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Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.

Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.

The provided document is a 510(k) Summary for a Disposable electrosurgical pencil. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each performance test with corresponding values. Instead, it states compliance with various standards. The "performance data" section describes the types of tests conducted and concludes that the device performed acceptably by meeting the requirements of recognized standards and guidance.

Here's a summary of the performance testing details:

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

• Sample Size for performance testing (Thermal Tissue Effects): The document states "Tissues of porcine kidney and porcine muscle were used for thermal effect testing." The specific number of samples (e.g., how many porcine kidneys or muscle pieces) is not provided.
• Data Provenance: Not explicitly stated. Given that Shenzhen Mecun Medical Supply Co., Ltd. is based in China, it's highly probable the testing was conducted there, but this is not confirmed in the document. The study is presented as performance testing for the subject device to demonstrate substantial equivalence, which implies it's prospective data for this 510(k) submission.

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

• Not Applicable. The described study focuses on the physical performance of the electrosurgical pencil (e.g., thermal effects on tissue). It is a non-clinical performance study rather than a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" here is the observable physical effect of the device on tissue under controlled conditions, measured instrumentally or visually by qualified personnel involved in the testing, but not explicitly as a panel of "experts" for ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not applicable here.

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

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

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

• Not Applicable. The device is a physical electrosurgical pencil, not a software algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" is not relevant.

7. The Type of Ground Truth Used

• For the performance testing on thermal tissue effects, the "ground truth" would be the physical and observable effects (cutting and coagulation characteristics, extent of thermal damage) on the porcine tissue, measured or observed directly during the test. This is an experimental observation under controlled conditions, not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm or a software device requiring a training set. The performance testing involves direct physical testing of the electrosurgical pencil.

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

• Not Applicable. As mentioned above, there is no training set for this type of device.

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The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure qlucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio MD100 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System.

The TysonBio MD100 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System.

The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of:
a. TysonBio MD100/MD100 Pro Blood Glucose Meter
b. TysonBio MD100/MD100 Pro Test Strips
TysonBio MD100 Control Solution

The provided text does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria. It is a 510(k) summary document that describes the device, its intended use, and states that performance studies were conducted and the device meets its intended use, but it does not detail these studies or their results in a way that allows for the extraction of the requested information.

Therefore, many of the requested details cannot be provided from this document.

However, based on the information that is present, I can provide the following:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document states "The performance of TysonBio MD100 / TysonBio MD100 Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use." However, it does not specify what those acceptance criteria were or what the actual reported performance metrics were against those criteria (e.g., accuracy percentages, bias, precision data).

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

This information is not provided in the document.

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. The document mentions "healthcare professionals" were involved in clinical settings, but does not specify their number or qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This information is not provided in the document. The device is a blood glucose monitoring system, which typically involves direct use by individuals or healthcare professionals rather than interpretation of medical images by multiple readers. Therefore, an MRMC study is highly unlikely for this type of device.

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

The device is a Blood Glucose Monitoring System, which by its nature is a standalone device that provides direct measurements to the user or healthcare professional. There is no "human-in-the-loop performance" that would be separate from the device's own measurement. So, in essence, the device's performance is its standalone performance. However, the document does not provide the details of this standalone performance.

7. The Type of Ground Truth Used:

The document implies that the ground truth for glucose measurements would be established through a reference method or laboratory analyzer, as is standard for glucose monitoring systems. While not explicitly stated, the phrase "quantitatively measure glucose" and the nature of the device suggest that comparison would be made against a more precise, established glucose measurement method.

8. The Sample Size for the Training Set:

This information is not provided in the document.

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

This information is not provided in the document.

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The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for hospital or home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool.

The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform. The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit, and storage chip.

The MD100 Handheld ECG Monitor is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to user or physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of MD100 has the feature of recording this real time data that is normally difficult to capture. When tested, the Heart Rate Value is displayed.

The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-Easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.

The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2* AAA batteries.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's ECG measurement accuracy, sensitivity, specificity, or similar. The document focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, AAMI EC38) and equivalence to the predicate device.
• Reported Device Performance: The document states that "Bench testing is performed to demonstrate safety and effectiveness and equivalency to the predicate device." It also mentions that the device "can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement." However, no specific performance metrics or comparative results from this bench testing are provided.

What would typically be expected for this section (but is missing):

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The Handheld ECG Monitor MD100 is intended for use in non-invasive recording and displaying ECG waveform by adult patients. It addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events. suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This ECG monitor allows the patient to record their ECG data into the device memory for display by healtheare professional during office visits.

The product is not a conventional diagnostic tool.

The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform.

The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our company.

The MD100 Handheld ECG Monitor is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of MD100 has the feature of recording this real time data that is normally difficult to capture.

The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-Easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.

The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2*AAA batteries.

The provided text appears to be a 510(k) summary for a medical device submission, focusing on establishing substantial equivalence rather than a detailed performance study as would be seen in a clinical trial report. As such, it does not contain the specific study design details like sample sizes, ground truth establishment, expert qualifications, or MRMC study results that you requested.

However, based on the provided text, I can infer and extract some information regarding acceptance criteria and performance as presented for the 510(k) submission.

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

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

The document focuses on establishing substantial equivalence to a predicate device (Omron HCG-801) rather than setting and reporting against specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" here are implied by meeting recognized standards and demonstrating similar capabilities to the predicate.

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

The document references "Performance Testing" and "bench testing" but does not specify any sample sizes for test sets (e.g., number of patients, number of ECGs). It does not mention clinical data or its provenance (country of origin, retrospective/prospective). The testing described is primarily bench testing for electrical safety and electromagnetic compatibility.

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

Not applicable based on the provided text. The submission focuses on substantial equivalence through engineering and safety standards, not clinical performance against expert-derived ground truth.

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

Not applicable. No clinical test set data requiring adjudication is mentioned.

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

Not applicable. This device is an ECG monitor, not an AI-assisted diagnostic tool for interpretation by human readers, and no MRMC study is mentioned.

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

Not applicable for diagnostic performance as an algorithm. The device records and displays ECG waveforms; it is not presented as automatically interpreting them diagnostically. Its "performance" is based on its ability to accurately capture and present the ECG data and meet safety standards.

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

For the "Performance Testing" mentioned, the ground truth would be against the defined parameters of the relevant standards (e.g., correct voltage readings, stable baseline, accurate heart rate measurement against a known signal, electromagnetic compatibility limits). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical performance study for diagnostic accuracy is described.

8. The sample size for the training set

Not applicable. The device is not described as utilizing a machine learning algorithm that requires a training set.

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

Not applicable (as above).

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Accessory to a cassette to convert X-Ray energy into light energy.

Not Found

The provided text is a 510(k) clearance letter from the FDA for "Konica Intensifying Screens MD100 and MM150." This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study details as would be found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document is a regulatory approval, not a scientific study report.

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