Search Results

Over-The-Counter Use:
a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Prescription Use:
a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
e. Model MINI-TENS-COMB is indicated for Rx TENS. 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
g. Model R-C101I is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;

Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics. The 8 models have Similar housing with a viewable LCD display,an accessible keypad.The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard.

The provided document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the "Combo Electrotherapy Device" to existing predicate devices. It focuses on technical specifications and safety standards rather than clinical performance or acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or detailed in this type of regulatory submission.

However, I can extract information related to acceptance criteria as demonstrated by compliance with recognized standards and a comparison to the predicate devices' performance.

The primary acceptance criteria for this device are demonstrated through compliance with recognized electrical safety and performance standards, as well as showing substantial equivalence to existing predicate devices in terms of intended use and technological characteristics.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, "acceptance criteria" are generally met by demonstrating compliance with applicable safety standards and showing that any differences from predicate devices do not raise new safety or effectiveness concerns. The "reported device performance" is primarily presented as a comparison to the predicate devices' specifications, along with statements of compliance to relevant IEC standards.

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

• Sample size: Not applicable. For a 510(k) submission based on technical equivalence, bench testing and compliance with standards are typically performed on representative units of the device itself, not a 'test set' of patient data in the clinical sense.
• Data provenance: The tests performed are "Non-Clinical Data" and "Bench Testing," conducted to verify device specifications and compliance with standards. These are typically laboratory tests of the device. The manufacturing company is Shenzhen Roundwhale Technology Co., Ltd. in Longgang District, Shenzhen, China.

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. This is a technical and safety review of an electrotherapy device, not an image-based diagnostic or screening AI device requiring expert ground truth for a test set.

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

• Not applicable. As above, this type of adjudication is for clinical or diagnostic studies, not for the technical bench testing 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

• Not applicable. This device is an electrotherapy device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The device is a physical electrotherapy device; its performance is independently verifiable through electrical measurements and safety standards compliance.

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

• The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, ISO 10993) and the specifications and performance of the legally marketed predicate devices. The testing confirmed that the subject device's performance aligned with these standards and was substantially equivalent to the predicate.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Not applicable. (See answer to point 8).

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The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA MATRIX12 M Probe and is intended for the continuous detection, measurement and visualization (in ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA MATRIX12 M Probe.

The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.

The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).

The MATRIX12 M Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadiusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located in a 3 x 4 sensor array. The sensors measure temperature by a thermistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 14Fr diameter probe is placed inside the esophagus.

The Probe is also equipped with 4 electrode sensors. By connecting the MATRIX12 M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for placement.

The provided text is a 510(k) summary for the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System. It describes the device, its intended use, and comparative testing against a predicate device (CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System, K200943).

However, the information provided does not describe a study involving an algorithm or AI that would require the in-depth data requested regarding sample sizes, expert ground truth, MRMC studies, or training/test sets. The device is a clinical electronic thermometer and sensing probe, and the testing described focuses on hardware performance, electrical safety, biocompatibility, and software system tests for an embedded system, not a diagnostic AI/algorithm.

Therefore, I cannot fully answer the request as the context of the input document is for a medical device that does not rely on an AI/algorithm based on the typical sense of machine learning models for diagnosis or prediction.

However, I can extract the acceptance criteria and performance data for the device itself from the provided tables, as well as information about the non-clinical testing.

Here's the information extracted concerning the device's acceptance criteria and proven performance:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Device Specifications (from Comparison Table, acting as implicit acceptance criteria):

• Temperature Measurement Range: 0 - 55 °C (subject device rated higher than predicate 0 - 45 °C, but still meets consensus standard ISO 80601-2-56 range of 34-43 °C).
• Number of Temperature Sensors: 12
• Temperature Sensor Type: NTC Thermistor (system accuracy ±0.3℃)
• Measurement Presentation / User Interface: LCD monitor, Touch screen monitor
• Alarm Temperature Range: Upper threshold (Alarm and Warning High), Lower Threshold (Alarm and Warning Low); Low threshold cannot be set higher than upper threshold.
• Alarm Signal: Visual (flashing yellow, blue, or red on LCD), Audible (intermittent sound).
• Power Requirements: 100 - 240 Vac
• Monitor Classification: Class I Medical Electrical Equipment, Type CF Applied Part, Defibrillation-Proof.
• Introduction: Esophageal (nose/throat)
• Signal Processing and Display: Actual temperature is a function of thermistor resistance; Temperature displayed in 0.1℃ increments; 1 input (single probe) available; 12 sensors per probe measurements and user-selected alarm limits displayed on LCD monitor.
• Operating Conditions: 0°C to 40°C; Non-condensed relative humidity: 30% to 75%.
• Precision and Repeatability: 0.1 °C
• Probe Sterilization: ETO Sterilized; Single-use only.
• Biocompatibility of Patient Contacting Part: Compliance to ISO 10993-1; Surface-contacting device, mucosal membrane; Limited exposure (A) – up to 24 h.
• Software: Compliance to IEC 62304.
• Electrical Safety: Compliance to IEC 60601-1.
• EMC: Compliance to IEC 60601-1-2.
• Performance Bench Testing: Compliance to ISO 80601-2-56.

Regarding points 2-9 (Sample sizes, experts, MRMC, training/test sets, ground truth):

These points are highly relevant to AI/ML software as a medical device (SaMD) clearances. However, the provided document describes a hardware medical device (a clinical electronic thermometer and probe). The "software system tests" mentioned refer to verification of embedded control software, not diagnostic AI algorithms. Therefore, the concepts of "test set," "training set," "experts for ground truth," "adjudication," and "MRMC comparative effectiveness studies" do not apply to the type of device and testing described in this 510(k) summary.

The non-clinical performance data provided focuses on:

• Biocompatibility
• Sterility
• Software (embedded system verification, not AI/ML)
• Electrical Safety and EMC
• Accuracy and Response Time (met standards for thermometers)
• Mapping Cable validation
• Performance in working environment (immunity to noise, compatibility with mapping systems)

There is no mention of any AI or machine learning component in the device's functionality, nor any clinical study involving human readers or comparative effectiveness in the way typically required for AI/ML SaMDs. This submission outlines a traditional medical device premarket notification based on substantial equivalence to a predicate device.

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The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.

The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.

The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).

The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.

The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.

The provided text describes a 510(k) premarket notification for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System. This is a medical device, and the submission aims to demonstrate its substantial equivalence to a legally marketed predicate device, not to showcase an AI algorithm.

Therefore, the requested information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, standalone algorithm performance, training sets, and ground truth establishment for training sets, is not present in the provided document. This document focuses on the equivalence of a physical medical device and its performance against established medical device standards.

However, I can extract information related to the device's functional performance testing and acceptance criteria as described for a physical medical device:

Device Performance and Acceptance Criteria (as described for a physical medical device)

The document outlines various non-clinical performance data for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System to demonstrate its compliance with recognized standards and its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

In addition, a key "acceptance criterion" for this type of submission is substantial equivalence to the predicate device. The comparison table (pages 5-6) and the "Substantial Equivalence Discussion" (pages 8-9) highlight this:

• Accuracy: The acceptance criterion for accuracy is ± 0.3°C within rated output range, as per ISO 80601-2-56 requirements. The device reported meeting this requirement.
• Response Time: The predicate device had a response time of approximately 1 second. The subject device's response time was deemed to show "substantial equivalence" despite being "an average of only 2 seconds faster" in heating and cooling transients when tested with the same methodology as the predicate.
• Temperature Measurement Range: Subject device: 0-45°C. Predicate device: 0-75°C. The subject device's range is lower but meets the consensus standard ISO 80601-2-56 requirement (34.0°C to 43.0°C).

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 does not explicitly state sample sizes for each non-clinical test. The tests are primarily laboratory-based and conducted on the device components or system. Data provenance is not specified beyond "non-clinical testing" and a "performance test in vivo (animal) setting." There is no mention of country of origin or whether the data is retrospective or prospective, as these are typically considerations for human clinical trials.

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

Not applicable. This filing describes the performance of a physical medical device against engineering standards (e.g., ISO, IEC) and internal testing protocols, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are relevant for human interpretation or AI-assisted studies where inter-reader variability or differences in opinion need to be resolved. This document details physical device performance.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the measurement standards and specifications of the relevant international and national standards (e.g., ISO 10993-1 for biocompatibility, ANSI/AAMI/ISO 11135 for sterility, IEC 62304 for software, IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, ISO 80601-2-56 for accuracy and response time, ANSI/AAMI EC53:2013 for mapping cable). The in-vivo animal study likely used direct measurements (e.g., fluoroscopy) as the ground truth for assessing mapping system accuracy.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As above, this is not an AI device.

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The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.

The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.

The provided text describes the regulatory clearance (K200674) for the AtriAmp device, which is an extension cable used with external pacemakers and ECG monitors. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance goal for an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance tests for the physical device (AtriAmp cable and accessories). These tests typically involve a sample of the manufactured device, but the specific number of units tested is not provided in this summary. The data provenance is not mentioned, but these are laboratory tests performed by the manufacturer to verify product specifications and regulatory standards. Given the nature of these tests, they are inherently prospective for the specific device being manufactured and tested.

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

Not applicable. The tests are for the physical and electrical characteristics, sterility, and biocompatibility of a medical device cable, not for an AI/ML algorithm requiring expert interpretation of medical images or data. The "ground truth" here is objective measurement against specified engineering and biological standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against established standards.

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 document is for a medical device (cable) and does not involve AI.

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

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm.

7. The type of ground truth used

The ground truth for these tests is based on established engineering and biological standards and test methods (e.g., ANSI/AAMI EC53, IEC 60601-1, ISO 11137-1, ISO 10993 series, ASTM F88, ASTM F2096, ASTM 4169-16). These are objective criteria for physical, electrical, and biological safety and performance.

8. The sample size for the training set

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.

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

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.

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Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (

Cortical Electrode (Per FDA Classification)

This document is a Traditional 510(k) Summary for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). It asserts substantial equivalence to a predicate device (AD-TECH Subdural Cortical Electrodes) rather than claiming specific performance criteria and a study to meet them. Therefore, the requested information on acceptance criteria and a study proving the device meets them cannot be directly extracted as it would for a claim of new performance.

However, I can interpret the document's content to provide related information about the device's safety and effectiveness testing where it implicitly establishes "acceptance criteria" through conformance to recognized standards and successful test results.

Here's a breakdown of the available information, structured to align as closely as possible with your request:

Acceptance Criteria and Device Performance (Indirectly Derived from Safety and Performance Testing)

The document focuses on demonstrating substantial equivalence to a predicate device, which means proving the new device is as safe and effective as the legally marketed predicate. The "acceptance criteria" are generally implied to be compliance with relevant standards and successful completion of various tests, demonstrating that the device performs as intended and does not raise new questions of safety or efficacy.

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The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.

The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The device is composed of the following cleared (K180047) system components:

• Monitor ESOTEST MULTI MONITOR
• Esophageal probe ESOTEST MULTI PROBE
• Patient cable ESOTEST MULTI PATIENT CABLE

The Adapter cable ESOTEST MULTI ADAPTER CABLE has been added to the system.

The ESOTEST MULTI MONITOR is a device for measuring the esophageal temperature through a sterile, single-use probe. This component, called ESOTEST MULTI PROBE, contains up to seven independent thermal sensors, each one consisting in T-type thermocouple soldered to a spherical steel electrode. The ESOTEST MULTI PATIENT CABLE connects the main unit of the monitor to the temperature probe and continuously converts to digital signals the analog voltages generated by the thermocouples. ESOTEST MULTI MONITOR is able to keep track of the esophageal temperature during clinical procedures which involve heating or cooling processes, with an accuracy of 0.3°C and a response time of 1s. The detected temperatures are visualized as numerical values, colored bars and scrolling plots. An integrated alarm system allows the operator to set 2 independent alarm thresholds, called "upper alarm threshold" and "lower alarm threshold". If any of the measured temperatures gets hotter than the upper threshold or colder than the lower threshold, ESOTEST MULTI MONITOR immediately emits sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions can be stored in the internal memory of the device and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). By connecting the ESOTEST MULTI to a mapping system through the optional component ESOTEST MULTI ADAPTER CABLE, the probe sensors can be visualized inside a 3D model of the patient's body for optimal placement.

The provided text describes the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization (subject device) and its substantial equivalence to a predicate device (K180047 – ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and performance specifications. The "acceptance criteria" can be inferred from the predicate device's established performance and relevant standards. The reported device performance is presented as being "Same" or compliant with the standards listed.

• Direct Measurement and Comparison: The performance parameters (e.g., temperature values, response times, residual levels) are directly measured and compared against the specified limits and benchmarks derived from these standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a measurement and monitoring system, not an AI algorithm that requires a training set.

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

Not applicable, as no training set is used for this device.

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The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, Pediatric); ST segment Analysis (Adult);

Contraindications: Not for transport outside the healthcare facility

The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.

This document describes the regulatory submission for the Philips Efficia CM10, CM12, CM100, CM120, and CM150 patient monitors, which are physiological vital signs monitors. The submission includes information about the device's intended use, parameters measured, and a comparison to predicate devices. The listed parameters, which include ECG, Respiration, NBP, SpO2, Temperature, IBP, Cardiac Output, Arrhythmia Analysis, and ST-Segment monitoring, also specify the patient types (adult, pediatric, neonatal) for which each parameter is indicated.

1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices." and that the devices "use the same algorithms and have the similar performance to their predicates." Specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) are not explicitly provided in the provided text, nor are specific numerical results for the device performance against such criteria. The submission relies on the assertion that the device's performance is at least equivalent to the predicate devices.

2. Sample size used for the test set and data provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for performance studies. It generally refers to "performance data" and a "device history file" without specific details.

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.

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, an effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the document states that the ECG, NBP, invasive blood pressure, arrhythmia, and ST-segment analysis algorithms are Philips proprietary or derived from established Philips algorithms, and other parameters use algorithms from other manufacturers (e.g., Masimo, Respironics), it does not explicitly detail a standalone performance study. The statement "Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices" implies some form of performance evaluation, but the methodology and whether it was standalone are not described.

7. The type of ground truth used
The type of ground truth used for performance evaluation is not specified in the provided text. It can be inferred that, for physiological parameters like ECG, NBP, SpO2, etc., ground truth would typically come from reference devices, established clinical methods, or expert interpretation of physiological waveforms.

8. The sample size for the training set
This information is not provided in the document. The algorithms are either Philips proprietary and "well established" or from other manufacturers and "unchanged," suggesting they were developed and trained prior to this specific submission, but details about the training set size are absent.

9. How the ground truth for the training set was established
This information is not provided in the document. As with the test set, the establishment of ground truth for training would likely involve reference devices, clinical standards, or expert review of physiological data, but no specifics are given.

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Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Electrode/Extension Cables, Models ATAR™

The provided text is a 510(k) clearance letter from the FDA for Electrode/Extension Cables. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device's AI or algorithmic component.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This document is a regulatory approval letter, not a study report.

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