(58 days)
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.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).