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The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.

The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.

The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.

The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).

The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.

The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.

Here's a breakdown of what can be extracted and what is missing based on your prompt:

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.

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

• NIBP: 119 subjects.
• TEMP: 105 subjects.
• SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
• Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not explicitly stated in the document.
• For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.

4. Adjudication Method for the Test Set:

• Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.

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

• No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.

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

• Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.

7. The Type of Ground Truth Used:

• Reference device measurements.
  • NIBP: "desktop sphygmomanometer"
  • TEMP: "registered mercury thermometer"
  • SpO2/PR: Data from a previously cleared device (K170047, K063641) presumably validated against arterial blood gas or CO-oximetry as typical for oximetry.
  • No pathology or outcomes data mentioned

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The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home.

The work principle of Non-contact Electronic Forehead Infrared Thermometer, Model FT3010, is by using the infrared sensor converts the radiated power into an electrical signal, electrical signal is processed by the ambient temperature compensation circuit and an internal MCU circuit. The electrical signal is displayed in degrees Celsius (or Fahrenheit) on LCD.

The Non-contact Electronic Forehead Infrared Thermometer has the following features:

• Measure the forehead temperature;
• . Provide the prompt tone for high or low body temperature alert;
• . Equip with 32 sets of measurement memories;
• LCD digital displayer with backlight;
• . Display unit of Fahrenheit or Celsius;
• Automatic shutdown feature to save energy;
• . Low battery detection;

The provided document describes the acceptance criteria and the study that proves the performance of the "Non-contact Electronic Forehead Infrared Thermometer. Model: FT3010."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references conformity with several standards, which implicitly define the acceptance criteria. The performance is reported as meeting these standards.

• $\pm 0.2$ °C for $35.0 \sim 42.0$ °C
• $\pm 0.3$ °C for $34$°C $\sim 34.9$°C and $42.1$°C $\sim 43$°C (based on predicate criteria, assumed similar for subject device based on "does not affect performance and accuracy") | Body temperature: $22.0$ °C ~ $43.0$ °C: $\pm 0.2$ °C
  $71.6$°F ~ $109.4$°F: $\pm 0.4$°F (The document states "The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98.") |
  | Measurement Range | As per ISO 80601-2-56:2017 and ASTM E1965-98. Specifically:
  Body mode: $34.0$ °C -$43.0$ °C ($93.2-109.4$ °F) (Based on predicate criteria) | Body temperature: $22.0 \sim 43.0$ °C ($71.6 \sim 109.4$ °F) (The document states "Wider body temperature measurement range... The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98.") |
  | Electrical Safety | IEC 60601-1:2005+AMD 1: 2012 | Passed safety testing in accordance to IEC 60601-1:2005+AMD 1: 2012 |
  | Electromagnetic Compatibility | IEC 60601-1-2:2014 | Passed safety testing in accordance to IEC 60601-1-2:2014 |
  | Home Healthcare Environment | IEC 60601-1-11:2015 | Passed safety testing in accordance to IEC 60601-1-11:2015 |
  | Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Passed biocompatibility tests in accordance to ISO 10993-5:2009 |
  | Biocompatibility - Irritation & Sensitization | ISO 10993-10:2010 | Passed biocompatibility tests in accordance to ISO 10993-10:2010 |
  | Clinical Performance (Bias & Repeatability) | Met the acceptance criteria of the clinical study protocol (as per ASTM E1965-98) | Clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol. |
  | Software Validation | Consistent with moderate level of concern as per FDA guidance | Software documentation consistent with moderate level of concern was submitted. |

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

• Sample size: 150 subjects
  • 50 infants (newborn to 1 year)
  • 50 children (1 - 5 years old)
  • 50 subjects (> 5 years old)
• Data provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation." It does not specify if it was retrospective or prospective, but clinical investigations are typically prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions a "clinical study" conducted in accordance with ASTM E1965-98 and ISO 80601-2-56, which are standards for clinical thermometers and imply the use of reference thermometers for ground truth.

4. Adjudication method for the test set

The document does not mention an adjudication method. It describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation."

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 standalone infrared thermometer, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, a standalone study was done. The entire document describes the performance of the device itself (Non-contact Electronic Forehead Infrared Thermometer), which operates as an algorithm-only device without human intervention beyond taking the measurement and reading the display. The clinical study and non-clinical bench tests evaluated the device's performance directly.

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

The ground truth for the clinical study would have been established using reference temperature measurement devices as per the requirements of ASTM E1965-98 and ISO 80601-2-56. These standards typically require comparison against highly accurate clinical reference thermometers to determine bias and repeatability.

8. The sample size for the training set

Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a training set in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification and validation steps, not machine learning model training.

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

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

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