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The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.

The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.

The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The system is not intended for use on patients receiving intensive medical intervention/therapy.

The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.

Here's a breakdown of the acceptance criteria and study details for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the statement "all test results were within acceptance criteria" in various sections. The reported performance is the achievement of these criteria. The specific numerical targets for each criterion are not always explicitly stated (e.g., for precision, linearity, hematocrit, interference), but the document confirms that the device met these criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a medical device, a Blood Glucose Monitoring System, which does not utilize AI or involve human readers for image interpretation. Therefore, questions related to AI models, human reader improvement with AI assistance, expert adjudication for ground truth related to image analysis, or MRMC studies are not applicable to this device.

Here's the relevant information based on the provided text:

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

   • Clinical Accuracy (Capillary Blood): 414 patients.
     • Provenance: Clinical study conducted at 3 U.S. sites and 6 Taiwan sites. Data is prospective as it was collected during an active clinical study with patients.
   • Accuracy at Extremes: 100 samples (50 for <80 mg/dL, 50 for >300 mg/dL).
     • Provenance: "Blood samples were collected and allowed to glycolyze or were spiked with high concentration glucose solution". Implies a laboratory-controlled, prospective or specially prepared sample set.

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

   • Not Applicable in the traditional sense of 'experts' interpreting data. For blood glucose monitoring systems, the "ground truth" is established by a highly accurate reference method.
   • The ground truth for the clinical and extreme glucose value studies was the YSI Model 2300 Glucose Analyzer. This is a laboratory-based, well-established, and highly accurate reference method for glucose measurement, not human experts.

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

   • Not Applicable. As ground truth is established by an automated reference analyzer (YSI-2300), there is no human interpretation or adjudication process involved in setting the ground truth for glucose values.

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:

   • Not Applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. There are no human readers or AI assistance in the interpretation of results from this device in the same way as an imaging study.

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

   • Yes, in essence. Blood glucose meters are inherently "standalone" in their function of measuring glucose. The clinical study directly compares the device's numerical output (algorithm's result) to the YSI-2300 reference method without human interpretation of the device's output influencing the direct comparison. The "human-in-the-loop" for this device is the user taking and reading the measurement, but the performance evaluation is on the accuracy of the numerical reading itself, independent of user interpretation for the primary outcome.

6. The type of ground truth used:

   • Reference Method: The YSI Model 2300 Glucose Analyzer, a laboratory-based, highly accurate method for quantitative glucose determination. Comparisons are quantitative.

7. The sample size for the training set:

   • Not directly applicable/not explicitly stated in terms of an "AI training set." This device is a traditional electrochemical biosensor, not an AI/machine learning model that undergoes a distinct "training" phase with a large dataset in the way a deep learning algorithm would. The development and calibration of such a device involve extensive laboratory testing and optimization, which could be considered an analogous "training" or development process for its internal algorithms, but it's not described as a separate, quantifiable "training set" with ground truth in the context of AI regulatory submissions.

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

   • Not applicable in the AI context. For this type of device, ground truth for development/calibration (analogous to "training") would be established through a combination of:
     • Highly controlled laboratory experiments using reference solutions of known glucose concentrations.
     • Comparisons to established reference methods (like YSI-2300) with well-characterized samples.
     • Controlled studies to characterize and mitigate interferences (e.g., hematocrit, medications).

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The FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.

The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).

Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).

The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).

The provided text describes the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System, a device for measuring glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood. It is a 510(k) summary, therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study for a novel device.

Based on the provided information, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

Key Takeaway: The document primarily focuses on non-clinical and clinical "studies" to demonstrate performance characteristics and compare them to predicate devices, rather than a single, large-scale comparative effectiveness study with human readers (MRMC). The "acceptance criteria" are implied by the performance characteristics tested and similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a table within the provided text. Instead, the document discusses "performance criteria were met" and that the device "met design specifications and requirements." The "acceptance criteria" are implied by meeting the established ranges and performance levels comparable to the predicate devices.

However, the "performance" is reported through the summary of testing. Since this is a 510(k) submission, the primary "performance" shown is that the device is substantially equivalent to the predicate devices. The listed similarities and differences in characteristics serve as the de facto "reported device performance."

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the sample sizes for the "non-clinical" or "clinical" studies. It only states that "Non-clinical and clinical studies were conducted to test, verify and validate the performance."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter's address (TaiDoc Technology Corporation, New Taipei City, Taiwan), it's highly probable the studies were conducted in Taiwan or involved participants from that region. The studies are described as "verification and validation testing" and "user evaluation," which suggests prospective data collection for the purpose of regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the summary. Since the device is a direct measurement system (glucose, ketone, cholesterol) and relies on chemical reactions rather than interpretation of medical images or complex diagnostic algorithms, the "ground truth" would typically be established by laboratory reference methods, not by expert consensus of clinicians/radiologists.
• Therefore, the concept of "experts" in the context of establishing ground truth for this type of device (an in-vitro diagnostic) would refer to the use of highly accurate laboratory equipment and trained laboratory personnel following established protocols, rather than medical specialists.

4. Adjudication Method (for test set)

• This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (often radiologists) interpret medical images and their interpretations need to be reconciled to establish ground truth or compare to AI performance. For an in-vitro diagnostic device that measures chemical concentrations, the ground truth comes from laboratory reference methods, not subjective human interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done (or at least not described in this summary). This type of study is relevant for imaging AI devices where the effect of AI assistance on human reader performance is evaluated.
• This device is an in-vitro diagnostic for direct chemical measurement, not an imaging AI. Therefore, an MRMC study is not relevant for demonstrating its performance or substantial equivalence.

6. Standalone (Algorithm Only) Performance

• No, not specified as a separate study type in the context of imaging AI.
• However, the "Non-Clinical Testing Summary" mentions "functional performance tests (precision, linearity, interference, flex studies)." These are essentially "standalone" performance evaluations of the device's accuracy and robustness under various conditions, independent of a human user's direct interpretive "performance" in the way an AI algorithm's standalone performance might be assessed. The "clinical testing" included a "user evaluation" to confirm accuracy and ease of use in a real-world scenario.

7. Type of Ground Truth Used

The ground truth used for this device would be laboratory reference methods.

• The test principle explicitly states that the device is "calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods."
• The non-clinical testing included "precision, linearity, interference, flex studies," all of which require comparison to a highly accurate reference method to establish the true concentration of the analytes (glucose, β-ketone, cholesterol).
• For the β-ketone and cholesterol measurements, the process involves enzymatic reactions that are proportional to the amount of the substance in the sample, which implies quantitative comparison to a known concentration.

8. Sample Size for the Training Set

• This information is not applicable and not provided. This device is a traditional in-vitro diagnostic, not a machine learning or AI-based device that would require a "training set" in the sense of AI model development. Its calibration and function are based on electrochemical biosensor technology and established chemical principles.

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

• This is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device's operational parameters would be established through calibration against known standards and validation against reference laboratory methods during its development and manufacturing process.

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The Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241) is an infrared thermometer intended for the non-contact measurement of human body temperature in people of all ages and may be used by medical professionals or by consumers in a home environment.

The Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241) is a handheld, battery powered, infrared forehead thermometer with a non-contact body temperature measuring function. It detects infrared energy emitted from forehead within 1.2 - 5 cm and converts to a body temperature. This device can be used on people of all ages by medical professionals and consumers in a home environment. The final measured temperature will be displayed on the LCD screen of the device. The users can transmit temperature results from the Clever Forehead Thermometer/Clever Medical Forehead Thermometer to Healthy Check on their mobile devices and Health care management system on pc via Bluetooth. The Healthy check and Health care management system provide an overview of users record with historical data and trend graph.

The provided text describes the regulatory submission for the Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241). It includes information about non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for the device are related to its accuracy, as defined by ASTM E1965-98 (2016). The reported performance indicates compliance with this standard.

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

• Sample Size for Clinical Accuracy Test Set: 250 subjects.
• Data Provenance: The text does not explicitly state the country of origin. It does state that the study was "clinical accuracy testing," implying a prospective study where data was collected directly for the purpose of the study.

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

The text states that the clinical accuracy testing compared the Clever Forehead Thermometer/Clever Medical Forehead Thermometer with a "comparator method (WelchAllyn SureTemp PLUS model 690 Thermometer)." This implies that the ground truth was established by a reference device, rather than human experts. Therefore, the concept of "number of experts" or their qualifications is not applicable in this context.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically used when human experts are disagreeing on a diagnosis or measurement, and a process is needed to resolve those disagreements to establish ground truth. Since the clinical accuracy study used a comparator device as the ground truth, an adjudication method is not described or applicable in this context.

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

No, an MRMC comparative effectiveness study was not reported. The study focused on the accuracy of the device itself against a comparator device, not on how human readers' performance improves with or without AI assistance.

6. Standalone Performance Done

Yes, a standalone performance study was done for the algorithm (the device itself). The "Clinical accuracy testing" directly evaluated the performance of the Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241) against a comparator method (WelchAllyn SureTemp PLUS model 690 Thermometer) without human-in-the-loop assistance for interpretation.

7. Type of Ground Truth Used

The ground truth used for the clinical accuracy study was established by a comparator device, specifically the "WelchAllyn SureTemp PLUS model 690 Thermometer." This is a form of reference standard.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This type of device (an infrared thermometer) typically relies on physical principles and calibration, not a machine learning model that requires a "training set" in the conventional sense of AI/ML. The "software and cybersecurity" section mentions "software life cycle processes" and "software verification and validation," implying traditional software development rather than AI/ML training.

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

As there is no mention of a training set for an AI/ML model, the establishment of ground truth for a training set is not applicable based on the provided text. The device's calibration and accuracy are validated against physical standards and a comparator device.

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The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips.

The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The TD-4183 system kit includes the TD-4183 Blood Glucose meter with blood glucose measuring function and the TD-4183 Blood Glucose test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control.

The provided document is a 510(k) summary for the TaiDoc TD-4183 Blood Glucose Monitoring System. It describes the device, its intended use, and a comparison to a predicate device (TD-4277 Blood Glucose Monitoring System). It also briefly mentions non-clinical and clinical studies conducted to support the substantial equivalence claim.

However, the document does not contain the detailed acceptance criteria and the results of a study that proves the device meets those criteria in the format requested. Specifically:

• No detailed table of acceptance criteria and reported device performance is provided. It only states that "all performance criteria were met."
• No specific sample sizes for the test set or training set are given for any of the studies (non-clinical or clinical).
• No information on data provenance (country of origin, retrospective/prospective) is provided.
• No details are available regarding expert involvement (number of experts, qualifications) for ground truth establishment or adjudication methods.
• No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, as this is a blood glucose monitoring system, not an imaging AI device where such studies are common.
• No mention of a standalone algorithm-only performance study for the same reason.
• No specific type of ground truth used is detailed, though for a blood glucose monitor, it would typically involve laboratory reference methods.
• No information on how ground truth for the training set was established (as sensor calibration and performance is generally based on known glucose concentrations from laboratory standards).

The document is primarily a regulatory submission summary, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical report of the studies performed.

Therefore, based on the provided text, I cannot complete the requested information in the specified format. The available information is too high-level for the detailed breakdown required by the prompt regarding acceptance criteria and study particulars.

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The FORA P100 Blood Pressure Monitoring System is intended to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. Do not use this system on babies, young children or persons who cannot express their consent.

FORA P100 Blood Pressure Monitoring System (Model: P100) can be operated by the device itself to assist in blood pressure testing, recording, tracking and monitoring in easy.

The TD-3130 in report is an internal model and FORA P100 is the marketing name for this system.

The FORA P100 Blood Pressure Monitoring System was validated by tests conducted according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the specific tests in the performance characteristics section, nor does it detail the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the device was validated by specific international standards.

3. Number of Experts and Qualifications:
The document does not provide information about the number of experts used to establish a ground truth or their qualifications. The validation relies on adherence to established international standards for medical devices, which typically involve standardized testing protocols rather than expert consensus on individual readings for ground truth in the context of blood pressure monitoring devices.

4. Adjudication Method:
The document does not mention an adjudication method for a test set. This type of method is usually associated with studies involving human interpretation (e.g., radiology images) rather than the direct measurement and algorithmic calculation performed by a blood pressure monitor.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The device's validation is based on its performance against recognized industry standards for accuracy and safety, rather than comparing human readers with and without AI assistance.

6. Standalone Performance:
The performance characteristics described (validation against IEC 80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009) implicitly refer to the standalone performance of the FORA P100 Blood Pressure Monitoring System, as these standards assess the accuracy and functionality of the device itself. The device uses an oscillometric method to determine blood pressure and pulse rate.

7. Type of Ground Truth Used:
For blood pressure monitors, the "ground truth" for accuracy studies (such as those conforming to ANSI/AAMI/ISO 81060-2) typically involves direct comparison with a reference method, often auscultation by trained observers using a mercury sphygmomanometer or another validated reference device, under strictly controlled conditions. The document states validation was done "according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009," which implies this type of ground truth was used for accuracy assessment.

8. Sample Size for the Training Set:
The document does not explicitly mention a training set or its sample size. This information is typically relevant for machine learning models, and while the device uses a "software algorithm," the document doesn't provide details on an explicit training phase for that algorithm within the context of the submission. The algorithm for blood pressure measurement based on the oscillometric method is well-established.

9. How Ground Truth for the Training Set Was Established:
Since no explicit training set is mentioned in the document, there is no information on how its ground truth might have been established.

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The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

This document outlines the acceptance criteria and the studies conducted to prove that the FORA NAS100 Electronic Nasal Aspirator meets these criteria.

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for each test listed (e.g., number of devices tested for IEC standards, number of animals for biocompatibility tests). The tests are based on established international standards (IEC, ISO), which typically outline the methodologies and sample size considerations for compliance. The document implies that sufficient samples were used to meet the requirements of these standards.

Data provenance (e.g., country of origin, retrospective/prospective) is not specified for the performance studies described in the document.

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

This information is not provided in the document. The performance tests described (e.g., IEC electrical safety, EMC, ISO biocompatibility) rely on standardized testing protocols and objective measurements rather than expert consensus on medical image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since the tests described are primarily objective engineering and biological safety evaluations according to international standards, an adjudication method for a test set in this context is not applicable and therefore not mentioned.

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

No MRMC comparative effectiveness study was mentioned or performed as this device is an electronic nasal aspirator, not an AI-assisted diagnostic device where human reader performance would be a relevant metric.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. The device is a physical electronic nasal aspirator, not an algorithm or AI system for which a standalone performance study would be relevant.

7. Type of Ground Truth Used

The "ground truth" for the tests performed is based on adherence to the defined limits and criteria set by international safety, performance, and biocompatibility standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 14971, ISO 10993 series). This includes:

• Objective measurements and observations: For electrical safety (e.g., temperature, current leakage, noise levels, electromagnetic compatibility), physical construction, and operational performance.
• Biological responses: For biocompatibility tests (e.g., cell viability in cytotoxicity, skin reactions in sensitization and irritation tests).
• Risk assessment: Evaluation against defined risk criteria in the risk management report.

8. The Sample Size for the Training Set

This information is not applicable. The FORA NAS100 Electronic Nasal Aspirator is a hardware medical device, and the evaluation described involves traditional engineering and biological safety testing, not machine learning model training.

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

This information is not applicable for the same reasons as #8.

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Prescription home use: The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions.

The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional.

Point-of-care use: The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only.

This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout

FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.

The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria. It is a 510(k) summary for the FORA MD6 Uric Acid Monitoring System and FORA MD6 Pro Uric Acid Monitoring System, which states that performance studies were conducted, but it does not specify the acceptance criteria or report the detailed performance metrics from those studies.

Therefore, I cannot provide the requested information based on the given input. The document generally states that the studies "demonstrated that the intended users can obtain uric acid results that are substantially equivalent to the current methods for uric acid measurements," but it lacks specific quantitative acceptance criteria and detailed performance data.

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The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component.

The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

The POPS!® one Blood Glucose Monitoring System is designed to make blood glucose testing and diabetes management easier and more convenient. The traditional test kit is replaced by a low-profile meter that contains everything needed for testing and requires no assembly. The meter pairs with a mobile app installed on the user's phone via Bluetooth, allowing the meter to perform glucose testing and send the results to the app where they are communicated to the user and automatically stored.

The POPS!® one Blood Glucose Monitoring System contains the following:

• . POPS!® one blood glucose meter works directly with the POPS!® app installed on the user's mobile phone. The meter performs a blood glucose test and sends the result to the POPS!" app.
• . POPS!® one blood glucose sensor module is individually packed and sterile. It contains 3 test sites with separate foil covers; each containing a lancet and test strip. The user inserts the sensor module in the meter and replaces a used sensor module with a new once all 3 test sites have been used. The sensor module not only provides all components for performing a glucose test to the user in a convenient, self-contained format but it also provides a new lancet for each test; preventing lancet re-use.
• . POPS!® mobile application acts as the primary interface with users; enabling them to test, communicating blood glucose results and messages, and allowing them to monitor trends on their phone.

The document describes the POPS!® one Blood Glucose Monitoring System and its substantial equivalence to a predicate device (TD-4277 Blood Glucose Monitoring System).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the POPS!® one Blood Glucose Monitoring System met all performance criteria as assessed by non-clinical and clinical studies. However, specific acceptance criteria values (e.g., accuracy percentages for various glucose ranges as per ISO 15197 or FDA guidance) are NOT explicitly listed in the provided text. The document generally refers to "performance criteria" being met, implying compliance with the FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.

Without the specific numerical acceptance criteria from that guidance, a table comparing them to reported device performance cannot be fully constructed from the provided text. The document only mentions that the system accuracy was "confirmed."

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

The document mentions "Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling." However, the specific sample size used for the test set (number of participants, number of samples) and the data provenance (e.g., country of origin, retrospective or prospective) are NOT provided in the text.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

The document describes a blood glucose monitoring system, which typically involves a single user taking a measurement and is not generally subject to MRMC studies designed for image interpretation or diagnosis by multiple readers. Therefore, an MRMC comparative effectiveness study was not done in the context of this device's evaluation as described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The device is a "Blood Glucose Monitoring System" intended for "Self-Monitoring." Its core function is the quantitative measurement of glucose from a blood sample using a meter and sensor module, with results displayed via a mobile app. This inherently involves human interaction (blood sampling, operating the device). Therefore, a purely "standalone" algorithm-only study, without human interaction, is not applicable or described for this type of medical device. The "system accuracy" would be evaluated with human users.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation (e.g., reference lab method, YSI analyzer). For blood glucose monitoring systems, ground truth is typically established by comparing device readings to a highly accurate laboratory reference method.

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This type of information is typically relevant for AI/ML-driven devices that learn from data, and while the device uses software (for display and storage), it's not described as having a learning algorithm in the context of its glucose measurement. The "non-clinical testing" likely involved engineering and analytical validation with simulated or controlled samples, but not a "training set" in the machine learning sense.

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

As no training set is described, this information is not applicable or provided.

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TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.

TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.

The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Laboratory Accuracy Test (A1.8): A sample size of 80 measurements was used.
• Clinical Test (A1.16): The document mentions "non-febrile and febrile group of subjects, infants (6 months and above), children, adults and elderly," but does not specify the exact sample size for the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that TaiDoc Technology Corporation is based in Taiwan, it is likely the studies were conducted there. The nature of the performance tests (laboratory, mechanical, storage, operating environment) suggests prospective testing. The clinical trial would also typically be prospective.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth, particularly for the clinical study. For temperature measurement, ground truth for clinical accuracy studies typically involves highly accurate reference thermometers or direct measurement of core body temperature by qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method.

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 medical device (thermometer), not an AI-assisted diagnostic tool that involves human "readers" interpreting cases.

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

This is a physical thermometer. The performance tests (A1.1 - A1.16) evaluate the device's inherent capabilities, which can be considered "standalone" as they assess the device's readings against established standards or reference measurements. There isn't an "algorithm only" in the sense of software interpreting medical images, but rather the device's internal processing of temperature signals.

7. The Type of Ground Truth Used

• Laboratory Accuracy Tests (A1.5, A1.6, A1.8, A1.9, A1.11): The acceptance criteria refer to "calculated error δ" against a known or reference temperature. This implies comparison against calibrated reference standards/devices in controlled laboratory environments.
• Clinical Test (A1.16): The clinical accuracy is verified "by comparing its output with that of a reference device, which has a specified uncertainty for measuring true temperature." This strongly suggests the use of a highly accurate reference thermometer or method to establish the "true" body temperature for comparison.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" as this is not an AI/machine learning device that typically involves distinct training data. The device's performance is based on its engineering design and calibration, not a learned model from a dataset.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.

The document describes the ActiveCare TD-4121 Blood Glucose Monitoring System, an over-the-counter device intended for quantitative measurement of glucose in fresh capillary whole blood from the finger. It is used by people with diabetes mellitus at home to monitor their diabetes control program but is not for diagnosis or screening of diabetes, nor for use on neonates.

The device's acceptance criteria are based on its performance compared to a predicate device (TD-4277 Blood Glucose Monitoring System) and its conformance to established accuracy standards for blood glucose meters.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly references ISO 15197 for accuracy standards, as is common for blood glucose monitoring systems. Although a specific table of acceptance criteria with numerical targets is not explicitly provided in the excerpt, the typical acceptance criteria for accuracy of blood glucose meters, as per ISO 15197:2013, are:

The document states under "Similarities" that the "Accuracy" of the ActiveCare TD-4121 Blood Glucose Monitoring System is similar to the predicate device (TD-4277 Blood Glucose Monitoring System). This implies that the device met the accuracy standards expected for the predicate, which would have been established during its 510(k) clearance (K100322). The "Conclusion" also states that the ActiveCare TD-4121 and TD-4277 systems are "substantially equivalent" based on the information provided, which includes meeting performance criteria.

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

• Sample Size: Not explicitly stated. The document refers to "clinical and non-clinical studies" but does not give specific numbers of participants or samples.
• Data Provenance: Not explicitly stated. However, the submitter is TaiDoc Technology Corporation, based in New Taipei City, Taiwan. It is reasonable to infer that the studies were conducted in Taiwan or by the manufacturer. The document does not specify if the studies were retrospective or prospective.

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

• Number of Experts: Not applicable. For blood glucose monitoring systems, ground truth is typically established by comparing device results to a highly accurate laboratory reference method, not by expert consensus on interpretations.
• Qualifications of Experts: Not applicable in the traditional sense of clinical experts.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used when there's subjective interpretation by human readers (e.g., in diagnostic imaging). For quantitative measurements like blood glucose, the "ground truth" is determined by a reference device.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not relevant for a standalone blood glucose monitoring system, which does not involve human interpretation or AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance study was implicitly done. The "clinical and non-clinical studies" mentioned involved comparing the device's measurements directly against a reference laboratory method (YSI-2300 Glucose Analyzer). This represents the performance of the device (meter and strip) as a standalone system, as it provides a quantitative measurement without human intervention for result interpretation beyond reading the display.

7. Type of Ground Truth Used:

• Laboratory Reference Method: The ground truth was established using the YSI-2300 Glucose Analyzer. The document explicitly states: "This system is compared to the YSI-2300 Glucose Analyzer in the clinical and non-clinical studies."

8. Sample Size for the Training Set:

• Not explicitly stated. The document describes a 510(k) submission for a device, not an AI/ML model, so the concept of a "training set" for an algorithm in the machine learning sense is not directly applicable here. The device's calibration and development would have involved internal testing and validation, but these are not typically referred to as "training sets" in the context of conventional medical devices.

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

• Not applicable in the machine learning "training set" sense. For the device itself, the accuracy and calibration would have been established against a reference method. The document mentions that "The YSI is calibrated with NIST (SRM) 917A reference material." This indicates that the primary reference method (YSI-2300) used for evaluating the device's accuracy is traceable to a recognized national standard, ensuring the reliability of the ground truth.

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