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Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.

The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable

The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.

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

Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.

The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.

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

This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.

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

No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.

7. Type of Ground Truth Used

The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:

• Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
• International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
• Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."

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

This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.

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FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.

FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.

FMT Disposable and Autoclavable Temperature Probes are intended by qualified medical professionals only.

FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.

FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (FMT Disposable and Autoclavable Temperature Probes). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the following information that you requested:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Sample size for the test set or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
• Information about a standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence, not on the detailed results of performance studies that would include the information you've asked for. Such details would typically be found in a separate performance study report submitted as part of the 510(k) application, but they are not included in this FDA clearance letter.

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The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

• Fully enclosed sensor helps ensure patient safety
• Satin Slip™ finish for easy insertion ●
• Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

• 1. Tube Blue
• 2. Sleeve GP
• 3. Thermistor Assembly
• 4. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

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The Emprint™ ablation system is intended for use in percutaneous, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Emprint™ ablation system is not intended for use in cardiac procedures.

The Emprint™ ablation system overlapping technique is only intended for use in the liver.

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014.

The Emprint™ Ablation System is a microwave-based ablation system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W, or 150W generator to deliver power to a single microwave ablation antenna. The Emprint™ Ablation 100W Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation 150W Generator utilizes software and firmware, however both generators' settings are controlled in the same fashion. Emprint™ Ablation Generators provide for user setting of ablation time (0-10 minutes) and ablation power (5 to 150W). With an optional temperature probe, the ablation generators can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.

The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient.

The 510(k) Cleared Emprint™ Ablation System consists of the following components:

• Emprint™ Ablation Generator (2450 MHz) ●
• Emprint™ HP Ablation Generator (2450 MHz) .
• EmprintTM Percutaneous Antenna (sterile, single use) ●
• Emprint™ Ablation Reusable Cable ●
• Emprint™ Ablation Pump ●

The system also includes the following optional equipment/accessories:

• . Emprint™ Ablation Cart (with Isolation Transformer)
• Emprint™ HP Ablation Cart (with Isolation Transformer)
• Ablation Footswitch ●
• Remote Temperature Probe (sterile, single use) ●

The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

The provided text does not contain information about the acceptance criteria or a study that proves a device (specifically an AI/machine learning device) meets acceptance criteria, as the Emprint Ablation System is a microwave ablation system, not an AI/machine learning device. The 510(k) submission for the Emprint Ablation System describes updates to the instructions for use (IFU) to include "overlapping" and "ramp-up" ablation techniques, which were already observed in published literature and clinician practice.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them for an AI/machine learning device based on the given input, as the device in question is a traditional medical device and the submission focuses on updating its IFU, not on AI/ML performance.

The "Performance Data" section (9.9) explicitly states:

• "Clinical Studies in human subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.2)
• "Studies or testing in animal subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.3)
• Bench testing was conducted to generate zone charts for updated techniques (9.9.1). This is a standard ex-vivo engineering characterization, not a clinical study involving AI/ML methods or human readers.

None of the points outlined in the prompt (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are relevant or discussed in the provided document, as it pertains to a physical medical device and not an AI/ML system.

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Reusable Temperature Probes:

Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Disposable Temperature Probes:

Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.

The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

The provided text describes the regulatory clearance of a medical device (Reusable and Disposable Temperature Probes) and its substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria through detailed performance metrics and a comparison to a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific study design elements (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are not present in the provided document.

However, I can extract the following information that is available:

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

The document mentions compliance with standards which inherently include performance criteria. Specifically, the "Accuracy" is listed.

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

• Sample Size for Test Set: Not specified. The document states "Non-clinical testing has been conducted to verify that the subject devices meet all design specifications." The exact number of units or measurements in these tests is not provided.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, Shenzhen SINO-K Medical Technology Co., Ltd., which is based in Shenzhen, Guangdong, China. The testing confirms compliance with international standards (IEC, ISO, ASTM).

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

• Number of Experts: Not applicable/not specified. The testing described is non-clinical performance testing against established international standards, not expert evaluation of medical images or diagnostic outputs.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This document describes objective performance testing against engineering standards, not a diagnostic study requiring expert adjudication.

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:

• MRMC Study: No. This device is a temperature probe, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, in the sense that the device's inherent performance (e.g., accuracy, measurement range) was demonstrated through non-clinical testing against standards (e.g., ISO 80601-2-56) without human interpretation of results beyond reading the device's output.

7. The type of ground truth used:

• Ground Truth Type: International standards (ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2), and established biocompatibility standards (ISO 10993 series). These specify acceptable ranges and methodologies for determining performance, forming the "ground truth" for compliance.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a hardware temperature probe, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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FMT Reusable Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Biolight, GE, HP/Philips, Mindray, MTRE, S& W, Siemens/Drager, Tecotherm.

These devices are used by qualified medical professional only.

FMT Reusable Temperature Probes

The provided text is a 510(k) clearance letter from the FDA for "FMT Reusable Temperature Probes." It acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance.

However, there is no information within the provided text regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about AI/ML algorithm validation.

This document is a regulatory approval, not a technical report detailing the performance evaluation of the device. Therefore, I cannot extract the requested information from the provided input.

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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 Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.

The probe is offered in the following two configurations:

• Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.

• Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.

Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable which is also included in the submission as an accessory. These probes have a skin or core contact with a patient.

These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.

Products are packed individually into a paper pouch in sterile condition.

The provided document is a 510(k) summary for a medical device (Sterile Disposable Temperature Probe). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device where performance metrics like accuracy, sensitivity, and specificity would be evaluated against a ground truth.

Instead, this document focuses on demonstrating substantial equivalence to an existing predicate device based on design specifications, intended use, and a series of non-clinical tests (biocompatibility, electrical safety, EMC, and compliance with general medical device standards like ISO 80601-2-56 for clinical thermometers).

Therefore, I cannot extract the information required to populate the table and answer the detailed questions about acceptance criteria for AI/ML performance, study design, sample size, expert adjudication, or MRMC studies. This type of information is not relevant to the 510(k) clearance process for this specific traditional medical device (a temperature probe).

The "Performance Data" section (Section 8) lists, for example, "Biocompatibility testing" and "Non-clinical data" showing compliance with various ISO and IEC standards. These are acceptance criteria in the sense of regulatory compliance for a temperature probe, but not performance metrics of an AI model.

Here's an attempt to structure what can be inferred from the document regarding acceptance criteria and performance, but it deviates significantly from the AI/ML context implied by the prompt's questions.

Based on the provided document, which describes a traditional medical device (Sterile Disposable Temperature Probe) and its 510(k) clearance, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to demonstrating substantial equivalence to a predicate device and compliance with relevant medical device standards, rather than the performance evaluation of an AI-powered diagnostic tool.

Therefore, most of the requested information (related to AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies) is not applicable to this document. I will fill in what can be inferred relating to the device's regulatory acceptance.

Acceptance Criteria and Device Performance (Regulatory Compliance)

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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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PlusCare Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for use by qualified medical personnel only.

The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only. Temperature probes measure temperature through a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

This document is a 510(k) Premarket Notification from the FDA regarding a temperature probe. It is not a document describing the acceptance criteria and study proving an AI/Machine Learning device meets acceptance criteria.

The information provided describes a traditional medical device (a temperature probe) and demonstrates its substantial equivalence to a predicate device. This process primarily relies on comparing design, materials, technological characteristics, and performance specifications, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the specific questions you've asked, which are highly relevant to AI/ML device evaluations, are not applicable to the content of this document. For instance:

• No AI/ML device: There is no AI component, so there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" to establish for AI, no "MRMC studies," no "standalone algorithm performance," and no "training set."
• Traditional device equivalence: The study instead focuses on demonstrating that the new temperature probe is "exactly the same" as a previously cleared predicate device in terms of its intended use, design, operating principle, materials, measurement range, accuracy, and compliance with relevant safety and biocompatibility standards (e.g., IEC 60601-1, ISO 80601-2-56, ISO 10993 series).

To answer your prompt based solely on the provided text, the response would be:

This document describes the 510(k) clearance for a traditional medical device, the PlusCare Temperature Probe, not an AI/Machine Learning enabled device. Therefore, the information requested regarding acceptance criteria and studies demonstrating performance for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable to this submission.

The "acceptance criteria" for this device relate to its ability to meet established performance standards for clinical thermometers and demonstrate substantial equivalence to a legally marketed predicate device (Unimed Temperature Probe, K121427). The study conducted was a non-clinical test data assessment to ensure compliance with recognized standards for safety, biocompatibility, and performance, demonstrating that the subject device's specifications (e.g., accuracy, measurement range) are identical to those of the predicate device.

Here's what can be extracted from the document relating to its clearance, even though it's not an AI device:

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

For a traditional device like a temperature probe, acceptance criteria are typically specified in recognized standards and internal company specifications. The document highlights the key performance characteristics that were compared and found to be "Same" as the predicate device, implying these represent the performance thresholds met.

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

• Not applicable for "test set" in the context of AI evaluation. This document does not describe patient-based clinical "test sets" for performance evaluation in the way an AI device would.
• The "testing" involved non-clinical lab tests to ensure the device itself met physical, electrical, and biocompatibility standards. The document doesn't specify sample sizes for these internal engineering or bench tests for components, but rather focuses on the device's adherence to established standards.
• Data Provenance: The testing was presumably conducted by the manufacturer (JKH USA, LLC). No country of origin for specific test data is provided, but the submission is to the US FDA. The tests are "non-clinical" which implies laboratory or bench testing, not patient data trials.

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. There is no "ground truth" established by experts in the context of interpreting medical images or data, as this is a measurement device, not an interpretative AI device. The ground truth for temperature measurement is established by calibrated reference thermometers and physical principles.

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

• Not applicable. No adjudication method for medical expert interpretations is relevant here. Performance is based on direct measurement and compliance with engineering/biocompatibility 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 relates to AI-assisted human performance, which is not relevant to a simple temperature probe.

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

• Not applicable. This describes an algorithm's performance without human interaction. This device is a sensor, not an algorithm.

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

• The "ground truth" for a temperature probe's accuracy is its ability to measure temperature precisely against traceable reference standards (e.g., highly accurate thermometers, known temperature baths).
• For safety and biocompatibility, the ground truth is compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).

8. The sample size for the training set

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

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

• Not applicable. As above.

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