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The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.

The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.

The compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

• NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
• NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
• NK-501: Nebulizer Cup, Air Tube, Mouthpiece
  This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

The provided FDA 510(k) clearance letter and summary for JOYTECH Healthcare Co., Ltd.'s Compressor Nebulizer (K243468) primarily details the substantial equivalence of the new device to a predicate device, focusing on non-clinical performance testing, specifically particle size characterization.

It's important to note that this document does not describe a study involving human subjects or artificial intelligence (AI). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications for a nebulizer, evaluated through laboratory testing against a predicate device and relevant standards. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, adjudication methods, and training sets for algorithms are not applicable to this specific device clearance.

Below is an interpretation of the provided information within the framework of your request, focusing on the relevant parts and explicitly stating where information is not available or not applicable.

Acceptance Criteria and Device Performance for JOYTECH Compressor Nebulizer (K243468)

The acceptance criteria for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (Omron Compressor Nebulizer Systems NE-C801, K110860) and by meeting relevant performance standards, particularly regarding aerosol particle characterization. The 'study' proving this is primarily the "Particle Size characterization testing" detailed in the submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "comparative particle test comparison" against the predicate device. The goal is to show that the proposed device performs similarly or equivalently to the predicate across key aerosolization parameters. The performance data provided is the direct result of this testing.

Table: Comparative Particle Test Comparison (Summary of Select Parameters)

Note: The ranges represent the lowest and highest values across the tested drugs (Albuterol Sulfate, Ipratropium Bromide, Budesonide) and patient interfaces (adult mask, child mask, mouthpiece) for both adult and pediatric conditions. The "Comparison Result" is the submitter's statement from the document.

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

• Sample Size: The tables show mean and standard deviation values for each parameter, implying multiple measurements were taken for each drug and interface combination. However, the exact number of replicates (sample size for each data point in the tables) is not explicitly stated in the provided text. It is typically standard practice in such testing to perform a minimum of triplicate measurements.
• Data Provenance: The data is generated from laboratory performance testing of the device and its predicate. This is a non-clinical study.
  • Country of Origin: The manufacturer, JOYTECH Healthcare Co., Ltd., is located in Hangzhou City, Zhejiang, China. The predicate manufacturer, Omron Healthcare, Incorporated, is typically based in Japan with a strong presence in the US. The testing itself would have been conducted in a certified lab, likely in China or an associated region.
  • Retrospective or Prospective: This is prospective laboratory testing conducted specifically for this 510(k) submission.

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

Not applicable. This study does not involve expert interpretation of medical images or patient data to establish a ground truth. Instead, it involves physical and chemical measurements (particle size and drug delivery) performed on the nebulizer using standardized laboratory methods outlined in FDA guidance and relevant ISO standards (e.g., ISO 18562 series). The "ground truth" is derived from these objective measurements and comparison to the predicate's performance.

4. Adjudication Method for the Test Set

Not applicable. As this is laboratory performance testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results are quantitative measurements.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical device for drug delivery, not an AI diagnostic or assistive tool for human readers. Therefore, there is no human-in-the-loop performance to improve with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is hardware (a compressor nebulizer), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is objective physical and chemical measurement data obtained through standardized laboratory protocols (e.g., cascade impaction for particle sizing, chemical analysis for drug quantity) rather than expert consensus, pathology, or outcomes data. The acceptability is determined by evaluating if these measurements are comparable to the well-established performance of a predicate device already on the market and align with general principles for effective nebulizer function.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. There is no "training set" or "ground truth" in the context of an AI model for this device.

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The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm and 40cm-56cm.

The Arm-type Blood Pressure Monitor (BPM) series is an automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The systolic and diastolic pressures are determined using the Oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats per minute.

The DBP-6286B embed bluetooth module to transfer data to APP. With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS.

Based on the provided FDA 510(k) clearance letter for the JOYTECH Healthcare Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186), here's a description of the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance for Blood Pressure Monitors

The acceptance criteria for blood pressure monitors are typically defined by recognized international standards, primarily ISO 81060-2:2018+AMD2020, which pertains to the clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. This standard specifies the accuracy requirements for blood pressure measurements.

The key acceptance criterion is that the accuracy of the blood pressure monitor must be within the acceptable scope specified in ISO 81060-2:2018+AMD2020. While the exact numerical thresholds for group means and standard deviations aren't explicitly stated in this clearance letter, the general requirement is clear.

The reported device performance confirms that the device meets these criteria.

Study Details Proving Device Meets Acceptance Criteria:

1. A table of acceptance criteria and the reported device performance: (See table above)

2. Sample sizes used for the test set and the data provenance:

   • Cuff (22-42cm): 91 valid subjects' data were used for analysis.
   • Cuff (40-56cm): 85 valid subjects' data were used for analysis.
   • Data Provenance: The document does not explicitly state the country of origin of the data, but it implies a prospective clinical study ("All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect").

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

   • The document implies the use of human observers for the reference measurements, as it states: "The manual Mercury Sphygmomanometer was used as a reference device." This suggests that the ground truth was established by human operators taking readings from a mercury sphygmomanometer against which the automated device's readings were compared. However, the exact number and qualifications of these "experts" (human observers) are not specified in the provided document.

4. Adjudication method for the test set:

   • The document states, "Same arm sequential method was adopted during clinical testing." This method involves comparing simultaneous or near-simultaneous measurements from the test device and a reference device on the same arm. While this describes the measurement procedure, it does not describe an adjudication method for discrepancies between readings, as would be typical for expert consensus. Given that the ground truth is a direct measurement from a mercury sphygmomanometer, an adjudication process in the traditional sense (e.g., for image interpretation) is not directly applicable.

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. This is a medical device clearance for a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and were not performed.

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

   • The study design (clinical validation against a reference standard) inherently evaluates the "standalone" performance of the automated blood pressure monitor's algorithm. The device itself is designed to operate without continuous human intervention during the measurement process, making its performance essentially "algorithm only" in terms of blood pressure determination from the oscillometric data.

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

   • The ground truth was established by direct measurement using a manual Mercury Sphygmomanometer. This is considered the clinical gold standard for non-invasive blood pressure measurement in this context.

8. The sample size for the training set:

   • The document does not specify a separate training set or its sample size. For traditional medical devices like blood pressure monitors, the "training" (development and calibration) often occurs during the device engineering and manufacturing phases, and clinical validation is then performed on a separate, independent test set as described.

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

   • As no specific "training set" is mentioned in the context of a separate clinical dataset, the method for establishing ground truth for such a set is not provided. The device's underlying algorithms would have been developed and refined through engineering and calibration processes, likely using extensive internal testing and validation against standardized pressure sources and reference measurements, rather than a distinct "clinical training set" in the AI/ML sense.

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The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood Pressure (systolic and diastolic) of adults and adolescents over 12 years of age with circumference ranging from 22cm to 24cm.

The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation measurements, an electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg.

Meanwhile, some models whith bluetooth function can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display measurement results from the blood pressure monitor device, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.

There are total 7 arm-type blood pressure monitor models we submitted: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6193 and they are both bodyworn medical devices.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the JOYTECH Arm-type Fully Automatic Digital Blood Pressure Monitor:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for a non-invasive blood pressure monitor are its accuracy in measuring systolic and diastolic blood pressure. The relevant standard cited is ISO 81060-2:2018+AMD2020 (Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type).

The document states: "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." While specific numerical performance values (e.g., mean difference and standard deviation for systolic and diastolic pressure) are not explicitly provided in this summary, the statement indicates that the device met the statistical requirements defined by this international standard for accuracy.

Table of Acceptance Criteria and Reported Device Performance

Details of the Study Proving Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: A total of 90 subjects were included in the clinical validation study.
   • Data Provenance: The document does not explicitly state the country of origin of the data, but the manufacturer is based in China. The study appears to be prospective as it describes recruitment of subjects, their participation, and the measurement process.

2. Number of Experts and Qualifications:

   • The document mentions "The manual Mercury Sphygmomanometer was used as a reference device." This implies measurements were taken by trained observers (experts) using this reference device. However, the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here) are not specified in the provided text. For blood pressure clinical validation, these would typically be trained clinicians or technicians.

3. Adjudication Method for the Test Set:

   • The study used a "Same arm sequential method." This means the test device measurements and reference device measurements were taken sequentially on the same arm.
   • The document does not describe a specific "adjudication method" in the sense of multiple experts reviewing and reaching consensus on an interpretation (as would be common in image-based AI studies). Instead, the comparison is made between the device readings and the reference standard readings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI devices that assist human readers in interpreting medical images (e.g., AI for chest X-rays assisting radiologists). The device in question is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation of complex data.

5. Standalone Performance:

   • Yes, a standalone performance study was done. The clinical validation detailed here assesses the accuracy of the blood pressure monitor itself (the algorithm and hardware) against a recognized gold standard (manual mercury sphygmomanometer). The device operates independently to provide blood pressure measurements.

6. Type of Ground Truth Used:

   • The ground truth used was manual Mercury Sphygmomanometer measurements. This is a widely accepted reference standard for validating automated blood pressure monitors, considered an expert consensus/reference standard method in this context.

7. Sample Size for the Training Set:

   • The document does not provide information regarding the sample size of a training set. This is typical for a traditional medical device like a blood pressure monitor where the "algorithm" is often based on well-established non-AI methods (oscillometric principles) and validated through clinical testing rather than trained on large datasets like deep learning models. If there are software algorithms involved, they are likely more deterministic or based on classical signal processing rather than machine learning that requires a separate "training set."

8. How Ground Truth for Training Set Was Established:

   • As no "training set" in the context of typical AI/machine learning is mentioned, this information is not applicable and therefore not provided in the document. The device's underlying measurement principles (oscillometric method) use known physical principles, not a data-driven training process that requires a labeled ground truth for learning.

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The Electric Breast Pump (Model LD-208L, LD-3010L, LD-3010, LD-2010) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump (LD-208L, LD-3010L, LD-3010, LD-3010, LD-2010) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The subject devices are capable of expression, stimulation, and the hybrid 'bionio' and 'variable frequency' modes. Stimulation mode is associated with six suction levels, and expression, bionic, and variable frequency modes are associated with nine suction levels. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator display, and mode displays. The LD-208L, LD-3010L, and LD-2010L pumps are powered by internal, nonreplaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The LD-2010 and LD-3010 are powered by alkaline batteries or AC power.

The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is pre-programmed in the devices. The devices are capable of producing peak suction levels between -40 and -290 mmHg at speeds between 20 and 120 cycles per minute. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism.

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

The provided document is a 510(k) summary for an Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010). This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness or advanced performance metrics typically associated with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance with effect sizes) is not applicable or generally required for a 510(k) clearance of a mechanical device like a breast pump.

Here's the information that can be extracted or inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

For a breast pump, the "acceptance criteria" and "device performance" are primarily based on meeting safety standards, functional specifications, and demonstrating equivalence to a predicate. The document highlights various tests performed to ensure this.

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

The document does not specify sample sizes for the performance tests (e.g., how many units were tested for vacuum levels, how many use-life cycles). Data provenance details (country of origin, retrospective/prospective) are not provided as these are primarily engineering performance tests rather than clinical studies on patient data.

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

Not applicable. The ground truth for these performance tests is based on engineering specifications and adherence to international standards, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings.

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 an electric breast pump, a mechanical medical device, and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not use algorithms for diagnostic or interpretive performance separate from its mechanical function.

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

The ground truth for the performance testing is based on:

• Engineering specifications: Pre-defined ranges for suction levels, cycles per minute, and other functional parameters.
• International standards: Compliance with standards like ISO 10993 for biocompatibility, IEC 60601 for electrical safety, and IEC 60601-1-2 for EMC.
• Design requirements verification: Ensuring the device meets its intended design functions (e.g., backflow protection, battery function).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device.

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

Not applicable. (See #8)

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Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.

The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.

The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.

The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:

l. data recording;

II. curve display;

III. alarm functions.

The light bar of DET-218 turns on green light when the measurement is < 38.0 ℃ (100.4 °F ). The alarm function refers to the light bar of the device DET-218 turns on red light when the measurement is ≥38.0 ℃ (100.4 下 ), the APP will give an alarm when the measurement received simultaneously from DET-218 displays≥38.0℃.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the infrared ear/forehead thermometerDET -218 are established by relevant international standards, particularly ASTM E1965-98 (2016) for clinical performance. The reported device performance is stated to comply with these requirements.

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

• Sample Size for Clinical Performance Test: 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical test data. It only mentions that "clinical tests were conducted on the DET-218." It is reasonable to assume it was a prospective study, as it was conducted to evaluate the device's performance against a standard. The study included three groups based on age:
  • Infants: newborn to one year
  • Children: greater than one to five years
  • Adults: greater than five years old

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical performance test. The ground truth method is described below.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The clinical performance test protocol and data analysis were conducted as per the requirements of ASTM E1965-98 (2016). This standard typically outlines the methods for comparison against a reference thermometer, implicitly defining the ground truth measurement process rather than an adjudication among multiple readings of the device under test.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against reference measurements rather than subjective human interpretation of cases.

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

Yes, a standalone performance evaluation was done. The entire summary focuses on the device (Infrared Ear/Forehead Thermometer DET-218) and its conformance to standards. The "clinical tests" described are for the device itself, not for an algorithm where human input is part of the performance metric. The device also has an associated app, but the app's function is for data visualization, recording, and alarm, not for independent diagnostic or measurement capabilities requiring a human in the loop for its core function.

7. The Type of Ground Truth Used

The ground truth for the clinical performance test was established by a reference measurement method as defined by ASTM E1965-98 (2016). This typically involves comparing the device's readings against highly accurate reference thermometers or established clinical measurement techniques to determine accuracy. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic imaging or similar devices.

8. The Sample Size for the Training Set

The document describes a clinical performance test, which is a test set evaluation. It does not mention a "training set" or any machine learning model training process for the core measurement functionality of the thermometer. The device's operation is based on physical principles (measuring thermal radiation), not a data-trained algorithm for its primary measurement.

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

As no training set is mentioned for the primary measurement function of the device, this question is not applicable based on the provided text.

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The Digital Thermometer is intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.

The digital thermometer DMT-4735b is hand held instruments which can measure human body's temperature orally, axillary (under the arm), and rectally The results can be displayed on LCD. And, the results measured by DMT-4735b can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for clinical or home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

The provided text describes a 510(k) submission for a Digital Thermometer (Model: DMT-4735b). The document asserts substantial equivalence to a predicate device (K163518, Model: DMT-4735). The acceptance criteria for this device are largely derived from international standards and performance specifications rather than a comparative effectiveness study with human readers or clinical trials.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as compliance with international standards and specific performance ranges. The table below summarizes the key performance aspects where criteria are implied by the predicate device comparison and reported performance is stated.

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

The document states: "Clinical testing was not required to establish equivalency of the device." This implies that no specific test set involving human subjects with associated sample sizes was used for demonstrating the performance of the device against a clinical ground truth. The acceptance is based on compliance with international standards and comparison to a predicate device.

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

Since "Clinical testing was not required," there would be no experts establishing ground truth for a clinical test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was described.

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

No. The document explicitly states "Clinical testing was not required." Therefore, no MRMC study, or any study involving human readers, was conducted or reported.

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

The device is a digital thermometer, not an AI/algorithm-based diagnostic tool that would typically undergo "standalone" algorithm performance testing in the sense of image recognition or diagnostic algorithms. Its "performance" refers to its accuracy, response time, and compliance with technical standards, which were evaluated through bench testing and compliance with various engineering and safety standards (e.g., electrical safety, EMC, biocompatibility) rather than a standalone algorithm performance independent of a human operator interpreting its output. While the device does have software/firmware and can connect to a mobile app, its primary function as a thermometer relies on its sensor and internal processing, which is verified through the listed engineering standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by physical standards and measurement traceability in laboratories and testing facilities that verify compliance with standards like ISO 80601-2-56 for clinical thermometers. For accuracy, this would involve comparing the device's readings against calibrated reference thermometers under controlled environmental conditions. For other aspects like electrical safety, EMC, and biocompatibility, the ground truth is defined by the specific test methods and limits outlined in the relevant IEC/ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a digital thermometer, not a machine learning model that requires a training set of data.

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

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

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Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane.DET-103 and DET-105 include probe cover that is optional.

The Infrared Ear Thermometers include probe which used to measure ear canal temperature,plastic enclosed the display window,buttons and the battery cover.

The provided text describes the 510(k) premarket notification for an Infrared Ear Thermometer. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML device or a device requiring a PMA.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set information are not available in this document. The document primarily focuses on explaining how the new device is similar to an existing one (the predicate device).

However, I can extract the safety and performance standards the device is stated to conform to, which serve as the "acceptance criteria" for this type of device based on regulatory standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a thermometer, "acceptance criteria" refer to the performance specifications defined by recognized standards.

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

The document mentions that "The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016)." However, it does not state the specific sample size used in this test, nor the country of origin of the data or whether it was retrospective or prospective. For a 510(k) for a thermometer, the clinical test usually involves human subjects to demonstrate accuracy against a reference method (e.g., oral/rectal mercury thermometer or a highly accurate electronic thermometer).

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)

Not applicable. For a thermometer, "ground truth" for temperature is typically established by comparing the device's reading to a laboratory-calibrated reference thermometer or medical device known for its accuracy in measuring body temperature (e.g., a rectal thermometer in a clinical setting). It does not involve expert readers like radiologists.

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

Not applicable. Adjudication methods like "2+1" are relevant for subjective image interpretation tasks, not for objective measurements like temperature.

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 not an AI-assisted diagnostic tool.

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

This refers to a traditional, non-AI medical device. Its "standalone" performance is its direct measurement output, as evaluated against the stated standards. The clinical test confirms its performance.

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

For a clinical thermometer, the ground truth for temperature measurement is typically derived from a reference standard thermometer (e.g., a highly accurate, calibrated electronic thermometer or sometimes a rectal mercury thermometer in a controlled clinical study).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

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

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The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.
The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).
The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The device has two modes of operation:

• Stimulation mode: Suction patterns with fast cycles and low vacuum to start milk flowing
• Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.

The provided document details the 510(k) summary for the Joytech Healthcare Co., Ltd. Electric Breast Pump (Models LD-202 and LD-213). It focuses on demonstrating substantial equivalence to a predicate device, the Medela Swing Breast Pump (K053052).

While the document describes performance tests conducted, it does not provide a table of specific acceptance criteria and detailed reported device performance for functional aspects (like vacuum pressure, battery life, or backflow leakage) that would be expected to demonstrate clinical effectiveness. Instead, it refers generally to "all requirements of the applicable standards" and lists the types of tests performed.

Therefore, for the information requested regarding acceptance criteria and detailed performance, I can only extract general statements and the types of tests, not specific numerical criteria or results.

Here's a summary of the information available, addressing your points as much as possible:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards." However, it does not provide a table with specific numerical acceptance criteria for functional performance (e.g., a specific vacuum range and the measured performance) nor the detailed reported device performance directly. It only lists the types of tests performed.

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

The document does not specify a sample size for any of the performance tests. The tests appear to be bench testing (laboratory-based) rather than clinical studies involving human subjects for performance evaluation, as indicated by the "Bench Performance Testing" section. Therefore, there is no mention of data provenance in terms of country of origin or retrospective/prospective nature for these tests.

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

Not applicable. The performance testing described is bench testing against established engineering and biocompatibility standards, not evaluation by clinical experts establishing ground truth for a diagnostic output.

4. Adjudication method for the test set

Not applicable. This is not a study involving human reader interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with or without AI assistance.

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

This device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The performance tests are for the device's physical and electrical functions.

7. The type of ground truth used

For the safety and performance tests, the "ground truth" would be established by the specifications and requirements outlined in the referenced international standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993 series) and the internal design specifications for the vacuum pressure, cycling, and battery life. There's no clinical "ground truth" like pathology or outcomes data needed for this type of device submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device. The performance data comes from testing the physical device.

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

Not applicable, as there is no training set for this device.

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The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.

The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

Here's an analysis of the acceptance criteria and study details for the JOYTECH Healthcare Co., Ltd. Wrist-type Fully Automatic Digital Blood Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 85 subjects
• Data Provenance: The study was conducted in a hospital, indicating prospective data collection. The country of origin is not explicitly stated, but the company (Joytech Healthcare Co., Ltd.) is based in Hangzhou, China, suggesting the study likely took place in China.

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

• Number of Experts: Two doctors ("two doctors")
• Qualifications: Not explicitly stated beyond "doctors." They performed "simultaneous and blinded blood pressure determinations," implying their expertise in taking manual blood pressure measurements.

4. Adjudication Method for the Test Set:

• The text states: "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies that the measurements from the two doctors served as the ground truth, but it doesn't describe a specific adjudication method (e.g., 2+1, 3+1). It is most likely a consensus or average, given the use of "averaged paired determinations" mentioned in Criterion B.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on the accuracy of the device against a reference standard, not its impact on human reader performance.

6. Standalone Performance Study:

• Yes, a standalone (algorithm only) performance study was conducted. The clinical validation directly assesses the device's accuracy in measuring blood pressure compared to a reference standard (mercury sphygmomanometer).

7. Type of Ground Truth Used:

• The ground truth used was expert consensus/reference standard measurement. Specifically, a "standard mercury sphygmomanometer was used as a reference standard," with readings taken by two doctors.

8. Sample Size for the Training Set:

• The document describes a clinical validation study for accuracy, not a training set for an AI/machine learning model. Therefore, a "training set" in the context of machine learning is not applicable to this device's validation. The device uses an "oscillometric method and silicon integrate pressure sensor technology," which is a traditional algorithm, not typically a deep learning AI requiring large training sets in the same way.

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

• As mentioned above, a training set for an AI/machine learning model is not applicable here. The device functions based on an oscillometric algorithm, which relies on physical principles and pre-programmed logic, not a data-driven training process in the AI sense. Its accuracy is evaluated against established clinical validation standards.

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