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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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