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Indications for Use:
• The Clarisonus Plus Esophageal Stethoscope with temperature sensor with attached earpiece is intended for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds.
• The Esophageal Stethoscope with temperature sensor is intended for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds.
• The Esophageal/Rectal Temperature Probe is indicated for continuous monitoring of esophageal, rectal, and nasopharyngeal temperatures.
The products are intended for use in surgical and critical care patients.

Esophageal Stethoscope has been used in clinical application for continuous measurement of temperature and auscultation of heart and lung sounds. Esophageal Stethoscope is used in anesthetized patients and is placed inside of esophagus.

The stethoscope consists of a sound transmitting part and a temperature monitoring part. Sound transmitting part consists of a PVC tube whose distal end has openings at the end and the side of the tube. The distal end is covered with a flexible membrane in form of a cuff. The proximal end of the tube has a Luer lock connector for the connection to the anesthesiologist monoscope with earpiece. Heart and lung sounds are transmitted across the esophageal wall and across the cuff membrane through distal openings into the PVC tube. The sound waves travel through the tube into the anesthesiologist monoscope and into the anesthesiologist's ear.

The temperature monitoring part consists of thermistor sub-assembly whose temperature sensing tip is placed inside of the PVC tube to the tube's distal end. On its proximal end, it terminates with an electrical connector for the connection to the patient monitoring system.

When in application, the sound transmitting part of the stethoscope is connected to a custom made connecting line with an earpiece or disposable monoscope. In many' situations the anesthesiologist forgets the earpiece or monoscope so that the auscultations of the heart and lung sounds are not performed.

The proposed device incorporates the esophageal stethoscope and a monoscope in a single unit which would provide the anesthesiologist with an ease of application. The earpiece at the end of the connecting line is made of a memory ear plug. Prior to the insertion, the foam is squeezed and placed inside of the ear canal for auscultation of heart and lung sounds.

The Esophageal stethoscope with temperature sensor and Esophageal/Rectal temperature probe are non-sterile version of predicate device K111050.

The provided 510(k) summary for K140134 describes the device and its substantial equivalence to predicate devices, but does not contain acceptance criteria for device performance or detailed study information typically found in a clinical trial report. The document focuses on regulatory compliance for device marketing based on substantial equivalence, rather than a detailed performance study with acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely inferred from the claim of substantial equivalence to the predicate device (K111050). The document states: "This device is substantially equivalent to the predicate devices based on material, technology, manufacturing processes, and performance." This means the new device is expected to perform at least as well as the predicate device in terms of safety and effectiveness, based on previous FDA clearances. The actual numerical acceptance criteria for temperature accuracy, for example, would be found in the documentation for the predicate device K111050.

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

• The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective).
• The "Performance Data" section mentions "bio-compatibility testing, accuracy testing, and electrical testing and comparison," but these are general categories of tests, not descriptions of a clinical or comparative study with a 'test set' in the traditional sense of evaluating an algorithm. This device is a hardware product, and the testing described appears to be bench testing and materials testing rather than a clinical trial with human subjects.

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

• Not applicable. This document describes a physical medical device (temperature probes/stethoscopes), not a data-driven algorithmic device that requires expert-established ground truth for a test set. The "accuracy testing" mentioned would typically involve comparing the device's temperature readings against a known, highly accurate reference standard (e.g., a calibrated thermometer in a controlled environment).

4. Adjudication Method for the Test Set

• Not applicable. As there is no mention of a formal 'test set' requiring expert review or adjudication in the context of an algorithm's performance, no adjudication method is described.

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

• No. An MRMC comparative effectiveness study was not done or described. This type of study is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging) to assess how AI assistance impacts human reader performance. This device is a direct measurement and auscultation tool.

6. Standalone Performance Study (Algorithm Only)

• No. This device is a physical product, not an algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance data described ("bio-compatibility testing, accuracy testing, and electrical testing") evaluates the physical device itself.

7. Type of Ground Truth Used

• For "accuracy testing," the ground truth would typically be established by a highly accurate reference measurement system (e.g., a calibrated thermometer or temperature bath) against which the device's temperature readings are compared.
• For "bio-compatibility testing," the ground truth is established by validated laboratory assays and standards (e.g., ISO 10993 series for medical devices) that determine if materials are cytotoxic, irritating, or sensitizing.
• For "electrical testing," the ground truth is established by electrical safety standards (e.g., IEC 60601 series).

8. Sample Size for the Training Set

• Not applicable. This document describes a physical medical device, not a machine learning 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 an algorithm, there is no ground truth established for it.

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Esophageal / Rectal temperature probe (4009-ER and 40012-ER):

The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum.

Esophageal Stethoscope with temperature sensor (4009-ES, 40012-ES, 40018-ES, and 40024-ES):

The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.

The Starboard Medical temperature probes are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The probes are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature probes or equivalent.

This 510(k) includes the following probes:

4009-ER (Esophageal / Rectal temperature probe - 9FR) 40012-ER (Esophageal / Rectal temperature probe - 12FR) 4009-ES (Esophageal Stethoscope with temperature sensor - 9FR) 40012-ES (Esophageal Stethoscope with temperature sensor - 12FR) 40018-ES (Esophageal Stethoscope with temperature sensor - 18FR) 40024-ES (Esophageal Stethoscope with temperature sensor - 24FR)

The probes are single use, and they are sterile.

This is a 510(k) summary for a set of disposable temperature probes/sensors, not an AI device. Therefore, the typical acceptance criteria and study mechanisms for AI-driven devices (like those involving test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies) are not applicable here.

The provided text describes a medical device clearance process for temperature probes, which relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific AI-related metrics.

Here's a breakdown of the relevant information provided:

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

The document does not specify quantitative acceptance criteria in the way an AI device would have accuracy or F1 scores. Instead, the "acceptance criteria" are based on the device's characteristics being "substantially equivalent" to predicate devices.

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

This information is not applicable. The device is a physical temperature probe, not a software algorithm that processes dataset inputs. Performance was assessed through engineering tests, not a clinical trial with a "test set" in the AI sense.

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 is not applicable. Ground truth, in the context of AI, refers to annotated data. For a temperature probe, performance is verified through metrological accuracy testing, not expert consensus on interpretations.

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

This is not applicable. There was no "test set" in the AI sense that required 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 is not applicable. An MRMC study is relevant for AI assistance to human readers, which is not the nature of this device.

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

This is not applicable. This is a standalone physical medical device (temperature probe), not a standalone AI algorithm.

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

This is not applicable in the AI sense. The performance of the temperature probes would be validated against calibrated temperature standards, which serves as the "ground truth" for temperature measurement accuracy.

8. The sample size for the training set

This is not applicable. There is no AI training set for this device.

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

This is not applicable. There is no AI training set for this device.

Summary of Device Performance Testing from the Document:

The document mentions that the devices underwent:

• Raw materials bio-compatibility testing: To ensure the materials are safe for patient contact.
• Accuracy testing: To verify that the temperature measurements are accurate. This would involve comparing the probe's readings against a known, accurate temperature source (the "ground truth" for a physical sensor).
• Electrical testing and comparison: To ensure electrical safety and performance, often compared against established standards or predicate devices.

The conclusion is that these tests support the claim that the differences between the new devices and the predicate devices are minor, establishing substantial equivalence.

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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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