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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 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 ESOTEST MULTI Temperature Monitoring System is composed of the following device components:

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

The LCD display of ESOTEST MULTI monitor shows the temperatures detected by the thermocouple sensors located in the probe, which is measuring the temperature of the patient's esophagus. Temperatures are displayed as numeric values and as scrolling plots. The user is able to set the value of an upper alarm threshold and that of a lower alarm threshold. If any measured temperature exceeds the upper alarm threshold or falls below the lower alarm threshold, ESOTEST MULTI monitor immediately emits visual and audible alarm signals.

The ESOTEST MULTI esophageal probe has a 7 French body equipped with 11 French sensors and is intended for the detection of esophageal temperature at multiple locations. The probe is connected to the monitor by ESOTEST MULTI patient cable.

The provided text describes the regulatory clearance of a medical device, the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. This is not an AI/ML powered device, therefore the information requested about the number of experts used to establish ground truth, the adjudication method, MRMC studies, or training set details are not applicable as these pertain to performance studies of AI/ML algorithms.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ESOTEST MULTI system are based on established international standards for clinical thermometers and medical device safety/performance.

Study Details

The studies performed are non-clinical bench and lab tests, not clinical studies involving human subjects or AI/ML algorithm evaluation.

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

   • The document does not specify exact sample sizes for each non-clinical test (e.g., how many probes were tested for accuracy, or how many sterilization cycles were validated).
   • The data provenance is from non-clinical laboratory testing performed by the manufacturer, Fiab SpA, in Italy. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.

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

   • This question is not applicable as the device is a direct measurement medical thermometer, not an AI/ML algorithm requiring expert interpretation of complex data for ground truth establishment. Ground truth for the device's accuracy and performance parameters (e.g., temperature values, alarm functionality) is established by calibration against known standards and physical measurements.

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

   • This question is not applicable as it pertains to the resolution of discrepancies in expert interpretations, typically for AI/ML performance studies, which is not relevant for this device.

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

   • This is not applicable. The device is an esophageal temperature monitoring system, not an imaging device or an AI-assisted diagnostic tool where human readers would be involved in interpreting data with or without AI assistance.

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

   • This is not applicable as there is no AI/ML algorithm in this device. The device performs direct physical measurements.

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

   • For temperature accuracy, the ground truth is established by calibrated reference standards (e.g., precision temperature baths and reference thermometers) that meet the requirements of relevant international standards (e.g., ISO 80601-2-56).
   • For other aspects like electrical safety, EMC, sterilization, and biocompatibility, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., IEC 60601-1, ISO 11135-1, ISO 10993-1).

7. The sample size for the training set:

   • This is not applicable as there is no AI/ML algorithm requiring a training set for this device.

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

   • This is not applicable as there is no AI/ML algorithm requiring a training set for this device.

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ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts: Monitor, Interconnect Cable, Esophageal Probe. Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm. Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable.

Here's an analysis of the provided 510(k) summary regarding the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System:

The document focuses on demonstrating substantial equivalence to a predicate device (S-Cath - Esophageal Temperature Probe and Temperature Monitoring System, K112376) through non-clinical performance testing. It does not describe a study involving human subjects or AI.

Acceptance Criteria and Reported Device Performance

Study Details for the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System

This summary does not contain information about studies involving human subjects, AI/algorithm performance, or extensive clinical trials. The "study" referenced is a set of non-clinical, bench-top performance tests.

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

   • Accuracy Test: 3 ESOTEST Monitors with 3 Probes (meaning 9 independent thermometers were tested, as each monitor has 3 thermometers).
   • Repeatability Test: 5 ESOTEST Monitors with Probes (meaning 15 independent thermometers were tested).
   • Response Time Test: 6 ESOTEST Monitors and probes.
   • Data Provenance: The tests were non-clinical, performed in a laboratory setting by FIAB SpA. The data is prospective, generated specifically for this 510(k) submission. No country of origin for patients or retrospective data is applicable as it's a bench test.

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

   • Not applicable. Ground truth for these non-clinical tests was established by a reference thermometer (Pt100) and a reference thermometer, both calibrated, conforming to standards (ISO 80601-2-56:2009 and NIST Technical Note 1297: 1994 Edition). No human experts were involved in establishing the "ground truth" for the device's technical specifications in these bench tests.

3. Adjudication method for the test set:

   • Not applicable. This was not a human interpretation study. The "adjudication" was a direct comparison of the ESOTEST device's readings against a calibrated reference instrument.

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

   • No MRMC comparative effectiveness study was done. This device is a temperature monitoring system and does not involve human readers interpreting images or data that AI would assist with.

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

   • Not applicable in the context of AI. The device itself is a standalone measurement system (without human-in-the-loop performance in terms of interpretation, though human intervention is required for placement and alarm setting). Its performance was tested as a standalone physical device.

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

   • Calibrated Reference Standard: The ground truth for all performance tests (accuracy, repeatability, response time) was established using highly accurate, calibrated reference thermometers and controlled laboratory conditions (thermostatic baths). This is a physical, objective standard.

7. The sample size for the training set:

   • Not applicable. This device is a hardware product with embedded firmware, not an AI model requiring a training set in the typical sense. Performance was evaluated through hardware testing.

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

   • Not applicable, as there is no AI training set for this device.

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Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required.

Self-powered devices for the cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.

The provided text describes a 510(k) submission for FIAB's high-temperature battery-powered cauteries. It details the device's intended use and performance testing based on general electromedical standards, but it does not include a conventional clinical study comparing the device's performance against specific acceptance criteria in a human or animal model with clearly defined endpoints and statistical analysis.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

Study Details for Device Performance

The provided document describes laboratory performance testing rather than a traditional clinical or comparative effectiveness study.

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 explicitly stated for each test. For the battery life test, it mentions "at least equal to 48" activations, implying a unit was tested to achieve this. For temperature, multiple measurements were taken both internally and by a third party.
• Data Provenance: The tests were conducted internally by FIAB (Vicchio Florence - Italy) and by an unspecified "third party" or "externally laboratory" presumably to corroborate internal findings. The data is prospective, as these are tests specifically carried out for the submission.

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

• Not Applicable. The "ground truth" for the performance criteria (temperature, battery life, biocompatibility, and safety standards) was established through objective physical measurements and adherence to engineering/biocompatibility standards, not through expert consensus on medical outcomes or images. Specialized technicians and engineers would have been involved in conducting these tests and interpreting the results against established physical standards.

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

• None (Not Applicable). Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation). These tests involve objective physical measurements and comparisons to predefined numerical targets (e.g., 1200°C temperature, 48 activations).

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 type of study is entirely irrelevant for a simple electrosurgical cautery device. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images, often with an AI assist. This device is a surgical tool.

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

• No. This concept is not applicable. The device itself is a physical tool, not an algorithm. Its performance is inherent in its physical operation.

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

• Objective Technical Specifications/Standards. The ground truth for these tests was based on engineering design specifications (e.g., "target temperature of 1200°C") and compliance with recognized international safety and biocompatibility standards (CEI EN 60601-1, CEI EN 60601-1-2). For biocompatibility, it's implied that material certificates or standard testing results served as ground truth.

8. The sample size for the training set

• Not Applicable. This device uses a simple electrical resistance heating mechanism, not a machine learning algorithm. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set for an algorithm, this question is irrelevant.

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Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.

Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.

The provided text is a 510(k) summary for a medical device (F7255 Fiab Disposable Cautery battery powered). This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering performance study would.

Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text.

The document states: "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that the regulatory pathway for this device at the time did not require detailed performance studies against specific acceptance criteria to demonstrate efficacy beyond what was required for substantial equivalence.

Here's a breakdown of what information can be extracted from the provided text, and what cannot:

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

• Not present. The document does not specify quantitative acceptance criteria for performance (e.g., specific temperatures, duration of heat, precision of cauterization, etc.) nor does it report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to a predicate device.

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

• Not present. No specific test set or data provenance for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and adherence to general regulations.

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/Not present. No ground truth establishment for a test set is discussed in the context of device performance, as there's no performance study described.

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

• Not applicable/Not present. No adjudication method is mentioned as there's no performance study with a test set.

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/Not present. This device is a simple battery-powered cautery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable/Not present. As mentioned above, this is not an algorithm-based device.

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

• Not applicable/Not present. Given the nature of the device and the submission type, a "ground truth" for performance comparison as in diagnostic imaging or AI is not part of this document. The "ground truth" for regulatory approval here is substantial equivalence to a legally marketed predicate and compliance with general safety and effectiveness regulations.

8. The sample size for the training set

• Not applicable/Not present. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable/Not present. No training set exists.

Summary of available information:

The provided document is a 510(k) summary for a "F7255 Fiab Disposable Cautery battery powered". The core of its regulatory submission is demonstrating substantial equivalence to an existing predicate device, the "AARON AA04 battery powered cautery".

• Intended Use (from the document): "The device is intended for use in ophthalmology." and "Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology."
• Comparison to Predicate: "The F7255 cautery has the same intended use as the predicate and do not imply new technological characteristics." This is the primary "proof" of meeting regulatory requirements for this type of submission.
• General Compliance: The document states, "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates general compliance with manufacturing and safety regulations, rather than specific performance metrics.
• Risk Assessment: "According to the risk-benefit analysis, the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks."

In essence, the "acceptance criteria" here are met by demonstrating the device is substantially equivalent to a legally marketed predicate and adheres to general safety and effectiveness requirements, rather than through specific performance metrics outlined in a detailed study within this document.

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PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.

PG47xW SERIES are disposable adhesive electrodes with solid conductive gel. They consist of a conductive pad made of three primary layers: a non-woven fabric top, a carbon filled film and a solid hydrogel adhesive layer. Between the conductive film and the insulating top a 10 cm long cable is attached, terminated with 2 mm touch proof socket for the connection with electro-stimulating devices. Multiple shapes and sizes are available to accommodate placement on various location on the body. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient's skin. The electrodes are non-sterile and for single patient use only.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for cutaneous electrodes (FIAB PG47xW SERIES). Its purpose is to demonstrate substantial equivalence to a predicate device (Valuetrode, K970426), not to present performance study data against
pre-defined acceptance criteria.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria: The document explicitly states: "Although there are no guidance performance standards, as reported in Section 18, the electrodes are produced and tested according to all requirements laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that there are no specific, quantitative acceptance criteria defined and presented in this summary for the device's performance.
• No Performance Study: The document claims equivalence based on "technological characteristics equivalent to those of the predicate devices" and that "The performance is expected to be the same as predicate device. See section 12 of the submission." Section 12 is referenced, but its content is not
  provided in this summary. This suggests that a direct performance study to meet specific acceptance criteria was either not conducted or not detailed in this publicly available summary. Instead, it relies on the presumed safety and effectiveness of the legally marketed predicate device.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth establishment, expert involvement, or multi-reader studies. The document does not provide such details.

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