeters are typically defined by recognized standards such as ISO 80601-2-61, which specifies the accuracy requirements (e.g., ARMS value).

Based on the provided text, here's an attempt to extract the relevant information and present it as requested.

Overview of Device Performance and Study

The Pulse Oximeter (WS20A) underwent clinical studies to verify its accuracy in measuring functional oxygen saturation of arterial hemoglobin (SpO2) against arterial blood CO-Oximetry, in accordance with ISO 80601-2-61:2017 and FDA guidance for Pulse Oximeters - Premarket Notification Submissions.

1. Table of Acceptance Criteria and Reported Device Performance

For pulse oximeters, the key performance metric for SpO2 accuracy is typically the Accuracy Root Mean Square (ARMS) value when compared to a reference method (CO-Oximetry). The acceptance criterion is generally that the ARMS value should be within a specified limit, commonly ± 3% for 70-100% SpO2 range as per ISO 80601-2-61.

• All subjects: 1.81%
• Female subjects: 1.80%
• Male subjects: 1.83%
• Light-skinned: 1.78%
• Dark-skinned: 1.91%

Pediatric Patients:

• 10 female subjects: 1.80%
• Light-skinned: 1.81%
• Dark-skinned: 1.74% |
  | PR Accuracy (bpm) | ± 3bpm (as per predicate device spec) | Not explicitly reported from clinical study for WS20A. The 510(k) submission document for WS20A lists its PR accuracy as ± 3 bpm, which aligns with its own stated specifications and is compared to a similar specification for the predicate. |

Note: The acceptance criteria for ARMS are not explicitly stated as a number in the provided text but are inferred from common regulatory expectations for pulse oximeters based on the ISO standard cited.

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

• Adult Patients: 13 healthy adult subjects. 315 data sets (SpO2 vs SaO2) were obtained.
• Pediatric Patients: 10 healthy female subjects. 243 data sets (SpO2 vs SaO2) were obtained. (Note: The description states "healthy female subjects, aged 22-30" for 'pediatric patients' which seems to be a typo given the 'pediatric' labeling and the age range overlaps with 'adult'. Assuming this refers to subjects representing a pediatric patient population as defined by the study design, or a mislabeling of the subject group based on physical characteristics matching the pediatric profile for device testing.)
• Data Provenance: The document does not specify the country of origin of the data. The studies were described as "clinical studies" and appear to be prospective in nature, as they involved actively obtaining data sets from healthy subjects under stationary (non-motion) conditions through controlled desaturation.

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

The ground truth for pulse oximetry accuracy studies is established through arterial blood CO-Oximetry, which is a direct invasive measurement of arterial oxygen saturation (SaO2). This is a gold standard laboratory method, not typically established by physician experts in the same way as image interpretation. The text does not mention the use of experts for ground truth establishment; rather, it relies on the direct physiological measurement.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for oxygen saturation in these studies is derived from direct physiological measurement (CO-Oximetry) rather than expert consensus requiring adjudication.

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

Not applicable. This device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic imaging device requiring human reader interpretation for a comparative effectiveness study.

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

Yes, the performance presented (ARMS values) represents the standalone accuracy of the pulse oximeter device algorithm in measuring SpO2 against the CO-Oximetry reference. While a human uses the device, the accuracy is derived from the device's measurement capabilities.

7. The Type of Ground Truth Used

The ground truth used was arterial blood CO-Oximetry (SaO2), which is a gold standard for measuring oxygen saturation in the blood. This is a direct physiological measurement, not expert consensus or pathology.

8. The Sample Size for the Training Set

The document describes clinical studies conducted to verify the accuracy of the proposed device. It does not explicitly mention a "training set" for an algorithm in the sense of machine learning. The data described (from 13 adult and 10 "pediatric" subjects) appears to be the test/validation set used to demonstrate the device's accuracy. For traditional medical devices like pulse oximeters, the core measurement principles are physics-based, not reliant on machine learning models that require distinct training sets. Any internal calibration or algorithm development would typically occur during the R&D phase, prior to these described validation studies, and the size of data used for such internal development is not generally disclosed in 510(k) summaries unless it's a novel AI/ML device.

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

Not applicable, as a distinct "training set" in the context of an AI/ML device is not described for this traditional pulse oximeter. If there were internal algorithm development or calibration, the ground truth would likely have been established using similar reference methods (CO-Oximetry) in controlled lab settings.

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The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.

The HS10A is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and functional arterial oxygen saturation in arterial blood. The HS10A include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings. The device also has menu features to allow the user to set the time, date and measurement alarm limits.

Here's a breakdown of the acceptance criteria and study information for the Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document directly states the SpO2 accuracy criterion and result. For other specifications like pulse rate, the acceptance criteria are not explicitly detailed for the subject device but are implicitly met through overall equivalence claims and conformance to standards. The predicate also has a SpO2 accuracy of "$70-100% no less than ±2%(No motion)$," which serves as the basis for the acceptance criteria for the new device.

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

• Sample Size for Test Set: 12 healthy adult male and female volunteers.
• Number of Blood Samples: 300 blood samples.
• Data Provenance: The study was conducted on "healthy adult male and female volunteers with light to dark skin pigmentations." The country of origin is not explicitly stated, but the company is based in China. The study appears to be prospective as it's described as "clinical testing" specifically for this device.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for SpO2 was established using a laboratory CO-Oximeter.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by instrumental measurement (CO-Oximeter), not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a laboratory reference.

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

Yes, a standalone study was done. The "clinical testing" described measures the intrinsic accuracy of the pulse oximeter (HS10A) itself against a reference standard.

7. The Type of Ground Truth Used

The ground truth used for the SpO2 accuracy evaluation was an instrumental reference standard, specifically a laboratory CO-Oximeter. This is compared to "outcomes data" in the sense that the CO-Oximeter provides definitive physiological measurements.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This suggests that the device's underlying algorithms or calibration were developed prior to this validation study, and details about their training are not part of this 510(k) summary. Pulse oximeters typically rely on established physiological models and calibration rather than machine learning training sets in the way AI algorithms do.

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

Not applicable, as no training set information is provided.

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The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

The proposed devices of Pulse Oximeter FS10A, FS20A are fingertip devices, which can display SpO2 and pulse rate value. The proposed devices consist of detector and emitter LED, CPU, display unit and power unit. 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 wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light overtime. 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Pulse Oximeters FS10A,FS20A share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse Oximeters FS10A, FS20A are the same. The devices are software-driven and the software validation is provided in Section of Software.

The provided document is a 510(k) premarket notification for the Pulse Oximeter, Model FS10A and FS20A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a device's specific acceptance criteria and a study proving it. Therefore, much of the requested information, particularly regarding detailed study methodologies, sample sizes for training/test sets, expert qualifications, and adjudication methods, is not explicitly available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SpO2 accuracy are implicitly defined by the stated accuracy specifications related to the predicate device and the clinical trial conclusion. The reported performance is also explicitly stated.

Study Proving Device Meets Acceptance Criteria:

A clinical trial was conducted for the FS20A model, following ISO80601-2-61:2011, Annex EE.2 Procedure for invasive laboratory testing. The conclusion states that "the accuracy Arms of the proposed device is smaller than 2%," which indicates it meets the standard for SpO2 accuracy within the specified range (70-100% for FS20A).

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

• Sample Size for Test Set: Not explicitly stated. The document only mentions "a clinical test for one of the proposed devices, and the model is FS20A." The specific number of subjects or data points is not provided.
• Data Provenance: The clinical test was conducted by the "Guangzhou Huangpu Traditional Chinese Medicine Hospital." This indicates the data is from China. It is implied to be prospective as it's a clinical trial related to the device's submission.

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

• This information is not provided in the document. The clinical trial described in the document is an "invasive laboratory testing" which likely involves direct measurement of arterial blood gas (ABG) for ground truth, rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Given the nature of a pulse oximeter clinical trial involving direct physiological measurements (ABG), "adjudication" in the sense of resolving conflicting expert opinions for ground truth is unlikely to be applicable. The ground truth would typically come from a reference standard instrument.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This document describes a clinical trial for a standalone device (pulse oximeter) to determine its accuracy against a reference standard, not a study evaluating human reader performance with or without AI assistance.

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

• Yes, a standalone study was done. The clinical trial described for the FS20A pulse oximeter is a standalone performance study. The device (algorithm and hardware) directly measures and displays SpO2 and pulse rate without human interpretation or intervention as part of the core measurement process.

7. The Type of Ground Truth Used

• The clinical trial followed "Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011," which for pulse oximeters, typically refers to invasive arterial blood gas (ABG) measurements as the reference standard for oxygen saturation. This is the gold standard for SpO2 ground truth.

8. The Sample Size for the Training Set

• This information is not provided in the document. The document describes a "clinical trial" which is usually a validation step for a device already developed, implying an algorithm may have been developed and "trained" prior to this validation. However, no details on a "training set" for the oximeter's algorithm are given.

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

• This information is not provided in the document, as no details on a training set or its ground truth establishment are mentioned. If the device uses a machine learning algorithm, the ground truth for training would typically involve similar methods to the test set (e.g., ABG measurements).

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