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The BT-1000 external Trigeminal Nerve Stimulation System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.

The provided document, a 510(k) Summary for the BT-1000 device, describes the device's technical specifications and performance testing but does not include a study proving the device meets acceptance criteria related to its clinical efficacy in treating ADHD.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System) based on technical specifications and non-clinical performance. The "acceptance criteria" presented are primarily related to safety, electrical performance, and physical integrity of the device components, rather than clinical effectiveness for ADHD treatment.

Therefore, I can provide information based on the safety and performance acceptance criteria and related tests, but not for a clinical efficacy study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Safety Focused)

The document primarily shows a comparison table for substantial equivalence, where the "acceptance criteria" are implied by matching the predicate device's specifications and by meeting recognized safety and electrical standards. The "reported device performance" is a statement that the device complied with these specifications or passed the tests.

2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set for evaluating the device's efficacy in ADHD treatment. All tests mentioned are non-clinical (bench testing, biocompatibility, electrical safety). Therefore, there is no information on a "sample size for the test set" in a clinical context or data provenance in terms of country of origin of patient data.

• For biocompatibility, the tests were performed on standard laboratory models/materials as per ISO standards.
• For electrical safety, EMC, and performance bench testing, the "test set" would be the device itself and its components, or simulated environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical test set requiring expert adjudication for ground truth. For non-clinical tests, "ground truth" is defined by the parameters of the test standards (e.g., ISO, IEC).

4. Adjudication Method for the Test Set
This information is not applicable due to the absence of a clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were considered necessary and performed." The device relies on substantial equivalence to a predicate, which would have undergone clinical testing, but this document does not contain such a study for the BT-1000.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of clinical efficacy for ADHD. The BT-1000 is an electrical stimulation device, not an "algorithm only" device in the sense of AI-powered diagnostic/interventional software. Its safety and technical performance were assessed without human-in-the-loop performance studies, but these were for non-clinical aspects.

7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, electrical safety, performance bench tests), the "ground truth" is established by:

• International Standards: e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC.
• Device Design Specifications: The device is tested against its own design specifications (e.g., for stimulation output, battery performance, duration, electrode properties).
• Predicate Device Specifications: Many "acceptance criteria" are based on matching the technical specifications of the legally marketed predicate device (Monarch eTNS System) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning or AI algorithm that would typically have a "training set" for model development. The software validation mentioned pertains to standard software development lifecycle processes and verification/validation, not AI model training.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI model, this question does not apply.

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The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.

The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.

Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).

Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.

This document is an FDA 510(k) Premarket Notification summary for the BiliTouch™ (Motif Phototherapy Blanket) and Infant Phototherapy Equipment (BT-450). It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical testing.

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

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

The document does not explicitly present "acceptance criteria" for an AI/algorithm's performance or "reported device performance" in the typical sense of metrics like accuracy, sensitivity, and specificity for diagnostics. Instead, it describes compliance with various safety and performance standards for a medical device (infant phototherapy equipment).

However, we can infer some "acceptance criteria" and "reported performance" from the "Summary table of technological characteristics of the device compared to the predicate device" and the "SUMMARY OF NON-CLINICAL TESTS" section.

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

The document explicitly states: "No clinical data were submitted." This implies that the 'test set' for demonstrating the device's safety and effectiveness was based purely on non-clinical, bench testing and adherence to recognized standards, rather than patient data. Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature of a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as no clinical data or expert-adjudicated ground truth was used for assessing the device's performance in a diagnostic or AI context. The assessment was based on compliance with device performance standards rather than a clinical ground truth derived from expert interpretation.

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

This section is Not Applicable as no clinical data requiring expert adjudication was used.

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

An MRMC study was Not Done. The device is an Infant Phototherapy Equipment, which is a physical device delivering light therapy, not an AI or imaging diagnostic aid that would assist human readers.

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

This section is Not Applicable as the device is not an algorithm for diagnosis or image interpretation. It is a phototherapy device.

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

For the purpose of this 510(k), where "No clinical data were submitted," the "ground truth" for the device's performance is established by its compliance with internationally recognized electrical, mechanical, biocompatibility, and phototherapy-specific safety and performance standards (e.g., IEC 60601 series, ISO 10993) and successful completion of internal bench performance tests.

8. The sample size for the training set

This section is Not Applicable. As stated, "No clinical data were submitted." The device is a physical medical device, not a software algorithm that requires a training set of data.

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

This section is Not Applicable as there was no training set in the context of an AI/algorithm development.

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Hi bebe super (Models BT-150S and BT-150L) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

Hi bebe wer are powered breast pumps that are modified versions of the predicate device, K160274. The pumps are intended to express and collect milk from the breast of lactating women and are only to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). All patient-contacting and breast milk-contacting materials are identical to the predicate device.

Hi bebesting includes two models, BT-150L and BT-150L includes a nursing lamp option, which is not available for BT-150S. Both models are comprised of a motor unit and accessories. The pumps are powered by rechargeable lithium ion batteries (7.4 V Li-ion polymer, 2200 mA) and are software-controlled. The Hi bebe®™ breast pumps have two operating modes: massage mode and expression mode. The subject device also includes backflow protection feature to prevent milk from contacting the pump during use. For accessories, a 32 mm size funnel is added in addition to 21/24/27 mm.

The provided text describes a 510(k) premarket notification for a breast pump, the "Hi bebe super" (Models BT-150S and BT-150L). However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is a typical FDA 510(k) submission summary for a physical medical device (a breast pump), demonstrating substantial equivalence to a predicate device. The "Software" section mentions verification and validation testing, and that the software was considered a "Moderate level of concern," but it does not describe a study to prove performance against specific clinical acceptance criteria, especially not in the way an AI/algorithm device would.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text relates to a breast pump and not an AI/algorithm. The information you are asking for (e.g., sample sizes for test sets, expert consensus, MRMC studies, standalone performance) is relevant to the evaluation of AI/algorithm-based medical devices, which this document does not cover. If you have a document about an AI/algorithm device, please provide that.

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The Hi bebeplus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

The Hi bebeplus, model BT-100, is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.. The pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The Hi bebeplus, model BT-100 also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. The Hi bebeplus, model BT-100 has two operating functions: basic massage/expression function and memory function to save the operating sequence. The Hi bebeplus, model BT-100, is capable of providing vacuum levels from 32-227 mmHg with cycling rates up to 63 cycles per minute.

This document is a 510(k) premarket notification for a powered breast pump (Hi bebePlus, model BT-100). The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Medela Ag Freestyle Deluxe, K150499).

Therefore, this document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance or diagnostic accuracy, as it is a breast pump, not a diagnostic or AI-powered medical device.

The information provided relates to non-clinical tests conducted to ensure safety and performance equivalence to a predicate device, which are standard for such medical devices seeking market clearance.

Here's an analysis of what is available in relation to your request, adapted for the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications that were tested. While not explicitly called "acceptance criteria" in a table format, these are the parameters against which the device's performance was measured.

Non-Clinical Acceptance Criteria (Compliance with Standards):

• Biocompatibility: In accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity) and AAMI / ANSI / ISO 10993-10:2010 (irritation and skin sensitization).
• Electrical Safety: In accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, and IEC 60601-1-11:2015.
• Electromagnetic Compatibility (EMC): In accordance with IEC 60601-1-2:2007.
• Software Verification and Validation: As recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).

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

This information is not provided in the document. The performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life) are noted as having been conducted "under conditions of single and double pumping mode and for the varying power sources." However, the specific number of units tested or the number of test cycles is not mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering and safety tests.

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

This information is not applicable or provided. For a breast pump, "ground truth" as it relates to expert consensus for diagnostic accuracy (e.g., radiologist reads) is not relevant. The ground truth for performance characteristics would be direct measurements against engineering specifications.

4. Adjudication method

This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data by multiple readers to establish a consensus ground truth, which is not relevant for this device.

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

This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices. This device is a breast pump and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

For the performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life), the "ground truth" would be the engineering specifications and direct measurements. For the compliance tests (biocompatibility, electrical safety, EMC, software V&V), the "ground truth" is adherence to published national and international standards.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set, as this device does not utilize machine learning or AI that would require one.

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

This information is not applicable as there is no training set mentioned for this device.

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BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. The fetal heart rate is measured using Doppler ultrasound.

Bistos' BT-220L, BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-220 irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

The provided document is a 510(k) summary for the Bistos Model BT-220L and BT-220C Ultrasonic Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device (BT-200T, K100885) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device itself.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not explicitly available in this document. The document refers to an "HR Accuracy Measuring Report (G)" which likely contains the performance data, but the report itself is not included in the provided text.

Based on the available information, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for the new device (BT-220L/220C). Instead, it relies on demonstrating substantial equivalence to the predicate device (BT-200T). It mentions an "HR Accuracy Measuring Report (G)," which implies that a study was conducted to measure heart rate (HR) accuracy. However, the specific metrics and acceptance thresholds from this report are not provided.

Inferred Acceptance Criterion (from substantial equivalence): The new device's HR accuracy is expected to be comparable to, or meet the performance of, the predicate device (BT-200T).

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The "HR Accuracy Measuring Report (G)" would presumably contain these details.

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

This information is not provided in the document. It's unclear if expert review was used or what their qualifications were.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC study comparing human readers with and without AI assistance is not applicable here as this device is a standalone fetal doppler, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance

Yes, a standalone performance assessment for the device (algorithm only, without human-in-the-loop performance) was performed. This is implied by the "HR Accuracy Measuring Report (G)" which assesses the device's ability to measure fetal heart rate. The device outputs a numerical heart rate on an LCD and audibly.

7. Type of Ground Truth Used

The document does not specify the exact type of ground truth used to establish HR accuracy. However, for a fetal heart rate monitor, the ground truth would typically be established by a reference standard measurement of fetal heart rate, possibly from a high-fidelity monitoring system or directly from a fetal electrocardiogram (ECG) if applicable, or by comparison to readings from a well-established and validated predicate device.

8. Sample Size for the Training Set

This information is not applicable/not provided. The BT-220L/220C is a traditional ultrasonic fetal doppler, not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on its hardware and signal processing algorithms, which are engineered rather than trained from data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided due to the nature of the device (not an AI/ML system requiring a training set).

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Bisto's BT-500 is a Infant Incubator and intended to keep Premature in a warm environment in the hood for Neonatal hypothermia, Observation and Examination in newborn nurseries.

BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to themn-regulate on their own physiology.

BT-500 is not intended for transport.

BT-500 Infant Incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.

Also Heater is equipped inside of the hood to control the Skin Temperature of Infant at a fixed level as measured by the skin probe and showing, measuring and graphing the humidity, Air Temperature, Skin Temperature, Weight and SpO2

This Incubator is provided with function to control the infant's skin temperature.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the BT-500 Infant Incubator, primarily focused on demonstrating substantial equivalence to a predicate device.

While it mentions "various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff -Neonatal Transport Incubator Premarket notifications," and states "all test report attached," the specific details of these tests, their acceptance criteria, and the reported performance are not included in the provided text.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies based on the given information.

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The BT-200V Vascular Doppler ( Brand Hi-dop ) detects arterial and venous Hood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker, By measuring fetal heart rate (FHR), they are able to predict fetal well-being, BT-200V irradiates fetal wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

4,5.8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate (PR) they are able to check vascular blood flow status.

BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

The following probes may be utilized with the BT-200V Vascular doppler:

2 MHz for fetal heart rate

4 MHz detections of arterial and venous blood flow velocity

5 MHz detections of arterial and venous blood flow velocity

8 MHz detections of arterial and venous blood flow velocity

The provided text is a 510(k) summary for the Bistos BT-200V Vascular Doppler and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically required for AI/ML-based diagnostic devices.

The document discusses:

• Substantial Equivalence: The primary assertion is that the BT-200V is substantially equivalent to a predicate device (Smartdop 45 Vascular Doppler Koven Technology Corp. model K050601) in terms of intended use, design, function, performance, operation principle, etc.
• Device Description: It describes the BT-200V as a pocket-sized ultrasound Doppler system that measures fetal heart rate (FHR) using a 2 MHz probe and vascular pulse rate (PR) using 4, 5, and 8 MHz probes.
• Indications for Use: Detects arterial and venous blood flow in extremities and fetal heart sounds, displaying velocity waveform, numerical data, and FHR with a heart beat indicator.
• Safety and Performance Testing: It vaguely states that the device "done various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff - Information for Manufacturers seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. All test report attached." However, no specific details of these tests, acceptance criteria, or results are provided in this summary.
• Biocompatibility: Mentions using the same material as a previously cleared device (Bistos BT-200T under K100885 Fetal Doppler) and compliance with ISO 10993.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment. The 510(k) summary relies on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against predefined acceptance criteria.

The requested fields would typically be found in a more detailed clinical validation or performance study report, which is not part of this 510(k) summary.

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The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test.) Therefore the Bt-350 is not used in delivery room. ,This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree. BT-350 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-350 analyzes this signal and displays the heart rate by LCD or LED(7-Segment). Also, BT-350 provides the sound from the heart of fetus. BT-350 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And BT-350 prints the heart rate of the fetus and the values of uterine contraction. BT-350 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer. BT-350 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. BT-350 has a free voltage(100 240VAC input) power adaptor.

The provided text describes the Bistos BT-350 Fetal Monitor and its 510(k) submission. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document outlines the device's function, its comparison to a predicate device, and compliance with general safety and EMC standards. It states, "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." This indicates that general safety and electromagnetic compatibility standards were met, but it doesn't provide specific performance acceptance criteria for the fetal heart rate measurement or uterine contraction measurement, nor does it detail a study proving such performance.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the limitations:

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

No further detailed performance acceptance criteria (e.g., accuracy, precision for FHR or uterine contraction) or specific study results demonstrating those criteria were met are provided in the document.

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

• Not specified. The document mentions "performance testing" but does not detail any clinical or performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical study or ground truth establishment process is described beyond general safety and EMC testing.

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

• Not applicable. No clinical study or adjudication process is described.

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. This device is a fetal monitor, not an AI-powered diagnostic imaging device. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This is a hardware device for monitoring, not an algorithm being tested in a standalone fashion. The general safety and performance testing would refer to the device's integrated operation.

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

• Not specified. For general safety and EMC testing, ground truth refers to compliance with the standards, verified by testing procedures outlined in those standards. No clinical "ground truth" for diagnostic accuracy is described.

8. The sample size for the training set

• Not applicable. This device is not described as utilizing machine learning or requiring a training set in the context of its performance validation.

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

• Not applicable. See point 8.

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The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.
BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.

Bistos' BT-200T is a pocket size Fetal Monitor that measures the fetal heart rate and out puts the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200T irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler Frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

This 510(k) submission for the Bistos BT-200T Fetal Monitor is primarily based on substantial equivalence to a predicate device (Bistos BT-200, K052190). As such, the information provided focuses on demonstrating equivalence rather than detailed de novo efficacy studies with specific acceptance criteria and performance metrics typically found in submissions for novel devices.

However, Section 9 describes a "Voluntary performed Clinical safety test result attached (E) - *HR Accuracy Measuring Report (E-1)". This is the most relevant section for performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to an "HR Accuracy Measuring Report (E-1)" but does not present the specific acceptance criteria or the reported performance data within the text. For a full understanding, this report would need to be reviewed.

Based on the typical requirements for Fetal Heart Rate (FHR) monitors, the acceptance criteria would likely be related to accuracy and precision of FHR measurement compared to a gold standard. Without the actual report, the detailed criteria cannot be specified.

Hypothetical table (based on common FHR monitor standards and lack of specific data in the document):

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The BT-300 is an Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.

The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.

BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-300 analyzes this signal and displays the heart rate by LED. Also, BT-300 provides the sound from the heart of fetus.

BT-300 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values.

And BT-300 prints the heart rate of the fetus and the values of uterine contraction.

BT-300 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer.
BT-300 is capable of Twin Monitoring with two pulsed Ultrasound Transducers.
BT-300 has a free voltage(100 240VAC input) power adaptor.
BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. BT-200 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus.

This 510(k) summary for the Bistos BT-300 and BT-200 Fetal Monitors does not contain the detailed information typically found in a clinical study report or performance evaluation that would address acceptance criteria and how a device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on safety, EMC, and general performance standards.

Therefore, many of the requested sections (1-9) cannot be fully populated from the provided text. The document primarily highlights adherence to electrical, mechanical, and environmental safety standards, and EMC testing.

Here's a breakdown of what can and cannot be extracted:

Based on the provided 510(k) summary for the Bistos BT-300 and BT-200 Fetal Monitors, the following information regarding acceptance criteria and performance studies can be reported:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, sensitivity, specificity) for measuring FHR or uterine contractions. Instead, it indicates compliance with general safety and electromagnetic compatibility (EMC) standards.

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain any information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the Fetal Monitor's performance in measuring FHR or uterine contractions. The document only references compliance with general safety and EMC standards.

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

The provided 510(k) summary does not contain any information about experts used to establish a ground truth.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not contain any information about an adjudication method.

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

The provided 510(k) summary does not contain any information regarding an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a fetal monitor, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance Study (Algorithm Only)

Given the nature of the device as a Fetal Monitor that measures and displays physiological data, rather than being an AI algorithm for interpretation, the concept of "standalone performance" is not directly applicable in the way it would be for an AI diagnostic device. The performance evaluation described is related to the device's adherence to safety and EMC standards, and its ability to physically measure and display FHR and uterine contractions, which is inherent to its function, not an "algorithm-only" performance study.

7. Type of Ground Truth Used

The provided 510(k) summary does not explicitly state the type of ground truth used for evaluating the primary functions of FHR and uterine contraction measurement. The clinical performance is implicitly validated through substantial equivalence to predicate devices and adherence to relevant performance standards, but no specific ground truth methodology (e.g., expert consensus, pathology, outcomes data) is described.

8. Sample Size for the Training Set

The provided 510(k) summary does not contain any information about a training set size. This device is not described as being based on machine learning or AI models that require training data.

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

The provided 510(k) summary does not contain any information about how ground truth for a training set was established, as it does not describe an AI/machine learning-based device requiring a training set.

Summary of Limitations:

The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, primarily through compliance with recognized standards for safety and performance (e.g., electrical, mechanical, EMC). It is not a detailed clinical study report and therefore lacks the specific clinical performance metrics, study designs, sample sizes, and ground truth methodologies that would typically be found in a performance evaluation for a more complex diagnostic or AI-driven device. The "satisfactory" results for safety and EMC are the main reported performance outcomes in this context.

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