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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 the comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperatur management system can be used with adult and pectratr patients.

The Bair Hugger temperature management system consists of:

• · a portable forced-air temperature management unit (200, 500, or 700 series),
• · a disposable Bair Hugger forced-air blanket (various models), and
• · the Model 459 patient cooling set (new disposable component of the system).

The temperature management unit delivers warmed or room-temperature air directly to a Bair Hugger blanket via a flexible hose, or it delivers room-temperature air to the Model 459 patient cooling set, which, when filled with common ice, cools the air before delivering it to a Bair Hugger blanket. Depending on the blanket model used, the blanket is placed around, over, or underneath the patient. Small perforations in the patient-side of the blanket disperse the air over the patient.

The new disposable Model 459 patient cooling set consists of an ice receptacle (flexible plastic bag) with an attached flexible hose assembly. The patient cooling set also has a handle to allow hanging it on an IV pole or similar stand near the temperature management unit.

The ice receptacle has:

• · a hose port that accepts the hose of a Bair Hugger® temperature management unit,
• · a resealable opening for adding and retaining ice,
• · a valve for draining meltwater, and
• · an integral divider that directs the flow of room-temperature air from the temperature management unit through the ice, which cools the air to a temperature ranging between 3.5℃ and room temperature, as required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bair Hugger Model 459 Patient Cooling Set:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.

The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery charger, temperature control unit, warming card, and a clean dressing called a wound cover that supports the warming card and holds it away from the wound and skin.

The wound cover is a disposable, single-patient-use wound dressing. It is comprised of a thin shell, a window, and a foam frame. The shell has an adhesive border to hold the wound cover in place. It is water-resistant and can be easily cleaned. A clear window in the center of the wound cover allows the caregiver to view and assess the wound, and a pocket on top of the window holds the warming card used during warming therapy. The foam frame absorbs wound fluid (exudate), and keeps the pocket above the wound surface so neither the window nor the warming card contact the wound.

The provided document is a 510(k) premarket notification for a medical device called the "Augustine Medical Wound Care System, Model 68XXX". It describes a device that maintains moisture and body temperature in wound beds. However, the document explicitly states that "No additional testing was performed" for this specific 510(k) submission (K020077) because it's a "Special 510(k) Modified Device" and "does not differ in design, technology, materials, or size relative to the cleared device, nor its intended use" (page 5).

Therefore, this document does not contain information about acceptance criteria or a study proving that this specific modified device meets acceptance criteria. It refers to a previously cleared device (Augustine Medical Wound Cover, Model 68XXX, K963293) as its equivalent marketed device. To answer your questions, one would need to access the documentation for K963293.

Based solely on the provided text for K020077, I cannot complete the table or answer most of your detailed questions regarding acceptance criteria and a study that proves the device meets those criteria.

However, I can provide limited information based on the explicitly stated lack of new testing:

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

• Acceptance Criteria: Not specified in this document for K020077.
• Reported Device Performance: Not reported in this document for K020077 as no new testing was performed.

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

• Not applicable for K020077, as no new test set was used. The document states "No additional testing was performed".

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 K020077, as no new test set was used and thus no new ground truth was established by experts for this submission.

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

• Not applicable for K020077, as no new test set was used.

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

• No MRMC study was done for K020077. This device is a wound dressing system, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

• Not applicable. This is a physical wound care system, not an algorithm.

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

• Not specified for K020077, as no new testing was performed. For the predicate device, it would likely involve clinical outcomes, efficacy in maintaining moisture and temperature, and safety data.

8. The sample size for the training set

• Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm that requires a training set.

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

• Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm.

In summary, the provided K020077 document is a "Special 510(k) Modified Device" submission, indicating that the device is substantially equivalent to a previously cleared device (K963293) and no new performance testing was conducted for this specific submission.

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The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

The Bair Hugger Blood/Fluid Warmer consists of a warming device and a disposable set. The warming device is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 500 ml/min. The Bair Hugger Blood/Fluid Warmer can deliver temperatures as high as and including 42°C, (temperatures in accordance with the American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services). Two types of sterile disposable sets are available. The disposables are composed of the same materials used in the predicate devices. The fluid warming bag, attached to the disposable set, is placed inside the warming device and contacts heated aluminum plates. Blood, blood products, and liquids pass through the warming bag and are heated as they flow through. The warming device controls the temperature of the aluminum plates, which are heated by means of electrical resistance. The device meets the requirements of UL 2601, IEC 601-1, and EN 60601.

Here's a breakdown of the acceptance criteria and study information for the Bair Hugger Blood/Fluid Warmer, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally doesn't include the detailed, extensive clinical utility studies often seen for novel devices. The "studies" mentioned here are likely bench tests and comparisons directly related to the safety and fundamental function for achieving substantial equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes nonclinical studies rather than extensive clinical trials for efficacy.

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

   • Sample Size: Not explicitly stated. The studies evaluated "percent hemolysis" during "flow and stop flow conditions." This suggests controlled laboratory experiments, not patient data.
   • Data Provenance: Not specified, but given the nature of the device (blood/fluid warmer), these would be in-vitro laboratory tests using blood samples, not human patient data from a specific country.

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

   • Not applicable. The studies mentioned (hemolysis evaluation) involve objective measurements of a physical/biological property (hemolysis percentage) rather than subjective expert interpretation for establishing a "ground truth" in the way it's used for diagnostic imaging or clinical assessment. The "ground truth" here would be the measured hemolysis itself.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments (like medical image interpretation) where multiple experts might disagree. These studies involve direct physical/chemical measurements.

4. 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 medical warming device, not an AI diagnostic tool or an imaging system. Therefore, MRMC studies are not relevant.

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

   • Not applicable. The device itself is a standalone warming unit that performs its function without a human "in the loop" in terms of continuous algorithmic decision-making. The "study" focused on its performance characteristics directly.

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

   • Objective Measurement/Biochemical Analysis: The ground truth for the hemolysis study would be the measured percentage of hemolysis in the blood samples, determined through standard laboratory techniques.

7. The sample size for the training set:

   • Not applicable in the context of this device and the described studies. The studies are evaluating the physical performance and biological effects of the warming device itself, not training an algorithm.

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

   • Not applicable, as there is no training set for an algorithm.

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The Bair Hugger® Model 630 Cardiac Blanket is intended to be used to warm adult patients during cardiac surgery.

The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System® - Modification. The Model 630 Cardiac Blanket is constructed of the same materials as the Model 525 Blanket and other blankets currently on the market.

This document describes the safety and effectiveness of the Bair Hugger® Total Temperature Management System® - Modification (Model 630 Cardiac Blanket) for warming adult patients during cardiac surgery. The submission is a 510(k) premarket notification, comparing the device to a predicate device, the Bair Hugger Patient Warming System, Model 525 Blanket (K903360).

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 explicitly state a separate "test set" in the context of a typical AI/algorithm evaluation. The evidence provided is primarily based on performance testing of the device's heating capabilities and existing studies on the predicate device's contamination prevention.

• For Thermal Safety: "Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C." The sample size for this performance testing is not specified, nor is the specific provenance, though it would be internal company testing.
• For Contamination Prevention: Two studies are cited as evidence: Hall, A. (1991) and Zink, RS. (1992 & 1993). The document states these studies "concluded that the Bair Hugger 500 Series Units... do not increase the incidence of microbial or wound contamination." The sample sizes and specific provenance (e.g., country of origin, retrospective/prospective) for these studies are not detailed within this 510(k) summary, referring to bibliography entries for full details.

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

This information is not applicable as the document does not describe the use of experts to establish a "ground truth" for a test set in the way this question implies (e.g., for image analysis or diagnostic accuracy). The safety and effectiveness claims are based on direct physical measurements and references to medical literature and prior studies. The "ground truth" for thermal safety is based on established scientific principles regarding burn thresholds and temperature measurements.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication process as would be typical for expert-reviewed data in AI studies.

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 document pertains to a physical medical device (patient warming system), not an AI algorithm, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

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

Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that its heating and safety mechanisms operate independently of human "intervention" in their core function, but it is always used with human-in-the-loop clinical monitoring and application.

7. The type of ground truth used

The "ground truth" for safety is based on:

• Established scientific understanding of thermal injury (per citations 1 & 2: Moritz AR, Henriques FC, and Stoll AM, Green LC).
• Direct temperature measurement through performance testing.
• Engineering design (thermostats for overtemperature detection).
• Clinical protocols for patient monitoring (instructions for use to prevent hyperthermia and systemic complications).

The "ground truth" for effectiveness is based on:

• Direct temperature measurement comparing the new model (630 Cardiac Blanket) to the predicate model (525 Blanket).
• Biological studies on microbial contamination (per citations 4 & 5: Hall, A. and Zink, RS).

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no concept of a "training set."

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

Not applicable, as there is no training set for an AI algorithm described here.

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The Augustine Medical Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.

The wound care system is comprised of a power supply/battery charger, heater control unit, heater card, and a sterile dressing/bandage called a Wound Cover which supports the heater card and holds it away from the wound and skin.

The Wound Cover is a disposable, single-use, sterile, non wound-contact dressing. The Wound Cover may be used either as a stand-alone wound dressing or as part of the Augustine Medical Wound Care System. The Wound Cover incorporates a clear or opaque window. The clear window allows the caregiver to view and assess the tissue. The Wound Cover surrounds and protects the wound, absorbs wound exudate and allows active warming of the periwound area by the application of radiant heat.

The warming components of the system include a thin heater card, a control unit, and a power supply/battery charger. The system operates on standard wall outlet electricity or the self-contained batteries. The heater card is sized appropriately to the Wound Cover and attaches easily over the clear window of the Wound Cover. The heater card does not contact the wound and is intended for single patient use. The control unit incorporates temperature safety limits.

Below is an analysis of the provided text regarding the Augustine Medical Wound Care System, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the device being "substantially equivalent" to predicate devices, rather than meeting specific numerical performance criteria in the way a diagnostic device might. The core acceptance criteria revolve around safety and effectiveness comparable to existing devices for the same intended use.

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

The document mentions several clinical studies were conducted:

• Number of Studies: Seven studies (completed or in progress) involving different wound types. (page 15)
• Sample Size for Test Set: Specific sample sizes for each study are not provided. The text only gives median percentage reduction values.
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the studies were likely conducted within the United States, given the context of FDA submission by a US-based company. The data is retrospective in the sense that results were submitted after the studies were, at least partially, completed to address FDA's request for additional information. It's not a prospective, pre-planned IDE study, but rather data gathered from existing or ongoing clinical work.

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

The document does not specify the number or qualifications of experts who established the "ground truth" for the clinical studies. The data presented are wound healing rates (median percentage reduction in wound area per day), which would typically be measured objectively (e.g., planimetry, digital imaging) rather than relying on expert consensus for each individual wound. The "ground truth" here is the measured healing rate itself. The "experts" would be the investigators running the studies.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the data collected in the clinical studies.

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 device, the Augustine Medical Wound Care System, is a wound care treatment system (physical device with heating capability and wound cover) and not an AI/Software as a Medical Device (SaMD) that typically undergoes MRMC studies involving human readers and AI assistance for interpretation. Therefore, no such study was performed or is relevant in this context.

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

Again, this is a physical medical device, not an algorithm or AI. Standalone performance as typically described for AI/SaMD devices is not applicable. The device's performance is inherently linked to its physical application and interaction with the wound and human users (healthcare professionals).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The ground truth for evaluating the device's effectiveness appears to be primarily outcomes data, specifically:

• Wound Healing Rates: "median percentage reduction of the wound area per day" (page 15).
• Absence of Adverse Effects: "no reports of any adverse effects or extended healing times" (page 15).
• Biocompatibility Test Results: "All materials passed biocompatibility testing" (page 20).
• Physical Test Results: "All testing of the product yielded acceptable results" (page 20).

8. The Sample Size for the Training Set

The concept of a "training set" is fundamentally tied to machine learning algorithms. Since the Augustine Medical Wound Care System is a physical medical device, there is no "training set" in the context of an AI algorithm. Its development would have involved engineering design, material selection, and iterative physical testing/prototyping, not data-driven model training.

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

As explained above, there is no algorithm or "training set" for this physical device. The "ground truth" for its development would be engineering specifications, material properties, and the intended physiological effects, established through standard biomedical engineering and clinical research practices.

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The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification.

This looks like a 510(k) summary for a medical device (a rolling stand for a patient warming system), not an AI/ML powered device. The questions you've asked (acceptance criteria, study details, ground truth, MRMC studies, etc.) are highly relevant to the evaluation of AI/ML diagnostic devices, but they don't apply to a physical device like a rolling stand.

Therefore, I cannot provide the requested information because the provided text describes a physical medical device (a rolling stand) and not an AI/ML powered diagnostic device that would have a "reported device performance" against specific "acceptance criteria" through a "study" involving "ground truth," "experts," or "training sets."

The document focuses on the safety and effectiveness of the rolling stand in terms of physical stability and proper usage with its intended warming unit, not on diagnostic accuracy based on an algorithm.

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The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit.

This is a 510(k) premarket notification for a medical device (Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit), not a study describing the validation of an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for an AI device is not available in the provided text.

The document discusses the safety and effectiveness of a patient warming system, comparing it to a predicate device (Model 500). It highlights safety concerns (tissue injury, hyperthermia, contamination) and the preventive measures implemented in the device. The "effectiveness" section only states that the Model 505 delivers air temperatures within the same specifications as the Model 500.

To answer your request, I would need a document related to the validation of an AI/ML medical device.

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