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 ± 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.

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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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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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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.

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Esophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B: The CSZ sesphageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or medal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.

Boohageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24: The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal caperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.

Disposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor s processed and displayed by the monitoring unit.

The provided text describes a 510(k) submission for Esophageal/Rectal Temperature Probes and Esophageal Stethoscopes with Temperature Sensors. This submission focuses on demonstrating substantial equivalence to predicate devices and does not detail an AI device or a study involving acceptance criteria for AI performance. Therefore, I cannot generate the requested information based on the provided text.

The document discusses:

• Device Name: Esophageal/Rectal Temperature Probe, and Esophageal Stethoscope With Temperature Sensor Probe
• Manufacturer: Cincinnati Sub-Zero Products, Inc. (CSZ)
• Intended Use: Continuous measurement of core body temperature through the esophagus or the rectum.
• Comparison to Predicate Devices: Smiths Level 1 Esophageal/Rectal Temperature Probe and Esophageal Stethoscope With Temperature Sensor Probe.
• Non-clinical Tests: Testing was done in accordance with BS EN 12470-4, Clinical Thermometers.
• Conclusion: The CSZ products meet the requirements of EN 12470-4 for Clinical Electronic Thermometers, and are therefore considered as safe and effective as the predicate device.

None of this information pertains to an AI device, its acceptance criteria, or related studies.

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Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".

The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end. A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.

The provided text describes a 510(k) premarket notification for the "Lifesound Esophageal Stethoscope and Temperature Sensor." This document focuses on demonstrating substantial equivalence to previously approved predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with defined quantitative metrics.

Here's a breakdown of the requested information based on the provided text, and where information is not available due to the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) premarket notification. For devices like an esophageal stethoscope, often the "acceptance criteria" are demonstrating substantial equivalence to pre-existing, legally marketed devices. There are no explicit quantitative performance criteria or a study designed to measure and report against them in this document. The "performance" section explicitly states "None applicable." The device's performance is assumed to be equivalent to the predicate devices.

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

• Sample Size: Not applicable. The document does not describe a performance study with a test set of data/patients. The submission relies on a comparison to predicate devices, inferring their established safety and effectiveness.
• Data Provenance: Not applicable. There is no performance data presented in the document itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no ground truth established for a test set in this 510(k) submission as no new clinical or performance study data is presented.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. This device is a passive medical instrument (stethoscope/temperature sensor). MRMC studies are typically for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret and make decisions. This submission does not involve such a study.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted or described.

7. Type of Ground Truth Used

• Not applicable. No ground truth is established or used within the context of a performance study for this submission. The "ground truth" for a 510(k) submission like this is essentially that the predicate devices are already deemed safe and effective.

8. Sample Size for the Training Set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm. Therefore, there is no training set involved.

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

• Not applicable. As there is no training set, no ground truth needed to be established for it.

Summary of the Study (or lack thereof) for Device Acceptance:

The "study" that proves the device meets "acceptance criteria" in this context is the 510(k) Substantial Equivalence pathway. The applicant, NovaMed LLC, demonstrates that their "Lifesound Esophageal Stethoscope and Temperature Sensor" is substantially equivalent to two legally marketed predicate devices:

1. Biomedical Concepts (NovaMed) esophageal stethoscope (K864858)
2. Shore Medical (K982193)

The key arguments for substantial equivalence are:

• Intended Use: Identical (esophageal stethoscope for heart/breath sounds, optional temperature sensing).
• Technological Characteristics: Similar design, materials (PVC for air pathway), and functional principles. The temperature sensor is compatible with standard YSI 400/700 series.
• Performance: The document explicitly states "Performance: None applicable," indicating that for this type of device and submission, no new performance data was required to establish substantial equivalence beyond the design and material comparison. The FDA's letter concurs with the substantial equivalence determination based on the provided information.

Thus, the device meets its "acceptance criteria" not through a new performance study with quantitative results, but by demonstrating that it is as safe and effective as devices already on the market through a detailed comparison of its features and intended use.

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GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only.

Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam naterial on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only.

Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and connes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Disposable temperature probes (Table below) are used during patient temperature measurement. These probes consist of the "Molex" plug connector on the adapter cable end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only. Esophageal stethoscopes with temperature probes have a dual role, in addition to temperature probe they can be used also as a stethoscope. The temperature 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. These probes have skin or core contact with a patient. Probes are shipped in sterile condition and there is a shelf life declared for each manufacturing batch.

The provided text describes disposable temperature probes and does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets the criteria, or any other related information for an AI/ML device.

The document discusses the regulatory submission (510(k)) for various types of disposable temperature probes (skin, general purpose, and esophageal with stethoscopes). The core of the submission focuses on the substantial equivalence of these probes to previously marketed predicate devices.

Key points from the document regarding the physical probes:

• Acceptance Criteria for the physical device: While specific numerical acceptance criteria for performance (e.g., temperature accuracy limits) are not explicitly detailed in the provided summary, the document states that the devices have been "thoroughly tested through validation and verification of specifications" against several standards. These standards implicitly define the performance acceptance criteria.
  • Relevant standards mentioned:
    • IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
    • IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient monitoring equipment)
    • EN 12470-4, Performance of Electrical Thermometers (This standard would contain specific performance criteria for electrical thermometers, including accuracy).
    • 21 CFR Part 898 (Likely pertains to performance standards for clinical electronic thermometers)
    • ISO 15223:2000, EN 980+A1+A2 (Labeling and symbols)
    • ISO 10993-x (Biological evaluation/biocompatibility)
    • ISO 14971:2000 (Risk management)
    • 510(k) Sterility Review Guidance K90-1 (Sterility)
• Study Proving Acceptance Criteria: The document states that "The disposable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications." This indicates that studies (validation and verification testing) were performed to confirm compliance with the aforementioned standards. However, the details of these studies (e.g., sample sizes, specific test protocols, precise results against numerical thresholds) are not provided in this summary.
• Data Provenance/Sample Size/Experts/Adjudication/MRMC/Standalone/Ground Truth/Training Set: These questions are not applicable to the provided document, as it describes a physical medical device (temperature probes) and not an AI/ML software. The document focuses on the hardware's compliance with established safety and performance standards.

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