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The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function. The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover. While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance."

This 510(k) summary (K083135) describes a modification to the ChillBuster® Model 8002 Portable Electric Blanket, specifically regarding the labeling for when to use sterile versus non-sterile blanket covers. It is not a study demonstrating device performance against specific acceptance criteria. Instead, it is a statement affirming that the modified device is substantially equivalent to its predicate device and that the change is a labeling update, not a change requiring new performance data.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this submission explicitly states no performance data was required for this particular change.

Here's why each point is not applicable based on the provided document:

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

Not Applicable. The document explicitly states: "Clearance of the subject of this submittal, requirements of when to use a sterile or non-sterile blanket cover, does not require performance data. The two cover types are the same in every way, save the state of sterility." Since no performance data was collected or required, there are no acceptance criteria or reported device performance for this specific modification.

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. No performance testing was conducted for this specific labeling modification, so there is no test set or associated data provenance.

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. As no performance testing was performed, there was no need for experts to establish ground truth for a test set. The change is related to the decision of a medical practitioner (implied expert in clinical practice) regarding sterility, not a diagnostic or therapeutic performance evaluation.

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

Not Applicable. No performance testing was performed, so no adjudication method was used for a test set.

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 portable electric blanket, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI is irrelevant and was not conducted.

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

Not Applicable. This is a hardware device (electric blanket) and not an algorithm. Standalone algorithm performance is not relevant to this submission.

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

Not Applicable. No performance testing was performed, so no ground truth was established for the purpose of evaluating the modified device's performance. The "ground truth" for the submission is the regulatory and clinical understanding that practitioners can determine when a sterile vs. non-sterile cover is needed.

8. The sample size for the training set

Not Applicable. This device uses a predicate device model; it doesn't involve machine learning or AI that would require a training set.

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

Not Applicable. As there is no training set, there is no ground truth to establish for it.

In summary, the provided document describes a regulatory submission for a labeling change to a medical device, not a study evaluating its performance against specific technical criteria. The core argument is that the change itself (allowing practitioner discretion for blanket cover sterility) does not impact safety or effectiveness and therefore does not require new performance data.

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The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

The ChillBuster® Model 8002 Portable Electric Blanket System features a special electrical resistively heated Blanket, a Controller to manage power and device function, a rechargeable Battery, special cabling, and means to connect to external DC or AC power for recharging the Battery and, at the option of the user, operating the Blanket. During therapy, the Blanket is encased in a Sterile, Single-Use Blanket Cover to prevent cross-contamination of successive patients and to prevent soiling. The device can perform therapy at virtually any interval in the following activities or activity chains: a) initial patient preparation and transport in the field, and at any stage of ER, surgery, and ICU or post-op care for injury victims from the field; b) pre-op, surgery, ICU or post-op care of in-facility patients; and c) special situations involving potential or actual hypothermia (e.g. hemodialysis; peritoneal dialysis; plasmapheresis; patient warming during transport from point to point, etc.).

This is a 510(k) summary for a portable electric blanket, not an AI device. As such, the requested information regarding AI device acceptance criteria, study details, ground truth, and expert involvement is not applicable or available in the provided text.

Here's an overview of the non-clinical performance data provided, which serves as the acceptance criteria for this non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size:
  • Washing/Drying: 1 blanket (subjected to 50 cycles).
  • Heating Performance: 1 blanket (tested across 5 sessions).
  • Submersion: 1 blanket.
• Data Provenance: Not explicitly stated, but the tests were conducted as non-clinical performance data studies, likely by the manufacturer. No country of origin for "data" in the context of patient data is relevant here, as this is a physical device testing. The studies are prospective in nature, as they involve actively testing the new device.

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 medical device (electric blanket) undergoing engineering and safety testing against established standards, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the pass/fail criteria of the tests and compliance with regulatory standards.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks in AI studies. For this device, performance is evaluated against predefined engineering standards and test protocols.

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 device, and therefore, no MRMC study involving human readers and AI assistance was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" refers to the device's functional and safety performance as described in point 1 above.

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

• The "ground truth" for this device's performance is established by international and national consensus standards for medical device safety and performance (e.g., IEC/EN 60601-1, IEC 60601-2-35, ISO 14971, CAN/CSA C22.2 No. 601.1-M90) and the physical attributes and intended function of the device. For example, the maximum temperature cutoff of 41 ± 1℃ is a safety standard specified in IEC 60601-2-35.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no "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, no ground truth needed to be established for it.

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ChillBuster™ Portable Electric Blanket is to be used to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.

The ChillBuster™ Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Cabling, Battery, AC adapter, Carrying Bag.

This document appears to be a 510(k) Pre-market Notification Summary for a medical device called the "ChillBuster™ Portable Electric Blanket." It primarily serves to establish substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a study demonstrating performance against specific acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of submission.

Here's the breakdown based on the provided text, indicating where information is present versus where it's absent or not relevant for this document type:

Acceptance Criteria and Device Performance Study Details (K022903)

This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a performance study with explicit acceptance criteria. The "acceptance criteria" here implicitly refer to meeting the requirements of the standards listed and performing equivalently to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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 / Not provided. This document does not detail a specific performance study with a test set of data points or patients. The testing referenced is related to compliance with electrical and safety standards for the device itself, not a clinical data set.

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 / Not provided. No ground truth establishment for a test set is discussed in this 510(k) summary.

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

• Not applicable / Not provided. No test set or related adjudication method is mentioned.

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 portable electric blanket, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• Not applicable / Not provided. No ground truth for a performance study is mentioned. The "ground truth" for this submission is implicitly the established safety and performance benchmarks of the predicate devices and the requirements of the cited industry standards.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/algorithm device, so there is no training set in the typical sense.

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

• Not applicable / Not provided. (See #8).

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The ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.

The ChillBuster® Model 8001 Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Battery, Cabling, AC Adapter, and Carrying Bag. The Blanket features a waterproof nylon outer layer, an inner layer of soft polar fleece, and a unique pattern of special thermal wire and a wire-adjacent thermistor. The Control Module contains an electronic circuit board, a User Interface Panel, Interconnect Wiring, and a Molded Chassis with a compartment for the Battery. The System uses a sealed lead acid, rechargeable Battery. Cabling includes a standard Blanket Interconnect Cable and an optional cable for connection to a vehicle cigarette lighter socket. All Systems include a standard AC-to-DC Adapter. The Carrying Bag conveys no impact on system safety.

The provided text does not contain acceptance criteria or study details for a medical device in the context of the requested information (AI/algorithm performance, ground truth, expert review, MRMC studies, etc.).

Instead, the document is a 510(k) summary for a "ChillBuster® Model 8001 Portable Electric Blanket System," which is a physical medical device, not a software algorithm or AI-based system.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about AI/algorithm performance. The non-clinical performance data section describes tests conducted on the physical electric blanket, focusing on safety standards (IEC, UL), general operation, warming performance, and comparison to a predicate device in terms of heat output and distribution.

To directly address your request given the provided input:

1. Table of acceptance criteria and reported device performance:
The document does not explicitly state "acceptance criteria" for an algorithm. It describes safety standards and functional verification for a physical electric blanket, and "product specifications" were met.

2. Sample size used for the test set and the data provenance: Not applicable for an AI/Algorithm test set. For the physical device, informal tests involved ">50 individuals" (independent subjects). The formal tests were conducted by Northwest EMC, Inc., an independent commercial firm. The data provenance is primarily from independent testing by Northwest EMC, Inc. and informal testing by ThermoGear™ in the US (Tigard, OR).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/algorithm is not discussed. For the physical device, compliance with standards and functional performance was assessed by an independent testing firm and informal user feedback.

4. Adjudication method for the test set: Not applicable.

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 describes a physical electric blanket, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable for an AI/algorithm. For the physical device, "ground truth" was based on adherence to recognized safety and EMC standards (IEC 601-1, UL 2601-1, IEC 601-1-2) and the observed functional characteristics during testing (e.g., heat generation, battery life, washing performance).

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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