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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 Thermometer is a non- invasive and re-usable electronic device for home use. The thermometer is intended for nonurgent ambulatory continuous left chest body temperature monitoring from ages 29 days and older.

Wireless Intelligent Thermometer

This document is a 510(k) clearance letter for the Jumper Wireless Intelligent Thermometer (K182437). It doesn't contain a detailed description of the acceptance criteria or the specific study that proves the device meets those criteria.

However, based on the nature of the device (a clinical electronic thermometer) and standard regulatory practices for such devices, we can infer the likely type of acceptance criteria and study that would have been performed.

Inferred Acceptance Criteria and Study Information (Based on common practices for clinical thermometers):

1. Table of Acceptance Criteria and Reported Device Performance

Study Description (Inferred for a Clinical Electronic Thermometer):

The study alluded to in a 510(k) submission for a thermometer would typically be a performance validation study, often comparing the new device against a legally marketed predicate device or a highly accurate reference standard.

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

• Sample Size for Test Set: For a clinical thermometer, the "test set" would typically refer to the number of subjects (persons) on whom the thermometer was tested and/or the number of temperature measurements taken.
  • Inferred: Likely involves a statistically significant number of subjects (e.g., several dozens to hundreds, possibly across different age groups if applicable, as the device is for "ages 29 days and older"). The sample size would be determined to ensure sufficient statistical power to detect equivalence or non-inferiority to the predicate device or a reference standard based on the accuracy criteria.
• Data Provenance:
  • Inferred: Most likely prospective clinical testing conducted in a controlled environment (e.g., a clinic or lab) or in a relevant home-use setting simulating real-world conditions. The country of origin for such testing would typically be where the manufacturer is based or a region where clinical trials can be efficiently and ethically conducted (e.g., China, or possibly a country with regulatory alignment).

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

• Inferred: For a thermometer, "ground truth" for temperature is typically established by highly accurate, calibrated reference thermometers or established clinical methods. It would not typically involve "experts" in the sense of clinicians interpreting images or diagnoses.
  • "Experts" (Metrology Technicians/Clinicians): The "experts" would be the skilled technicians or clinical staff responsible for operating the reference thermometer, performing the measurements correctly, ensuring calibration, and recording data accurately. Their qualifications would involve training in metrology and clinical measurement techniques.

4. Adjudication Method for the Test Set

• Inferred: Adjudication methods like "2+1" or "3+1" are primarily for subjective assessments (e.g., image interpretation). For objective measurements like temperature, there is no "adjudication" of the ground truth itself in that sense.
  • Method: Instead, the method would involve direct comparison of the device's readings against a highly accurate, calibrated reference thermometer or against the predicate device's readings. Statistical methods (e.g., Bland-Altman analysis, regression analysis) would be used to compare agreement and bias.

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

• Inferred: No, an MRMC study is highly unlikely for a clinical electronic thermometer. MRMC studies are specific to diagnostic devices where multiple human readers interpret medical images or data. Temperature measurement is an objective, automated process once the device is in place.

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

• Inferred: Yes, the fundamental performance testing of a thermometer (its accuracy, precision, response time) is inherently a standalone assessment of the device's measurement capabilities. While human interaction is needed to place the thermometer, the temperature reading itself is generated by the device's sensors and algorithms. The device's performance would be evaluated purely on its ability to accurately and consistently measure temperature. "Human-in-the-loop" would primarily refer to usability aspects, not the core measurement function's accuracy.

7. The Type of Ground Truth Used

• Inferred: The ground truth for temperature measurement is typically established using:
  • Reference Standard Instruments: Highly accurate, calibrated thermometers (e.g., mercury-in-glass thermometers traceable to national standards, or precise electronic reference thermometers).
  • Established Clinical Methods: Simultaneous measurement using the device under test and a cleared/approved clinical thermometer on the same subject or body site.

8. The Sample Size for the Training Set

• Inferred: For a device like a thermometer, there isn't typically a "training set" in the sense of machine learning algorithms that learn from labeled data. The thermometer's underlying measurement principle is based on physics and calibrated sensors, not a trained AI model.
• If there are any digital signal processing or adaptive algorithms (e.g., for noise reduction or artifact rejection) that might be considered "AI," these would likely be developed and validated internally using lab data, simulations, and possibly limited human data, but not a formally defined "training set" as seen in diagnostic AI.
• Most Likely: No distinct "training set" for the core temperature measurement function.

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

• Inferred: Since there's unlikely a formal "training set" in the AI/ML sense:
  • Any internal development or calibration of sensor parameters or basic signal processing would rely on physical models, laboratory measurements with highly accurate reference instruments, and engineering specifications.
  • If any adaptive algorithms exist, the "ground truth" for their development would similarly come from controlled experiments using reference measurements.

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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. ±0.3°C (±0.5°F) from 32.0°C-35.9°C/89.6°F-96.7°F
3. ±0.3°C (±0.5°F) for 39.1°C-42.2°C/102.3°F-108.0°F
   (Comment in table: "For the forehead temperature mode: same as Predicate Device 2. For the ear canal temperature mode: same as Predicate Device 1.") |
   | Measurement Range | Predicate 1 (Ear): 32-43°C; Predicate 2 (Forehead): 32.2-43.3°C | Forehead: 0.0°C-100.0°C; Ear: 0.0°C-100.0°C
   (Note 02: "The subject devices' measuring range is larger than that of both predicate device 1 and predicate device 2. Due to the subject devices also apply to measuring the environmental temperature, so their measuring range is larger.") |
   | Display Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F |
   | Measurement Mode | Predicate 1: Ear; Predicate 2: Forehead | Ear and Forehead measurement mode (Matches both predicates) |
   | Auto Power-off | Yes | Yes |
   | °C/°F Switchable | Yes | Yes |
   | Working Ambient Temp. | Predicate 1: 10-40°C; Predicate 2: 10-40°C | 10°C-40°C |
   | Electrical Safety | AAMI ANSI ES60601-1:2005/(R)2012+A1:2012; IEC 60601-1:1988+A1:1991+A2:1995 | Compliance stated. |
   | EMC | IEC 60601-1-2: 2014 / 2007; ETSI EN 301 489-1; ETSI EN 301 489-17 | Compliance stated, including specific tests for Bluetooth functionality (JPD-FR400). |
   | Home Healthcare Env. | IEC 60601-1-11:2015 / 2010 | Compliance stated. |
   | Risk Management | ISO 14971:2007 | Compliance stated. |
   | Biocompatibility | ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010 | Compliance stated. |
   | Clinical Performance | ASTM E 1965-98 (Reapproved 2009) requirements | "The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009)." |
   | Waterproof | Predicate 1/2: No | IP22 (Different from predicates, but indicates better performance/feature and passed IEC60601-1 and IEC60601-1-11 test.) |
   | Bluetooth Function | Predicate 1/2: No | JPD-FR400: Yes (Passed FCC, EN301489-1, EN301489-17, EN 300328, wireless coexistence test.) JPD-FR402: No. |

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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The JPD-500A Fingertip Pulse Oximeter is non-invasive device intended for spot-checking 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).

The JPD-500A fingertip pulse oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital.

The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, very easy to use it.

Principle of the fingertip pulse oximeter as follows:

A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.

Operation principle of the instrument:

Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Study for JPD-500A Fingertip Pulse Oximeter

This document describes the JPD-500A Fingertip Pulse Oximeter, a non-invasive device intended for spot-checking functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult and pediatric patients in home and hospital environments.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SpO2 accuracy are implicitly derived from the comparison to the predicate device and the standard ISO 80601-2-61. For pulse rate accuracy, it is directly stated.

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

• Test Set Sample Size: 10 healthy, non-smoking, light-to-dark-skinned subjects were used for the clinical hypoxia accuracy testing. An additional 5 subjects were enrolled but excluded, bringing the initial enrollment to 15 subjects.
• Data Provenance: The study was conducted in an independent research laboratory, implying prospective data collection specifically for this device's validation. The country of origin of the data is not explicitly stated, but the device manufacturer is Shenzhen Jumper Medical Equipment Co., Ltd. in China.

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

The ground truth was established by a CO-oximeter, not by human experts.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was derived from instrumental measurement (CO-oximeter) rather than expert review requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a standalone medical instrument (pulse oximeter) and does not involve AI or human reader interpretation for its primary function.

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

Yes, a standalone study was performed. The device's performance was compared directly to a CO-oximeter (the gold standard) in a controlled desaturation study. This assesses the algorithm/device's accuracy independently.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy was the arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. This is an objective, instrumental measurement.

8. The Sample Size for the Training Set

The document does not mention a training set, as this is a medical device (pulse oximeter) validated through clinical accuracy studies against a gold standard, not a machine learning algorithm that requires a separate training set.

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

Not applicable, as no training set is mentioned or implied for this type of device validation.

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The Fetal Doppler JPD-100B is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

JPD-100B Fetal Doppler is device prescribed by a licensed physician for use in hospitals and the homecare environment. It is a hand-held, battery powered audio Doppler device integrated with 2.5 MHz probe, used for detecting fetal heart beats. And the device is for prescription use and is intended for use at or after 12 weeks gestation.

The provided text is a 510(k) summary for the Shenzhen Jumper Medical Equipment Co., Ltd. Fetal Doppler JPD-100B. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria through clinical testing. Instead, it demonstrates substantial equivalence to a predicate device (MD800 Fetal Doppler, K112911) by comparing technological characteristics and adherence to relevant standards.

Here's an analysis of the information that is and is not present, based on your requested categories:

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance criteria and results from a clinical study for the JPD-100B. It states that the device "can detect the Fetal Heart Rate" and "can display values of fetal heart rate" but doesn't provide numerical targets or achievement of these targets.

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

This information is not provided. The document explicitly states "Brief discussion of clinical tests: Not applicable." This indicates that a clinical test set, in the traditional sense, was not used for this 510(k) submission. The equivalence is based on non-clinical tests (standards adherence) and comparison of technical specifications to the predicate.

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)

This information is not provided as there was no clinical test set mentioned.

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

This information is not provided as there was no clinical test set mentioned.

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

This information is not applicable/provided. The device is a Fetal Doppler, a diagnostic instrument for detecting fetal heartbeats, not an AI-assisted diagnostic tool that would involve "human readers" in the context of image interpretation or complex analysis.

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

This information is not explicitly provided in terms of formal standalone performance study results. The device itself is a standalone instrument (a Fetal Doppler) that provides direct output (audio and displayed FHR values). However, a formal "standalone" performance study demonstrating accuracy against a ground truth (e.g., comparing FHR readings to a gold standard over a large sample) is not detailed. The non-clinical tests listed focus on electrical safety, EMC, and biological compatibility with standards like IEC 61266, which covers performance requirements and methods of measurement and reporting for hand-held probe Doppler fetal heartbeat detectors. This standard would indirectly address the device's functional performance in a standalone capacity.

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

This information is not explicitly provided as no clinical study or specific test set with a ground truth is described. For non-clinical tests, the "ground truth" would be the specifications and performance requirements outlined in the referenced standards (e.g., IEC 61266 for performance).

8. The sample size for the training set

This information is not applicable/provided as the device is a hardware Fetal Doppler and does not involve AI/machine learning models that require a training set.

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

This information is not applicable/provided as the device does not involve AI/machine learning models and thus no training set.

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Non-conact Infrared Themometer, model JPD-FR 100, can measure for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicated device KI-8280, use the same detection principle to measure the patient's temperature.

The subject device also use the focusing design to collect the infrared emitted from nearby area of patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature.

The compact, small and light-weight design, the Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.

The medical device in question is a Non-contact Infrared Thermometer, Model JPD-FR100.

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

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion mentioned is compliance with the ASTM E1965-98 (2009) standard for infrared thermometers.

Further details about the specific accuracy requirements within ASTM E1965 for different temperature ranges, as well as repeatability and other performance metrics, are not explicitly detailed in the provided summary. However, the study "complied with the requirements of ASTM E1965."

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

• Sample Size: The document does not explicitly state the sample size used for the clinical test set. It mentions "the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). ASTM E1965 specifies clinical testing, implying prospective data collection on human subjects, but the location is not provided.

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

Not applicable. For a thermometer, the "ground truth" for temperature measurement is typically established using a reference thermometer or a controlled environment, not through expert human interpretation. The ASTM E1965 standard defines the methodology for this.

4. Adjudication Method for the Test Set

Not applicable. Temperature measurement through a device like a thermometer does not involve human adjudication in the way medical image analysis or diagnostic studies do. The ground truth is a direct measurement.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. For a thermometer, the device provides a direct measurement, and human interpretation is not the primary factor of interest in its performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature." This indicates that the device's accuracy was assessed independently against the ASTM standard.

7. Type of Ground Truth Used

The ground truth used for the clinical performance test would be simultaneous measurements from a calibrated reference thermometer as per the methodology defined in ASTM E1965. The standard dictates how to compare the device's readings to highly accurate ground truth measurements.

8. Sample Size for the Training Set

Not applicable. The device is a non-contact infrared thermometer, which is a sensor-based measurement device. It does not employ machine learning or AI models that would require a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection.

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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The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

JPD-100S Fetal Doppler is a prescription from licensed physician in hospitals, clinics and private offices. It is a hand-held, battery powered audio Doppler device integrated with 3MHz probe, used for detecting fetal heart beats. And the device is normally applied to pregnancy for more than twelve weeks.

The provided document describes the acceptance criteria and a study for the Fetal Doppler JPD-100S. However, the study conducted is primarily for substantive equivalence to a predicate device, focusing on electrical safety, EMC, and biological compatibility, rather than a clinical performance study with defined performance metrics like sensitivity or specificity.

Here's an analysis based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for detecting fetal heartbeats). Instead, the "acceptance criteria" are implied by the standards the device was tested against and found compliant.

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

This information is not provided in the document. The "Test Conclusion" section mentions "Laboratory testing" but does not detail a clinical test set, sample size of patients, or data provenance. The assessment focuses on hardware compliance with standards.

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

This information is not provided. As no clinical test set for detecting fetal heartbeats is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as a clinical test set is not described.

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

No, an MRMC comparative effectiveness study was not done. The study described is a submission for substantial equivalence based on technical specifications and compliance with standards, not a clinical trial comparing human readers with and without AI assistance, or comparing this device to others clinically.

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

The device is a "hand-held, battery powered audio Doppler device used for detecting fetal heart beats." This implies human-in-the-loop operation, and the documentation does not describe an "algorithm only" standalone performance evaluation. The "detection" is performed by the device, and the output (audio) is interpreted by a human user. The study focuses on the device's technical specifications and safety, not its standalone diagnostic accuracy as an autonomous algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/clinical performance studies (e.g., pathology, outcomes data) is not applicable to the data presented. The "ground truth" for the tests performed was compliance with engineering and safety standards (e.g., electrical safety tests, EMC tests, acoustic output measurements, biocompatibility tests). For the function of detecting fetal heartbeats, the "performance requirements" of IEC 61266 (1994) would define what constitutes "detection," but the document doesn't detail how this was clinically verified beyond stating compliance with the standard.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set," as the device described is a hardware medical device (fetal Doppler) and not an AI/machine learning algorithm requiring a training phase for its core function.

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

This information is not provided and is not applicable as there is no mention of a training set for an AI/ML algorithm.

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