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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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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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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 disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.

Disposable temperature probe is used during patient temperature measurement. The probe consists of a phone plug connector on the adapter cable end and a thermistor on the patient end. The probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable.

The probe is used with legacy Edan Instruments, Inc. patient monitors iM50, which was cleared under K113623.

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

The provided text is a 510(k) Summary for a disposable temperature probe. Based on the content, the acceptance criteria and the study proving the device meets these criteria can be described as follows:

Acceptance Criteria and Device Performance Study for a Disposable Temperature Probe

This medical device is a Disposable Temperature Probe. The acceptance criteria and the performance study were conducted to demonstrate substantial equivalence to a predicate device (Caremed Disposable Temperature Probe K182755).

1. Table of Acceptance Criteria and Reported Device Performance

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Rectal Temperature Probe:

The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Skin Temperature Probe:

The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Disposable temperature probes are used during patient temperature measurement. These probes consist of a 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. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.

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 ".

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.

Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.

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The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.

The provided text describes the acceptance criteria and the study that demonstrates the performance of the Disposable Temperature Probe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any test sets (e.g., for accuracy, biocompatibility, electrical safety, or EMC). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It generally states that "Non-clinical testings have been conducted" and refers to compliance with international standards.

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

This information is not provided in the document. The document refers to compliance with international standards for performance and safety tests, which typically involve laboratory testing rather than expert-established ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not provided in the document. As mentioned above, the tests described are primarily engineering and laboratory-based, not clinical studies requiring adjudications.

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

An MRMC comparative effectiveness study was not conducted. This device is a disposable temperature probe, which is a physical measurement device, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

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

This concept is not applicable to this device. The Disposable Temperature Probe is a sensor; it does not contain an algorithm in the sense of AI or image analysis. Its performance is evaluated through direct physical measurements against established standards.

7. The type of ground truth used

For accuracy, the ground truth would be precise temperature measurements from calibrated reference instruments or environments during laboratory testing. For biocompatibility, the ground truth is established by the accepted biological responses to materials as defined by ISO 10993 standards. For electrical safety and EMC, the ground truth is compliance with the limits and conditions specified in the respective IEC standards.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable.

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

As there is no training set for this device, this information is not applicable.

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Skin Temperature Sensor (400-STS)

The Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin.

Tympanic Temperature Sensor (400-TY, 400-TYP)

The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane.

Interconnect Instrument Cables (C400MP-M, C400MP-MJ, C400P-M, and C400M-MJ)

The instrument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.

The Starboard Medical temperature sensors are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The sensors are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature sensors or equivalent. The Interconnect Instrument cables are used to interconnect the disposable temperature probe / sensor with the patient monitor.

This 510(k) includes the following probes:
400-SK (Skin Temperature Sensor)
400-TY (Tympanic Temperature Sensor - Adult)
400-TYP (Tympanic Temperature Sensor - Pediatric)
C400MP-M (Interconnect Instrument Cable)
C400MP-MJ (Interconnect Instrument Cable)
C400P-M (Interconnect Instrument Cable)
C400P-MJ (Interconnect Instrument Cable)

The probes / sensors are single use, and they are sterile.

The provided text describes Starboard Medical's Disposable Temperature probes/sensors and Interconnect Instrument Cables. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria.

Therefore, for aspects of your request that require such detail (e.g., specific acceptance criteria values, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), the information is not available in the provided document.

Here's an analysis based on the available information:

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

This information is not explicitly provided in the given text. The document states: "Both devices have been subjected to materials bio-compatibility testing, accuracy testing, and electrical testing and comparison." It then concludes: "We believe the differences between the Starboard Medical devices and the predicate devices are minor, and conclude that the subject devices are as safe and effective as the predicate devices, therefore substantially equivalent to the predicate devices." This implies that existing performance standards for similar devices were met, but the specific numerical acceptance criteria and reported device performance values are not detailed.

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

This information is not available in the provided text. The document mentions "accuracy testing" but does not specify the sample size or the data provenance.

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

This information is not available in the provided text. The study discussed involves physical device performance (temperature measurement), not expert interpretation of medical images or data. Therefore, the concept of "experts establishing ground truth" in that context is not applicable.

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

This information is not applicable/available from the provided text. As mentioned above, the study focuses on physical device performance, not expert review or 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

This information is not applicable/available from the provided text. This study pertains to a temperature sensor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with AI assistance would not be relevant.

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

This information is not directly applicable/available as presented. The device is a physical temperature sensor, not a standalone algorithm. The "performance data" refers to the device's accuracy in measuring temperature.

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

Based on the nature of the device (temperature sensor), the ground truth for "accuracy testing" would typically be established by a highly accurate reference thermometer or calibrated temperature source. The document does not explicitly state this, but it is the standard method for validating temperature measurement devices.

8. The sample size for the training set

This information is not applicable/available in the provided text. The devices are hardware temperature sensors, not machine learning algorithms that require a "training set."

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

This information is not applicable/available in the provided text. As explained above, the concept of a "training set" for this type of device is not relevant.

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Skin Temperature Sensor (487M and 499B): The CSZ skin temperature sensor is intended for use in routine continuous monitoring skin temperature when the other sensors which might better reflect core body temperature are not indicated clinically. The sensor is designed for placement on the surface of the skin.

Tympanic Temperature Sensor (495M and 495M-P): The tympanic temperature sensor is intended for use in routine continuous monitoring tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated.

Instrument Cables (4872MS and 4900B): The intended use of the instrument cable is to interconnect the disposable temperature sensor/probe with the temperature monitoring instrument.

The basic component of these sensors is a resistance chip, which is sensitive to changes in temperature. The chip is in the form of "400" series thermistor connected to a lead wire and encapsulated in a PVC cup. At the end of the lead wires an insert molded connector or standard phone connector provides for the interconnection with the instrument cable.

These sensors are inserted in the structure that fits specific anatomy where the temperature is measured.

The skin sensor is placed on the surface of the skin and is a part of the foam enclosure which provides thermal insulation for more accurate temperature measurement.

The tympanic probe is designed for placement in proximity to the tympanic membrane, The probe incorporates a small foam tip for atraumatic insertion and a large compressible foam cylinder for securement and thermal insulation.

The distal end of the skin sensor and the tympanic sensor is terminated with a Molex or phone connector for interconnection with the instrument cable.

The probes are individually packaged in sterilizable bags. There are 20 probes per box and 10 boxes per shipping carton. Probes are ethylene oxide sterilized.

The following probes and cables are included in this 510k application:

Probes:

Skin Temperature Sensor (487M, 499B) Tympanic Temperature Sensor (495M, 495M-P) Cables (4872MS, 4900B)

These probes can be used with Smith's Level 1 TM-200 temperature/monitors or any other multi-channel patient monitor compatible with the "400" series thermistors or equivalent.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:

Device: Disposable Temperature Probes (Skin Temperature Sensor, Tympanic Temperature Sensor)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text for non-clinical tests.
• Data Provenance: The tests were conducted in "the laboratory" of the manufacturer (Cincinnati Sub-Zero Products, Inc). This implies the data is retrospective and likely from in-house testing. No country of origin for specific testing data is mentioned beyond the company's location in Ohio, USA.

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

• Not applicable. The study is a non-clinical, laboratory-based assessment against standards and comparison to a predicate device. It does not involve human expert interpretation of device output in a diagnostic or clinical context.

4. Adjudication Method for the Test Set

• Not applicable. This was a non-clinical testing and comparison study, not a study requiring adjudication of expert interpretations.

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 is a temperature probe, not an imaging or diagnostic AI device that would typically undergo an MRMC study.

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

• Yes, effectively. The "study" described is a standalone non-clinical evaluation of the device's technical specifications, safety, and performance against established standards and comparison to a predicate device. It assesses the device's inherent characteristics without directly involving human-in-the-loop performance for interpretation or decision-making.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on technical standards and specifications for thermistors and medical devices (e.g., "400" series thermistor requirements, IEC, ISO standards for accuracy, safety, biocompatibility) and comparison to the established performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware temperature probe, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable as there is no training set for this type of device.

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