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All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.

The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.

The provided text is a 510(k) summary for a medical device called "All Silicone Foley Catheter with Temperature Sensor." It discusses the device's intended use, description, and comparison to a predicate device, focusing on its MR compatibility. However, the document does not contain information regarding acceptance criteria and a study proving that the device meets these criteria in the context of AI/ML performance.

The document is a regulatory submission for a physical medical device (catheter) and the "testing" mentioned refers to bench-top non-clinical testing for MR compatibility of the physical device, not performance benchmarks for an AI/ML algorithm.

Therefore, I cannot extract the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance (for an AI/ML system).
2. Sample size used for an AI/ML test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for AI/ML.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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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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The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Not Found

Please note that the provided document is a 510(k) clearance letter from the FDA for a medical device (a Foley catheter with a temperature sensor). This type of document does not contain the detailed study information, acceptance criteria, or performance metrics that would be generated by a clinical or performance study.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria. Therefore, most of the requested information regarding study details, ground truth, and sample sizes will not be present in this document.

However, I can extract the following relevant information and explain why other requested details are not available:

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

This document does not specify quantitative acceptance criteria or detailed reported device performance in this format. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same design, materials, and intended use, and performs as safely and effectively as the predicate. Performance data, if submitted, would be intended to support this equivalence, not necessarily to meet pre-defined, publicly disclosed acceptance criteria in the manner one might find for a novel drug or a high-risk device requiring a PMA.

The closest to "performance" mentioned is in the "Indications for Use" section (Page 3), which states: "The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals." This is a statement of intended function, not a quantitative performance metric.

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 available in the provided document. The 510(k) clearance letter itself does not include details about specific test set sample sizes or data provenance. Such information would be part of the predicate device's historical data or a new device's performance testing reports, which are part of the full 510(k) submission, but not typically summarized in the clearance letter.

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 applicable and therefore not available in the provided document. This device is a physical medical device (Foley catheter with temperature sensor), not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. Its performance relies on physical specifications, material compatibility, and temperature sensing accuracy, not on interpretations of complex data by experts.

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

This information is not applicable and therefore not available. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often in diagnostic imaging or clinical trials where multiple experts assess the same cases. This is not relevant for a physical device like a Foley catheter.

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 and therefore not available. An MRMC study is relevant for diagnostic performance, particularly with AI assistance, where different readers analyze cases. This device is a physical catheter, not an AI diagnostic tool.

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

This information is not applicable and therefore not available. A "standalone algorithm" is not relevant for a physical medical device like a Foley catheter.

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

Again, the concept of "ground truth" as it applies to AI diagnostics or complex clinical endpoints is not directly applicable to this device in the context of this 510(k) letter. For a Foley catheter with a temperature sensor, "ground truth" would be related to:

• Physical measurements: Accuracy of the temperature sensor against a calibrated standard.
• Biocompatibility: In vitro and in vivo testing for material safety.
• Mechanical integrity: Tensile strength, balloon inflation/deflation, tip integrity, etc.
• Sterility: Confirmation of sterility.
  These types of "ground truth" are established through engineering testing, laboratory standards, and biocompatibility assessments, not typically through expert consensus on clinical cases or pathology. The document does not detail these specific test methods or their "ground truth" establishment.

8. The sample size for the training set

This information is not available in the provided document and likely not applicable in the context of this device. Training sets are relevant for machine learning algorithms. This device is a conventional medical device, not an AI/ML product.

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

This information is not applicable and therefore not available, for the same reasons as point 8.

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