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Measure, monitor, and trend body temperature of adult and pediatric patients.

The 3M™ SpotOn™ temperature monitoring system consists of a disposable sensor, a control unit, a power supply cord, and an optional interface cable that allows temperature data to be transmitted to a standard YSI-400 input on a vital signs monitor.

Here's an analysis of the provided text regarding the 3M™ SpotOn™ temperature monitoring system, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the device's performance in terms of accuracy (e.g., a specific delta or range). Instead, it relies on a comparison to established standards and the substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "method comparison trial design" and "mean bias observed in any subgroup," which implies a cohort of patients was included, but the specific number is omitted.
• Data Provenance: The document does not specify the country of origin for the clinical trial data. It does state that the clinical tests were a "method comparison trial design," which generally implies prospective data collection, but this is not explicitly confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not mention the involvement of experts for establishing ground truth in the clinical study. The reference temperature was obtained using "a standard clinical thermometer" at "either oral or rectal sites."

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Ground truth was established by direct measurement with standard clinical thermometers, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not performed. The study described is a method comparison trial for device performance against traditional thermometers, not an evaluation of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the clinical "method comparison trial" evaluates the standalone performance of the 3M™ SpotOn™ system against reference thermometers. The device's output (temperature measurement) is directly compared to the reference measurement. There is no human interpretation of the device's output mentioned as part of this performance evaluation.

7. The Type of Ground Truth Used

• The ground truth used was direct measurement from standard clinical thermometers at either oral or rectal sites. This is a form of reference standard measurement.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. The 3M™ SpotOn™ temperature monitoring system is an electronic thermometer, not a machine learning or AI-based device that would typically have a "training set" in the context of algorithm development. Its function is based on direct-connection, zero-heat-flux thermometry.

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

• Not applicable/Not mentioned, as there is no indication of a training set for an AI/ML algorithm.

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The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

The Ranger Rapid Flow blood/fluid warming system is a stand-alone system that warms fluid, detects fluid level within the bubble trap, controls a patient valve, and delivers high volumes of fluid under pressure. The warming system consists of warming plates, fluid detection, valve control, pressure infusors and a fluid warming disposable set.

The provided text describes a 510(k) premarket notification for the "Ranger Rapid Flow Blood/Fluid Warming System." This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for a new AI/diagnostic device.

Therefore, many of the requested categories (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The document emphasizes that clinical tests were not necessary for the Ranger Rapid Flow blood/fluid warming system to demonstrate substantial equivalence, which further confirms the absence of the specific types of studies you've inquired about.

Here's an attempt to fill in what information is available, and explicitly state what is not applicable or not provided:

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

The document does not specify "acceptance criteria" in the typical sense of a diagnostic device's performance metrics (e.g., sensitivity, specificity). Instead, the comparison is based on technological characteristics and intended use to demonstrate substantial equivalence to predicate devices. The table provided compares features of the new device to two predicate devices.

The general "acceptance criterion" for this 510(k) submission is that the device demonstrates substantial equivalence to existing legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The conclusion states: "The Ranger Rapid Flow blood/fluid warming system has similar technological characteristics, components, and materials, and the same intended use as devices currently on the market. Therefore, because of the similarities to the predicate devices, Arizant Healthcare this new device does not raise any new safety or effectiveness issues."

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

Not applicable. The document explicitly states: "Clinical tests were not necessary regarding the use of the Ranger Rapid Flow blood/fluid warming system." This implies no formal clinical test set or data was used in the context of human patient data for this submission. The comparison is based on engineering specifications and intended use.

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)

Not applicable. No ground truth establishment by experts for a test set is described, as clinical testing was deemed unnecessary.

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

Not applicable. No clinical test set and thus no adjudication method is 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

Not applicable. This device is a blood/fluid warming system, not an AI or diagnostic imaging device. An MRMC study is irrelevant for this product type.

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

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation.

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

Not applicable. No ground truth in this context was established or used, as no clinical studies with human data were performed for this submission. The "truth" for this submission is based on the functional specifications and performance characteristics of the device being sufficiently similar to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a training set.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

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The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

The Ranger Irrigation Fluid Warming System consists of a warming device and an irrigation fluid warming disposable set. The warming device consists of the electronic control circuitry and aluminum plates contacted by heating elements. The irrigation disposable sets are an integral component of the total fluid warming system. One standard irrigation fluid warming disposable set is available. The irrigation sets include a warming cassette (heat exchanger), tubing, connectors, flow chamber with float, and clamps. The warming cassette fits inside a slot in the warming device; liquids are warmed as they pass through it.

This document pertains to the Ranger Irrigation Fluid Warming System, a device intended to warm irrigation fluids. However, the provided text does not contain acceptance criteria or detailed descriptions of specific studies designed to prove device performance against such criteria.

The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics through detailed studies. Therefore, I cannot provide the requested table of acceptance criteria, device performance, sample sizes, ground truth information, or details about MRMC or standalone studies.

The text primarily includes:

• Device Name: Ranger Irrigation Fluid Warming System
• Intended Use: To warm irrigation fluids.
• Regulatory Information: Class II device, regulation number, product code.
• Predicate Devices: Bair Hugger Blood/Fluid Warmer (K973741), Bair Hugger Patient Warming System (K933726), Smiths Level 1 IR-600 Normothermic Irrigating Set (K873435).
• Comparison of Technological Characteristics: A table comparing features like flow rates, method of operation, electronics, temperature control, and alarms between the Ranger system and its predicate devices.
• Conclusion: States that the Ranger system has similar technological characteristics, components, materials, and intended use as predicate devices, and therefore does not raise new safety or effectiveness issues.
• Discussion of Nonclinical Studies and Clinical Tests: Explicitly states "Not applicable."

In summary, the provided document focuses on demonstrating substantial equivalence to existing devices rather than presenting data from studies proving performance against pre-defined acceptance criteria.

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The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.

The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.

The provided document (K060865) is a Special 510(k) Modified Product Labeling submission for the Bair Paws® Temperature Management System. This type of submission is a declaration of substantial equivalence to a legally marketed predicate device rather than a study proving new performance claims or meeting specific acceptance criteria for a novel device.

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance based on a study of the Bair Paws® system. Instead, it provides a comparison of technological characteristics to a predicate device.
• Sample sizes for test sets, data provenance, or details of a study methodology.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
• Standalone (algorithm only) performance studies.
• Types of ground truth used in a study.
• Sample size for training sets or how ground truth for training sets was established.

Instead, the document focuses on demonstrating substantial equivalence to the Bair Hugger® Temperature Management System (K053645) by comparing their technological characteristics.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance
This document provides a comparison of technological characteristics between the Bair Paws® Temperature Management System and its predicate device, the Bair Hugger® Temperature Management System (K053645). It does not present specific acceptance criteria or performance data for the Bair Paws® system from a study. The implication is that since the Bair Paws® system is substantially equivalent to the predicate, it meets the existing performance expectations of that predicate.

2. Sample size used for the test set and the data provenance: Not applicable. This document is a 510(k) equivalency submission, not a study report. No test set or data provenance is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is not part of this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is 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: Not applicable. This is not an AI-enabled device and no MRMC study information is provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device and no standalone performance study information is provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This document does not describe a study involving ground truth. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for a training set is mentioned.

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The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.

The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.

This document K053645 is a Special 510(k) for modified product labeling of the Bair Hugger family of Temperature Management Systems. It states that the "Technological characteristics of the cleared devices do not change with this modification to product labeling." This type of submission, concerning only labeling changes and explicitly stating no change in technological characteristics, typically does not involve new performance studies or acceptance criteria beyond ensuring the new labeling accurately reflects the existing, cleared device. Therefore, the information requested in the prompt regarding acceptance criteria and performance studies is not present in this document.

To answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in this Special 510(k) submission, as it relates to a labeling modification, not a new device or significant performance change study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission.
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): Not applicable for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.
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. The device is a thermal regulating system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a thermal regulating system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this type of submission.
8. The sample size for the training set: Not applicable for this type of submission.
9. How the ground truth for the training set was established: Not applicable for this type of submission.

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The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.

The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).

This document is a 510(k) summary for a modified product labeling for the Bair Hugger Temperature Management System. It primarily focuses on regulatory approval based on substantial equivalence to previously cleared devices.

Therefore, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "The technological characteristics of the cleared devices do not change with this modification to product labeling." This indicates that no new performance studies were conducted or required, as the device's technical specifications and function remain the same. The submission is for modifying the product labeling, not for a new or significantly modified device requiring new performance evaluations.

As a result, I cannot provide the requested information from the given text.

To address your request, if this were a document detailing a new device or significant modification requiring performance studies, I would look for sections describing:

1. Performance data/clinical data: This would typically include tables of results, statistical analyses, and comparisons to established benchmarks or predicate devices.
2. Test methods: Descriptions of how the device was tested.
3. Ground truth establishment: How the "correct" answers or outcomes were determined for the study.
4. Sample sizes: The number of subjects or cases included in the study.
5. Expert qualifications and adjudication: If human evaluation was part of the ground truth or study design.

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