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The Disposable Thermometer Probe Sheaths are intended for use as barriers between digital thermometers and users' oral cavities to avoid the possible contamination and infection during temperature measuring. The sheaths are non-sterile and intended for single use only.

The Disposable Thermometer Probe Sheaths are used for oral measurements for digital thermometers. The products and packaging are non-sterile, not made with natural rubber latex, and intended for single patient use only.

The proposed device is a shell-like device, made of PE/EVA, use to cover the oral thermometer as barrier for avoiding possible contamination and infection during measurement of temperature. The device is covered by the paper (Medical Kraft Paper) at the top and bottom which to avoid unnecessary touch with the device before usage and will be removed from the device before use. The outer most packing material is carton box. Each outer packing contains 100 pieces of the device.

Here's a breakdown of the acceptance criteria and study information for the {0} device, based on the provided text:

Device Name: Disposable Thermometer Probe Sheath

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The "Available Dimension" and "Outsider Dimension" are listed as comparative information but not explicitly stated as acceptance criteria with numerical targets in the text beyond simply reporting the device's values.)

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

The document does not explicitly state the sample size used for the test set for its performance evaluations (e.g., strength, accuracy, biocompatibility). It mentions "non clinical tests were conducted," but not the number of units tested.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It implies internal testing by the manufacturer.

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

This information is not applicable. The device is a physical barrier (thermometer probe sheath), and its performance is evaluated against engineering standards and material properties, not through expert interpretation or clinical judgment requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not applicable. As explained above, the testing involves objective measurements against predefined standards rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Disposable Thermometer Probe Sheath is a physical barrier accessory, and its effectiveness is determined by its physical properties and ability to maintain thermometer accuracy, not by human interpretation.

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

Yes, a standalone performance evaluation was done. The non-clinical tests described (strength, accuracy, biocompatibility) are evaluations of the device's inherent properties and performance without human interaction beyond operating test equipment. The device itself does not involve algorithms or AI. The standard tests (ASTM E1104, ASTM E1112, ISO 10993) assess the device's standalone physical and functional characteristics.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of the Disposable Thermometer Probe Sheath is established by internationally recognized engineering and biocompatibility standards. Specifically:

• ASTM E1104-98: Standard Specification for Clinical Thermometer Probe Covers and Sheaths
• ASTM E1112-00: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
• ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

These standards define the acceptable limits and methodologies for testing these types of devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a manufactured medical accessory, not an AI/ML model that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.

This device is a cover for blood pressure cuffs. It is made of soft medical grade paper with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff barrier can reduce the need to clean blood pressure cuffs. In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff barrier has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff barrier has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff barrier is a single use product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff barrier. The blood cuff barrier has a two layer structure. The inner layer that has immediate contact with patient skin is made of soft medical grade paper. The outer layer that has immediate contact underneath the blood pressure cuff is made of cast film of polyethylene. The whole barrier is approximately 20 um thick and is available in various different length and width. The barrier can be secured around the patient arm by two sided adhesive tape with removable liner. The adhesive tape and liner are located at the end of outer layer and do not contact the patient skin.

The provided text is a 510(k) summary for the SAMA Disposable Blood Pressure Cuff Barriers. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and study designs. The document is a regulatory submission demonstrating substantial equivalence, not a scientific paper detailing a comprehensive study with performance metrics in the way your questions suggest.

Here's an attempt to answer the questions based only on the provided text, highlighting what information is missing:

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

The document states: "Bench testing was performed per ISO 10993-1, and internal procedures to ensure that the SAMA Disposable Blood Pressure Cuff Barriers met its specifications. All tests were verified to meet acceptance criteria."

However, it does not explicitly list the acceptance criteria or the specific reported device performance values for each criterion. It only states that the device "met its specifications" and "all tests were verified to meet acceptance criteria."

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

The document states "Bench testing was performed..." but does not specify the sample size used for the test set or the data provenance. It can be inferred that the testing was likely conducted in China, given the manufacturer's location, but this is not explicitly stated for the data provenance. It's a bench test, so concepts like "retrospective or prospective" don't directly apply in the same way they would to a clinical study.

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 provided in the document. Bench testing for a barrier device typically wouldn't involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth would be physical measurements and material properties.

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

This information is not provided. Adjudication methods are typically relevant for human interpretation of data (e.g., medical images), which is not explicitly mentioned as part of the bench testing for this device.

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

There is no indication of an MRMC comparative effectiveness study being performed. This type of study is completely irrelevant to a blood pressure cuff barrier device, which does not involve human "readers" or AI assistance for interpretation.

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

There is no indication that an algorithm-only or AI-related study was performed. This device is a physical barrier, not a software or AI-driven system.

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

For bench testing of a physical device like a barrier, the "ground truth" would be the physical and chemical properties of the materials and the performance of the barrier under specific test conditions (e.g., ability to block contaminants, material strength, biocompatibility). The document mentions "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used." This implies that standards for biocompatibility (e.g., ISO 10993-1) define the "ground truth" for material safety.

8. The sample size for the training set

There is no mention of a training set. This concept is typically associated with machine learning or AI development, which is not applicable to this physical medical device.

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

As there is no mention of a training set, this question is not applicable.

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