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The Electric Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts.The device is intended for a single user.

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The provided text is an FDA 510(k) clearance letter for an "Electric breast pump." This document details the regulatory clearance of a physical medical device, not a software-based AI/ML device.

Therefore, the information required to answer your query – acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), and training set details – is not present in the provided text.

This document is a regulatory approval for a mechanical device and does not contain the kind of performance data and study design details typically found in submissions for AI/ML-driven diagnostic or assistive technologies.

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The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.

The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user. Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit. The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.

Here's an analysis of the provided FDA 510(k) summary for the Finger Pulse Oximeter, Model: X1906P, organized to address your specific points about acceptance criteria and study proof.

It's important to note that this document is a summary for a 510(k) submission, and therefore provides high-level information. Full details of the protocols, raw data, and statistical analyses would be found in the complete submission documents, which are not provided here.

Acceptance Criteria and Device Performance

The core of the performance evaluation for a pulse oximeter revolves around its accuracy in measuring oxygen saturation (SpO2) and pulse rate (PR). The key standard referenced is ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Fingertip Pulse Oximeter Equipment. The acceptance criteria are typically derived from this standard.

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria Interpretation: The document states that "Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017... standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104." This implies the acceptance criteria were the specific performance requirements outlined in that ISO standard for accuracy, which is typically Average Root Mean Square (ARMS) difference for SpO2. The specific numerical ARMS values are not explicitly stated for the device's performance, but rather that it "conformed with the requirements."

Study Details

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

• Sample Size: 13 adult volunteers.
  • Breakdown: 5 males, 8 females.
  • Fitzpatrick skin types included: 3 subjects with Fitzpatrick VI, 3 subjects with Fitzpatrick II, and 7 subjects with Fitzpatrick IV. This inclusion of diverse skin tones is crucial for pulse oximetry accuracy.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. Given the manufacturer (Shenzhen Changkun Technology Co., Ltd. from China) and consultant (Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. from China), it is highly probable the study was conducted in China.
• Retrospective or Prospective: The study description "Clinical studies were conducted to verify the accuracy of proposed device" and "There were 13 adult volunteers to validated the accuracy of finger pulse oximeter" indicates a prospective clinical study.

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 in the traditional sense of image adjudication or clinical interpretation, as this is a pulse oximeter accuracy study. The "ground truth" for SpO2 and pulse rate is established through direct, highly accurate physiological measurements:

• SpO2 Ground Truth: Measured by a blood gas analyzer (SaO2).
• Pulse Rate Ground Truth: Measured by a patient monitor (HR).

These are considered gold standards for these physiological parameters. Therefore, the concept of "experts establishing ground truth" as it applies to subjective interpretation (like radiology reads) is not directly applicable here. The expertise lies in the certified laboratory/clinical personnel performing the blood gas analysis and operating the patient monitor, ensuring proper calibration and technique. Specific qualifications of these operators are not detailed but are assumed to be standard for clinical laboratory and patient monitoring practices.

4. Adjudication Method for the Test Set:

Not applicable in the context of this study. This study directly compares the device's numerical output against gold-standard physiological measurements (blood gas analyzer for SaO2, patient monitor for HR). There is no "adjudication" of the device's readings by human experts in the sense of consensus reading or interpretation.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. For a pulse oximeter, the study design is centered on direct numerical accuracy against a gold standard, not human reader performance.

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

Yes, the clinical accuracy study described for the pulse oximeter is effectively a standalone study. The device's measurement (SpO2 and PR) is directly compared to the reference measurement (blood gas analyzer and patient monitor) without an explicit "human-in-the-loop" component influencing the device's output or the ground truth measurement. The user of the oximeter reads the displayed value, but the study validates the intrinsic accuracy of the measurement.

7. The Type of Ground Truth Used:

• SpO2 Ground Truth: Physiological measurement via arterial blood gas analysis (SaO2). This is considered a gold standard for true arterial oxygen saturation.
• Pulse Rate Ground Truth: Physiological measurement via a patient monitor (HR). This is also considered a gold standard for heart rate.

8. The Sample Size for the Training Set:

The document does not provide information on a training set size. For a traditional medical device like a pulse oximeter, "training set" is usually not a relevant concept in the same way it is for AI/ML algorithms. The device's underlying principles (Lambert Beer Law, photo-plethysmography) are based on established physics and physiology, not on learning from a dataset. Any internal calibration or algorithm refinement would be part of the engineering design process, not typically referred to as a "training set" in the context of FDA submissions for such devices.

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

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable. The device's design and calibration are based on established scientific principles and engineering practices, not on a machine learning training dataset. The clinical study validates the final, produced device's performance against established physiological ground truth.

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Wrist Electronic Sphygmomanometer is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.

The Wrist Electronic Sphygmomanometer is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the oscillometric technique.

The device uses the oscillometric method to determine blood pressure. This is accomplished by means of a sensitive transducer, which measures cuff pressure and minute pressure oscillations within the cuff. The first determination sequence initially pumps up to a cuff pressure of about 180-230mmHg for adults. After inflating the cuff, the Wrist Electronic Sphygmomanometer begins to deflate it at a rate of 3-6 mmHq/sec, and measures systolic, mean, and diastolic pressure. The Wrist Electronic Sphygmomanometer deflates the cuff one step each time it detects two pulsations of relatively equal amplitude ("peak matching"). The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Wrist Electronic Sphygmomanometer is unable to find any pulse within several seconds, it will deflate to the process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances accuracy.

The device will obtain the pressure point, which is before the maximum peak and whose amplitude of peak is 0.45 times the reference amplitude, is determined to be the systolic pressure; and the pressure point, which is after the maximum peak and whose amplitude of peak is 0.75 times the reference amplitude, is determine to be the diastolic. When the diastolic pressure has been determined, the NIBP Meter finishes deflating the cuff and updates the screen.

The provided document describes the Wrist Electronic Sphygmomanometer (models CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358) and its substantial equivalence to a predicate device, the Med-link Wrist Digital Blood Pressure Monitor (Model: ESM101). The primary study proving the device meets acceptance criteria appears to be a performance evaluation according to the AAMI / ANSI / ISO 81060-2 standard, which is a standard for non-invasive blood pressure monitors.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document largely details equivalence to a predicate device rather than precise acceptance criteria and specific performance numbers for the subject device beyond the general range and accuracy claims. However, the performance specifications listed for the subject device can be inferred as its reported performance, and by extension, the acceptance criteria as meeting these specifications (and demonstrating equivalence to the predicate which also meets these).

The document notes that the device "meets the requirements as safety and performance standards required," implying that its performance aligns with what is expected by relevant standards like AAMI / ANSI / ISO 81060-2.

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

The document states that "Performance according to AAMI / ANSI / ISO 81060-2 standard" was conducted. This standard typically specifies requirements for clinical validation, often involving a certain number of subjects. However, the exact sample size used for the test set (clinical validation cohort) is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not provide this information. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a reference device, not necessarily "experts" in the context of image interpretation. The ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements.

4. Adjudication Method for the Test Set

The document does not provide this information. For blood pressure device validation, adjudication usually refers to how discrepancies between multiple reference measurements are handled, which is part of the ISO 81060-2 methodology but not detailed here.

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 (N/A). This device is a non-invasive blood pressure measurement system and not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

The performance evaluation according to AAMI / ANSI / ISO 81060-2 is inherently a standalone performance study of the device, as it evaluates the algorithm's accuracy in measuring blood pressure compared to a reference standard without human intervention in the measurement process (though humans apply the device and record results).

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

For blood pressure monitoring devices, the ground truth is established through simultaneous measurements using a validated reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer as per AAMI/ISO standards). The document states "Performance according to AAMI / ANSI / ISO 81060-2 standard," which defines how this ground truth is established.

8. The Sample Size for the Training Set

The document does not provide this information. Blood pressure monitors typically do not have a "training set" in the machine learning sense. The device's algorithm is developed based on physiological principles and validated against clinical data.

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

The document does not provide this information. As mentioned above, the concept of a "training set" with established ground truth is not typically relevant for this type of medical device in the same way it would be for an AI/ML algorithm. The underlying oscillometric algorithm is based on established scientific principles and previously collected physiological data, but not usually in a "training set" context as defined for AI.

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Infrared Thermometer (model: CK-T1501, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Infrared Thermometer (model: CK-T1501,CK-T1502,CK-T1503) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when meas ure from 3-5 cm of the subiect's forehead with no contact.

lt uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.

It composed by a measuring sensor, PCB, 4 buttons, a LCD and an enclosure. The functions of the three models are similar. The functions of "Temperature Alarm Point", "Temperature Offset", and "Warning Tone Switch" can be set. When measuring body temperature, users need to measure in body mode from 3-5 cm from their forehead. Press the measuring key, after 0.5 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 15 sec. The No. and stored value of the stored data are displayed at the bottom of the LCD screen. Press "+" / " -" to view the previous or next stored data, it can store 32 sets of measurements.

User contact components are the enclosure and keys. The materials of the components are ABS plastic.

The provided text describes the 510(k) premarket notification for an Infrared Thermometer (Models: CK-T1501, CK-T1502, CK-T1503). Here's a breakdown 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 primarily references compliance with established standards rather than specific acceptance criteria values in a table. However, based on the Comparison to predicate device and conclusion section (page 5), and the Summary of Non-Clinical Testing and Discussion of Clinical Tests Performed sections (pages 7-8), we can infer the acceptance criteria and reported performance:

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

• Sample Size for Test Set: 240 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the test was a "clinical performance test" conducted in accordance with ASTM E1965-98 (2009/2016) and ISO 80601-2-56. These standards typically involve prospective clinical studies where actual body temperatures are measured. The document refers to "clinical tests evaluated 240 of subjects," strongly implying a prospective study.

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)

The document does not provide details on the number or qualifications of experts used to establish ground truth. For clinical thermometers, ground truth for body temperature is typically established by simultaneously measuring temperature with a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measuring device) as specified by the testing standards (ASTM E1965-98 and ISO 80601-2-56). The text only states that "the clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009)."

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

The document does not describe an adjudication method. For clinical thermometer studies, adjudication of ground truth measurements by multiple human experts is not typically applicable in the same way it would be for image-based diagnostic AI. The gold standard for temperature measurement is usually a precise physical sensor.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of medical images or data. This device is a standalone infrared thermometer, which does not involve human "readers" or AI assistance in a diagnostic capacity, but rather directly provides a measurement.

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

• Yes, a standalone performance assessment was done. The entire clinical and non-clinical testing described assesses the performance of the device itself (algorithm and hardware combined) in measuring temperature, without human interpretation of its output being part of the primary performance evaluation. The device provides a direct temperature reading.

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

The ground truth for the clinical performance study would be simultaneous, direct body temperature measurements using a highly accurate reference thermometer (e.g., rectal, oral, or axillary measurements with a calibrated clinical electronic thermometer) as prescribed by the testing standards (ISO 80601-2-56 and ASTM E1965-98). While not explicitly stated, this is the standard method for validating thermometer accuracy.

8. The sample size for the training set

• Not applicable. This device is a traditional medical device (infrared thermometer), not an AI/ML-based diagnostic system that typically requires a large training set of data to "learn" patterns. Its internal firmware/algorithm would have been developed and validated through engineering principles and testing against specifications, not through machine learning on a "training set" of patient data in the typical sense.

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

• Not applicable. As stated above, this device does not involve a training set for machine learning. The "ground truth" for its development would be the fundamental laws of physics related to infrared radiation and temperature, and established metrological standards for temperature measurement, used to design and calibrate the hardware and firmware.

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