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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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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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Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.

The probes are indicated for use by qualified medical personnel only.

Prescription use only.

Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.

Sensatronic Reusable Temperature Probes are constructed with the following features:

• . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
• . Two internal conductors for connection to the thermistor
• . Internal Kevlar fibers for strength and pull resistance
• Biocompatible outer jacket of thermoplastic rubber (TPR)
• . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
• The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
• 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Sensatronic Reusable Temperature Probes:

Acceptance Criteria and Device Performance

Study Information

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

   • The document does not specify a numerical sample size for the test set in terms of individual devices tested for each criterion. The studies are referred to as "laboratory tested."
   • Data Provenance: The studies were "laboratory tested," implying a controlled environment. The country of origin of the data is not explicitly stated, but the manufacturer is Sensatronic GmbH, located in Germany, suggesting the testing likely occurred there or at a contract lab. The studies were non-clinical.

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 temperature probe, and its performance is evaluated against physical standards (e.g., NIST-traceable temperature references) and established engineering/medical device standards, not against human expert interpretation of data. Therefore, "ground truth" here refers to objective measurements and standard compliance.

3. Adjudication method for the test set:

   • Not applicable. Performance is determined by objective measurement against established standards and criteria, not by expert adjudication.

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. This is a medical device for temperature measurement, not an AI or imaging diagnostic software. Therefore, an MRMC study is not relevant.

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

   • Yes, in essence. The testing performed was primarily "standalone" in the sense that the device's technical performance (accuracy, electrical safety, EMC, durability, sterilization efficacy, biocompatibility, etc.) was evaluated objectively against predefined standards, without direct human-in-the-loop performance in a clinical diagnostic sense. Its function is to provide a measurement, which is then used by human medical personnel. However, the term "standalone" is usually used in the context of AI algorithms, which isn't the case here.

6. The type of ground truth used:

   • The ground truth consists of established engineering and medical device standards, physical measurement references, and predefined performance criteria. For instance, temperature accuracy is measured against traceable reference thermometers, and safety/EMC against the limits specified in the relevant IEC standards. Biocompatibility results are compared against the limits defined in ISO 10993.

7. The sample size for the training set:

   • Not applicable. This device is a hardware product (temperature probe), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The design and manufacturing processes are likely iterative, but this is not a "training set" in the sense of data used to train an algorithm.

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

   • Not applicable for the same reason as point 7.

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Med-link Reusable Temperature Probes:

Med-link 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 Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL.

These devices are used by qualified medical professional only.

Med-link Disposable Temperature Probes:

Med-link 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 Model B20 and Philips Model IntelliVueMP50.

These devices are used by qualified medical professional only.

The proposed devices are used for patient temperature measurement. The probes are reusable 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 proposed devices are designed to be used in healthcare facilities like hospital.

The provided text describes the 510(k) summary for Med-link Reusable and Disposable Temperature Probes. While it outlines the device's characteristics and comparison to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of AI/ML algorithm evaluation.

The document states:

• "No clinical studies were performed to demonstrate substantial equivalence." (Section 10)
• The non-clinical tests focused on safety, essential performance, and biocompatibility in accordance with relevant IEC and ISO standards for medical electrical equipment and biocompatibility. The performance standard cited is ISO 80601-2-56 for body temperature measurement.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML algorithm's performance, as this document is for a traditional medical device (temperature probes) and does not involve AI/ML.

However, I can extract the reported device performance and testing information that is present in the document for the temperature probes themselves, which is related to the accuracy of the temperature measurement.

Reported Device Performance (for the temperature probes, not an AI/ML algorithm):

Regarding the other requested information for AI/ML algorithms:

1. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML algorithm. Non-clinical tests were performed to assess safety and effectiveness against standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device calibration and accuracy testing typically refer to established laboratory methods and reference standards, rather than expert interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device itself is standalone in its function as a temperature probe; there is no AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For temperature accuracy, the ground truth would typically be established by calibrated reference thermometers in a controlled environment, adhering to the requirements of the relevant performance standards (e.g., ISO 80601-2-56).
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor 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 either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

The provided text describes the performance data for the Reusable Temperature Probe (Models: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) in support of its substantial equivalence determination.

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

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

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The reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.

These devices are indicated for use by qualified medical personnel only.

Reusable temperature probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are used during patient temperature measurement. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only.

Temperature probes measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175).

Products are packed individually into a plastic bag in non-sterile condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution "Rx Only (USA), U.S. Federal law restricts this device to sale by or on the order of a physician."

This is an interesting case where the provided document is a 510(k) summary for a medical device that isn't AI-powered. Therefore, much of the requested information about AI model performance, ground truth, and expert evaluation is not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study proving the non-AI device meets those criteria from the provided text.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study or AI performance metrics. Instead, it refers to compliance with established international and national standards for medical devices, particularly regarding safety and performance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is referred to as "validation and verification of specifications" against the listed standards. This is not a clinical study with human subjects, but rather a series of engineering and quality assurance tests. The document states: "The reusable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications."

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

This is not applicable as the device is a physical temperature probe and not an AI algorithm processing data. The "test set" refers to the specific probes manufactured and subjected to testing to ensure compliance with the standards. There is no mention of a fixed "sample size" for a data test set in the context of AI.

The data provenance, again, is not applicable in the AI sense. The "data" here would be the measurements and test results from the physical probes themselves during their validation and verification.

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

This is not applicable. Ground truth, in the context of AI, refers to annotated data. For a physical device like a temperature probe, the "ground truth" for accuracy is typically established by comparing the probe's readings to highly accurate reference thermometers traceable to national standards, carried out by laboratory technicians or engineers, not medical experts establishing a diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1 for resolving disagreements among human annotators) are relevant for establishing ground truth in AI training or evaluation data. For physical device testing, the methods involve standardized test procedures and measurement comparison.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable as the device is a physical temperature probe, not an AI algorithm assisting human readers. Therefore, no MRMC study looking at human reader improvement with AI assistance would have been conducted or is relevant.

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

This is not applicable for the same reason as above. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of these temperature probes (specifically accuracy) would be established by comparison to reference standards (e.g., highly accurate, calibrated thermometers in a controlled environment), not expert consensus, pathology, or outcomes data. The document explicitly mentions "accuracy in 32 to 42° C range" among its similarities to the predicate device, suggesting this was a key performance metric evaluated against an objective standard.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This is not applicable as this is a physical medical device, not an AI model.

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