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Vivatmo pro-S nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Vivatmo pro-S is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older.

Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.

The Vivatmo pro-S system is a automated, non-invasive (in-vitro diagnostic) medical device for professional environment for the quantitative measurement of FeNO (fractional exhaled Nitric Oxide) in human breath.

Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as asthma.

FeNO is recommended by the American Thoracic Society (ATS) in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to airway inflammation [ATS, 2011].

The Vivatmo pro-S device consists of the following main elements:

• Vivatmo pro-S handheld which holds the measuring module with electronics, display and a battery including software to drive the handheld.
• Vivatmo pro Oxycap/Vivatmo me Oxycap, which is a disposable mouthpiece to prepare the exhaled air for the measurement
• Vivatmo pro Level 0, a disposable mouthpiece to facilitate a measurement with 0 ppb FeNO for QC purpose (optional)

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The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The VIVACE is intended for single user and multiple users in home and healthcare environments.

The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home or health care and by a single user and multiple users. VIVACE is both AC- powered battery-powered. The AC adapter uses a 100-240 VAC, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.

I am sorry, but the provided text is a 510(k) summary for a powered breast pump (VIVACE) and does not contain the specific information requested about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML or diagnostic performance.

The document focuses on:

• Regulatory clearance (510(k) for a medical device).
• Comparison to a predicate device (OPERA) for substantial equivalence.
• Non-clinical performance testing: Biocompatibility, electrical safety, electromagnetic compatibility, software evaluation, and general performance tests (vacuum level, backflow protection, use life, battery performance, multi-user cross-contamination).

It does not include:

• A table of acceptance criteria and reported device performance for a diagnostic or AI-driven system.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for AI/ML performance.
• Information about expert adjudication, MRMC studies, standalone AI performance, or training set details.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The ducose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions meeting "FDA SMBG OTC Guidance and industry standards" for clinical performance. A specific detailed table of acceptance criteria and reported performance is not explicitly provided in the excerpt. However, based on the context of Blood Glucose Monitoring Systems, the primary acceptance criteria would relate to the accuracy of glucose readings compared to a reference method. The document states that the clinical studies data showed that the clinical performance met the FDA SMBG OTC Guidance, implying the device successfully passed these criteria. Without the specific guidance document referenced, a detailed table cannot be created from this text alone.

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

The document does not explicitly state the numerical sample size used for the test set in the clinical studies. It mentions "non-professional, inexperienced lay persons" were used for user evaluations.

• Data Provenance: The studies were conducted by Vivachek Biotech (Hangzhou) Co., Ltd, located in Zhejiang, China. The document does not explicitly state if the data was retrospective or prospective, but clinical studies (user evaluations) generally imply prospective data collection in a controlled environment.

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

This information is not provided in the document. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the ground truth for blood glucose is typically a laboratory reference measurement, adjudication by experts wouldn't be directly applicable in the same way it would be for image-based diagnostics.

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

This is not applicable to a Blood Glucose Monitoring System. MRMC studies are relevant for AI in diagnostic imaging where human readers interpret cases. This device is a direct measurement system.

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

The device itself is a standalone system for glucose measurement. The "study" here refers to the overall performance of the device in the hands of the intended users. The clinical studies (user evaluations) assess the device's performance when used by individuals (humans in the loop). The "algorithm only" concept doesn't apply as it's a physical meter and test strip system.

7. The Type of Ground Truth Used

While not explicitly stated for all studies, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI Glucose Analyzer) on venous blood samples. The document implies this by stating that clinical performance met FDA SMBG OTC Guidance, which mandates comparison to such reference methods.

8. The Sample Size for the Training Set

This information is not provided. For a physical device like a blood glucose meter, there isn't a "training set" in the same sense as machine learning algorithms. The device's calibration and performance characteristics are established during its design and manufacturing process, and then validated through laboratory and clinical studies.

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

Not applicable as there is no traditional "training set" for an AI algorithm here. The performance is validated against established reference methods and clinical guidelines.

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

VIVACE is an electric breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home environment by a single user. VIVACE is both AC-powered/battery-powered. The AC adapter uses a 100-240 V a.c, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA regarding a powered breast pump called VIVACE. It details the device's characteristics, comparison to a predicate device, and a summary of non-clinical performance testing.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the device's effectiveness in terms of milk expression efficiency, comfort, or user experience (e.g., a multi-reader multi-case study for an AI-powered device).

The "performance testing" section (Section 9) focuses on:

• Biocompatibility: Testing materials for cytotoxicity, sensitization, and irritation.
• Electrical Safety: Conformance to IEC standards.
• Electromagnetic Compatibility: Conformance to IEC standards.
• Software: Evaluation based on FDA guidance.
• Other performance testing:
  • Vacuum level verification: Ensures the device meets mode/cycle specifications.
  • Backflow protection: Verifies no liquid backflow into tubing.
  • Use life testing: Demonstrates maintained specifications throughout proposed use life.
  • Battery performance testing: Demonstrates functionality during stated use-life.
  • Battery status indicator testing: Demonstrates functionality during stated battery life.

These are primarily safety and basic functional performance tests to ensure the device operates as intended and is safe for the user, rather than a clinical study evaluating its effectiveness in milk expression compared to a gold standard or human performance. The document focuses on showing substantial equivalence to an existing predicate device based on these engineering and safety parameters.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of effectiveness or superiority, as there is no mention of such a study in the provided text. The device is a powered breast pump, not an AI-powered diagnostic device, so concepts like "multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone performance," or "ground truth for the test set" are not applicable to the information given in this document.

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Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment of FeNO by Vivatmo pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti- inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.

The provided text is a 510(k) summary for the Vivatmo pro device, a breath nitric oxide test system. It focuses on regulatory approval and substantial equivalence and does not contain detailed information about the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the full 510(k) submission, which is not provided.

Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document primarily confirms the FDA's determination of substantial equivalence.

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The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. VIVA combo RF System consists of S_VCS_F, MRFALogger and STAR Logger. The S VCS F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly. MRFALogger software can be stored and monitored on PC or tablet the RF output parameter (power, impedance, current, temperature and energy). STAR Logger can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).

The provided text describes a 510(k) premarket notification for the "VIVA combo RF System". This submission is for an electrosurgical cutting and coagulation device, and the specific change for which this 510(k) is submitted is the replacement of the "VIVA Logger" software with "STAR Logger" for using a tablet with the device.

Based on the document, here's what we can extract regarding acceptance criteria and the study:

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

The document does not provide a table of acceptance criteria with reported device performance. It states that "Software verification and validation was conducted on the changed to VIVA combo RF System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA staff." It further states, "The VIVA combo RF System demonstrated passing results on all applicable testing."

This indicates that internal acceptance criteria were met, but the specific metrics and their corresponding performance values are not detailed in this summary. The assessment appears to be focused on functional equivalence and safety rather than a comparative performance study against specific, quantified acceptance thresholds for clinical efficacy using data.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data. The "testing" mentioned refers to software verification and validation, which is typically conducted on the software itself and the integrated system, not a data set of patient cases.
• Data Provenance: Not applicable, as no clinical data or test sets derived from patient data are mentioned for the software validation.

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

Not applicable. No ground truth establishment for a test set of clinical data is mentioned, as the study is a software verification and validation, not a clinical performance study.

4. Adjudication method for the test set:

Not applicable. There's no mention of a test set requiring adjudication in the context of clinical interpretation or diagnosis.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were considered necessary and performed." This means there's no comparison of human readers with or without AI assistance.

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

The software's function is to "display certain data that is also shown on the VIVA combo RF Generator" and to "store and monitor... RF output parameter (power, impedance, current, temperature and energy)." It continuously monitors these parameters and adjusts RF output. While this is algorithmic behavior, the document does not describe a standalone "performance" study in the sense of a diagnostic algorithm's accuracy as it is an operational control and monitoring software. The "performance" assessment was for its functional correctness and safety, ensuring it behaves as intended and doesn't introduce new risks.

7. The type of ground truth used:

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for this software validation would be the functional requirements and design specifications. The software was validated against these specifications to ensure it accurately monitors and displays the intended parameters and maintains safety.

8. The sample size for the training set:

Not applicable. This is not an AI/ML product developed with a training set of data. It's software for controlling and monitoring an electrosurgical device.

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

Not applicable, as no training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a software verification and validation process. This process was conducted on the changed software (STAR Logger) to ensure it performs its intended function safely and effectively within the VIVA combo RF System.

• Acceptance Criteria (Implicit): The implicit acceptance criteria were that the "STAR Logger" software would accurately display and store the RF output parameters (power, impedance, current, temperature, energy) and communicate correctly with the VIVA combo RF generator without introducing new safety or effectiveness concerns. These criteria were derived from the device's design documentation and aligned with general software validation guidance from the FDA.
• Reported Device Performance: The document states, "The VIVA combo RF System demonstrated passing results on all applicable testing." This implies that the software met all pre-defined functional and safety requirements during verification and validation.
• Safety and Risk Assessment: A risk assessment was conducted, evaluating compliance with FDA-recognized consensus standards for medical device software (ANSI AAMI ISO 14971, IEC 62304, IEC TIR80002-1). This confirms that the altered software does not pose new or increased risks.
• Nature of the Change: The change was specifically replacing the "VIVA Logger" software with "STAR Logger" to enable tablet use with a new UI. The core technological characteristics and indications for use of the VIVA combo RF system itself remained unchanged.
• No Clinical Studies: No clinical studies were deemed necessary because the software change was considered minor and did not impact the fundamental safety or effectiveness of the device's therapeutic action. The change was related to user interface and data display/storage for operational parameters.

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VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.

VivaChek™ Link Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek Link Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

VivaChek Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.

The provided text describes the VivaChek™ Link Plus Blood Glucose Monitoring System, an in-vitro diagnostic device. Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that various laboratory studies were performed, and for these studies, "the test results indicated that the acceptance criteria were met."

Therefore, based on the provided text, a generic representation of this would be:

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

• Sample Size for Test Set: The document mentions "clinical study (user evaluation) was conducted with intended users." However, it does not specify the number of users or samples included in this evaluation.
• Data Provenance: The document does not explicitly state the country of origin for the data. It also directly states that the user evaluation was conducted as a "clinical study," implying it was a prospective study, though not explicitly labelled as such. The other laboratory studies listed are implicitly prospective tests performed by the manufacturer.

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

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" for glucose levels would typically be established using a laboratory reference method (e.g., a YSI analyzer), not by human experts interpreting results. The user evaluation focuses on the usability and ability of lay persons to obtain readings, not on expert interpretation of the device's output.

4. Adjudication method for the test set

This information is not applicable/provided in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret images or complex data to establish a consensus ground truth, often for AI-assisted diagnostic tools. For a blood glucose meter, the reference method (e.g., YSI) provides the objective ground truth, and device readings are compared directly to this.

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 comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI where human readers interact with AI assistance. The VivaChek™ Link Plus Blood Glucose Monitoring System is a standalone measurement device for self-testing; it does not involve human readers interpreting AI-generated insights.
• Effect size of improvement with AI vs without AI assistance is not applicable.

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

• Yes, a standalone performance evaluation was done. The entire suite of laboratory studies (e.g., precision, linearity, interference, stability, environmental, safety) represents the standalone performance evaluation of the device system (meter and test strips) without human interpretation in the loop. The "user evaluation" section primarily assesses usability rather than the intrinsic accuracy of the algorithm/device itself. The device is designed for "self-testing outside the body (in vitro diagnostic use)," operating without professional human-in-the-loop interpretation of its results for diagnosis.

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

The document does not explicitly state the specific reference method used for establishing ground truth for glucose levels. However, in the context of blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose concentration measurements. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided and is generally not applicable in this context. Blood glucose monitoring systems are typically designed and calibrated based on biochemical principles and rigorous testing, rather than "training" a machine learning algorithm with a dataset in the way an AI diagnostic tool would be trained. The "training set" concept is usually associated with AI/ML development.

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

As noted above, a "training set" in the AI/ML sense is likely not applicable here. Device calibration and verification are based on established analytical chemistry methods where the "ground truth" for glucose concentrations in control solutions or reference samples would be determined using highly accurate laboratory reference instruments.

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The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.

The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.

Here is a summary of the acceptance criteria and study information for the Vivally System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical study in the form of numerical thresholds for responder rates or symptom reduction required for clearance. Instead, it describes what was reported from the study. The FDA's conclusion indicates that the study demonstrated clinically meaningful improvement in UUI and urinary urgency symptoms.

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

• Sample Size (Test Set):
  • Intent-to-Treat (ITT) population: 96 subjects
  • Evaluable population: 94 subjects
  • Per Protocol (PP) population: 73 subjects
  • 6-month follow-up: 47 subjects
  • 12-month follow-up: 39 subjects
• Data Provenance: Prospective, multi-center study conducted at nine centers within the United States.

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

The document describes a clinical study where subjects reported their symptoms using a 3-day bladder diary. There is no mention of external experts establishing the ground truth for the test set. The patients themselves provided the data on their symptoms (UUI, urges, voids) which served as the "ground truth" for assessing effectiveness, as measured by symptom reduction and responder rates against their baseline.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The symptom data was derived from patient-recorded 3-day bladder diaries.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a single-arm clinical trial evaluating the device in a cohort of patients, not comparing human readers' performance with and without AI assistance.

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

Yes, the effectiveness outcomes presented are for the device (Vivally System) as a standalone treatment used by the patient at home. While personalization of therapeutic range was set by a physician, and a mobile application and cloud database are part of the system for therapy management and patient/physician access, the effectiveness results are based on the device's direct therapeutic action. The study assessed the device's ability to reduce symptoms and improve QOL.

7. The Type of Ground Truth Used

The ground truth for effectiveness outcomes was based on patient-reported symptoms recorded in a 3-day bladder diary at baseline and various follow-up periods. Quality of Life (QOL) assessments were also patient-reported using validated questionnaires (OAB-q, I-QoL, IIQ-7, PGIC, and OHG).

8. The Sample Size for the Training Set

The document describes a clinical study for product evaluation, not an AI/algorithm development study with distinct "training" and "test" sets in the typical machine learning sense. Therefore, there is no specified "training set" sample size for an algorithm in this context. The clinical study enrolled 96 subjects who served as the study population for evaluating the device's effectiveness.

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

As there is no distinct "training set" in the context of an AI algorithm, this question is not applicable based on the provided text. The clinical study evaluated the device's performance directly using patient-reported outcomes as the "ground truth."

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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The VIVACE Electrosurgical System is comprised of the following components:

• . The system main body, consisting of:
  • LCD touch screen control panel O
  • High-frequency generating output section (main P.C.B board or RF Generator) O
  • Power supply component Switch Mode Power Supply (SMPS) O
• The accessories to the device include: ●
  • Handpiece with Handpiece Connector o
  • Disposable micro-needle cartridge (electrode) for insertion into Handpiece O
  • Foot switch O
    Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

The provided text is a 510(k) Summary for the VIVACE Electrosurgical System. It outlines the device's technical specifications and the performance data submitted to the FDA to establish its safety and efficacy and demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device, which is what your request implies.

The "Performance Data" section (Page 6 of the input) lists various tests that were conducted (electrical testing, biocompatibility testing, sterility testing, shelf life/packaging, software verification/validation, and thermal testing) and states that "All acceptance criteria were met." However, it does not define these acceptance criteria, nor does it provide detailed results or specific studies that you've requested (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI/ML performance studies).

The "Thermal Testing" section briefly mentions:

• An ex vivo animal study using a porcine tissue model.
• Standardized H&E staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation.
• The finding that the vivace microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.

This is a performance test, not a study to establish clinical effectiveness or compare AI performance against a human or a human-assisted AI.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study proving the device meets them as described in your prompt (which is structured for an AI/ML device performance study) because this regulatory document for the VIVACE Electrosurgical System does not contain such information. It focuses on demonstrating substantial equivalence through engineering and biological performance testing, not AI model performance.

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VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.

The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.

VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability.

Here's a breakdown of the acceptance criteria and study information for the VivaChek™ Blood Glucose and ß-Ketone Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria values for most studies, but rather states that the studies "Pass" or "were acceptable." For the performance characteristics, it focuses on demonstrating equivalence to the predicate device. For the clinical study, the acceptance criteria were based on participants' ability to obtain readings and satisfaction with ease of operation and overall performance.

For the B-Ketone performance studies, generally, the acceptance criteria for a blood ketone monitoring system would align with ISO 15197 or similar guidelines, requiring a certain percentage of results to fall within defined accuracy ranges when compared to a reference method (e.g., laboratory analyzer). While not explicitly stated with numerical targets, the "Pass" conclusion for studies like Linearity, Precision, and Interfering Agents implies adherence to such generally accepted analytical performance standards.

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

The document does not explicitly state the sample sizes for the individual non-clinical (laboratory) studies. For the User Evaluation (clinical study), it refers to "participated lay persons" without specifying the exact number.

The provenance of the data is not mentioned in terms of country of origin. The studies are described as "non-clinical (laboratory) studies" and a "clinical (user evaluation) study," indicating they are likely prospective experiments conducted specifically for this submission.

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. For analytical devices like this, ground truth for accuracy studies (e.g., Linearity, Precision) would typically be established by a reference laboratory method using highly accurate and calibrated instruments, not necessarily by experts in the sense of human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of a quantitative measurement device, the comparison would typically be against a reference method, rather than requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation of images or other subjective data, which is not the case for a blood ketone and glucose monitoring system.

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

Yes, the analytical and performance studies listed (e.g., Linearity, Precision, Hematocrit Effect, Interference) represent standalone (algorithm only) performance of the device without human-in-the-loop interpretation beyond operating the device. The device provides a quantitative numerical output directly. The "User Evaluation" did involve humans, but primarily to assess their ability to use the device and obtain a reading, not to interpret the reading itself.

7. The Type of Ground Truth Used

For the analytical performance studies (e.g., Linearity, Precision, Hematocrit, Interference), the ground truth would typically be established by a reference laboratory method or highly accurate comparative instrument. The document refers to "corresponding study protocols," which would detail these reference methods, but the specific methods are not described in this summary.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is not described as using machine learning or AI that would require a distinct training set in the conventional sense. Its performance is based on established electrochemical principles.

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

As no training set is mentioned or implied for an AI/ML context, this information is not applicable.

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