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The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body temperature.

The Foley Catheter with Temperature Sensor is used for drainage of the urinary bladder and simultaneous monitoring of core body temperature. The device consists of a temperature-sensing wire set secured inside the lumen of a silicone Foley catheter. It is available in 14, 16, and 18 French size catheters. The French size and balloon volume are designated on the device itself. The wire set contains a thermistor chip, which is located near the distal tip of the catheter. The thermistor passively modifies the electrical current traveling through the wire set. A blue connector is located at the proximal end of the device. This connector interfaces with a cable that is connected to an independent temperature monitor used to display temperature readings. The catheters are individually packaged and sold sterile. The subject device is identical to the predicate device with the exception of the encapsulation method of the thermistor chip.

This document describes the regulatory approval for a medical device, specifically a "Foley Catheter with Temperature Sensor." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets strict acceptance criteria through a clinical study in the way an AI/ML device might.

Therefore, many of the typical acceptance criteria and study details requested in your prompt (such as "sample size used for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details") are not applicable to this document. This is because the device is a piece of hardware (a catheter with a temperature sensor), not an AI/ML diagnostic tool.

The document primarily relies on bench testing and biocompatibility testing to prove safety and effectiveness, ensuring the modified device performs similarly to its predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is not:

• Device Type: Hardware Medical Device (Foley Catheter with integrated temperature sensor).
• Purpose: Drainage of the urinary bladder and simultaneous monitoring of core body temperature.
• Regulatory Pathway: 510(k) Premarket Notification – seeking substantial equivalence to a legally marketed predicate device.

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

The document does not provide a quantitative table of acceptance criteria with specific numerical targets and reported performance values for accuracy, sensitivity, or specificity in a clinical context. Instead, it refers to compliance with established medical device standards.

Acceptance Criteria (as implied by the document):

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

• Sample Size: The document does not specify exact sample sizes for the test set in terms of clinical cases or human subjects. The testing described (biocompatibility, electrical safety, accuracy, time response, leakage current) was performed on "final, finished products manufactured with the proposed modification." This implies a bench test or laboratory setting with a statistically relevant number of manufactured units, rather than a clinical trial with patient data.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from laboratory and bench testing of the manufactured devices. It is implied to be prospective testing of newly manufactured devices.

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)

• N/A. This information is not relevant for a hardware device undergoing bench and biocompatibility testing. Ground truth (e.g., true temperature) would be established by calibrated reference instruments in a laboratory setting, not by human experts interpreting data or images.

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

• N/A. No adjudication method is mentioned or relevant, as there is no human interpretation or consensus-building involved in the testing described.

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

• N/A. This is a hardware device, not an AI/ML system. No MRMC comparative effectiveness study was conducted or is applicable.

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

• N/A. This is a hardware device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "standalone" performance as a hardware unit is demonstrated through the laboratory testing against standards (e.g., accuracy of the temperature sensor).

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

• For temperature accuracy: The ground truth would be established by a primary, highly accurate, and calibrated temperature standard in a laboratory environment, as per ISO 80601-2-56.
• For electrical safety/leakage: Ground truth is defined by the limits set in the relevant IEC standards.
• For biocompatibility: Ground truth is established by the cellular responses or systemic effects observed in validated biological assays following ISO 10993 standards.

8. The sample size for the training set

• N/A. This device does not use machine learning or AI, so there is no "training set."

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

• N/A. As there is no training set, this question is not applicable.

Summary of Device Performance and Equivalence Claim:

The core of the submission is to demonstrate that the small change in the thermistor chip's encapsulation method does not alter the device's safety or effectiveness compared to the predicate. The document concludes:

"The results of performance testing demonstrate the Foley Catheter with Temperature Sensor is as safe and effective as the predicate. The proposed device is substantially equivalent to the predicate."

This 510(k) summary focuses on engineering validation and compliance with standards rather than clinical study results typically associated with AI/ML device clearances.

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Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):

The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days.

The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.

Disposable Foley catheters with temperature probe are used for drainage of the urinary bladder and simultaneous patient temperature measurement. These Foley catheters with temperature probe consist of the "Molex" plug connector on the adapter cable end, urine output flow path with a balloon and a thermistor inside the catheter. These probes are to be used with 400-series compatible temperature measurement systems only. 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 catheters have a skin and core contact with a patient. Catheters are shipped in sterile condition and there is a shelf life declared for each manufacturing batch. These Foley catheters with temperature probe can be used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed products (inside a plastic/ paper pouch) in sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA). U.S. Federal law restricts this device to sale by or on the order of a physician." There is one instruction for use insert in the sales package of 25 probes.

The provided document is a 510(k) Premarket Notification for Foley catheters with temperature probes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy for a diagnostic AI device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type, training set sample size, how training ground truth was established) are not applicable or not provided in this type of submission.

This submission is for a physical medical device (catheter with a temperature sensor), not an AI/ML-driven diagnostic or prognostic device that would typically involve the detailed performance studies you're asking about. The "study" mentioned here refers to verification and validation activities against recognized standards to ensure the device performs as intended and is safe.

Here's what can be extracted and inferred from the document based on the context of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific performance acceptance criteria (like diagnostic accuracy, sensitivity, specificity) with reported device performance for an AI/ML system. Instead, for this device, "acceptance criteria" are related to compliance with recognized standards and demonstrating substantial equivalence.

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

This document does not describe a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to verification and validation activities conducted on the physical device to ensure compliance with standards and specifications. Therefore, sample sizes and data provenance (country, retrospective/prospective) are not applicable in the AI/ML sense but would refer to engineering test samples and bench testing.

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

Not applicable. This pertains to an AI/ML diagnostic device, not a physical temperature-sensing Foley catheter. The "ground truth" here would be established by reference temperature measurement standards and calibrated equipment during engineering verification.

4. Adjudication method for the test set

Not applicable. As above, this is for AI/ML diagnostic performance testing.

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 device is a physical catheter with a temperature sensor, not an AI/ML system that directly assists human readers/diagnosticians.

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

Not applicable. This device is a physical catheter, not an algorithm. Its "standalone" performance would be measured as part of its physical and electrical testing (e.g., temperature accuracy, material integrity).

7. The type of ground truth used

For the temperature sensing function, the "ground truth" for proving accuracy would be established using calibrated reference thermometers and temperature control baths. For the catheter's physical properties, the ground truth would be established through material specifications, mechanical testing standards, and biological compatibility testing protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors are to be used for drainage of the urinary bladder and monitoring of temperature.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Foley Catheter. It indicates that the device has been found substantially equivalent to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of detailed study information is typically found in the 510(k) submission summary or a separate clinical/performance report, not in the FDA clearance letter itself.

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