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The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

The Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor, comprised of the host machine and the wrist cuff. It can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can store 199 groups of measurement data for two users.

This document describes the regulatory approval of an Electronic Blood Pressure Monitor (Models HWA11, HWA10) by Shenzhen Jumper Medical Equipment Co., Ltd. The approval is based on demonstrating substantial equivalence to a predicate device (Omron Model BP6100, K182127).

The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in the prompt (e.g., specific thresholds for accuracy, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC study details, etc.).

However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:

Implied Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily implied by conformance to international standards for blood pressure monitors and demonstration of statistical equivalence to a recognized measurement method.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):

Study Information (Extracted and Inferred):

1. Sample size used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The text mentions a "clinical investigation" but does not specify the number of subjects. However, for validation to ANSI/AAMI/ISO 81060-2:2013, a specific number of subjects (usually 85 for the initial phase, and more for specific populations) from a defined demographic (e.g., age and blood pressure ranges) are typically required.
   • Data Provenance: Not explicitly stated, but clinical studies for such devices are typically prospective. The text does not mention the country of origin where the clinical study was conducted.

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

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: "Trained medical staff" were used for the auscultation method. ANSI/AAMI/ISO 81060-2:2013 guidelines require specific training and certification for these observers.

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

   • No adjudication method is mentioned. The ground truth was established by "trained medical staff" using the auscultation method, implying a direct comparison rather than a multi-reader consensus process for image interpretation.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was NOT done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device. The "study" here refers to the clinical validation of its measurement accuracy compared to a standard reference method (auscultation), not a human-in-the-loop diagnostic improvement study.

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

   • Yes, in essence, this was a standalone performance study for the device. The study validated the "accuracy of blood pressure measurements by HWA11 based on an oscillometric method as compared to an auscultation method." This is the device's inherent performance.

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

   • Expert Reference Method (Auscultation): The ground truth for blood pressure measurements was established using the "auscultation method using a calibrated sphygmomanometer by trained medical staff." This is considered the gold standard for clinical blood pressure measurement in such validation studies.

7. The sample size for the training set:

   • This is not applicable for this type of device and study. The device is a non-AI, oscillometric blood pressure monitor. It uses a defined algorithm, not a machine learning model that requires a "training set" in the common AI sense.

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

   • Not applicable (see point 7).

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

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The provided text is a U.S. FDA 510(k) clearance letter for the "Mini TENS Therapy Device Model JPD-ES100". This document is a regulatory communication stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about acceptance criteria, device performance study results, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/medical imaging device.

The 510(k) clearance process for a TENS device typically relies on demonstrating substantial equivalence to pre-existing devices by showing it meets recognized standards for electrical safety and performance, rather than clinical efficacy studies with the kind of details requested in your prompt (e.g., expert reads, ground truth, MRMC studies) which are more common for novel diagnostic or AI-powered devices.

Therefore, I cannot extract the information requested in your prompt from the provided document. The 510(k) letter primarily focuses on the regulatory clearance and general controls applicable to the device.

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The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The main differences are product appearance. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document is a 510(k) premarket notification for an Electronic Blood Pressure Monitor (models JPD-HA120 and JPD-HA121). The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or, if there are differences, that these differences do not raise new questions of safety and effectiveness.

The document focuses on comparing the new device to a predicate device and detailing the non-clinical and clinical testing performed to support substantial equivalence.

Here's an analysis addressing your specific questions, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly present a pre-defined table of acceptance criteria with corresponding performance results in the way you might expect for a typical scientific study's results section. Instead, for blood pressure monitors, accuracy is defined by industry standards like ISO 81060-2. The acceptance criteria are implicitly met if the device complies with the accuracy requirements of this standard.

The general acceptance criteria for a non-invasive blood pressure monitor would be its accuracy in measuring systolic and diastolic blood pressure, and pulse rate. The document states the device's accuracy specifications:

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

It is explicitly stated that the system complies with ISO 80601-2-30:2009 (for performance effectiveness) and ISO 81060-2:2013 (for clinical validation), meaning it met the requirements set forth in those standards. The accuracy stated in the "Comparison" table (Page 4) reflects the accuracy specifications of the device, which are the same as the predicate device and are presumed to meet the standard's requirements.

Study Details

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

The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

• Sample Size: The ISO 81060-2 standard specifies the minimum number of subjects required for clinical validation (typically 85 subjects with specific age/sex/BP distribution). While the document does not explicitly state the sample size used in this specific study, it implies compliance with the standard's requirements.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are almost always prospective.

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)

For blood pressure monitor validation studies adhering to ISO 81060-2:2013, ground truth (reference blood pressure) is established using auscultation by trained observers. The standard typically requires two or three independent trained observers:

• Number of experts: ISO 81060-2:2013 requires measurements from two trained observers simultaneously using a mercury sphygmomanometer or validated alternative. A third observer might be used for adjudication if the first two differ significantly.
• Qualifications of experts: These are typically medical professionals or trained technicians who are specifically trained and certified in the auscultation method for blood pressure measurement, following strict protocols outlined in the standard. The document doesn't specify their direct qualifications, but compliance with the standard implies they met these criteria.

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

For clinical validation following ISO 81060-2:2013, the ground truth is established by simultaneous auscultatory measurements often by two observers. If their readings differ by more than a specified amount, a third observer might be involved or the measurement discarded. The standard itself outlines the specific methodology for comparing automated device readings to reference readings. The document does not explicitly state the adjudication method beyond "Clinical testing is conducted per ISO 81060-2: 2013".

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 study was not done. This type of study (MRMC) is typically performed for diagnostic imaging AI algorithms where AI is assisting human interpretation. Blood pressure monitors are automated devices that provide a direct measurement; there's no human "reader" whose performance needs to be improved by AI assistance in this context.

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

• Yes, in effect, a standalone performance evaluation was done. The device itself is an automated measurement system. When it undergoes clinical validation per ISO 81060-2, its performance is evaluated as a standalone system against a reference standard (auscultation). There isn't a "human-in-the-loop" once the device is initiated for a measurement.

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

• The ground truth for blood pressure measurement in clinical validation studies for oscillometric devices is typically established by simultaneous, independent auscultatory measurements performed by trained human observers using a standardized reference method (e.g., mercury sphygmomanometer). This can be considered a form of "expert consensus," specifically expert measurement.

8. The sample size for the training set

• The document does not specify a training set size. For blood pressure monitors, the "algorithm" is the oscillometric method itself, which is well-established. While the device's internal algorithm might have been tuned or developed using performance data, this is not typically disclosed as a distinct "training set" in a 510(k) unless a novel, data-driven AI algorithm is at its core. This device likely relies on a standard oscillometric algorithm.

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

• As a training set is not explicitly mentioned or suggested for a novel AI algorithm, the method for establishing ground truth for a training set is not applicable/provided in this 510(k) submission. The underlying principles of oscillometry are based on established physiological responses, not on training a machine learning model on a specific dataset.

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The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.

The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD. And, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .

This document describes the premarket notification for a non-contact infrared thermometer (models JPD-FR400, JPD-FR402). The information provided pertains to the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to previously marketed devices.

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

Key Takeaways:

• This submission is for a medical device (non-contact infrared thermometer), not an AI/ML diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., ground truth establishment for training, MRMC studies, human-in-the-loop performance, expert consensus) are not applicable.
• The primary method for demonstrating acceptance and substantial equivalence is through compliance with recognized performance standards for clinical thermometers and non-clinical testing.
• A clinical performance test was conducted, which is crucial for proving the accuracy of a thermometer.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from recognized standards like ASTM E 1965-98. The document does not present a formal table of "acceptance criteria" vs. "reported performance" in the typical AI/ML sense (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance complied with the requirements of the standards.

However, we can infer some key performance criteria and the device's reported capabilities from the "Substantial Equivalence Comparison" table and "Non-clinical Performance Testing" section.

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

• Sample Size: The document explicitly states: "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)." This standard specifies the methodology for clinical accuracy testing of infrared thermometers. While the exact number of subjects or measurements is not explicitly stated in this summary document, adherence to ASTM E 1965-98 implies a sufficient sample size as mandated by that standard.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document is a 510(k) submission from Shenzhen Jumper Medical Equipment Co., Ltd. in China. Given the manufacturer's location, the testing was likely conducted in China.
• Retrospective or Prospective: Unspecified, but clinical performance testing for medical device approval is typically prospective to ensure controlled conditions and data collection.

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

• This category is not applicable in the context of this device. A non-contact infrared thermometer directly measures temperature. The "ground truth" for thermometer accuracy is established by comparing the device's readings against a highly accurate reference thermometer, typically in a controlled clinical setting or using a black body calibrator. It does not rely on subjective expert interpretation like radiological images.

4. Adjudication Method for the Test Set

• Not applicable. As above, the "truth" is a physical measurement, not a subjective interpretation 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 is a standalone medical device (thermometer), not an AI-based diagnostic tool that assists human readers.

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

• Yes, in effect. The device's primary function is to provide an objective temperature reading, acting as a standalone measurement tool. The "clinical performance test" evaluates the device's accuracy in a clinical setting without human interpretation impacting the reading itself. The performance is assessed based on how closely its readings match reference measurements.

7. The Type of Ground Truth Used

• Reference Thermometer Readings / Clinical Patient Temperatures: The ground truth for a clinical thermometer's accuracy is established by comparing its readings to known, accurate body temperatures obtained via a reference method (e.g., rectal thermometer or an established highly accurate clinical thermometer) in subjects, or by using precisely controlled temperature sources (e.g., black body calibrators) for calibration and laboratory accuracy testing. The text states "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)," which details how this ground truth is established (e.g., using a reference thermometer to perform simultaneous or near-simultaneous measurements on subjects).

8. The Sample Size for the Training Set

• Not applicable / Unknown: This device is a traditional infrared thermometer. It is not an AI/ML device that undergoes "training" on a data set in the way a deep learning model would. Its "training" or calibration would involve engineering and manufacturing processes to ensure its sensor and algorithms accurately convert infrared radiation to temperature readings according to physical principles.

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

• Not applicable: As discussed above, this is a traditional medical device, not an AI/ML model requiring a distinct "training set" with established ground truth in the AI sense. Its "ground truth" for manufacturing calibration would involve highly accurate laboratory temperature references.

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The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

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This FDA 510(k) clearance letter for the Fingertip Pulse Oximeter (Model JPD-500F) does not contain detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria.

FDA 510(k) clearance letters primarily state that the device is "substantially equivalent" to a legally marketed predicate device. They typically do not include the raw data, study designs, or detailed performance metrics that would be found in a full submission. The letter confirms the device type, its classification, and intended use.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, one would need to access the full 510(k) submission document or a summary thereof, which often includes details of the performance testing and acceptance criteria.

However, I can infer some general information about what would typically be required for a pulse oximeter's acceptance criteria and how a study would prove it, even if the specifics are not in this document:

Inferred Information (Based on typical regulatory requirements for pulse oximeters, not directly from this document):

1. Table of Acceptance Criteria and Reported Device Performance: This would typically involve accuracy and precision metrics for SpO2 and pulse rate.

   • Acceptance Criteria (Example):
     • SpO2 Accuracy: Aroot mean square (ARMS) difference between the device reading and reference measurement ≤ 3.0% saturation for SpO2 values between 70% and 100%. Clinical bias (mean difference) might also be specified.
     • Pulse Rate Accuracy: Mean absolute difference (MAD) or ARMS difference between device reading and reference measurement ≤ 5 bpm for pulse rates between X and Y bpm.
   • Reported Device Performance: This would be the actual ARMS, bias, or MAD values achieved in the clinical study.

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

   • Sample Size: For SpO2 accuracy, typically involves at least 10-15 healthy adult volunteers for induced hypoxia studies (SpO2 levels typically varied down to ~70%). The number of measurements taken for each subject at various saturation levels would be substantial. Pediatric studies would involve a separate cohort.
   • Data Provenance: Prospective, controlled clinical study; likely performed in a clinical setting (e.g., hospital, specialized lab) where reference SpO2 can be accurately measured (e.g., using arterial blood gas analysis with a co-oximeter). Country of origin is often the manufacturing country or a location with appropriate facilities for such studies.

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

   • Not applicable for SpO2 and Pulse Rate accuracy. The "ground truth" for pulse oximetry is typically established through direct physiological measurements, not expert consensus.
   • For SpO2, the gold standard (ground truth) is typically arterial blood gas analysis using a co-oximeter. This is a direct laboratory measurement, not an expert visual assessment.
   • For Pulse Rate, the ground truth can be simultaneously recorded ECG or a direct arterial line measurement.

4. Adjudication method for the test set:

   • Not applicable for SpO2 and Pulse Rate accuracy. Adjudication is used when human interpretation is part of the ground truth establishment (e.g., reading medical images). Here, direct instrumental measurements provide the ground truth.

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 measurement device, not an AI-assisted diagnostic tool that interprets complex data for human readers. Therefore, an MRMC study is irrelevant.

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

   • Yes, this is a standalone performance study. Pulse oximeters are designed to provide direct measurements, so their performance is inherently evaluated in a standalone manner. The device outputs SpO2 and pulse rate, and these outputs are compared against a reference standard.

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

   • For SpO2: Co-oximetry of arterial blood samples.
   • For Pulse Rate: Electrocardiogram (ECG) or arterial line measurement.

8. The sample size for the training set:

   • This information would not be relevant for a traditional pulse oximeter like this (JPD-500F). Pulse oximeters rely on optical principles and signal processing algorithms that are typically developed based on physiological models and empirical calibration, not machine learning algorithms that require large "training sets" in the sense understood in AI/ML contexts. The "calibration" would be performed during device design and manufacturing using established standards.

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

   • As above, not applicable in the AI/ML sense. Calibration procedures involve ensuring the device's optical sensors and algorithms accurately convert light absorption measurements into SpO2 and pulse rate, typically checked against known physical standards and reference instruments during development and manufacturing.

To summarize, while the provided document confirms the FDA clearance for the device, it lacks the detailed performance study information. The questions regarding expert consensus, adjudication, MRMC studies, and AI-like "training sets" are generally not applicable to the analytical performance evaluation of a pulse oximeter, which relies on comparing device output against direct physiological reference measurements.

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