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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

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

The document does not specify a distinct "test set" in terms of subject or patient count for overall device performance. The testing reported appears to be primarily bench testing and standard compliance verification rather than a clinical study with a human subject test set.

• Sample Size: Not applicable in the context of a "test set" for human patients for performance, as the study focuses on bench testing and mechanical/electrical characteristics. The "samples" would refer to the probes themselves tested for accuracy, time response, safety, and EMC. The document does not specify the number of probes tested for each criterion.
• Data Provenance: The studies were conducted as non-clinical testing. There is no indication of country of origin for this specific testing, nor whether it was retrospective or prospective in a clinical setting. It is assumed to be prospective engineering and laboratory testing.

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

Not applicable. This device is a temperature probe, and its performance (e.g., accuracy, time response) is assessed against objective engineering standards and specifications, not against a "ground truth" established by human experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is measured against objective standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for AI/image interpretation devices to assess the impact of AI assistance on human reader performance. This device is a temperature probe, not an AI-based diagnostic tool.

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

Yes, in essence. The "Performance" section explicitly states "Laboratory accuracy" and "Time response" were tested. While the probe needs to be connected to a monitor (EDAN model iM50), the accuracy and time response are inherent characteristics of the probe itself in combination with the specified monitor, and these tests are conducted in a controlled, standalone manner (i.e., without human interpretation or intervention in the measurement process). The safety, EMC, and usability tests are also "standalone" in the sense of directly evaluating the device's compliance with technical standards.

7. The Type of Ground Truth Used

The ground truth for the performance claims (accuracy, time response) would be established by:

• Reference Standards: Highly accurate, calibrated temperature measurement devices used in a laboratory setting.
• Industry Standards: Compliance with established international standards such as ISO 80601-2-56 for essential performance and IEC 60601-1/-2 for safety and EMC.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (temperature probe), not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable, for the reasons stated in point 8.

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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.

Notes on the Table:

• The document doesn't explicitly state "acceptance criteria" as a separate list, but rather "Performance Data" which includes the tests conducted and their "Pass" results, demonstrating compliance with established standards and equivalence to the predicate.
• The "Accuracy" value listed under "Features" in the comparison table (±0.1°C) is more stringent than the general laboratory accuracy acceptance criterion (Not greater than 0.3 °C). However, the document states Pass for the laboratory accuracy test, implying it met the more stringent ±0.1°C as well, given the direct comparison to the predicate.

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

The document does not specify the sample size used for the performance tests (e.g., how many probes were tested for accuracy, biocompatibility, etc.).

• Data Provenance: Not explicitly stated as "country of origin" for the test data itself (e.g., where the lab tests were conducted). However, the manufacturer is Shenzhen Caremed Medical Technology Co., Ltd. in China, and the correspondent is also in China, suggesting the testing likely occurred there or was overseen by the Chinese entity preparing the submission.
• Retrospective or Prospective: The testing described (biocompatibility, electrical safety, EMC, laboratory accuracy, time response) appears to be prospective testing conducted specifically for the purpose of this 510(k) submission, rather than retrospective analysis of existing data.

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

This type of information is not provided in the document. For a temperature probe, "ground truth" for performance would typically be established by calibrated laboratory equipment and standard test methods (e.g., temperature baths, reference thermometers) rather than human experts. Biocompatibility testing follows laboratory protocols and analysis by qualified lab personnel.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication" usually refers to a process where multiple human readers or experts review data and resolve discrepancies to establish a consensus ground truth. This is not how performance data for a temperature probe is typically validated; it relies on objective physical measurements and standardized test procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging AI devices where human interpretation is a critical component, to assess how AI assistance impacts human reader performance. This device is a measurement tool, not an AI diagnostic tool.

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

This question is not applicable in the context of this device. The disposable temperature probe is a physical measuring device, not an AI algorithm. Its performance is inherent in its design and manufacturing, not an algorithm that operates independently. The device's performance characteristics (accuracy, time response) are "standalone" in that they are measured directly from the device's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

• Standardized laboratory measurements: Using calibrated equipment and following established international standards (e.g.,
  • ASTM E1112 for "Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature" (implied for accuracy)
  • ISO 80601-2-56 for "Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement" (referenced for EMC and time response)
  • IEC 60601-1 for "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" (referenced for electrical safety)
• Biocompatibility testing: Following ISO 10993 series standards, which involve in-vitro and/or in-vivo tests to assess biological responses.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "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 this 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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