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The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.

The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket.

The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only.

The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room.

The provided text describes the regulatory clearance for the Cocoon Convective Warming System, Model CWS7000. It includes a summary of nonclinical testing but explicitly states that clinical testing is not applicable. Therefore, I can provide information based on the nonclinical testing, but there is no study described that proves the device meets acceptance criteria through clinical performance.

Here's an analysis based on the provided text, focusing on what's available and noting what is not applicable:

Acceptance Criteria and Reported Device Performance (Nonclinical)

The acceptance criteria for the Cocoon Convective Warming System, Model CWS7000 are based on compliance with various international standards for medical electrical equipment, electromagnetic compatibility, software life cycle processes, heating devices, biological evaluation, and risk management. The reported performance is simply "Pass" or "Meets requirements" for each of these standards.

Study Details (for nonclinical testing as clinical testing was not applicable)

• Sample size used for the test set and the data provenance: Not specified in terms of patient data, as clinical testing was deemed not applicable. The sample size for nonclinical engineering and safety tests would refer to the number of units or components tested, which is not detailed but assumed to be sufficient for compliance with the listed standards. Data provenance is not applicable as it's not a study involving human or animal data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For nonclinical standards compliance, "ground truth" is established by the specifications and requirements of the standards themselves. The testing would be conducted by qualified engineers and technicians.
• Adjudication method for the test set: Not applicable for nonclinical standards testing. Compliance is determined by whether the device meets the specified parameters and requirements of each standard.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating observer performance with medical images or clinical judgment, which is not relevant to a convective warming system.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided information refers to the device itself (hardware and embedded software), not a standalone algorithm. The device's performance was evaluated independently against the standards.
• The type of ground truth used: For this device, the "ground truth" for demonstrating performance is derived from the requirements and specifications of the referenced international technical and safety standards (e.g., IEC 60601-1, IEC 60601-2-35, ISO 10993-1). These standards define acceptable levels for electrical safety, electromagnetic compatibility, temperature control accuracy, biocompatibility, and risk management.
• The sample size for the training set: Not applicable, as this is not an AI/ML-based device that undergoes a training phase with a dataset.
• How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

In summary, the provided document focuses on the regulatory clearance of a medical device based on its compliance with established nonclinical safety and performance standards, rather than clinical efficacy studies or AI performance metrics.

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CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273ºF / 134ºC for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.

CareGUARD* Sterilization Wrap is made from 100% polypropylene spunbond-meltblownspunbond (SMS) non-woven fabric. The sterilization wrap is provided in three different material basis weights of three product offerings in various dimensions. CareGUARD* Single Layer Sterilization wrap is comprised of a single sheet or one layer of SMS fabric. CareGUARD* Dual Layers Sterilization Wrap and CareGUARD* Contrast Sterilization Wrap, are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing edges. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All basis weights utilize the same material technology. This product is a single-use and a non-sterile medical device.

CareGUARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using pre-vacuum steam at 273°F/134°C for 4 minutes.

The "CareGUARD* Sterilization Wrap" device, which is a single-use, non-woven sterilization wrap, has undergone non-clinical testing to demonstrate its performance and substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state the exact sample sizes for each test in the test set. However, it indicates:

• For the Pre-vacuum steam Sterility Maintenance Study, the load used was: "50 GSM: 21 in. x 10 in. x 4 ¾ in. (54 cm x 25 cm x 12 cm) tray containing 13.7 lbs (6.2 kg) of metal mass. The metal mass included surgical instruments used for orthopedic joint replacement." This describes the type of load rather than a numerical sample size.
• The studies are non-clinical (laboratory-based performance tests), not clinical trials involving human subjects or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective does not apply in the same way it would for clinical studies. The standards referenced (e.g., ISO, EN, ASTM, AS/NZS, ANSI/AAMI) suggest international standardization of testing methodologies.

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

This information is not applicable. For non-clinical performance and material characteristic tests like those conducted for a sterilization wrap, "ground truth" is established by adherence to recognized international and national standards and validated testing protocols, not by expert consensus on observational data.

4. Adjudication method for the test set:

This information is not applicable. Non-clinical performance tests follow predefined analytical methods and acceptance criteria from standards, rather than requiring adjudication of subjective observations by experts. The results are quantitative measurements or qualitative pass/fail outcomes against objective criteria.

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. The device is a physical sterilization wrap, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is established by:

• Compliance with recognized international and national standards: Such as ISO 11607-1, EN 868-2, ISO 10993 series, ASTM F2101-14, AS/NZS 4187:2014, ANSI/AAMI/ST8:2013, ANSI/AAMI ST79:2017, and EN 285:2015+A1:2021.
• Scientifically validated test methods and predefined acceptance criteria: These standards outline specific methodologies and thresholds for determining performance characteristics like physical properties, chemical properties, biocompatibility, bacterial filtration efficiency, sterilization validation, sterilant penetration, dry time, and maintenance of sterility.

8. The sample size for the training set:

This information is not applicable. The CareGUARD* Sterilization Wrap is a physical product, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above; there is no AI training set for this device.

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

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for the "Cocoon Convective Warming System." It confirms the device's substantial equivalence to a legally marketed predicate device and outlines general regulatory information.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI/device. These details are typically found in the clinical study report or performance testing documentation, which is not part of this 510(k) clearance letter.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

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The Cocoon Convective Warming 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 Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.

The Cocoon Convective Warming system incorporates the Convective Warming Machine CWS4000, and the Cocoon Disposable Patient Warming Blankets. The Convective Warming Machine is a mains-powered, microprocessor-controlled device that delivers a continuous flow of temperature-controlled air through a flexible hose to the warming blanket. The temperature of the air delivered to the blanket can be set to one of six settings: Ambient, 34℃, 37℃, 40℃, 43ºC, or 46ºC. When a temperature of 46ºC is selected, the setting automatically drops to 43ºC after 10 minutes.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document describes a 510(k) summary for the Cocoon Convective Warming System, outlining its characteristics, intended use, and substantial equivalence to predicate devices.

Specifically, it states: "Care Essentials Pty Ltd did not conduct a clinical study as defined in the guidance for Industry Financial Disclosures by Clinical Investigators to determine substantial equivalence. Care Essentials Pty Ltd conducted performance testing with satisfactory results." This indicates that no human clinical study was performed to establish performance against acceptance criteria.

The non-clinical testing section mentions validation against "the company's specified design requirements" and conformance with voluntary standards (ANSI/AAMI/ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971). However, it does not provide specific acceptance criteria values or the results of these performance tests in a format that would allow for the table requested.

Therefore, I cannot provide the requested information.

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