Search Results

The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.

The DeRoyal Esophageal Stethoscope with Temperature Sensor is inserted into the esophagus of anesthetized patients to monitor core body temperature as well as heart and respiratory sounds. The probe consists of a small diameter plastic tube upon which a blue cuff is placed. When inserted in the esophagus, the cuff facilitates transmission of sound to an ear piece attached at the proximal end of the tube. Additionally, a wire set is placed inside the plastic tube. This wire set contains a thermistor chip at the distal end that passively modifies the electrical current traveling through the probe. A blue connector at the proximal end of the wire set interfaces with a cable that is connected to an independent temperature monitor that is used to display the temperature readings.

The probe is sterile and individually packaged. It is available in 9, 12, 18, and 24 French sizes and may come with 400 or 700 series sensors. The stethoscope has a male luer fitting for attachment to standard ear pieces.

The provided text describes a 510(k) submission for a medical device, the "DeRoyal Esophageal Stethoscope with Temperature Sensor". This submission is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT about proving an AI/ML algorithm's performance. It's about a hardware medical device (a stethoscope with a temperature sensor). Therefore, many of the requested points, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "ground truth for the test set," and "training set," are not applicable to this type of device submission.

The document discusses performance tests for manufacturing quality and safety, not for an AI model's diagnostic accuracy.

However, I can extract the relevant information regarding the device's acceptance criteria and the proofs provided within the scope of this hardware device submission.

Acceptance Criteria and Device Performance (for a Hardware Device)

The device in question is the DeRoyal Esophageal Stethoscope with Temperature Sensor. Its primary functions are:

1. Monitoring core body temperature.
2. Monitoring heart and respiratory sounds.

The submission aims to prove substantial equivalence to a predicate device, the DeBusk Temperature Systems Esophageal Stethoscope (K925789).

Here's a table summarizing the acceptance criteria (as implicitly defined by equivalence to the predicate and relevant standards) and the reported device performance:

Study Details (Relevant to Hardware Device Testing)

Since this is a hardware device and not an AI/ML algorithm, many of the requested categories are not directly applicable. I will address the relevant ones and explicitly state when a category is not applicable for this context.

1. A table of acceptance criteria and the reported device performance: (Provided above)

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

   • Sample Size: The document repeatedly states "All testing was performed on a final, finished device manufactured with the proposed modification." It does not specify a quantitative sample size (e.g., N units). This is typical for engineering verification and validation of medical devices where tests are performed on a representative sample of finished products to ensure design specifications are met.
   • Data Provenance: The testing was performed internally by the manufacturer (DeRoyal Industries, Inc.) or by contracted labs following specified standards (e.g., ISO, IEC). No information about "country of origin of the data" or "retrospective/prospective" studies in the clinical sense is provided as it's not a clinical trial of a diagnostic algorithm.

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

   • Not Applicable. This is a hardware device; "ground truth" in the AI/ML sense (e.g., expert labels on images) is not established. Device performance is measured against established engineering standards (e.g., temperature accuracy to $\pm$ 0.2°C, electrical safety limits). The "ground truth" is typically defined by metrological standards and calibrated reference instruments.

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

   • Not Applicable. Adjudication methods are relevant for subjective interpretations (like medical image reading). Hardware device testing involves objective measurements against predefined specifications.

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:

   • Not Applicable. This is a hardware medical device, not an AI/ML diagnostic system. No human reader studies or AI assistance are involved.

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

   • Not Applicable. There is no algorithm. The device's performance is inherently "standalone" in that its physical functions (temperature sensing, sound transmission) are tested directly.

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

   • Ground Truth: For temperature accuracy, the "ground truth" would be established by measurements using a highly accurate, calibrated reference thermometer in a controlled environment (e.g., a water bath at a known temperature). For electrical safety, the "ground truth" refers to compliance with the limits set by standards like IEC 60601-1. For acoustic responsiveness, it would be measured against expected sound transmission properties. This is about physical properties and engineering standards, not medical diagnoses.

8. The sample size for the training set:

   • Not Applicable. There is no AI/ML model, hence no training data or training set.

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

   • Not Applicable. As there is no training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stathoscopes are provided "packaged clean" and are for "single use" only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for an Esophageal Stethoscope. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance based on its similarity to existing devices. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria or a study from the given text. This type of information would typically be found in the 510(k) submission itself, or in associated test reports, which are not part of this FDA clearance letter.

Ask a specific question about this device

The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.

Esophageal Stethoscope

The provided text is a 510(k) clearance letter from the FDA for an "Esophageal Stethoscope." This document confirms the device's substantial equivalence to a legally marketed predicate device, allowing it to be marketed.

However, the letter does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on the regulatory aspects of the device, such as its classification, general controls, and the process for marketing it. It states the "Indications for Use" which define what the device is intended for, but not how its performance was measured or validated.

Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets acceptance criteria.

Ask a specific question about this device